Lacosamide UCB

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 50 mg film-coated tablets 
Lacosamide UCB 100 mg film-coated tablets 
Lacosamide UCB 150 mg film-coated tablets 
Lacosamide UCB 200 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Lacosamide UCB 50 mg film-coated tablets 
 
Each film-coated tablet contains 50 mg lacosamide. 
 
Lacosamide UCB 100 mg film-coated tablets 
 
Each film-coated tablet contains 100 mg lacosamide. 
 
Lacosamide UCB 150 mg film-coated tablets 
 
Each film-coated tablet contains 150 mg lacosamide. 
 
Lacosamide UCB 200 mg film-coated tablets 
 
Each film-coated tablet contains 200 mg lacosamide. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet 
 
Lacosamide UCB 50 mg film-coated tablets 
Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed 
with ‘SP’ on one side and ‘50’ on the other side. 
 
Lacosamide UCB 100 mg film-coated tablets 
Dark yellow, oval film-coated tablets with approximate dimensions of 13.2 mm x 6.1 mm, and 
debossed with ‘SP’ on one side and ‘100’ on the other side. 
 
Lacosamide UCB 150 mg film-coated tablets 
Salmon, oval film-coated tablets with approximate dimensions of 15.1 mm x 7.0 mm, and debossed 
with ‘SP’ on one side and ‘150’ on the other side. 
 
Lacosamide UCB 200 mg film-coated tablets 
Blue, oval film-coated tablets with approximate dimensions of 16.6 mm x 7.8 mm, and debossed with 
‘SP’ on one side and ‘200’ on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Lacosamide UCB is indicated as monotherapy in the treatment of partial-onset seizures with or 
without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.  
Lacosamide UCB is indicated as adjunctive therapy 



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• in the treatment of partial-onset seizures with or without secondary generalisation in adults, 
adolescents and children from 4 years of age with epilepsy. 

• in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and 
children from 4 years of age with idiopathic generalised epilepsy. 

 
4.2 Posology and method of administration 
 
Posology 
 
Lacosamide must be taken twice a day (usually once in the morning and once in the evening). 
Lacosamide may be taken with or without food. 
If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to 
take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose 
within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide 
at the regularly scheduled time. Patients should not take a double dose. 
 

Adolescents and children weighing 50 kg or more, and adults 

 
The following table summarises the recommended posology for adolescents and children weighing 
50 kg or more, and for adults. More details are provided in the table below. 
 
 Monotherapy Adjunctive therapy 
Starting dose 
 

100 mg/day or 200 mg/day 100 mg/day 

Single loading dose  
(if applicable) 

200 mg 200 mg 

Titration (incremental steps) 50 mg twice a day (100 mg/day) 
at weekly intervals 

50 mg twice a day (100 mg/day) 
at weekly intervals 

Maximum recommended dose up to 600 mg/day up to 400 mg/day 
 

Monotherapy (in the treatment of partial-onset seizures) 

The recommended starting dose is 50 mg twice a day which should be increased to an initial 
therapeutic dose of 100 mg twice a day after one week. 
Lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's 
assessment of required seizure reduction versus potential side effects. 
Depending on response and tolerability, the maintenance dose can be further increased at weekly 
intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg 
twice a day (600 mg/day).  
In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic 
medicinal product, the posology that is recommended for adjunctive therapy below should be 
followed. 
 
Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary 

generalised tonic-clonic seizures) 

The recommended starting dose is 50 mg twice a day which should be increased to an initial 
therapeutic dose of 100 mg twice a day after one week.  
Depending on response and tolerability, the maintenance dose can be further increased at weekly 
intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg 
(200 mg twice a day).  
 

Initiation of lacosamide treatment with a loading dose (initial monotherapy or conversion to 

monotherapy in the treatment of partial-onset seizures or adjunctive therapy in the treatment of 

partial-onset seizures or adjunctive therapy in the treatment of primary generalised tonic-clonic 

seizures) 

Lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed 
approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. 



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Subsequent dose adjustments should be performed according to individual response and tolerability as 
described above. A loading dose may be initiated in patients in situations when the physician 
determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic 
effect is warranted. It should be administered under medical supervision with consideration of the 
potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse 
reactions (see section 4.8). Administration of a loading dose has not been studied in acute conditions 
such as status epilepticus. 
 
Discontinuation 

In accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended 
this be done gradually (e.g. taper the daily dose by 200 mg/week). 
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be 
performed and if needed lacosamide should be discontinued. 
 
Special populations 
 
Elderly (over 65 years of age) 

No dose reduction is necessary in elderly patients. Age associated decreased renal clearance with an 
increase in AUC levels should be considered in elderly patients (see following paragraph ‘renal 
impairment’ and section 5.2). There is limited clinical data in the elderly patients with epilepsy, 
particularly at doses greater than 400 mg/day (see sections 4.4, 4.8, and 5.1). 
 
Renal impairment 

No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric 
patients (CLCR > 30 ml/min). In paediatric patients weighing 50 kg or more and in adult patients with 
mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose 
titration (> 200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or 
more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal 
disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed 
with caution. If a loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily 
regimen for the first week should be used. In paediatric patients weighing less than 50 kg with severe 
renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of 
the maximum dose is recommended. For all patients requiring haemodialysis a supplement of up to 
50 % of the divided daily dose directly after the end of haemodialysis is recommended. Treatment of 
patients with end-stage renal disease should be made with caution as there is little clinical experience 
and accumulation of a metabolite (with no known pharmacological activity).  
 
Hepatic impairment 

A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and 
for adult patients with mild to moderate hepatic impairment.  
The dose titration in these patients should be performed with caution considering co-existing renal 
impairment. In adolescents and adults weighing 50 kg or more, a loading dose of 200 mg may be 
considered, but further dose titration (> 200 mg daily) should be performed with caution. Based on 
data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic 
impairment, a reduction of 25 % of the maximum dose should be applied. The pharmacokinetics of 
lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2). Lacosamide 
should be administered to adult and paediatric patients with severe hepatic impairment only when the 
expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be 
adjusted while carefully observing disease activity and potential side effects in the patient. 
 
Paediatric population 
 

The physician should prescribe the most appropriate formulation and strength according to weight and 
dose.  
 
Adolescents and children weighing 50 kg or more 

Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above). 



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Children (from 4 years of age) and adolescents weighing less than 50 kg 

The dose is determined based on body weight. It is therefore recommended to initiate treatment with 
the syrup and switch to tablets, if desired.  
 

Monotherapy (in the treatment of partial-onset seizures) 

The recommended starting dose is 2 mg/kg/day which should be increased to an initial therapeutic 
dose of 4 mg/kg/day after one week. 
Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day 
every week. The dose should be gradually increased until the optimum response is obtained. In 
children weighing less than 40 kg, a maximum dose of up to 12 mg/kg/day is recommended. In 
children weighing from 40 to under 50 kg, a maximum dose of 10 mg/kg/day is recommended. 
 
The following table summarises the recommended posology in monotherapy for children and 
adolescents weighing less than 50 kg. 

Starting dose 
 

2 mg/kg/day  

Single loading dose  Not recommended 
Titration (incremental steps) 2 mg/kg/day every week 
Maximum recommended dose in patients < 40 kg up to 12 mg/kg/day 
Maximum recommended dose in patients ≥ 40 kg 
to < 50 kg 

up to 10 mg/kg/day 

 

Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary 

generalised tonic-clonic seizures) 

The recommended starting dose is 2 mg/kg/day which should be increased to an initial therapeutic 
dose of 4 mg/kg/day after one week. 
Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day 
every week. The dose should be gradually adjusted until the optimum response is obtained. In children 
weighing less than 20 kg, due to an increased clearance compared to adults, a maximum dose of up to 
12 mg/kg/day is recommended. In children weighing from 20 to under 30 kg, a maximum dose of 
10 mg/kg/day is recommended and in children weighing from 30 to under 50 kg, a maximum dose of 
8 mg/kg/day is recommended, although in open-label studies (see sections 4.8 and 5.2), a dose up to 
12 mg/kg/day has been used by a small number of these children.  
 
The following table summarises the recommended posology in adjunctive therapy for children and 
adolescents weighing less than 50 kg. 

Starting dose 
 

2 mg/kg/day  

Single loading dose  Not recommended 
Titration (incremental steps) 2 mg/kg/day every week 
Maximum recommended dose in patients 
< 20 kg 

up to 12 mg/kg/day 

Maximum recommended dose in patients ≥ 20 kg 
to < 30 kg 

up to 10 mg/kg/day 

Maximum recommended dose in patients ≥ 30 kg 
to < 50 kg  

up to 8 mg/kg/day  

 
Loading dose 
Administration of a loading dose has not been studied in children. Use of a loading dose is not 
recommended in adolescents and children weighing less than 50 kg. 
 
Children less than 4 years 

The safety and efficacy of lacosamide in children aged below 4 years have not yet been established. 
No data are available. 
 



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Method of administration 
 
Lacosamide film-coated tablets are for oral use. Lacosamide may be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Known second- or third-degree atrioventricular (AV) block.  
 
4.4 Special warnings and precautions for use 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal 
products in several indications. A meta-analysis of randomised placebo-controlled studies of 
antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and 
behaviour. The mechanism of this risk is not known and the available data do not exclude the 
possibility of an increased risk for lacosamide. 
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate 
treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical 
advice should signs of suicidal ideation or behaviour emerge (see section 4.8). 
 
Cardiac rhythm and conduction 
 
Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies. 
Lacosamide should be used with caution in patients with underlying proarrhythmic conditions such as 
patients with known cardiac conduction problems or severe cardiac disease (e.g. myocardial 
ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or 
patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and 
sodium channel blocking antiepileptic medicinal products (see section 4.5), as well as in elderly 
patients. 
In these patients it should be considered to perform an ECG before a lacosamide dose increase above 
400 mg/day and after lacosamide is titrated to steady-state. 
 
In the placebo-controlled studies of lacosamide in epilepsy patients, atrial fibrillation or flutter were 
not reported; however, both have been reported in open-label epilepsy studies and in post-marketing 
experience. 
 
In post-marketing experience, AV block (including second degree or higher AV block) has been 
reported. In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In 
rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying 
proarrhythmic conditions. 
 
Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular 
pulse, palpitations, shortness of breath, feeling lightheaded, fainting). Patients should be counselled to 
seek immediate medical advice if these symptoms occur. 
 
Dizziness 
 
Treatment with lacosamide has been associated with dizziness which could increase the occurrence of 
accidental injury or falls. Therefore, patients should be advised to exercise caution until they are 
familiar with the potential effects of the medicine (see section 4.8). 
 



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Potential for new onset or worsening of myoclonic seizures 
 
New onset or worsening of myoclonic seizures has been reported in both adult and paediatric patients 
with PGTCS, in particular during titration. In patients with more than one seizure type, the observed 
benefit of control for one seizure type should be weighed against any observed worsening in another 
seizure type. 
 
Potential for electro-clinical worsening in specific paediatric epilepsy syndromes 
 
The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal 
and generalised seizures may coexist have not been determined. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Lacosamide should be used with caution in patients treated with medicinal products known to be 
associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) 
and in patients treated with antiarrhythmics. However, subgroup analysis in clinical studies did not 
identify an increased magnitude of PR prolongation in patients with concomitant administration of 
carbamazepine or lamotrigine. 
 
In vitro data 
 
Data generally suggest that lacosamide has a low interaction potential. In vitro studies indicate that the 
enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, 
CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP2E1 are not inhibited by lacosamide at plasma 
concentrations observed in clinical studies. An in vitro study indicated that lacosamide is not 
transported by P-glycoprotein in the intestine. In vitro data show that CYP2C9, CYP2C19 and 
CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite. 
 
In vivo data 
 
Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent. 
Lacosamide did not affect the AUC of midazolam (metabolised by CYP3A4, lacosamide given 
200 mg twice a day), but Cmax of midazolam was slightly increased (30 %). Lacosamide did not affect 
the pharmacokinetics of omeprazole (metabolised by CYP2C19 and CYP3A4, lacosamide given 
300 mg twice a day).  
The CYP2C19 inhibitor omeprazole (40 mg once daily) did not give rise to a clinically significant 
change in lacosamide exposure. Thus, moderate inhibitors of CYP2C19 are unlikely to affect systemic 
lacosamide exposure to a clinically relevant extent.  
Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (e.g. 
fluconazole) and CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead 
to increased systemic exposure of lacosamide. Such interactions have not been established in vivo, but 
are possible based on in vitro data. 
 
Strong enzyme inducers such as rifampicin or St John’s wort (Hypericum perforatum) may moderately 
reduce the systemic exposure of lacosamide. Therefore, starting or ending treatment with these 
enzyme inducers should be done with caution. 
 
Antiepileptic medicinal products  
 
In interaction studies lacosamide did not significantly affect the plasma concentrations of 
carbamazepine and valproic acid. Lacosamide plasma concentrations were not affected by 
carbamazepine and by valproic acid. Population pharmacokinetic analyses in different age groups 
estimated that concomitant treatment with other antiepileptic medicinal products known to be enzyme 
inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic 
exposure of lacosamide by 25 % in adults and 17 % in paediatric patients.  
 



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Oral contraceptives 
 
In an interaction study there was no clinically relevant interaction between lacosamide and the oral 
contraceptives ethinylestradiol and levonorgestrel. Progesterone concentrations were not affected 
when the medicinal products were co-administered. 
 
Others 
 
Interaction studies showed that lacosamide had no effect on the pharmacokinetics of digoxin. There 
was no clinically relevant interaction between lacosamide and metformin.  
Co-administration of warfarin with lacosamide does not result in a clinically relevant change in the 
pharmacokinetics and pharmacodynamics of warfarin. 
Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available, a 
pharmacodynamic effect cannot be excluded. 
Lacosamide has a low protein binding of less than 15 %. Therefore, clinically relevant interactions 
with other medicinal products through competition for protein binding sites are considered unlikely. 
 
4.6 Fertility, pregnancy and lactation 
 

Pregnancy 
 

Risk related to epilepsy and antiepileptic medicinal products in general  

For all antiepileptic medicinal products, it has been shown that in the offspring of treated women with 
epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 
3 % in the general population. In the treated population, an increase in malformations has been noted 
with polytherapy, however, the extent to which the treatment and/or the illness is responsible has not 
been elucidated. 
Moreover, effective antiepileptic therapy must not be interrupted, since the aggravation of the illness is 
detrimental to both the mother and the foetus. 
 
Risk related to lacosamide 

There are no adequate data from the use of lacosamide in pregnant women. Studies in animals did not 
indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits 
at maternal toxic doses (see section 5.3). The potential risk for humans is unknown. 
Lacosamide should not be used during pregnancy unless clearly necessary (if the benefit to the mother 
clearly outweighs the potential risk to the foetus). If women decide to become pregnant, the use of this 
product should be carefully re-evaluated. 
 
Breastfeeding 
 
It is unknown whether lacosamide is excreted in human breast milk. A risk to the newborns/infants 
cannot be excluded. Animal studies have shown excretion of lacosamide in breast milk. For 
precautionary measures, breast-feeding should be discontinued during treatment with lacosamide. 
 
Fertility 
 
No adverse reactions on male or female fertility or reproduction were observed in rats at doses 
producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the 
maximum recommended human dose (MRHD). 
 
4.7 Effects on ability to drive and use machines 
 
Lacosamide has minor to moderate influence on the ability to drive and use machines. Lacosamide 
treatment has been associated with dizziness or blurred vision.  
Accordingly, patients should be advised not to drive or to operate other potentially hazardous 
machinery until they are familiar with the effects of lacosamide on their ability to perform such 
activities. 



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4.8 Undesirable effects 
 
Summary of safety profile 
 
Based on the analysis of pooled placebo-controlled clinical studies in adjunctive therapy in 
1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomised to lacosamide and 
35.2 % of patients randomised to placebo reported at least 1 adverse reaction. The most frequently 
reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and 
diplopia. They were usually mild to moderate in intensity. Some were dose-related and could be 
alleviated by reducing the dose. Incidence and severity of central nervous system (CNS) and 
gastrointestinal (GI) adverse reactions usually decreased over time. 
In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for 
patients randomised to lacosamide and 1.6 % for patients randomised to placebo. The most common 
adverse reaction resulting in discontinuation of lacosamide therapy was dizziness.  
Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. 
 
Based on the analysis of data from a non-inferiority monotherapy clinical study comparing lacosamide 
to carbamazepine controlled release (CR), the most frequently reported adverse reactions (≥ 10 %) for 
lacosamide were headache and dizziness. The discontinuation rate due to adverse reactions was 
10.6 % for patients treated with lacosamide and 15.6 % for patients treated with carbamazepine CR.  
 
The safety profile of lacosamide reported in a study conducted in patients aged 4 years and older with 
idiopathic generalised epilepsy with primary generalised tonic-clonic seizures (PGTCS) was consistent 
with the safety profile reported from the pooled placebo-controlled clinical studies in partial-onset 
seizures. Additional adverse reactions reported in PGTCS patients were myoclonic epilepsy (2.5 % in 
the lacosamide-group and 0 % in the placebo-group) and ataxia (3.3 % in the lacosamide-group and 
0 % in the placebo-group). The most frequently reported adverse reactions were dizziness and 
somnolence. The most common adverse reactions resulting in discontinuation of lacosamide therapy 
were dizziness and suicidal ideation. The discontinuation rate due to adverse reactions was 9.1 % in 
the lacosamide group and 4.1 % in the placebo group. 
 
Tabulated list of adverse reactions 
 
The table below shows the frequencies of adverse reactions which have been reported in clinical 
studies and post-marketing experience. The frequencies are defined as follows: very common (≥ 1/10), 
common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be 
estimated from available data). Within each frequency grouping, undesirable effects are presented in 
order of decreasing seriousness. 
 

System organ 
class 

Very 
common 

Common Uncommon Not known 

Blood and 
lymphatic 
disorders 

   Agranulocytosis(1) 

Immune system 
disorders 

  Drug 
hypersensitivity(1) 

Drug reaction with 
eosinophilia and 
systemic symptoms 
(DRESS) (1,2) 

Psychiatric 
disorders 

 Depression 
Confusional state 
Insomnia(1) 

Aggression 
Agitation(1)  
Euphoric mood(1) 

Psychotic 
disorder(1) 

Suicide attempt (1) 
Suicidal ideation 

Hallucination (1) 

 



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System organ 
class 

Very 
common 

Common Uncommon Not known 

Nervous system 
disorders 

Dizziness 
Headache 
 

Myoclonic 
seizures(3) 

Ataxia 
Balance disorder  
Memory 
impairment  
Cognitive disorder  
Somnolence 
Tremor  
Nystagmus 
Hypoesthesia  
Dysarthria 
Disturbance in 
attention 

Paraesthesia 

Syncope(2) 
Coordination 
abnormal 
 

Convulsion 

Eye disorders Diplopia Vision blurred   
Ear and labyrinth 
disorders 

 Vertigo 
Tinnitus 

  

Cardiac disorders   Atrioventricular 
block(1,2) 
Bradycardia(1,2) 

Atrial Fibrillation 
(1,2) 

Atrial Flutter (1,2) 

Ventricular 
tachyarrhythmia (1) 

Gastrointestinal 
disorders 

Nausea 
 

Vomiting  
Constipation 
Flatulence  
Dyspepsia 
Dry mouth 

Diarrhoea 

  

Hepatobiliary 
disorders 

  Liver function test 
abnormal(2) 

Hepatic enzyme 
increased 
(> 2x ULN) (1) 

 

Skin and 
subcutaneous 
tissue disorders 

 Pruritus 
Rash(1) 

Angioedema(1)  
Urticaria(1) 

Stevens-Johnson 
syndrome(1) 
Toxic epidermal 
necrolysis(1) 

Musculoskeletal 
and connective 
tissue disorders 

 Muscle spasms   

General disorders 
and administration 
site conditions  

 Gait disturbance 
Asthenia  
Fatigue 
Irritability 

Feeling drunk 

  

Injury, poisoning 
and procedural 
complications 

 Fall  
Skin laceration 
Contusion 

  

(1) Adverse reactions reported in post marketing experience. 
(2) See Description of selected adverse reactions.  
(3) Reported in PGTCS studies. 
 



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Description of selected adverse reactions 
 
The use of lacosamide is associated with dose-related increase in the PR interval. Adverse reactions 
associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur.  
In adjunctive clinical studies in epilepsy patients, the incidence rate of reported first-degree AV Block 
is uncommon, 0.7 %, 0 %, 0.5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, 
respectively. No second- or higher degree AV Block was seen in these studies. However, cases with 
second- and third-degree AV Block associated with lacosamide treatment have been reported in 
post-marketing experience. In the monotherapy clinical study comparing lacosamide to carbamazepine 
CR, the extent of increase in PR interval was comparable between lacosamide and carbamazepine. 
The incidence rate for syncope reported in pooled adjunctive therapy clinical studies is uncommon and 
did not differ between lacosamide (n=944) treated epilepsy patients (0.1 %) and placebo (n=364) 
treated epilepsy patients (0.3 %). In the monotherapy clinical study comparing lacosamide to 
carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) 
carbamazepine CR patients. 
Atrial fibrillation or flutter were not reported in short term clinical studies; however, both have been 
reported in open-label epilepsy studies and in post-marketing experience. 
 
Laboratory abnormalities 

Abnormalities in liver function tests have been observed in placebo-controlled studies with lacosamide 
in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic medicinal 
products. Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide UCB patients and 
0 % (0/356) of placebo patients. 
 
Multiorgan hypersensitivity reactions 

Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic 
Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products. 
These reactions are variable in expression, but typically present with fever and rash and can be 
associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is 
suspected, lacosamide should be discontinued. 
 
Paediatric population 
 
The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in open-
label studies (n=408) in adjunctive therapy in children from 4 years of age with partial-onset seizures 
was consistent with the safety profile observed in adults although the frequency of some adverse 
reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions 
(nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have 
been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence 
(14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), 
pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %). 
A total of 67.8 % of patients randomised to lacosamide and 58.1 % of patients randomised to placebo 
reported at least 1 adverse reaction. 
Behavioural, cognition and emotional functioning were measured by the questionnaires Achenbach 
CBCL and BRIEF that were applied at baseline and throughout the studies and were mainly stable 
during the course of the studies. 
 
Elderly population  
 
In the monotherapy study comparing lacosamide to carbamazepine CR, the types of adverse reactions 
related to lacosamide in elderly patients (≥ 65 years of age) appear to be similar to that observed in 
patients less than 65 years of age. However, a higher incidence (≥ 5 % difference) of fall, diarrhoea 
and tremor has been reported in elderly patients compared to younger adult patients. The most 
frequent cardiac-related adverse reaction reported in elderly compared to the younger adult population 
was first-degree AV block. This was reported with lacosamide in 4.8 % (3/62) in elderly patients 
versus 1.6 % (6/382) in younger adult patients. The discontinuation rate due to adverse events 
observed with lacosamide was 21.0 % (13/62) in elderly patients versus 9.2 % (35/382) in younger 



12 

adult patients. These differences between elderly and younger adult patients were similar to those 
observed in the active comparator group. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 

Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated 
with CNS and gastrointestinal system. 

 The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 
800 mg were not clinically different from those of patients administered recommended doses 
of lacosamide. 

 Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, 
seizures (generalised tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, 
shock and coma have also been observed. Fatalities have been reported in patients following 
an intake of acute single overdose of several grams of lacosamide. 

 
Management 
 
There is no specific antidote for overdose with lacosamide. Treatment of lacosamide overdose should 
include general supportive measures and may include haemodialysis if necessary (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18  
 
Mechanism of action 
 
The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a 
functionalised amino acid. 
The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be 
fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances 
slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable 
neuronal membranes.  
 
Pharmacodynamic effects 
 
Lacosamide protected against seizures in a broad range of animal models of partial and primary 
generalised seizures and delayed kindling development.  
In non-clinical experiments lacosamide in combination with levetiracetam, carbamazepine, phenytoin, 
valproate, lamotrigine, topiramate or gabapentin showed synergistic or additive anticonvulsant effects. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


13 

Clinical efficacy and safety (partial-onset seizures) 
Adult population 
 

Monotherapy 

Efficacy of lacosamide as monotherapy was established in a double-blind, parallel group, non-
inferiority comparison to carbamazepine CR in 886 patients 16 years of age or older with newly or 
recently diagnosed epilepsy. The patients had to present with unprovoked partial-onset seizures with 
or without secondary generalisation. The patients were randomised to carbamazepine CR or 
lacosamide, provided as tablets, in a 1:1 ratio. The dose was based on dose-response and ranged from 
400 to 1,200 mg/day for carbamazepine CR and from 200 to 600 mg/day for lacosamide. The duration 
of the treatment was up to 121 weeks depending on the response. 
The estimated 6-month seizure freedom rates were 89.8 % for lacosamide-treated patients and 91.1 % 
for carbamazepine CR treated patients using the Kaplan-Meier survival analysis method. The adjusted 
absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8). The Kaplan-Meier estimates 
of 12-month seizure freedom rates were 77.8 % for lacosamide-treated patients and 82.7 % for 
carbamazepine CR treated patients. 
The 6-month seizure freedom rates in elderly patients of 65 and above (62 patients in lacosamide, 
57 patients in carbamazepine CR) were similar between both treatment groups. The rates were also 
similar to those observed in the overall population. In the elderly population, the maintenance 
lacosamide dose was 200 mg/day in 55 patients (88.7 %), 400 mg/day in 6 patients (9.7 %) and the 
dose was escalated to over 400 mg/day in 1 patient (1.6 %). 
 
Conversion to monotherapy 

The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historical-
controlled, multicentre, double-blind, randomised trial. In this study, 425 patients aged 16 to 70 years 
with uncontrolled partial-onset seizures taking stable doses of 1 or 2 marketed antiepileptic medicinal 
products were randomised to be converted to lacosamide monotherapy (either 400 mg/day or 
300 mg/day in a 3:1 ratio). In treated patients who completed titration and started withdrawing 
antiepileptic medicinal products (284 and 99 respectively), monotherapy was maintained in 71.5 % 
and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation 
period of 70 days. 
 
Adjunctive therapy 

The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) 
was established in 3 multicenter, randomised, placebo-controlled clinical studies with a 12-week 
maintenance period. Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive 
therapy studies, although the efficacy was similar to 400 mg/day and patients were less likely to 
tolerate this dose because of CNS- and gastrointestinal-related adverse reactions. Thus, the 
600 mg/day dose is not recommended. The maximum recommended dose is 400 mg/day. These 
studies, involving 1,308 patients with a history of an average of 23 years of partial-onset seizures, 
were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly 
with 1-3 antiepileptic medicinal products in patients with uncontrolled partial-onset seizures with or 
without secondary generalisation. Overall the proportion of subjects with a 50 % reduction in seizure 
frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 
400 mg/day.  
 
The pharmacokinetics and safety of a single loading dose of intravenous lacosamide were determined 
in a multicenter, open-label study designed to assess the safety and tolerability of rapid initiation of 
lacosamide using a single intravenous loading dose (including 200 mg) followed by twice daily oral 
dosing (equivalent to the intravenous dose) as adjunctive therapy in adult subjects 16 to 60 years of 
age with partial-onset seizures.  
 
Paediatric population 
 
Partial-onset seizures have a similar clinical expression in children from 4 years of age and in adults. 
The efficacy of lacosamide in children aged 4 years and older has been extrapolated from data of 
adolescents and adults with partial-onset seizures, for whom a similar response was expected provided 



14 

the paediatric dose adaptations are established (see section 4.2) and safety has been demonstrated (see 
section 4.8).  
The efficacy supported by the extrapolation principle stated above was confirmed by a double-blind, 
randomised, placebo-controlled study. The study consisted of an 8-week baseline period followed by a 
6-week titration period. Eligible patients on a stable dose regimen of 1 to ≤ 3 antiepileptic medicinal 
products, who still experienced at least 2 partial-onset seizures during the 4 weeks prior to screening 
with seizure-free phase no longer than 21 days in the 8-week period prior to entry into the baseline 
period, were randomised to receive either placebo (n=172) or lacosamide (n=171).  
Dosing was initiated at a dose of 2 mg/kg/day in subjects weighing less than 50 kg or 100 mg/day in 
subjects weighing 50 kg or more in 2 divided doses. During the titration period, lacosamide doses 
were adjusted in 1or 2 mg/kg/day increments in subjects weighing less than 50 kg or 50 or 100 mg/day 
in subjects weighing 50 kg or more at weekly intervals to achieve the target maintenance period dose 
range. 
Subjects must have achieved the minimum target dose for their body weight category for the final 
3 days of the titration period to be eligible for entry into the 10-week maintenance period. Subjects 
were to remain on stable lacosamide dose throughout the maintenance period or were withdrawn and 
entered in the blinded taper period. 
Statistically significant (p=0.0003) and clinically relevant reduction in partial-onset seizure frequency 
per 28 days from baseline to the maintenance period was observed between the lacosamide and the 
placebo group. The percent reduction over placebo based on analysis of covariance was 31.72 % 
(95 % CI: 16.342, 44.277). 
Overall, the proportion of subjects with at least a 50 % reduction in partial-onset seizure frequency per 
28 days from baseline to the maintenance period was 52.9 % in the lacosamide group compared with 
33.3 % in the placebo group. 
The quality of life assessed by the Pediatric Quality of Life Inventory indicated that subjects in both 
lacosamide and placebo groups had a similar and stable health-related quality of life during the entire 
treatment period. 
 
Clinical efficacy and safety (primary generalized tonic-clonic seizures) 
 
The efficacy of lacosamide as adjunctive therapy in patients 4 years of age and older with idiopathic 
generalized epilepsy experiencing primary generalized tonic-clonic seizures (PGTCS) was established 
in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study. The 
study consisted of a 12-week historical baseline period, a 4-week prospective baseline period and a 24-
week treatment period (which included a 6-week titration period and an 18-week maintenance period). 
Eligible patients on a stable dose of 1 to 3 antiepileptic drugs experiencing at least 3 documented 
PGTCS during the 16-week combined baseline period were randomized 1 to 1 to receive lacosamide 
or placebo (patients in the full analysis set: lacosamide n=118, placebo n=121; of them 8 patients in 
the ≥ 4 to < 12 years age group and 16 patients in the ≥ 12 to < 18 years range were treated with LCM 
and 9 and 16 patients, respectively with placebo).  
Patients were titrated up to the target maintenance period dose of 12 mg/kg/day in patients weighing 
less than 30 kg, 8 mg/kg/day in patients weighing from 30 to less than 50 kg or 400 mg/day in patients 
weighing 50 kg or more.  
 

Efficacy variable 
Parameter 

Placebo 
N=121 

Lacosamide 
N=118 

Time to second PGTCS 
Median (days) 77.0 - 
95 % CI 49.0, 128.0 - 
Lacosamide – Placebo  
Hazard Ratio 0.540 
95 % CI 0.377, 0.774 
p-value < 0.001 

Seizure freedom   
Stratified Kaplan-Meier estimate (%) 17.2 31.3 
95 % CI 10.4, 24.0 22.8, 39.9 
Lacosamide – Placebo 14.1 



15 

Efficacy variable 
Parameter 

Placebo 
N=121 

Lacosamide 
N=118 

95 % CI 3.2, 25.1 
p-value 0.011 

Note: For the lacosamide group, the median time to second PGTCS could not be estimated by Kaplan-
Meier methods because ˃ 50% of patients did not experience a second PGTCS by Day 166. 
 
The findings in the pediatric subgroup were consistent with the results of the overall population for the 
primary, secondary and other efficacy endpoints.  
 
5.2 Pharmacokinetic properties 
 
Absorption  
 
Lacosamide is rapidly and completely absorbed after oral administration. The oral bioavailability of 
lacosamide tablets is approximately 100 %. Following oral administration, the plasma concentration of 
unchanged lacosamide increases rapidly and reaches Cmax about 0.5 to 4 hours post-dose. Lacosamide 
UCB tablets and oral syrup are bioequivalent. Food does not affect the rate and extent of absorption. 
 
Distribution 
 
The volume of distribution is approximately 0.6 L/kg. Lacosamide is less than 15 % bound to plasma 
proteins. 
 
Biotransformation 
 
95 % of the dose is excreted in the urine as lacosamide and metabolites. The metabolism of 
lacosamide has not been completely characterised.  
The major compounds excreted in urine are unchanged lacosamide (approximately 40 % of the dose) 
and its O-desmethyl metabolite less than 30 %.  
A polar fraction proposed to be serine derivatives accounted for approximately 20 % in urine, but was 
detected only in small amounts (0-2 %) in human plasma of some subjects. Small amounts (0.5-2 %) 
of additional metabolites were found in the urine.  
In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of 
the O-desmethyl metabolite but the main contributing isoenzyme has not been confirmed in vivo. No 
clinically relevant difference in lacosamide exposure was observed comparing its pharmacokinetics in 
extensive metabolisers (EMs, with a functional CYP2C19) and poor metabolisers (PMs, lacking a 
functional CYP2C19). Furthermore an interaction study with omeprazole (CYP2C19-inhibitor) 
demonstrated no clinically relevant changes in lacosamide plasma concentrations indicating that the 
importance of this pathway is minor. The plasma concentration of O-desmethyl-lacosamide is 
approximately 15 % of the concentration of lacosamide in plasma. This major metabolite has no 
known pharmacological activity. 
 
Elimination 
 
Lacosamide is primarily eliminated from the systemic circulation by renal excretion and 
biotransformation. After oral and intravenous administration of radiolabeled lacosamide, 
approximately 95 % of radioactivity administered was recovered in the urine and less than 0.5 % in the 
faeces. The elimination half-life of lacosamide is approximately 13 hours. The pharmacokinetics is 
dose-proportional and constant over time, with low intra- and inter-subject variability. Following twice 
daily dosing, steady state plasma concentrations are achieved after a 3 day period. The plasma 
concentration increases with an accumulation factor of approximately 2. 
 
A single loading dose of 200 mg approximates steady-state concentrations comparable to 100 mg 
twice daily oral administration. 
 



16 

Pharmacokinetics in special patient groups 
 
Gender 

Clinical studies indicate that gender does not have a clinically significant influence on the plasma 
concentrations of lacosamide. 
 
Renal impairment 

The AUC of lacosamide was increased by approximately 30 % in mildly and moderately and 60 % in 
severely renal impaired patients and patients with end-stage renal disease requiring haemodialysis 
compared to healthy subjects, whereas Cmax was unaffected. 
Lacosamide is effectively removed from plasma by haemodialysis. Following a 4-hour haemodialysis 
treatment, AUC of lacosamide is reduced by approximately 50 %. Therefore, dosage supplementation 
following haemodialysis is recommended (see section 4.2). The exposure of the O-desmethyl 
metabolite was several-fold increased in patients with moderate and severe renal impairment. In 
absence of haemodialysis in patients with end-stage renal disease, the levels were increased and 
continuously rising during the 24-hour sampling. It is unknown whether the increased metabolite 
exposure in end-stage renal disease subjects could give rise to adverse effects but no pharmacological 
activity of the metabolite has been identified. 
 
Hepatic impairment 

Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of 
lacosamide (approximately 50 % higher AUCnorm). The higher exposure was partly due to a reduced 
renal function in the studied subjects. The decrease in non-renal clearance in the patients of the study 
was estimated to give a 20 % increase in the AUC of lacosamide. The pharmacokinetics of lacosamide 
has not been evaluated in severe hepatic impairment (see section 4.2). 
 
Elderly (over 65 years of age) 

In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 
50 % increased compared to young men, respectively. This is partly related to lower body weight. The 
body weight normalized difference is 26 and 23 %, respectively. An increased variability in exposure 
was also observed. The renal clearance of lacosamide was only slightly reduced in elderly subjects in 
this study.  
A general dose reduction is not considered to be necessary unless indicated due to reduced renal 
function (see section 4.2). 
 
Paediatric population 
The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic 
analysis using sparse plasma concentration data obtained in one placebo-controlled randomised study 
and three open-label studies in 414 children with epilepsy aged 6 months to 17 years. The 
administered lacosamide doses ranged from 2 to 17.8 mg/kg/day in twice daily intake, with a 
maximum of 600 mg/day for children weighing 50 kg or more. 
The typical plasma clearance was estimated to be 1.04 L/h, 1.32 L/h and 1.86 L/h for children 
weighing 20 kg, 30 kg and 50 kg respectively. In comparison, plasma clearance was estimated at 
1.92 L/h in adults (70 kg body weight). 
Population pharmacokinetic analysis using sparse pharmacokinetic samples from PGTCS study 
showed a similar exposure in patients with PGTCS and in patients with partial-onset seizures. 
 
5.3 Preclinical safety data 
 
In the toxicity studies, the plasma concentrations of lacosamide obtained were similar or only 
marginally higher than those observed in patients, which leaves low or non-existing margins to human 
exposure. 
A safety pharmacology study with intravenous administration of lacosamide in anesthetised dogs 
showed transient increases in PR interval and QRS complex duration and decreases in blood pressure 
most likely due to a cardiodepressant action. These transient changes started in the same concentration 
range as after maximum recommended clinical dosing. In anesthetised dogs and Cynomolgus 



17 

monkeys, at intravenous doses of 15-60 mg/kg, slowing of atrial and ventricular conductivity, 
atrioventricular block and atrioventricular dissociation were seen. 
In the repeated dose toxicity studies, mild reversible liver changes were observed in rats starting at 
about 3 times the clinical exposure. These changes included an increased organ weight, hypertrophy of 
hepatocytes, increases in serum concentrations of liver enzymes and increases in total cholesterol and 
triglycerides. Apart from the hypertrophy of hepatocytes, no other histopathologic changes were 
observed. 
In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but an 
increase in numbers of stillborn pups and pup deaths in the peripartum period, and slightly reduced 
live litter sizes and pup body weights were observed at maternal toxic doses in rats corresponding to 
systemic exposure levels similar to the expected clinical exposure. Since higher exposure levels could 
not be tested in animals due to maternal toxicity, data are insufficient to fully characterise the 
embryofetotoxic and teratogenic potential of lacosamide. 
Studies in rats revealed that lacosamide and/or its metabolites readily crossed the placental barrier. 
In juvenile rats and dogs, the types of toxicity do not differ qualitatively from those observed in adult 
animals. In juvenile rats, a reduced body weight was observed at systemic exposure levels similar to 
the expected clinical exposure. In juvenile dogs, transient and dose-related CNS clinical signs started 
to be observed at systemic exposure levels below the expected clinical exposure. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
microcrystalline cellulose 
hydroxypropylcellulose 
hydroxypropylcellulose (low substituted) 
silica, colloidal, anhydrous  
crospovidone (polyplasdone XL-10 Pharmaceutical Grade) 
magnesium stearate 
 
Tablet coat 
 
Lacosamide UCB 50 mg film-coated tablets 

 
polyvinyl alcohol 
polyethylene glycol 3350 
talc 
titanium dioxide (E171) 
red iron oxide (E172) 
black iron oxide (E172) 
indigo carmine aluminium lake (E132) 
 
Lacosamide UCB 100 mg film-coated tablets 

 
polyvinyl alcohol 
polyethylene glycol 3350 
talc 
titanium dioxide (E171) 
yellow iron oxide (E172) 
 
Lacosamide UCB 150 mg film-coated tablets 

 
polyvinyl alcohol 
polyethylene glycol 3350 



18 

talc 
titanium dioxide (E171) 
yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) 
 
Lacosamide UCB 200 mg film-coated tablets 

 
polyvinyl alcohol 
polyethylene glycol 3350 
talc 
titanium dioxide (E171) 
indigo carmine aluminium lake (E132) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
5 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Lacosamide UCB 50 mg film-coated tablets 
 
Packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.  
Packs of 14 x 1 and 56 x 1 film-coated tablet in PVC/PVDC perforated unit dose blisters sealed with 
an aluminium foil. 
 
Lacosamide UCB 100 mg film-coated tablets 
 
Packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil. 
Packs of 14 x 1 and 56 x 1 film-coated tablet in PVC/PVDC perforated unit dose blisters sealed with 
an aluminium foil.  
 
Lacosamide UCB 150 mg film-coated tablets 
 
Packs of 14, 28 and 56 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil. 
Multipacks containing 168 (3 packs of 56 tablets) film-coated tablets in PVC/PVDC blister sealed 
with an aluminium foil. 
Packs of 14 x 1 and 56 x 1 film-coated tablet in PVC/PVDC perforated unit dose blisters sealed with 
an aluminium foil.  
 
Lacosamide UCB 200 mg film-coated tablets 
 
Packs of 14, 28 and 56 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil. 
Multipacks containing 168 (3 packs of 56 tablets) film-coated tablets in PVC/PVDC blister sealed 
with an aluminium foil. 
Packs of 14 x 1 and 56 x 1 film-coated tablet in PVC/PVDC perforated unit dose blisters sealed with 
an aluminium foil.  
 
Not all pack sizes may be marketed. 
 



19 

6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/004 
EU/1/19/1383/005 
EU/1/19/1383/006 
EU/1/19/1383/007 
EU/1/19/1383/008 
EU/1/19/1383/009 
EU/1/19/1383/010 
EU/1/19/1383/011 
EU/1/19/1383/012 
EU/1/19/1383/013 
EU/1/19/1383/014 
EU/1/19/1383/015 
EU/1/19/1383/016 
EU/1/19/1383/017 
EU/1/19/1383/018 
EU/1/19/1383/019 
EU/1/19/1383/020 
EU/1/19/1383/021 
EU/1/19/1383/022 
EU/1/19/1383/023 
EU/1/19/1383/024 
EU/1/19/1383/025 
EU/1/19/1383/026 
EU/1/19/1383/027 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 August 2019 
Date of latest renewal:  
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 

http://www.ema.europa.eu/


20 

1. NAME OF THE MEDICINAL PRODUCT 
 
Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) 
Lacosamide UCB 50 mg film-coated tablets 
Lacosamide UCB 100 mg film-coated tablets 
Lacosamide UCB 150 mg film-coated tablets 
Lacosamide UCB 200 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Lacosamide UCB 50 mg film-coated tablets 
 
Each film-coated tablet contains 50 mg lacosamide. 
 
Lacosamide UCB 100 mg film-coated tablets 
 
Each film-coated tablet contains 100 mg lacosamide. 
 
Lacosamide UCB 150 mg film-coated tablets 
 
Each film-coated tablet contains 150 mg lacosamide. 
 
Lacosamide UCB 200 mg film-coated tablets 
 
Each film-coated tablet contains 200 mg lacosamide. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet 
 
Lacosamide UCB 50 mg film-coated tablets 
Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed 
with ‘SP’ on one side and ‘50’ on the other side. 
 
Lacosamide UCB 100 mg film-coated tablets 
Dark yellow, oval film-coated tablets with approximate dimensions of 13.2 mm x 6.1 mm, and 
debossed with ‘SP’ on one side and ‘100’ on the other side. 
 
Lacosamide UCB 150 mg film-coated tablets 
Salmon, oval film-coated tablets with approximate dimensions of 15.1 mm x 7.0 mm, and debossed 
with ‘SP’ on one side and ‘150’ on the other side. 
 
Lacosamide UCB 200 mg film-coated tablets 
Blue, oval film-coated tablets with approximate dimensions of 16.6 mm x 7.8 mm, and debossed with 
‘SP’ on one side and ‘200’ on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Lacosamide UCB is indicated as monotherapy in the treatment of partial-onset seizures with or 
without secondary generalisation in adolescents and children from 4 years of age weighing 50 kg or 



21 

more and in adults with epilepsy.  

Lacosamide UCB is indicated as adjunctive therapy 
• in the treatment of partial-onset seizures with or without secondary generalisation in 

adolescents and children from 4 years of age weighing 50 kg or more and in adults with 
epilepsy. 

• in the treatment of primary generalised tonic-clonic seizures in adolescents and children from 
4 years of age weighing 50 kg or more and in adults with idiopathic generalised epilepsy. 

 
4.2 Posology and method of administration 
 
Posology 
 
Lacosamide must be taken twice a day (usually once in the morning and once in the evening). 
Lacosamide may be taken with or without food. 
If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to 
take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose 
within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide 
at the regularly scheduled time. Patients should not take a double dose. 
 
Adolescents and children weighing 50 kg or more, and adults 

 
Monotherapy (in the treatment of partial-onset seizures) 

The recommended starting dose is 50 mg twice a day which should be increased to an initial 
therapeutic dose of 100 mg twice a day after one week. 
Lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's 
assessment of required seizure reduction versus potential side effects. 
Depending on response and tolerability, the maintenance dose can be further increased at weekly 
intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg 
twice a day (600 mg/day).  
In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic 
medicinal product, the posology that is recommended for adjunctive therapy below should be 
followed. 
 

Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary 

generalised tonic-clonic seizures) 

The recommended starting dose is 50 mg twice a day which should be increased to an initial 
therapeutic dose of 100 mg twice a day after one week.  
Depending on response and tolerability, the maintenance dose can be further increased at weekly 
intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg 
(200 mg twice a day). 
 
Lacosamide UCB treatment initiation pack contains 4 different packages (one for each tablet strength) 
with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient’s response and 
tolerability. The packages are marked with ‘week 1 (2, 3 or 4)’. 
On the first day of treatment the patient starts with Lacosamide UCB 50 mg tablets twice a day. 
During the second week, the patient takes Lacosamide UCB 100 mg tablets twice a day. 
Depending on response and tolerability, Lacosamide UCB 150 mg tablets may be taken twice a day 
during the third week and Lacosamide UCB 200 mg tablets twice a day during the fourth week. 
 
Discontinuation 

In accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended 
this be done gradually (e.g. taper the daily dose by 200 mg/week).  
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be 
performed and if needed lacosamide should be discontinued. 
 



22 

Special populations 
 
Elderly (over 65 years of age) 

No dose reduction is necessary in elderly patients. Age associated decreased renal clearance with an 
increase in AUC levels should be considered in elderly patients (see following paragraph ‘renal 
impairment’ and section 5.2). There is limited clinical data in the elderly patients with epilepsy, 
particularly at doses greater than 400 mg/day (see sections 4.4, 4.8, and 5.1). 
 
Renal impairment 

No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric 
patients (CLCR > 30 ml/min). A maximum dose of 250 mg/day is recommended for paediatric patients 
weighing 50 kg or more and for adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or 
with end-stage renal disease. In paediatric patients weighing less than 50 kg with severe renal 
impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the 
maximum dose is recommended. For all patients requiring haemodialysis a supplement of up to 50 % 
of the divided daily dose directly after the end of haemodialysis is recommended. Treatment of 
patients with end-stage renal disease should be made with caution as there is little clinical experience 
and accumulation of a metabolite (with no known pharmacological activity). In all patients with renal 
impairment, the dose titration should be performed with caution (see section 5.2).  
 
Hepatic impairment 

A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and 
for adult patients with mild to moderate hepatic impairment.  
The dose titration in these patients should be performed with caution considering co-existing renal 
impairment. Based on data in adults, in paediatric patients weighing less than 50 kg with mild to 
moderate hepatic impairment, a reduction of 25 % of the maximum dose should be applied. The 
pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see 
section 5.2). Lacosamide should be administered to adult and paediatric patients with severe hepatic 
impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. 
The dose may need to be adjusted while carefully observing disease activity and potential side effects 
in the patient. 
 
Paediatric population 
 

Adolescents and children weighing 50 kg or more  

Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above). 
 
Children (from 4 years of age) and adolescents weighing below 50 kg 

This presentation is not suitable for this category of patients. 
 
Children less than 4 years 
The safety and efficacy of lacosamide in children aged below 4 years have not yet been established. 
No data are available. 
 
Method of administration 
 
Lacosamide film-coated tablets are for oral use. Lacosamide may be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Known second- or third-degree atrioventricular (AV) block.  
 



23 

4.4 Special warnings and precautions for use 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal 
products in several indications. A meta-analysis of randomised placebo-controlled studies of 
antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and 
behaviour. The mechanism of this risk is not known and the available data do not exclude the 
possibility of an increased risk for lacosamide. 
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate 
treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical 
advice should signs of suicidal ideation or behaviour emerge (see section 4.8). 
 
Cardiac rhythm and conduction 
 
Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies. 
Lacosamide should be used with caution in patients with underlying proarrhythmic conditions such as 
patients with known cardiac conduction problems or severe cardiac disease (e.g. myocardial 
ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or 
patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and 
sodium channel blocking antiepileptic medicinal products (see section 4.5), as well as in elderly 
patients. 
In these patients it should be considered to perform an ECG before a lacosamide dose increase above 
400 mg/day and after lacosamide is titrated to steady-state. 
 
In the placebo-controlled studies of lacosamide in epilepsy patients, atrial fibrillation or flutter were 
not reported; however, both have been reported in open-label epilepsy studies and in post-marketing 
experience. 
 
In post-marketing experience, AV block (including second degree or higher AV block) has been 
reported. In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In 
rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying 
proarrhythmic conditions. 
 
Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular 
pulse, palpitations, shortness of breath, feeling lightheaded, fainting). Patients should be counselled to 
seek immediate medical advice if these symptoms occur. 
 
Dizziness 
 
Treatment with lacosamide has been associated with dizziness which could increase the occurrence of 
accidental injury or falls. Therefore, patients should be advised to exercise caution until they are 
familiar with the potential effects of the medicine (see section 4.8). 
 
Potential for new onset or worsening of myoclonic seizures 
 
New onset or worsening of myoclonic seizures has been reported in both adult and paediatric patients 
with PGTCS, in particular during titration. In patients with more than one seizure type, the observed 
benefit of control for one seizure type should be weighed against any observed worsening in another 
seizure type. 
 
Potential for electro-clinical worsening in specific paediatric epilepsy syndromes 
 
The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal 
and generalised seizures may coexist have not been determined. 
 



24 

4.5 Interaction with other medicinal products and other forms of interaction 
 
Lacosamide should be used with caution in patients treated with medicinal products known to be 
associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) 
and in patients treated with antiarrhythmics. However, subgroup analysis in clinical studies did not 
identify an increased magnitude of PR prolongation in patients with concomitant administration of 
carbamazepine or lamotrigine. 
 
In vitro data 
 
Data generally suggest that lacosamide has a low interaction potential. In vitro studies indicate that the 
enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, 
CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP2E1 are not inhibited by lacosamide at plasma 
concentrations observed in clinical studies. An in vitro study indicated that lacosamide is not 
transported by P-glycoprotein in the intestine. In vitro data show that CYP2C9, CYP2C19 and 
CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite. 
 
In vivo data 
 
Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent. 
Lacosamide did not affect the AUC of midazolam (metabolised by CYP3A4, lacosamide given 
200 mg twice a day) but Cmax of midazolam was slightly increased (30 %). Lacosamide did not affect 
the pharmacokinetics of omeprazole (metabolised by CYP2C19 and CYP3A4, lacosamide given 
300 mg twice a day).  
The CYP2C19 inhibitor omeprazole (40 mg once daily) did not give rise to a clinically significant 
change in lacosamide exposure. Thus, moderate inhibitors of CYP2C19 are unlikely to affect systemic 
lacosamide exposure to a clinically relevant extent.  
Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (e.g. 
fluconazole) and CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead 
to increased systemic exposure of lacosamide. Such interactions have not been established in vivo but 
are possible based on in vitro data. 
 
Strong enzyme inducers such as rifampicin or St. John’s wort (Hypericum perforatum) may 
moderately reduce the systemic exposure of lacosamide. Therefore, starting or ending treatment with 
these enzyme inducers should be done with caution. 
 
Antiepileptic medicinal products 
 
In interaction studies lacosamide did not significantly affect the plasma concentrations of 
carbamazepine and valproic acid. Lacosamide plasma concentrations were not affected by 
carbamazepine and by valproic acid. Population pharmacokinetic analyses in different age groups 
estimated that concomitant treatment with other antiepileptic medicinal products known to be enzyme 
inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic 
exposure of lacosamide by 25 % in adults and 17 % in paediatric patients.  
 
Oral contraceptives 
 
In an interaction study there was no clinically relevant interaction between lacosamide and the oral 
contraceptives ethinylestradiol and levonorgestrel. Progesterone concentrations were not affected 
when the medicinal products were co-administered. 
 
Others 
 
Interaction studies showed that lacosamide had no effect on the pharmacokinetics of digoxin. There 
was no clinically relevant interaction between lacosamide and metformin.  
Co-administration of warfarin with lacosamide does not result in a clinically relevant change in the 
pharmacokinetics and pharmacodynamics of warfarin. 



25 

Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available, a 
pharmacodynamic effect cannot be excluded. 
Lacosamide has a low protein binding of less than 15 %. Therefore, clinically relevant interactions 
with other medicinal products through competition for protein binding sites are considered unlikely. 
 
4.6 Fertility, pregnancy and lactation 
 

Pregnancy 
 
Risk related to epilepsy and antiepileptic medicinal products in general  

For all antiepileptic medicinal products, it has been shown that in the offspring of treated women with 
epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 
3 % in the general population. In the treated population, an increase in malformations has been noted 
with polytherapy, however, the extent to which the treatment and/or the illness is responsible has not 
been elucidated. 
Moreover, effective antiepileptic therapy must not be interrupted, since the aggravation of the illness is 
detrimental to both the mother and the foetus. 
 
Risk related to lacosamide 

There are no adequate data from the use of lacosamide in pregnant women. Studies in animals did not 
indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits 
at maternal toxic doses (see section 5.3). The potential risk for humans is unknown. 
Lacosamide should not be used during pregnancy unless clearly necessary (if the benefit to the mother 
clearly outweighs the potential risk to the foetus). If women decide to become pregnant, the use of this 
product should be carefully re-evaluated. 
 
Breastfeeding 
 
It is unknown whether lacosamide is excreted in human breast milk. A risk to the newborns/infants 
cannot be excluded. Animal studies have shown excretion of lacosamide in breast milk. For 
precautionary measures, breast-feeding should be discontinued during treatment with lacosamide. 
 
Fertility 
 
No adverse reactions on male or female fertility or reproduction were observed in rats at doses 
producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the 
maximum recommended human dose (MRHD). 
 
4.7 Effects on ability to drive and use machines 
 
Lacosamide has minor to moderate influence on the ability to drive and use machines. Lacosamide 
treatment has been associated with dizziness or blurred vision.  
Accordingly, patients should be advised not to drive or to operate other potentially hazardous 
machinery until they are familiar with the effects of lacosamide on their ability to perform such 
activities. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Based on the analysis of pooled placebo-controlled clinical studies in adjunctive therapy in 
1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomised to lacosamide and 
35.2 % of patients randomised to placebo reported at least 1 adverse reaction. The most frequently 
reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and 
diplopia. They were usually mild to moderate in intensity. Some were dose-related and could be 
alleviated by reducing the dose. Incidence and severity of central nervous system (CNS) and 
gastrointestinal (GI) adverse reactions usually decreased over time. 



26 

In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for 
patients randomised to lacosamide and 1.6 % for patients randomised to placebo. The most common 
adverse reaction resulting in discontinuation of lacosamide therapy was dizziness.  
 
Based on the analysis of data from a non-inferiority monotherapy clinical study comparing lacosamide 
to carbamazepine controlled release (CR), the most frequently reported adverse reactions (≥10 %) for 
lacosamide were headache and dizziness. The discontinuation rate due to adverse reactions was 
10.6 % for patients treated with lacosamide and 15.6 % for patients treated with carbamazepine CR.  
 
The safety profile of lacosamide reported in a study conducted in patients aged 4 years and older with 
idiopathic generalised epilepsy with primary generalised tonic-clonic seizures (PGTCS) was consistent 
with the safety profile reported from the pooled placebo-controlled clinical studies in partial-onset 
seizures. Additional adverse reactions reported in PGTCS patients were myoclonic epilepsy (2.5 % in 
the lacosamide-group and 0 % in the placebo-group) and ataxia (3.3 % in the lacosamide-group and 
0 % in the placebo-group). The most frequently reported adverse reactions were dizziness and 
somnolence. The most common adverse reactions resulting in discontinuation of lacosamide therapy 
were dizziness and suicidal ideation. The discontinuation rate due to adverse reactions was 9.1 % in 
the lacosamide group and 4.1 % in the placebo group. 
 
Tabulated list of adverse reactions 
 
The table below shows the frequencies of adverse reactions which have been reported in clinical 
studies and post-marketing experience. The frequencies are defined as follows: very common (≥ 1/10), 
common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be 
estimated from available data). Within each frequency grouping, undesirable effects are presented in 
order of decreasing seriousness. 
 

System organ 
class 

Very 
common 

Common Uncommon Not known 

Blood and 
lymphatic 
disorders 

   Agranulocytosis(1) 

Immune system 
disorders 

  Drug 
hypersensitivity(1) 

Drug reaction with 
eosinophilia and 
systemic symptoms 
(DRESS) (1,2) 

Psychiatric 
disorders 

 Depression 
Confusional state 
Insomnia(1) 

Aggression 
Agitation(1)  
Euphoric mood(1) 

Psychotic 
disorder(1) 

Suicide attempt (1) 
Suicidal ideation 

Hallucination (1) 

 

Nervous system 
disorders 

Dizziness 
Headache 
 

Myoclonic 
seizures(3) 

Ataxia 
Balance disorder  
Memory 
impairment  
Cognitive disorder  
Somnolence 
Tremor  
Nystagmus 
Hypoesthesia 
Dysarthria 

Syncope(2) 
Coordination 
abnormal 
 

Convulsion 



27 

System organ 
class 

Very 
common 

Common Uncommon Not known 

Disturbance in 
attention 

Paraesthesia 
Eye disorders Diplopia Vision blurred   
Ear and labyrinth 
disorders 

 Vertigo 
Tinnitus 

  

Cardiac disorders   Atrioventricular 
block(1,2) 
Bradycardia(1,2) 

Atrial Fibrillation 
(1,2) 

Atrial Flutter (1,2) 

Ventricular 
tachyarrhythmia (1) 

Gastrointestinal 
disorders 

Nausea 
 

Vomiting  
Constipation 
Flatulence  
Dyspepsia 
Dry mouth 

Diarrhoea 

  

Hepatobiliary 
disorders 

  Liver function test 
abnormal(2)  
Hepatic enzyme 
increased 
(> 2x ULN) (1) 

 

Skin and 
subcutaneous 
tissue disorders 

 Pruritus 
Rash(1) 

Angioedema(1)  
Urticaria(1) 

Stevens-Johnson 
syndrome(1) 
Toxic epidermal 
necrolysis(1) 

Musculoskeletal 
and connective 
tissue disorders 

 Muscle spasms   

General disorders 
and administration 
site conditions  

 Gait disturbance 
Asthenia  
Fatigue 
Irritability 

Feeling drunk 

  

Injury, poisoning 
and procedural 
complications 

 Fall  
Skin laceration 
Contusion 

  

(1) Adverse reactions reported in post marketing experience.  
(2) See Description of selected adverse reactions.  
(3) Reported in PGTCS studies. 
 
Description of selected adverse reactions 
 
The use of lacosamide is associated with dose-related increase in the PR interval. Adverse reactions 
associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur.  
In adjunctive clinical studies in epilepsy patients, the incidence rate of reported first-degree AV Block 
is uncommon, 0.7 %, 0 %, 0.5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, 
respectively. No second- or higher degree AV Block was seen in these studies. However, cases with 
second- and third-degree AV Block associated with lacosamide treatment have been reported in post-
marketing experience. In the monotherapy clinical study comparing lacosamide to carbamazepine CR, 
the extent of increase in PR interval was comparable between lacosamide and carbamazepine. 
The incidence rate for syncope reported in pooled adjunctive therapy clinical studies is uncommon and 
did not differ between lacosamide (n=944) treated epilepsy patients (0.1 %) and placebo (n=364) 
treated epilepsy patients (0.3 %). In the monotherapy clinical study comparing lacosamide to 



28 

carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) 
carbamazepine CR patients. 
Atrial fibrillation or flutter were not reported in short term clinical studies; however, both have been 
reported in open-label epilepsy studies and in post-marketing experience. 
 
Laboratory abnormalities 

Abnormalities in liver function tests have been observed in placebo-controlled studies with lacosamide 
in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic medicinal 
products. Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide UCB patients and 
0 % (0/356) of placebo patients. 
 
Multiorgan hypersensitivity reactions 

Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic 
Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products. 
These reactions are variable in expression but typically present with fever and rash and can be 
associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is 
suspected, lacosamide should be discontinued. 
 
Paediatric population 
 
The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in open-
label studies (n=408) in adjunctive therapy in children from 4 years of age with partial-onset seizures 
was consistent with the safety profile observed in adults although the frequency of some adverse 
reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions 
(nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have 
been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence 
(14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), 
pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %). 
A total of 67.8 % of patients randomised to lacosamide and 58.1 % of patients randomised to placebo 
reported at least 1 adverse reaction. 
Behavioural, cognition and emotional functioning were measured by the questionnaires Achenbach 
CBCL and BRIEF that were applied at baseline and throughout the studies and were mainly stable 
during the course of the studies. 
 
Elderly population  
 
In the monotherapy study comparing lacosamide to carbamazepine CR, the types of adverse reactions 
related to lacosamide in elderly patients (≥ 65 years of age) appear to be similar to that observed in 
patients less than 65 years of age. However, a higher incidence (≥ 5 % difference) of fall, diarrhoea 
and tremor has been reported in elderly patients compared to younger adult patients. The most 
frequent cardiac-related adverse reaction reported in elderly compared to the younger adult population 
was first-degree AV block. This was reported with lacosamide in 4.8 % (3/62) in elderly patients 
versus 1.6 % (6/382) in younger adult patients. The discontinuation rate due to adverse events 
observed with lacosamide was 21.0 % (13/62) in elderly patients versus 9.2 % (35/382) in younger 
adult patients. These differences between elderly and younger adult patients were similar to those 
observed in the active comparator group.  
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


29 

4.9 Overdose 
 
Symptoms 
 
Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated 
with CNS and gastrointestinal system. 

 The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 
800 mg were not clinically different from those of patients administered recommended doses 
of lacosamide. 

 Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, 
seizures (generalised tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, 
shock and coma have also been observed. Fatalities have been reported in patients following 
an intake of acute single overdose of several grams of lacosamide. 

 
Management 
 
There is no specific antidote for overdose with lacosamide. Treatment of lacosamide overdose should 
include general supportive measures and may include haemodialysis if necessary (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18  
 
Mechanism of action 
 
The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a 
functionalised amino acid. 
The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be 
fully elucidated. 
In vitro electrophysiological studies have shown that lacosamide selectively enhances slow 
inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal 
membranes.  
 
Pharmacodynamic effects 
 
Lacosamide protected against seizures in a broad range of animal models of partial and primary 
generalised seizures and delayed kindling development.  
In non-clinical experiments lacosamide in combination with levetiracetam, carbamazepine, phenytoin, 
valproate, lamotrigine, topiramate or gabapentin showed synergistic or additive anticonvulsant effects. 
 
Clinical efficacy and safety (partial-onset seizures) 
Adult population 
 

Monotherapy 

Efficacy of lacosamide as monotherapy was established in a double-blind, parallel group, non-
inferiority comparison to carbamazepine CR in 886 patients 16 years of age or older with newly or 
recently diagnosed epilepsy. The patients had to present with unprovoked partial-onset seizures with 
or without secondary generalisation. The patients were randomised to carbamazepine CR or 
lacosamide, provided as tablets, in a 1:1 ratio. The dose was based on dose-response and ranged from 
400 to 1,200 mg/day for carbamazepine CR and from 200 to 600 mg/day for lacosamide. The duration 
of the treatment was up to 121 weeks depending on the response. 
The estimated 6-month seizure freedom rates were 89.8 % for lacosamide-treated patients and 91.1 % 
for carbamazepine CR treated patients using the Kaplan-Meier survival analysis method. The adjusted 
absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8). The Kaplan-Meier estimates 



30 

of 12-month seizure freedom rates were 77.8 % for lacosamide-treated patients and 82.7 % for 
carbamazepine CR treated patients. 
The 6-month seizure freedom rates in elderly patients of 65 and above (62 patients in lacosamide, 
57 patients in carbamazepine CR) were similar between both treatment groups. The rates were also 
similar to those observed in the overall population. In the elderly population, the maintenance 
lacosamide dose was 200 mg/day in 55 patients (88.7 %), 400 mg/day in 6 patients (9.7 %) and the 
dose was escalated to over 400 mg/day in 1 patient (1.6 %). 
 
Conversion to monotherapy 

The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historical-
controlled, multicentre, double-blind, randomised trial. In this study, 425 patients aged 16 to 70 years 
with uncontrolled partial-onset seizures taking stable doses of 1 or 2 marketed antiepileptic medicinal 
products were randomised to be converted to lacosamide monotherapy (either 400 mg/day or 
300 mg/day in a 3:1 ratio). In treated patients who completed titration and started withdrawing 
antiepileptic medicinal products (284 and 99 respectively), monotherapy was maintained in 71.5 % 
and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation 
period of 70 days. 
 
Adjunctive therapy 

The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) 
was established in 3 multicenter, randomised, placebo-controlled clinical studies with a 12-week 
maintenance period. Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive 
therapy studies, although the efficacy was similar to 400 mg/day and patients were less likely to 
tolerate this dose because of CNS- and gastrointestinal-related adverse reactions. Thus, the 
600 mg/day dose is not recommended. The maximum recommended dose is 400 mg/day. These 
studies, involving 1,308 patients with a history of an average of 23 years of partial-onset seizures, 
were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly 
with 1-3 antiepileptic medicinal products in patients with uncontrolled partial-onset seizures with or 
without secondary generalisation. Overall the proportion of subjects with a 50 % reduction in seizure 
frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 
400 mg/day.  
 
Paediatric population 
 
Partial-onset seizures have a similar clinical expression in children from 4 years of age and in adults. 
The efficacy of lacosamide in children aged 4 years and older has been extrapolated from data of 
adolescents and adults with partial-onset seizures, for whom a similar response was expected provided 
the paediatric dose adaptations are established (see section 4.2) and safety has been demonstrated (see 
section 4.8). 
The efficacy supported by the extrapolation principle stated above was confirmed by a double-blind, 
randomised, placebo-controlled study. The study consisted of an 8-week baseline period followed by a 
6-week titration period. Eligible patients on a stable dose regimen of 1 to ≤ 3 antiepileptic medicinal 
products, who still experienced at least 2 partial-onset seizures during the 4 weeks prior to screening 
with seizure-free phase no longer than 21 days in the 8-week period prior to entry into the baseline 
period, were randomised to receive either placebo (n=172) or lacosamide (n=171).  
Dosing was initiated at a dose of 2 mg/kg/day in subjects weighing less than 50 kg or 100 mg/day in 
subjects weighing 50 kg or more in 2 divided doses. During the titration period, lacosamide doses 
were adjusted in 1or 2 mg/kg/day increments in subjects weighing less than 50 kg or 50 or 100 mg/day 
in subjects weighing 50 kg or more at weekly intervals to achieve the target maintenance period dose 
range. 
Subjects must have achieved the minimum target dose for their body weight category for the final 
3 days of the titration period to be eligible for entry into the 10-week maintenance period. Subjects 
were to remain on stable lacosamide dose throughout the maintenance period or were withdrawn and 
entered in the blinded taper period. 
Statistically significant (p=0.0003) and clinically relevant reduction in partial-onset seizure frequency 
per 28 days from baseline to the maintenance period was observed between the lacosamide and the 



31 

placebo group. The percent reduction over placebo based on analysis of covariance was 31.72 % 
(95 % CI: 16.342, 44.277). 
Overall, the proportion of subjects with at least a 50 % reduction in partial-onset seizure frequency per 
28 days from baseline to the maintenance period was 52.9 % in the lacosamide group compared with 
33.3 % in the placebo group. 
The quality of life assessed by the Pediatric Quality of Life Inventory indicated that subjects in both 
lacosamide and placebo groups had a similar and stable health-related quality of life during the entire 
treatment period. 
 
Clinical efficacy and safety (primary generalized tonic-clonic seizures) 
 
The efficacy of lacosamide as adjunctive therapy in patients 4 years of age and older with idiopathic 
generalized epilepsy experiencing primary generalized tonic-clonic seizures (PGTCS) was established 
in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study. The 
study consisted of a 12-week historical baseline period, a 4-week prospective baseline period and a 24-
week treatment period (which included a 6-week titration period and an 18-week maintenance period). 
Eligible patients on a stable dose of 1 to 3 antiepileptic drugs experiencing at least 3 documented 
PGTCS during the 16-week combined baseline period were randomized 1 to 1 to receive lacosamide 
or placebo (patients in the full analysis set: lacosamide n=118, placebo n=121; of them 8 patients in 
the ≥ 4 to < 12 years age group and 16 patients in the ≥ 12 to < 18 years range were treated with LCM 
and 9 and 16 patients, respectively with placebo).  
Patients were titrated up to the target maintenance period dose of 12 mg/kg/day in patients weighing 
less than 30 kg, 8 mg/kg/day in patients weighing from 30 to less than 50 kg or 400 mg/day in patients 
weighing 50 kg or more.  
 

Efficacy variable 
Parameter 

Placebo 
N=121 

Lacosamide 
N=118 

Time to second PGTCS 
Median (days) 77.0 - 
95 % CI 49.0, 128.0 - 
Lacosamide – Placebo  
Hazard Ratio 0.540 
95 % CI 0.377, 0.774 
p-value < 0.001 

Seizure freedom   
Stratified Kaplan-Meier estimate (%) 17.2 31.3 
95 % CI 10.4, 24.0 22.8, 39.9 
Lacosamide – Placebo 14.1 
95 % CI 3.2, 25.1 
p-value 0.011 

Note: For the lacosamide group, the median time to second PGTCS could not be estimated by Kaplan-
Meier methods because ˃ 50% of patients did not experience a second PGTCS by Day 166. 
 
The findings in the pediatric subgroup were consistent with the results of the overall population for the 
primary, secondary and other efficacy endpoints.  
 
5.2 Pharmacokinetic properties 
 
Absorption  
 
Lacosamide is rapidly and completely absorbed after oral administration. The oral bioavailability of 
lacosamide tablets is approximately 100 %. Following oral administration, the plasma concentration of 
unchanged lacosamide increases rapidly and reaches Cmax about 0.5 to 4 hours post-dose. Lacosamide 
UCB tablets and oral syrup are bioequivalent. Food does not affect the rate and extent of absorption. 
 



32 

Distribution 
 
The volume of distribution is approximately 0.6 L/kg. Lacosamide is less than 15 % bound to plasma 
proteins. 
 
Biotransformation 
 
95 % of the dose is excreted in the urine as lacosamide and metabolites. The metabolism of 
lacosamide has not been completely characterised.  
The major compounds excreted in urine are unchanged lacosamide (approximately 40 % of the dose) 
and its O-desmethyl metabolite less than 30 %.  
A polar fraction proposed to be serine derivatives accounted for approximately 20 % in urine, but was 
detected only in small amounts (0-2 %) in human plasma of some subjects. Small amounts (0.5-2 %) 
of additional metabolites were found in the urine.  
In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of 
the O-desmethyl metabolite but the main contributing isoenzyme has not been confirmed in vivo. No 
clinically relevant difference in lacosamide exposure was observed comparing its pharmacokinetics in 
extensive metabolisers (EMs, with a functional CYP2C19) and poor metabolisers (PMs, lacking a 
functional CYP2C19). Furthermore an interaction study with omeprazole (CYP2C19-inhibitor) 
demonstrated no clinically relevant changes in lacosamide plasma concentrations indicating that the 
importance of this pathway is minor. The plasma concentration of O-desmethyl-lacosamide is 
approximately 15 % of the concentration of lacosamide in plasma. This major metabolite has no 
known pharmacological activity. 
 
Elimination 
 
Lacosamide is primarily eliminated from the systemic circulation by renal excretion and 
biotransformation. After oral and intravenous administration of radiolabeled lacosamide, 
approximately 95 % of radioactivity administered was recovered in the urine and less than 0.5 % in the 
faeces. The elimination half-life of lacosamide is approximately 13 hours. The pharmacokinetics is 
dose-proportional and constant over time, with low intra- and inter-subject variability. Following twice 
daily dosing, steady state plasma concentrations are achieved after a 3 day period. The plasma 
concentration increases with an accumulation factor of approximately 2. 
 
Pharmacokinetics in special patient groups 
 
Gender 

Clinical studies indicate that gender does not have a clinically significant influence on the plasma 
concentrations of lacosamide. 
 
Renal impairment 

The AUC of lacosamide was increased by approximately 30 % in mildly and moderately and 60 % in 
severely renal impaired patients and patients with end-stage renal disease requiring haemodialysis 
compared to healthy subjects, whereas Cmax was unaffected.  
Lacosamide is effectively removed from plasma by haemodialysis. Following a 4-hour haemodialysis 
treatment, AUC of lacosamide is reduced by approximately 50 %. Therefore, dosage supplementation 
following haemodialysis is recommended (see section 4.2). The exposure of the O-desmethyl 
metabolite was several-fold increased in patients with moderate and severe renal impairment. In 
absence of haemodialysis in patients with end-stage renal disease, the levels were increased and 
continuously rising during the 24-hour sampling. It is unknown whether the increased metabolite 
exposure in end-stage renal disease subjects could give rise to adverse effects but no pharmacological 
activity of the metabolite has been identified. 
 
Hepatic impairment 

Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of 
lacosamide (approximately 50 % higher AUCnorm). The higher exposure was partly due to a reduced 



33 

renal function in the studied subjects. The decrease in non-renal clearance in the patients of the study 
was estimated to give a 20 % increase in the AUC of lacosamide. The pharmacokinetics of lacosamide 
has not been evaluated in severe hepatic impairment (see section 4.2). 
 
Elderly (over 65 years of age) 

In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 
50 % increased compared to young men, respectively. This is partly related to lower body weight. The 
body weight normalized difference is 26 and 23 %, respectively. An increased variability in exposure 
was also observed. The renal clearance of lacosamide was only slightly reduced in elderly subjects in 
this study.  
A general dose reduction is not considered to be necessary unless indicated due to reduced renal 
function (see section 4.2). 
 
Paediatric population 
The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic 
analysis using sparse plasma concentration data obtained in one placebo-controlled randomised study 
and three open-label studies in 414 children with epilepsy aged 6 months to 17 years. The 
administered lacosamide doses ranged from 2 to 17.8 mg/kg/day in twice daily intake, with a 
maximum of 600 mg/day for children weighing 50 kg or more. 
The typical plasma clearance was estimated to be 1.04 L/h, 1.32 L/h and 1.86 L/h for children 
weighing 20 kg, 30 kg and 50 kg respectively. In comparison, plasma clearance was estimated at 
1.92 L/h in adults (70 kg body weight). 
Population pharmacokinetic analysis using sparse pharmacokinetic samples from PGTCS study 
showed a similar exposure in patients with PGTCS and in patients with partial-onset seizures. 
 
5.3 Preclinical safety data 
 
In the toxicity studies, the plasma concentrations of lacosamide obtained were similar or only 
marginally higher than those observed in patients, which leaves low or non-existing margins to human 
exposure. 
A safety pharmacology study with intravenous administration of lacosamide in anesthetised dogs 
showed transient increases in PR interval and QRS complex duration and decreases in blood pressure 
most likely due to a cardiodepressant action. These transient changes started in the same concentration 
range as after maximum recommended clinical dosing. In anesthetised dogs and Cynomolgus 
monkeys, at intravenous doses of 15-60 mg/kg, slowing of atrial and ventricular conductivity, 
atrioventricular block and atrioventricular dissociation were seen. 
In the repeated dose toxicity studies, mild reversible liver changes were observed in rats starting at 
about 3 times the clinical exposure. These changes included an increased organ weight, hypertrophy of 
hepatocytes, increases in serum concentrations of liver enzymes and increases in total cholesterol and 
triglycerides. Apart from the hypertrophy of hepatocytes, no other histopathologic changes were 
observed. 
In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but an 
increase in numbers of stillborn pups and pup deaths in the peripartum period, and slightly reduced 
live litter sizes and pup body weights were observed at maternal toxic doses in rats corresponding to 
systemic exposure levels similar to the expected clinical exposure. Since higher exposure levels could 
not be tested in animals due to maternal toxicity, data are insufficient to fully characterise the 
embryofetotoxic and teratogenic potential of lacosamide. 
Studies in rats revealed that lacosamide and/or its metabolites readily crossed the placental barrier. 
In juvenile rats and dogs, the types of toxicity do not differ qualitatively from those observed in adult 
animals. In juvenile rats, a reduced body weight was observed at systemic exposure levels similar to 
the expected clinical exposure. In juvenile dogs, transient and dose-related CNS clinical signs started 
to be observed at systemic exposure levels below the expected clinical exposure. 
 
 



34 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
microcrystalline cellulose 
hydroxypropylcellulose 
hydroxypropylcellulose (low substituted) 
silica, colloidal, anhydrous  
crospovidone (polyplasdone XL-10 Pharmaceutical Grade) 
magnesium stearate 
 
Tablet coat 
 
polyvinyl alcohol 
polyethylene glycol 3350 
talc 
titanium dioxide (E171) 
 
Lacosamide UCB 50 mg film-coated tablets: red iron oxide (E172), black iron oxide (E172), indigo 
carmine aluminium lake (E132) 
Lacosamide UCB 100 mg film-coated tablets: yellow iron oxide (E172) 
Lacosamide UCB 150 mg film-coated tablets: yellow iron oxide (E172), red iron oxide (E172), black 
iron oxide (E172) 
Lacosamide UCB 200 mg film-coated tablets: indigo carmine aluminium lake (E132) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
5 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
PVC/PVDC blister sealed with an aluminium foil. 
The treatment initiation pack contains 4 cartons, each carton with 14 Lacosamide UCB film-coated 
tablets of 50 mg, 100 mg, 150 mg and 200 mg. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 



35 

 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/028 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 August 2019 
Date of latest renewal:  
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 

http://www.ema.europa.eu/


36 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 10 mg/ml syrup 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml of syrup contains 10 mg lacosamide. 
1 bottle of 200 ml contains 2,000 mg lacosamide. 
 
Excipients with known effect: 
Each ml of Lacosamide UCB syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl 
parahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg sodium, and 
0.032 mg aspartame (E951).  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Syrup. 
A slightly viscous clear, colourless to yellow-brown liquid. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Lacosamide UCB is indicated as monotherapy in the treatment of partial-onset seizures with or 
without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.  

Lacosamide UCB is indicated as adjunctive therapy 
• in the treatment of partial-onset seizures with or without secondary generalisation in adults, 

adolescents and children from 4 years of age with epilepsy. 
• in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and 

children from 4 years of age with idiopathic generalised epilepsy. 
 
4.2 Posology and method of administration 
 
Posology 
 
Lacosamide must be taken twice a day (usually once in the morning and once in the evening). 
Lacosamide may be taken with or without food. 
If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to 
take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose 
within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide 
at the regularly scheduled time. Patients should not take a double dose. 
 
Adolescents and children weighing 50 kg or more, and adults 

 
The following table summarises the recommended posology for adolescents and children weighing 
50 kg or more, and for adults. More details are provided in the table below. 
 



37 

 Monotherapy Adjunctive therapy 
Starting dose 
 

100 mg/day or 200 mg/day 100 mg/day 

Single loading dose  
(if applicable) 

200 mg 200 mg 

Titration (incremental steps) 50 mg twice a day (100 mg/day) 
at weekly intervals 

50 mg twice a day (100 mg/day) 
at weekly intervals 

Maximum recommended dose up to 600 mg/day up to 400 mg/day 
 
Monotherapy (in the treatment of partial-onset seizures) 

The recommended starting dose is 50 mg twice a day which should be increased to an initial 
therapeutic dose of 100 mg twice a day after one week. 
Lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's 
assessment of required seizure reduction versus potential side effects. 
Depending on response and tolerability, the maintenance dose can be further increased at weekly 
intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg 
twice a day (600 mg/day).  
In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic 
medicinal product, the posology that is recommended for adjunctive therapy below should be 
followed. 
 
Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary 

generalised tonic-clonic seizures) 

The recommended starting dose is 50 mg twice a day which should be increased to an initial 
therapeutic dose of 100 mg twice a day after one week.  
Depending on response and tolerability, the maintenance dose can be further increased at weekly 
intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg 
(200 mg twice a day).  
 
Initiation of lacosamide treatment with a loading dose (initial monotherapy or conversion to 

monotherapy in the treatment of partial-onset seizures or adjunctive therapy in the treatment of 

partial-onset seizures or adjunctive therapy in the treatment of primary generalised tonic-clonic 

seizures) 

Lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed 
approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. 
Subsequent dose adjustments should be performed according to individual response and tolerability as 
described above. A loading dose may be initiated in patients in situations when the physician 
determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic 
effect is warranted. It should be administered under medical supervision with consideration of the 
potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse 
reactions (see section 4.8). Administration of a loading dose has not been studied in acute conditions 
such as status epilepticus. 
 
Discontinuation 

In accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended 
this be done gradually (e.g. taper the daily dose by 200 mg/week).  
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be 
performed and if needed lacosamide should be discontinued. 
 
Special populations 
 
Elderly (over 65 years of age) 

No dose reduction is necessary in elderly patients. Age associated decreased renal clearance with an 
increase in AUC levels should be considered in elderly patients (see following paragraph ‘renal 
impairment’ and section 5.2). There is limited clinical data in the elderly patients with epilepsy, 
particularly at doses greater than 400 mg/day (see sections 4.4, 4.8, and 5.1). 



38 

 
Renal impairment 

No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric 
patients (CLCR > 30 ml/min). In paediatric patients weighing 50 kg or more and in adult patients with 
mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose 
titration (> 200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or 
more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal 
disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed 
with caution. If a loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily 
regimen for the first week should be used. In paediatric patients weighing less than 50 kg with severe 
renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of 
the maximum dose is recommended. For all patients requiring haemodialysis a supplement of up to 
50 % of the divided daily dose directly after the end of haemodialysis is recommended. Treatment of 
patients with end-stage renal disease should be made with caution as there is little clinical experience 
and accumulation of a metabolite (with no known pharmacological activity).  
 
Hepatic impairment 

A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and 
for adult patients with mild to moderate hepatic impairment.  
The dose titration in these patients should be performed with caution considering co-existing renal 
impairment. In adolescents and adults weighing 50 kg or more, a loading dose of 200 mg may be 
considered, but further dose titration (> 200 mg daily) should be performed with caution. Based on 
data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic 
impairment a reduction of 25 % of the maximum dose should be applied. The pharmacokinetics of 
lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2). Lacosamide 
should be administered to adult and paediatric patients with severe hepatic impairment only when the 
expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be 
adjusted while carefully observing disease activity and potential side effects in the patient. 
 
Paediatric population 
 

The physician should prescribe the most appropriate formulation and strength according to weight and 
dose.  
 
Adolescents and children weighing 50 kg or more 

Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above). 
 
Children (from 4 years of age) and adolescents weighing less than 50 kg 

The dose is determined based on body weight. It is therefore recommended to initiate treatment with 
the syrup and switch to tablets, if desired. When prescribing the syrup the dose should be expressed in 
volume (ml) rather than weight (mg). 
 

Monotherapy (in the treatment of partial-onset seizures) 

The recommended starting dose is 2 mg/kg/day which should be increased to an initial therapeutic 
dose of 4 mg/kg/day after one week. 
Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day 
every week. The dose should be gradually increased until the optimum response is obtained. In 
children weighing less than 40 kg, a maximum dose of up to 12 mg/kg/day is recommended. In 
children weighing from 40 to under 50 kg, a maximum dose of 10 mg/kg/day is recommended. 
 



39 

The following table summarises the recommended posology in monotherapy for children and 
adolescents weighing less than 50 kg. 

Starting dose 
 

2 mg/kg/day  

Single loading dose  Not recommended 
Titration (incremental steps) 2 mg/kg/day every week 
Maximum recommended dose in patients < 40 kg up to 12 mg/kg/day 
Maximum recommended dose in patients ≥ 40 kg 
to < 50 kg 

up to 10 mg/kg/day 

 
The tables below provide examples of volumes of syrup per intake depending on prescribed dose and 
body weight. The precise volume of syrup is to be calculated according to the exact body weight of the 
child. 
 
Monotherapy doses to be taken twice daily for children from 4 years of age weighing less than 
40 kg(1): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting 
dose 

0.2 ml/kg  
(2 mg/kg) 
 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg) 

0.5 ml/kg 
(5 mg/kg) 

0.6 ml/kg 
(6 mg/kg) 
Maximum 
recommended 
dose 

10 kg 1 ml  
(10 mg) 

2 ml  
(20 mg) 

3 ml  
(30 mg) 

4 ml  
(40 mg) 

5 ml  
(50 mg) 

6 ml  
(60 mg) 

15 kg 1.5 ml  
(15 mg) 

3 ml  
(30 mg) 

4.5 ml  
(45 mg) 

6 ml  
(60 mg) 

7.5 ml  
(75 mg) 

9 ml  
(90 mg) 

20 kg 2 ml  
(20 mg) 

4 ml  
(40 mg) 

6 ml  
(60 mg) 

8 ml  
(80 mg) 

10 ml  
(100 mg) 

12 ml  
(120 mg) 

25 kg 2.5 ml  
(25 mg) 

5 ml  
(50 mg) 

7.5 ml  
(75 mg) 

10 ml  
(100 mg) 

12.5 ml  
(125 mg) 

15 ml  
(150 mg) 

30 kg 3 ml  
(30 mg) 

6 ml  
(60 mg) 

9 ml  
(90 mg) 

12 ml  
(120 mg) 

15 ml  
(150 mg) 

18 ml  
(180 mg) 

35 kg 3.5 ml  
(35 mg) 

7 ml  
(70 mg) 

10.5 ml  
(105 mg) 

14 ml  
(140 mg) 

17.5 ml  
(175 mg) 

21 ml  
(210 mg) 

(1) children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup. 
 
Monotherapy doses to be taken twice daily for children and adolescents from 4 years of age 
weighing 40 kg to under 50 kg(1) (2): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting dose 

0.2 ml/kg  
(2 mg/kg) 
 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg) 

0.5 ml/kg 
(5 mg/kg)  
Maximum 
recommended 
dose 

40 kg 4 ml  
(40 mg) 

8 ml  
(80 mg) 

12 ml  
(120 mg) 

16 ml  
(160 mg) 

20 ml  
(200 mg) 

45 kg 4.5 ml  
(45 mg) 

9 ml  
(90 mg) 

13.5 ml  
(135 mg) 

18 ml  
(180 mg) 

22.5 ml  
(225 mg) 

(1) children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup 
(2) Dosage in adolescents 50 kg or more is the same as in adults. 

 

Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary 

generalised tonic-clonic seizures) 

The recommended starting dose is 2 mg/kg/day which should be increased to an initial therapeutic 
dose of 4 mg/kg/day after one week. 
Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day 
every week. The dose should be gradually adjusted until the optimum response is obtained. In children 
weighing less than 20 kg, due to an increased clearance compared to adults, a maximum dose of up to 



40 

12 mg/kg/day is recommended. In children weighing from 20 to under 30 kg, a maximum dose of 
10 mg/kg/day is recommended and in children weighing from 30 to under 50 kg a maximum dose of 
8 mg/kg/day is recommended, although in open-label studies (see sections 4.8 and 5.2), a dose up to 
12 mg/kg/day has been used by a small number of these children.  
 
The following table summarises the recommended posology in adjunctive therapy for children and 
adolescents weighing less than 50 kg. 

Starting dose 
 

2 mg/kg/day  

Single loading dose  Not recommended 
Titration (incremental steps) 2 mg/kg/day every week 
Maximum recommended dose in patients to 
< 20 kg 

up to 12 mg/kg/day 

Maximum recommended dose in patients ≥ 20 kg 
to < 30 kg 

up to 10 mg/kg/day 

Maximum recommended dose in patients ≥ 30 kg 
to < 50 kg  

up to 8 mg/kg/day  

 
The tables below provide examples of volumes of syrup per intake depending on prescribed dose and 
body weight. The precise volume of syrup is to be calculated according to the exact body weight of the 
child. 
 
Adjunctive therapy doses to be taken twice daily for children from 4 years of age weighing less than 
20 kg(1): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting 
dose 

0.2 ml/kg  
(2 mg/kg) 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg) 

0.5 ml/kg 
(5 mg/kg) 

0.6 ml/kg 
(6 mg/kg) 
Maximum 
recommended 
dose 

10 kg 1 ml  
(10 mg) 

2 ml  
(20 mg) 

3 ml  
(30 mg) 

4 ml  
(40 mg) 

5 ml  
(50 mg) 

6 ml  
(60 mg) 

15 kg 1.5 ml  
(15 mg) 

3 ml  
(30 mg) 

4.5 ml  
(45 mg) 

6 ml  
(60 mg) 

7.5 ml  
(75 mg) 

9 ml  
(90 mg) 

(1) children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup 
 
Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age 
weighing 20 kg to under 30 kg(1): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting dose 

0.2 ml/kg  
(2 mg/kg) 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg)  
 

0.5 ml/kg 
(5 mg/kg)  
Maximum 
recommended 
dose 

20 kg 2 ml  
(20 mg) 

4 ml  
(40 mg) 

6 ml  
(60 mg) 

8 ml  
(80 mg) 

10 ml  
(100 mg) 

25 kg 2.5 ml  
(25 mg) 

5 ml  
(50 mg) 

7.5 ml  
(75 mg) 

10 ml  
(100 mg) 

12.5 ml  
(125 mg) 

(1) children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 
10 mg/ml syrup 

 

 



41 

Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age 
weighing 30 kg to under 50 kg(1): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting dose 

0.2 ml/kg  
(2 mg/kg) 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg)  
Maximum 
recommended dose 

30 kg 3 ml (30 mg) 6 ml (60 mg) 9 ml (90 mg) 12 ml (120 mg) 
35 kg 3.5 ml (35 mg) 7 ml (70 mg) 10.5 ml (105 mg) 14 ml (140 mg) 
40 kg 4 ml (40 mg) 8 ml (80 mg) 12 ml (120 mg) 16 ml (160 mg) 
45 kg 4.5 ml (45 mg) 9 ml (90 mg) 13.5 ml (135 mg) 18 ml (180 mg) 
(1) children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup 

 
Loading dose 

Administration of a loading dose has not been studied in children. Use of a loading dose is not 
recommended in adolescents and children weighing less than 50 kg. 
 
Children less than 4 years 

The safety and efficacy of lacosamide in children aged below 4 years have not yet been established. 
No data are available. 
 
Method of administration 
 
Lacosamide syrup must be taken orally.  
 
The bottle containing Lacosamide UCB syrup should be shaken well before use. Lacosamide may be 
taken with or without food. 
Lacosamide syrup is provided with a measuring cup with graduation marks (for patients weighing 
50 kg or more) and with an oral syringe with an adaptor (for patients weighing less than 50 kg).  
 
Measuring cup (for adolescents and children weighing 50 kg or more, and adults) 
Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg lacosamide.  
 
Dosing oral syringe (10 ml graduated every 0.25 ml) with an adaptor (for children and adolescents 

from 4 years of age weighing less than 50 kg) 
One full oral syringe (10 ml) corresponds to 100 mg of lacosamide. The minimum extractable volume 
is 1 ml which is 10 mg of lacosamide. As from the 1 ml graduation mark, each graduation corresponds 
to 0.25 ml which is 2.5 mg of lacosamide. 
 
Instructions for use are provided in the package leaflet.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Known second- or third-degree atrioventricular (AV) block.  
 
4.4 Special warnings and precautions for use 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal 
products in several indications. A meta-analysis of randomised placebo-controlled studies of 
antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and 
behaviour. The mechanism of this risk is not known and the available data do not exclude the 
possibility of an increased risk for lacosamide. 
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate 
treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical 



42 

advice should signs of suicidal ideation or behaviour emerge (see section 4.8). 
 
Cardiac rhythm and conduction 
 
Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies. 
Lacosamide should be used with caution in patients with underlying proarrhythmic conditions such as 
patients with known cardiac conduction problems or severe cardiac disease (e.g. myocardial 
ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or 
patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and 
sodium channel blocking antiepileptic medicinal products (see section 4.5), as well as in elderly 
patients. 
In these patients it should be considered to perform an ECG before a lacosamide dose increase above 
400 mg/day and after lacosamide is titrated to steady-state. 
 
In the placebo-controlled studies of lacosamide in epilepsy patients, atrial fibrillation or flutter were 
not reported; however, both have been reported in open-label epilepsy studies and in post-marketing 
experience. 
 
In post-marketing experience, AV block (including second degree or higher AV block) has been 
reported. In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In 
rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying 
proarrhythmic conditions. 
 
Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular 
pulse, palpitations, shortness of breath, feeling lightheaded, fainting). Patients should be counselled to 
seek immediate medical advice if these symptoms occur. 
 
Dizziness 
 
Treatment with lacosamide has been associated with dizziness which could increase the occurrence of 
accidental injury or falls. Therefore, patients should be advised to exercise caution until they are 
familiar with the potential effects of the medicine (see section 4.8). 
 
Potential for new onset or worsening of myoclonic seizures 
 
New onset or worsening of myoclonic seizures has been reported in both adult and paediatric patients 
with PGTCS, in particular during titration. In patients with more than one seizure type, the observed 
benefit of control for one seizure type should be weighed against any observed worsening in another 
seizure type. 
 
Potential for electro-clinical worsening in specific paediatric epilepsy syndromes 
 
The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal 
and generalised seizures may coexist have not been determined. 
 
Excipients 
 
Excipients which may cause intolerance 
Lacosamide UCB syrup contains sodium methyl parahydroxybenzoate (E219), which may cause 
allergic reactions (possibly delayed). 
Lacosamide UCB syrup contains sorbitol (E420). Patients with rare hereditary problems of fructose 
intolerance should not take this medicine. Sorbitol may cause gastrointestinal discomfort and mild 
laxative effect. 
Lacosamide UCB syrup contains aspartame (E951), a source of phenylalanine, which may be harmful 
for people with phenylketonuria.  
Lacosamide UCB syrup contains propylene glycol (E1520). 
 



43 

Sodium content 

Lacosamide UCB syrup contains 1.42 mg sodium per ml, equivalent to 0.07 % of the WHO 
recommended maximum daily intake of 2 g sodium for an adult. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Lacosamide should be used with caution in patients treated with medicinal products known to be 
associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) 
and in patients treated with antiarrhythmics. However, subgroup analysis in clinical studies did not 
identify an increased magnitude of PR prolongation in patients with concomitant administration of 
carbamazepine or lamotrigine. 
 

In vitro data 
 
Data generally suggest that lacosamide has a low interaction potential. In vitro studies indicate that the 
enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, 
CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP2E1 are not inhibited by lacosamide at plasma 
concentrations observed in clinical studies. An in vitro study indicated that lacosamide is not 
transported by P-glycoprotein in the intestine. In vitro data show that CYP2C9, CYP2C19 and 
CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite. 
 

In vivo data 
 
Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent. 
Lacosamide did not affect the AUC of midazolam (metabolised by CYP3A4, lacosamide given 
200 mg twice a day) but Cmax of midazolam was slightly increased (30 %). Lacosamide did not affect 
the pharmacokinetics of omeprazole (metabolised by CYP2C19 and CYP3A4, lacosamide given 
300 mg twice a day).  
The CYP2C19 inhibitor omeprazole (40 mg once daily) did not give rise to a clinically significant 
change in lacosamide exposure. Thus, moderate inhibitors of CYP2C19 are unlikely to affect systemic 
lacosamide exposure to a clinically relevant extent. 
Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (e.g. 
fluconazole) and CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead 
to increased systemic exposure of lacosamide. Such interactions have not been established in vivo but 
are possible based on in vitro data. 
 
Strong enzyme inducers such as rifampicin or St. John’s wort (Hypericum perforatum) may 
moderately reduce the systemic exposure of lacosamide. Therefore, starting or ending treatment with 
these enzyme inducers should be done with caution. 
 
Antiepileptic medicinal products 
 
In interaction studies lacosamide did not significantly affect the plasma concentrations of 
carbamazepine and valproic acid. Lacosamide plasma concentrations were not affected by 
carbamazepine and by valproic acid. Population pharmacokinetic analyses in different age groups 
estimated that concomitant treatment with other antiepileptic medicinal products known to be enzyme 
inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic 
exposure of lacosamide by 25 % in adults and 17 % in paediatric patients.  
 
Oral contraceptives 
 
In an interaction study there was no clinically relevant interaction between lacosamide and the oral 
contraceptives ethinylestradiol and levonorgestrel. Progesterone concentrations were not affected 
when the medicinal products were co-administered. 
 



44 

Others 
 
Interaction studies showed that lacosamide had no effect on the pharmacokinetics of digoxin. There 
was no clinically relevant interaction between lacosamide and metformin.  
Co-administration of warfarin with lacosamide does not result in a clinically relevant change in the 
pharmacokinetics and pharmacodynamics of warfarin. 
Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available, a 
pharmacodynamic effect cannot be excluded. 
Lacosamide has a low protein binding of less than 15 %. Therefore, clinically relevant interactions 
with other medicinal products through competition for protein binding sites are considered unlikely. 
 
4.6 Fertility, pregnancy and lactation 
 

Pregnancy 
 
Risk related to epilepsy and antiepileptic medicinal products in general  

For all antiepileptic medicinal products, it has been shown that in the offspring of treated women with 
epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 
3 % in the general population. In the treated population, an increase in malformations has been noted 
with polytherapy, however, the extent to which the treatment and/or the illness is responsible has not 
been elucidated. 
Moreover, effective antiepileptic therapy must not be interrupted, since the aggravation of the illness is 
detrimental to both the mother and the foetus. 
 
Risk related to lacosamide 

There are no adequate data from the use of lacosamide in pregnant women. Studies in animals did not 
indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits 
at maternal toxic doses (see section 5.3). The potential risk for humans is unknown. 
Lacosamide should not be used during pregnancy unless clearly necessary (if the benefit to the mother 
clearly outweighs the potential risk to the foetus). If women decide to become pregnant, the use of this 
product should be carefully re-evaluated. 
 
Breastfeeding 
 
It is unknown whether lacosamide is excreted in human breast milk. A risk to the newborns/infants 
cannot be excluded. Animal studies have shown excretion of lacosamide in breast milk. For 
precautionary measures, breast-feeding should be discontinued during treatment with lacosamide. 
 
Fertility 
 
No adverse reactions on male or female fertility or reproduction were observed in rats at doses 
producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the 
maximum recommended human dose (MRHD). 
 
4.7 Effects on ability to drive and use machines 
 
Lacosamide has minor to moderate influence on the ability to drive and use machines. Lacosamide 
treatment has been associated with dizziness or blurred vision.  
Accordingly, patients should be advised not to drive or to operate other potentially hazardous 
machinery until they are familiar with the effects of lacosamide on their ability to perform such 
activities. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Based on the analysis of pooled placebo-controlled clinical studies in adjunctive therapy in 



45 

1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomised to lacosamide and 
35.2 % of patients randomised to placebo reported at least 1 adverse reaction. The most frequently 
reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and 
diplopia. They were usually mild to moderate in intensity. Some were dose-related and could be 
alleviated by reducing the dose. Incidence and severity of central nervous system (CNS) and 
gastrointestinal (GI) adverse reactions usually decreased over time. 
In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for 
patients randomised to lacosamide and 1.6 % for patients randomised to placebo. The most common 
adverse reaction resulting in discontinuation of lacosamide therapy was dizziness.  
Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. 
 
Based on the analysis of data from a non-inferiority monotherapy clinical study comparing lacosamide 
to carbamazepine controlled release (CR), the most frequently reported adverse reactions (≥ 10 %) for 
lacosamide were headache and dizziness. The discontinuation rate due to adverse reactions was 
10.6 % for patients treated with lacosamide and 15.6 % for patients treated with carbamazepine CR.  
 
The safety profile of lacosamide reported in a study conducted in patients aged 4 years and older with 
idiopathic generalised epilepsy with primary generalised tonic-clonic seizures (PGTCS) was consistent 
with the safety profile reported from the pooled placebo-controlled clinical studies in partial-onset 
seizures. Additional adverse reactions reported in PGTCS patients were myoclonic epilepsy (2.5 % in 
the lacosamide-group and 0 % in the placebo-group) and ataxia (3.3 % in the lacosamide-group and 
0 % in the placebo-group). The most frequently reported adverse reactions were dizziness and 
somnolence. The most common adverse reactions resulting in discontinuation of lacosamide therapy 
were dizziness and suicidal ideation. The discontinuation rate due to adverse reactions was 9.1 % in 
the lacosamide group and 4.1 % in the placebo group. 
 
Tabulated list of adverse reactions 
 
The table below shows the frequencies of adverse reactions which have been reported in clinical 
studies and post-marketing experience. The frequencies are defined as follows: very common (≥ 1/10), 
common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be 
estimated from available data). Within each frequency grouping, undesirable effects are presented in 
order of decreasing seriousness. 
 

System organ 
class 

Very 
common 

Common Uncommon Not known 

Blood and 
lymphatic 
disorders 

   Agranulocytosis(1) 

Immune system 
disorders 

  Drug 
hypersensitivity(1) 

Drug reaction with 
eosinophilia and 
systemic symptoms 
(DRESS) (1,2) 

Psychiatric 
disorders 

 Depression 
Confusional state 

Insomnia(1) 

Aggression 
Agitation(1)  
Euphoric mood(1) 

Psychotic 
disorder(1) 

Suicide attempt (1) 
Suicidal ideation 

Hallucination (1) 

 



46 

System organ 
class 

Very 
common 

Common Uncommon Not known 

Nervous system 
disorders 

Dizziness 
Headache 
 

Myoclonic 
seizures(3) 

Ataxia 
Balance disorder  
Memory 
impairment  
Cognitive disorder  
Somnolence 
Tremor  
Nystagmus 
Hypoesthesia  
Dysarthria 
Disturbance in 
attention 
Paraesthesia 

Syncope(2) 
Coordination 
abnormal 
 

Convulsion 

Eye disorders Diplopia Vision blurred   
Ear and labyrinth 
disorders 

 Vertigo 
Tinnitus 

  

Cardiac disorders   Atrioventricular 
block(1,2) 
Bradycardia(1,2) 

Atrial Fibrillation 
(1,2) 

Atrial Flutter (1,2) 

Ventricular 
tachyarrhythmia (1) 

Gastrointestinal 
disorders 

Nausea 
 

Vomiting  
Constipation 
Flatulence  
Dyspepsia 
Dry mouth 

Diarrhoea 

  

Hepatobiliary 
disorders 

  Liver function test 
abnormal(2)  
Hepatic enzyme 
increased 
(> 2x ULN) (1) 

 

Skin and 
subcutaneous 
tissue disorders 

 Pruritus 
Rash(1) 

Angioedema(1)  
Urticaria(1) 

Stevens-Johnson 
syndrome(1) 
Toxic epidermal 
necrolysis(1) 

Musculoskeletal 
and connective 
tissue disorders 

 Muscle spasms   

General disorders 
and administration 
site conditions  

 Gait disturbance 
Asthenia  
Fatigue 
Irritability 

Feeling drunk 

  

Injury, poisoning 
and procedural 
complications 

 Fall  
Skin laceration 
Contusion 

  

(1) Adverse reactions reported in post marketing experience.  
(2) See Description of selected adverse reactions.  
(3) Reported in PGTCS studies. 
 



47 

Description of selected adverse reactions 
 
The use of lacosamide is associated with dose-related increase in the PR interval. Adverse reactions 
associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur.  
In adjunctive clinical studies in epilepsy patients, the incidence rate of reported first-degree AV Block 
is uncommon, 0.7 %, 0 %, 0.5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, 
respectively. No second- or higher degree AV Block was seen in these studies. However, cases with 
second- and third-degree AV Block associated with lacosamide treatment have been reported in post-
marketing experience. In the monotherapy clinical study comparing lacosamide to carbamazepine CR, 
the extent of increase in PR interval was comparable between lacosamide and carbamazepine. 
The incidence rate for syncope reported in pooled adjunctive therapy clinical studies is uncommon and 
did not differ between lacosamide (n=944) treated epilepsy patients (0.1 %) and placebo (n=364) 
treated epilepsy patients (0.3 %). In the monotherapy clinical study comparing lacosamide to 
carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) 
carbamazepine CR patients. 
Atrial fibrillation or flutter were not reported in short term clinical studies; however, both have been 
reported in open-label epilepsy studies and in post-marketing experience. 
 
Laboratory abnormalities 

Abnormalities in liver function tests have been observed in placebo-controlled studies with lacosamide 
in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic medicinal 
products. Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide UCB patients and 
0 % (0/356) of placebo patients. 
 
Multiorgan hypersensitivity reactions 

Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic 
Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products. 
These reactions are variable in expression but typically present with fever and rash and can be 
associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is 
suspected, lacosamide should be discontinued. 
 
Paediatric population 
 
The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in open-
label studies (n=408) in adjunctive therapy in children from 4 years of age with partial-onset seizures 
was consistent with the safety profile observed in adults although the frequency of some adverse 
reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions 
(nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have 
been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence 
(14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), 
pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %). 
A total of 67.8 % of patients randomised to lacosamide and 58.1 % of patients randomised to placebo 
reported at least 1 adverse reaction. 
Behavioural, cognition and emotional functioning were measured by the questionnaires Achenbach 
CBCL and BRIEF that were applied at baseline and throughout the studies and were mainly stable 
during the course of the studies. 
 
Elderly population  
 
In the monotherapy study comparing lacosamide to carbamazepine CR, the types of adverse reactions 
related to lacosamide in elderly patients (≥ 65 years of age) appear to be similar to that observed in 
patients less than 65 years of age. However, a higher incidence (≥ 5 % difference) of fall, diarrhoea 
and tremor has been reported in elderly patients compared to younger adult patients. The most 
frequent cardiac-related adverse reaction reported in elderly compared to the younger adult population 
was first-degree AV block. This was reported with lacosamide in 4.8 % (3/62) in elderly patients 
versus 1.6 % (6/382) in younger adult patients. The discontinuation rate due to adverse events 
observed with lacosamide was 21.0 % (13/62) in elderly patients versus 9.2 % (35/382) in younger 



48 

adult patients. These differences between elderly and younger adult patients were similar to those 
observed in the active comparator group.  
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 
Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated 
with CNS and gastrointestinal system. 

 The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 
800 mg were not clinically different from those of patients administered recommended doses 
of lacosamide. 

 Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, 
seizures (generalised tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, 
shock and coma have also been observed. Fatalities have been reported in patients following 
an intake of acute single overdose of several grams of lacosamide. 

 
Management 
 
There is no specific antidote for overdose with lacosamide. Treatment of lacosamide overdose should 
include general supportive measures and may include haemodialysis if necessary (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18  
 
Mechanism of action 
 
The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a 
functionalised amino acid. 
The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be 
fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances 
slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable 
neuronal membranes. 
 
Pharmacodynamic effects 
 
Lacosamide protected against seizures in a broad range of animal models of partial and primary 
generalised seizures and delayed kindling development.  
In non-clinical experiments lacosamide in combination with levetiracetam, carbamazepine, phenytoin, 
valproate, lamotrigine, topiramate or gabapentin showed synergistic or additive anticonvulsant effects. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


49 

Clinical efficacy and safety (partial-onset seizures) 
Adult population 
 

Monotherapy 

Efficacy of lacosamide as monotherapy was established in a double-blind, parallel group, non-
inferiority comparison to carbamazepine CR in 886 patients 16 years of age or older with newly or 
recently diagnosed epilepsy. The patients had to present with unprovoked partial-onset seizures with 
or without secondary generalisation. The patients were randomised to carbamazepine CR or 
lacosamide, provided as tablets, in a 1:1 ratio. The dose was based on dose-response and ranged from 
400 to 1,200 mg/day for carbamazepine CR and from 200 to 600 mg/day for lacosamide. The duration 
of the treatment was up to 121 weeks depending on the response. 
The estimated 6-month seizure freedom rates were 89.8 % for lacosamide-treated patients and 91.1 % 
for carbamazepine CR treated patients using the Kaplan-Meier survival analysis method. The adjusted 
absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8). The Kaplan-Meier estimates 
of 12-month seizure freedom rates were 77.8 % for lacosamide-treated patients and 82.7 % for 
carbamazepine CR treated patients. 
The 6-month seizure freedom rates in elderly patients of 65 and above (62 patients in lacosamide, 
57 patients in carbamazepine CR) were similar between both treatment groups. The rates were also 
similar to those observed in the overall population. In the elderly population, the maintenance 
lacosamide dose was 200 mg/day in 55 patients (88.7 %), 400 mg/day in 6 patients (9.7 %) and the 
dose was escalated to over 400 mg/day in 1 patient (1.6 %). 
 
Conversion to monotherapy 

The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historical-
controlled, multicentre, double-blind, randomised trial. In this study, 425 patients aged 16 to 70 years 
with uncontrolled partial-onset seizures taking stable doses of 1 or 2 marketed antiepileptic medicinal 
products were randomised to be converted to lacosamide monotherapy (either 400 mg/day or 
300 mg/day in a 3:1 ratio). In treated patients who completed titration and started withdrawing 
antiepileptic medicinal products (284 and 99 respectively), monotherapy was maintained in 71.5 % 
and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation 
period of 70 days. 
 
Adjunctive therapy 

The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) 
was established in 3 multicenter, randomised, placebo-controlled clinical studies with a 12-week 
maintenance period. Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive 
therapy studies, although the efficacy was similar to 400 mg/day and patients were less likely to 
tolerate this dose because of CNS- and gastrointestinal-related adverse reactions. Thus, the 
600 mg/day dose is not recommended. The maximum recommended dose is 400 mg/day. These 
studies, involving 1,308 patients with a history of an average of 23 years of partial-onset seizures, 
were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly 
with 1-3 antiepileptic medicinal products in patients with uncontrolled partial-onset seizures with or 
without secondary generalisation. Overall the proportion of subjects with a 50 % reduction in seizure 
frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 
400 mg/day. 
 
The pharmacokinetics and safety of a single loading dose of intravenous lacosamide were determined 
in a multicenter, open-label study designed to assess the safety and tolerability of rapid initiation of 
lacosamide using a single intravenous loading dose (including 200 mg) followed by twice daily oral 
dosing (equivalent to the intravenous dose) as adjunctive therapy in adult subjects 16 to 60 years of 
age with partial-onset seizures.  
 
Paediatric population 
 
Partial-onset seizures have a similar clinical expression in children from 4 years of age and in adults. 
The efficacy of lacosamide in children aged 4 years and older has been extrapolated from data of 
adolescents and adults with partial-onset seizures, for whom a similar response was expected provided 



50 

the paediatric dose adaptations are established (see section 4.2) and safety has been demonstrated (see 
section 4.8). 
The efficacy supported by the extrapolation principle stated above was confirmed by a double-blind, 
randomised, placebo-controlled study. The study consisted of an 8-week baseline period followed by a 
6-week titration period. Eligible patients on a stable dose regimen of 1 to ≤ 3 antiepileptic medicinal 
products, who still experienced at least 2 partial-onset seizures during the 4 weeks prior to screening 
with seizure-free phase no longer than 21 days in the 8-week period prior to entry into the baseline 
period, were randomised to receive either placebo (n=172) or lacosamide (n=171).  
Dosing was initiated at a dose of 2 mg/kg/day in subjects weighing less than 50 kg or 100 mg/day in 
subjects weighing 50 kg or more in 2 divided doses. During the titration period, lacosamide doses 
were adjusted in 1or 2 mg/kg/day increments in subjects weighing less than 50 kg or 50 or 100 mg/day 
in subjects weighing 50 kg or more at weekly intervals to achieve the target maintenance period dose 
range. 
Subjects must have achieved the minimum target dose for their body weight category for the final 
3 days of the titration period to be eligible for entry into the 10-week maintenance period. Subjects 
were to remain on stable lacosamide dose throughout the maintenance period or were withdrawn and 
entered in the blinded taper period. 
Statistically significant (p=0.0003) and clinically relevant reduction in partial-onset seizure frequency 
per 28 days from baseline to the maintenance period was observed between the lacosamide and the 
placebo group. The percent reduction over placebo based on analysis of covariance was 31.72 % 
(95 % CI: 16.342, 44.277). 
Overall, the proportion of subjects with at least a 50 % reduction in partial-onset seizure frequency per 
28 days from baseline to the maintenance period was 52.9 % in the lacosamide group compared with 
33.3 % in the placebo group. 
The quality of life assessed by the Pediatric Quality of Life Inventory indicated that subjects in both 
lacosamide and placebo groups had a similar and stable health-related quality of life during the entire 
treatment period. 
 
Clinical efficacy and safety (primary generalized tonic-clonic seizures) 
 
The efficacy of lacosamide as adjunctive therapy in patients 4 years of age and older with idiopathic 
generalized epilepsy experiencing primary generalized tonic-clonic seizures (PGTCS) was established 
in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study. The 
study consisted of a 12-week historical baseline period, a 4-week prospective baseline period and a 24-
week treatment period (which included a 6-week titration period and an 18-week maintenance period). 
Eligible patients on a stable dose of 1 to 3 antiepileptic drugs experiencing at least 3 documented 
PGTCS during the 16-week combined baseline period were randomized 1 to 1 to receive lacosamide 
or placebo (patients in the full analysis set: lacosamide n=118, placebo n=121; of them 8 patients in 
the ≥ 4 to < 12 years age group and 16 patients in the ≥ 12 to < 18 years range were treated with LCM 
and 9 and 16 patients, respectively with placebo).  
Patients were titrated up to the target maintenance period dose of 12 mg/kg/day in patients weighing 
less than 30 kg, 8 mg/kg/day in patients weighing from 30 to less than 50 kg or 400 mg/day in patients 
weighing 50 kg or more.  
 

Efficacy variable 
Parameter 

Placebo 
N=121 

Lacosamide 
N=118 

Time to second PGTCS 
Median (days) 77.0 - 
95 % CI 49.0, 128.0 - 
Lacosamide – Placebo  
Hazard Ratio 0.540 
95 % CI 0.377, 0.774 
p-value < 0.001 

Seizure freedom   
Stratified Kaplan-Meier estimate (%) 17.2 31.3 
95 % CI 10.4, 24.0 22.8, 39.9 
Lacosamide – Placebo 14.1 



51 

Efficacy variable 
Parameter 

Placebo 
N=121 

Lacosamide 
N=118 

95 % CI 3.2, 25.1 
p-value 0.011 

Note: For the lacosamide group, the median time to second PGTCS could not be estimated by Kaplan-
Meier methods because ˃ 50% of patients did not experience a second PGTCS by Day 166. 
 
The findings in the pediatric subgroup were consistent with the results of the overall population for the 
primary, secondary and other efficacy endpoints.  
 
5.2 Pharmacokinetic properties 
 
Absorption  
 
Lacosamide is rapidly and completely absorbed after oral administration. The oral bioavailability of 
lacosamide tablets is approximately 100 %. Following oral administration, the plasma concentration of 
unchanged lacosamide increases rapidly and reaches Cmax about 0.5 to 4 hours post-dose. Lacosamide 
UCB tablets and syrup are bioequivalent. Food does not affect the rate and extent of absorption. 
 
Distribution 
 
The volume of distribution is approximately 0.6 L/kg. Lacosamide is less than 15 % bound to plasma 
proteins. 
 
Biotransformation 
 
95 % of the dose is excreted in the urine as lacosamide and metabolites. The metabolism of 
lacosamide has not been completely characterised.  
The major compounds excreted in urine are unchanged lacosamide (approximately 40 % of the dose) 
and its O-desmethyl metabolite less than 30 %.  
A polar fraction proposed to be serine derivatives accounted for approximately 20 % in urine, but was 
detected only in small amounts (0-2 %) in human plasma of some subjects. Small amounts (0.5-2 %) 
of additional metabolites were found in the urine.  
In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of 
the O-desmethyl metabolite but the main contributing isoenzyme has not been confirmed in vivo. No 
clinically relevant difference in lacosamide exposure was observed comparing its pharmacokinetics in 
extensive metabolisers (EMs, with a functional CYP2C19) and poor metabolisers (PMs, lacking a 
functional CYP2C19). Furthermore an interaction study with omeprazole (CYP2C19-inhibitor) 
demonstrated no clinically relevant changes in lacosamide plasma concentrations indicating that the 
importance of this pathway is minor. The plasma concentration of O-desmethyl-lacosamide is 
approximately 15 % of the concentration of lacosamide in plasma. This major metabolite has no 
known pharmacological activity. 
 
Elimination 
 
Lacosamide is primarily eliminated from the systemic circulation by renal excretion and 
biotransformation. After oral and intravenous administration of radiolabeled lacosamide, 
approximately 95 % of radioactivity administered was recovered in the urine and less than 0.5 % in the 
faeces. The elimination half-life of lacosamide is approximately 13 hours. The pharmacokinetics is 
dose-proportional and constant over time, with low intra- and inter-subject variability. Following twice 
daily dosing, steady state plasma concentrations are achieved after a 3 day period. The plasma 
concentration increases with an accumulation factor of approximately 2. 
 
A single loading dose of 200 mg approximates steady-state concentrations comparable to 100 mg 
twice daily oral administration. 
 



52 

Pharmacokinetics in special patient groups 
 
Gender 

Clinical studies indicate that gender does not have a clinically significant influence on the plasma 
concentrations of lacosamide. 
 
Renal impairment 

The AUC of lacosamide was increased by approximately 30 % in mildly and moderately and 60 % in 
severely renal impaired patients and patients with end-stage renal disease requiring haemodialysis 
compared to healthy subjects, whereas Cmax was unaffected.  
Lacosamide is effectively removed from plasma by haemodialysis. Following a 4-hour haemodialysis 
treatment, AUC of lacosamide is reduced by approximately 50 %. Therefore, dosage supplementation 
following haemodialysis is recommended (see section 4.2). The exposure of the O-desmethyl 
metabolite was several-fold increased in patients with moderate and severe renal impairment. In 
absence of haemodialysis in patients with end-stage renal disease, the levels were increased and 
continuously rising during the 24-hour sampling. It is unknown whether the increased metabolite 
exposure in end-stage renal disease subjects could give rise to adverse effects but no pharmacological 
activity of the metabolite has been identified. 
 
Hepatic impairment 

Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of 
lacosamide (approximately 50 % higher AUCnorm). The higher exposure was partly due to a reduced 
renal function in the studied subjects. The decrease in non-renal clearance in the patients of the study 
was estimated to give a 20 % increase in the AUC of lacosamide. The pharmacokinetics of lacosamide 
has not been evaluated in severe hepatic impairment (see section 4.2). 
 
Elderly (over 65 years of age) 

In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 
50 % increased compared to young men, respectively. This is partly related to lower body weight. The 
body weight normalized difference is 26 and 23 %, respectively. An increased variability in exposure 
was also observed. The renal clearance of lacosamide was only slightly reduced in elderly subjects in 
this study.  
A general dose reduction is not considered to be necessary unless indicated due to reduced renal 
function (see section 4.2). 
 
Paediatric population 
The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic 
analysis using sparse plasma concentration data obtained in one placebo-controlled randomised study 
and three open-label studies in 414 children with epilepsy aged 6 months to 17 years. The 
administered lacosamide doses ranged from 2 to 17.8 mg/kg/day in twice daily intake, with a 
maximum of 600 mg/day for children weighing 50 kg or more. 
The typical plasma clearance was estimated to be 1.04 L/h, 1.32 L/h and 1.86 L/h for children 
weighing 20 kg, 30 kg and 50 kg respectively. In comparison, plasma clearance was estimated at 
1.92 L/h in adults (70 kg body weight). 
Population pharmacokinetic analysis using sparse pharmacokinetic samples from PGTCS study 
showed a similar exposure in patients with PGTCS and in patients with partial-onset seizures. 
 
5.3 Preclinical safety data 
 
In the toxicity studies, the plasma concentrations of lacosamide obtained were similar or only 
marginally higher than those observed in patients, which leaves low or non-existing margins to human 
exposure. 
A safety pharmacology study with intravenous administration of lacosamide in anesthetised dogs 
showed transient increases in PR interval and QRS complex duration and decreases in blood pressure 
most likely due to a cardiodepressant action. These transient changes started in the same concentration 
range as after maximum recommended clinical dosing. In anesthetised dogs and Cynomolgus 



53 

monkeys, at intravenous doses of 15-60 mg/kg, slowing of atrial and ventricular conductivity, 
atrioventricular block and atrioventricular dissociation were seen. 
In the repeated dose toxicity studies, mild reversible liver changes were observed in rats starting at 
about 3 times the clinical exposure. These changes included an increased organ weight, hypertrophy of 
hepatocytes, increases in serum concentrations of liver enzymes and increases in total cholesterol and 
triglycerides. Apart from the hypertrophy of hepatocytes, no other histopathologic changes were 
observed. 
In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but an 
increase in numbers of stillborn pups and pup deaths in the peripartum period, and slightly reduced 
live litter sizes and pup body weights were observed at maternal toxic doses in rats corresponding to 
systemic exposure levels similar to the expected clinical exposure. Since higher exposure levels could 
not be tested in animals due to maternal toxicity, data are insufficient to fully characterise the 
embryofetotoxic and teratogenic potential of lacosamide. 
Studies in rats revealed that lacosamide and/or its metabolites readily crossed the placental barrier. 
In juvenile rats and dogs, the types of toxicity do not differ qualitatively from those observed in adult 
animals. In juvenile rats, a reduced body weight was observed at systemic exposure levels similar to 
the expected clinical exposure. In juvenile dogs, transient and dose-related CNS clinical signs started 
to be observed at systemic exposure levels below the expected clinical exposure. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Glycerol (E422) 
Carmellose sodium 
Sorbitol liquid (crystallizing) (E420) 
Polyethylene glycol 4000 
Sodium chloride 
Citric acid, anhydrous 
Acesulfame potassium (E950) 
Sodium methyl parahydroxybenzoate (E219) 
Strawberry flavour (contains propylene glycol (E1520), maltol) 
Masking flavour (contains propylene glycol (E1520), aspartame (E951), acesulfame potassium 
(E950), maltol, deionised water) 
purified water 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
After first opening: 2 months. 
 
6.4 Special precautions for storage 
 
Do not refrigerate.  
 
6.5 Nature and contents of container 
 
A 200 ml amber glass bottle with white polypropylene screw cap, a measuring cup and an oral syringe 
with an adaptor. 
Each graduation mark (5 ml) of the 30 ml measuring cup corresponds to 50 mg of lacosamide (for 
example 2 graduation marks correspond to 100 mg).  



54 

One full 10 ml oral syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 
1 ml which is 10 mg of lacosamide. As from the 1 ml graduation mark, each graduation corresponds to 
0.25 ml which is 2.5 mg of lacosamide. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 August  2019 
Date of latest renewal:  
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 

http://www.ema.europa.eu/


55 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 10 mg/ml solution for infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml of solution for infusion contains 10 mg lacosamide. 
Each vial of 20 ml solution for infusion contains 200 mg lacosamide. 
 
Excipients with known effect: 
Each ml of solution for infusion contains 2.99 mg sodium.  
 
For the full list of excipients, see section 6.1 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for infusion. 
Clear, colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Lacosamide UCB is indicated as monotherapy in the treatment of partial-onset seizures with or 
without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.  

Lacosamide UCB is indicated as adjunctive therapy 
• in the treatment of partial-onset seizures with or without secondary generalisation in adults, 

adolescents and children from 4 years of age with epilepsy. 
• in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and 

children from 4 years of age with idiopathic generalised epilepsy. 
 
4.2 Posology and method of administration 
 
Posology 
 
Lacosamide therapy can be initiated with either oral or intravenous administration. Solution for 
infusion is an alternative for patients when oral administration is temporarily not feasible. The overall 
duration of treatment with intravenous lacosamide is at the physician’s discretion; there is experience 
from clinical studies with twice daily infusions of lacosamide for up to 5 days in adjunctive therapy. 
Conversion to or from oral and intravenous administration can be done directly without titration. The 
total daily dose and twice daily administration should be maintained. Monitor closely patients with 
known cardiac conduction problems, on concomitant medications that prolong PR interval, or with 
severe cardiac disease (e.g. myocardial ischemia, heart failure) when lacosamide dose is higher than 
400 mg/day (see Method of administration below and section 4.4). 
Lacosamide must be taken twice a day (usually once in the morning and once in the evening). 
 



56 

Adolescents and children weighing 50 kg or more, and adults 

 
The following table summarises the recommended posology for adolescents and children weighing 
50 kg or more, and for adults. More details are provided in the table below. 
 Monotherapy Adjunctive therapy 
Starting dose 
 

100 mg/day or 200 mg/day 100 mg/day 

Single loading dose  
(if applicable) 

200 mg 200 mg 

Titration (incremental steps) 50 mg twice a day (100 mg/day) 
at weekly intervals 

50 mg twice a day (100 mg/day) 
at weekly intervals 

Maximum recommended dose up to 600 mg/day up to 400 mg/day 
 
Monotherapy (in the treatment of partial-onset seizures) 

The recommended starting dose is 50 mg twice a day which should be increased to an initial 
therapeutic dose of 100 mg twice a day after one week. 
Lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's 
assessment of required seizure reduction versus potential side effects. 
Depending on response and tolerability, the maintenance dose can be further increased at weekly 
intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg 
twice a day (600 mg/day).  
In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic 
medicinal product, the posology that is recommended for adjunctive therapy below should be 
followed. 
 
Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary 

generalised tonic-clonic seizures) 

The recommended starting dose is 50 mg twice a day which should be increased to an initial 
therapeutic dose of 100 mg twice a day after one week.  
Depending on response and tolerability, the maintenance dose can be further increased at weekly 
intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg 
(200 mg twice a day).  
 
Initiation of lacosamide treatment with a loading dose (initial monotherapy or conversion to 

monotherapy in the treatment of partial-onset seizures or adjunctive therapy in the treatment of 

partial-onset seizures or adjunctive therapy in the treatment of primary generalised tonic-clonic 

seizures) 

Lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed 
approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. 
Subsequent dose adjustments should be performed according to individual response and tolerability as 
described above. A loading dose may be initiated in patients in situations when the physician 
determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic 
effect is warranted. It should be administered under medical supervision with consideration of the 
potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse 
reactions (see section 4.8). Administration of a loading dose has not been studied in acute conditions 
such as status epilepticus. 
 

Discontinuation 

In accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended 
this be done gradually (e.g. taper the daily dose by 200 mg/week).  
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be 
performed and if needed lacosamide should be discontinued. 
 



57 

Special populations 
 
Elderly (over 65 years of age) 

No dose reduction is necessary in elderly patients. Age associated decreased renal clearance with an 
increase in AUC levels should be considered in elderly patients (see following paragraph ‘renal 
impairment’ and section 5.2). There is limited clinical data in the elderly patients with epilepsy, 
particularly at doses greater than 400 mg/day (see sections 4.4, 4.8, and 5.1). 
 
Renal impairment 

No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric 
patients (CLCR > 30 ml/min). In paediatric patients weighing 50 kg or more and in adult patients with 
mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose 
titration (> 200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or 
more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal 
disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed 
with caution. If a loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily 
regimen for the first week should be used. In paediatric patients weighing less than 50 kg with severe 
renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of 
the maximum dose is recommended. For all patients requiring haemodialysis a supplement of up to 
50 % of the divided daily dose directly after the end of haemodialysis is recommended. Treatment of 
patients with end-stage renal disease should be made with caution as there is little clinical experience 
and accumulation of a metabolite (with no known pharmacological activity).  
 
Hepatic impairment 

A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and 
for adult patients with mild to moderate hepatic impairment.  
The dose titration in these patients should be performed with caution considering co-existing renal 
impairment. In adolescents and adults weighing 50 kg or more, a loading dose of 200 mg may be 
considered, but further dose titration (> 200 mg daily) should be performed with caution. Based on 
data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic 
impairment a reduction of 25 % of the maximum dose should be applied. The pharmacokinetics of 
lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2). Lacosamide 
should be administered to adult and paediatric patients with severe hepatic impairment only when the 
expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be 
adjusted while carefully observing disease activity and potential side effects in the patient. 
 
Paediatric population 
 

The physician should prescribe the most appropriate formulation and strength according to weight and 
dose. 
 
Adolescents and children weighing 50 kg or more  

Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above). 
 
Children (from 4 years of age) and adolescents weighing less than 50 kg 

 

Monotherapy (in the treatment of partial-onset seizures) 

The recommended starting dose is 2 mg/kg/day which should be increased to an initial therapeutic 
dose of 4 mg/kg/day after one week. 
Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day 
every week. The dose should be gradually increased until the optimum response is obtained. In 
children weighing less than 40 kg, a maximum dose of up to 12 mg/kg/day is recommended. In 
children weighing from 40 to under 50 kg, a maximum dose of 10 mg/kg/day is recommended. 
 



58 

The following table below summarises the recommended posology in monotherapy for children and 
adolescents weighing less than 50 kg. 

Starting dose 
 

2 mg/kg/day  

Single loading dose  Not recommended 
Titration (incremental steps) 2 mg/kg/day every week 
Maximum recommended dose in patients < 40 kg up to 12 mg/kg/day 
Maximum recommended dose in patients ≥ 40 kg 
to < 50 kg 

up to 10 mg/kg/day 

 
The tables below provide examples of volumes of solution for infusion per administration depending 
on prescribed dose and body weight. The precise volume of solution for infusion is to be calculated 
according to the exact body weight of the child. 
 
Monotherapy doses to be taken twice daily for children from 4 years of age weighing less than 
40 kg(1): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting 
dose 

0.2 ml/kg  
(2 mg/kg) 
 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg) 

0.5 ml/kg 
(5 mg/kg) 

0.6 ml/kg 
(6 mg/kg) 
Maximum 
recommended 
dose 

10 kg 1 ml  
(10 mg) 

2 ml  
(20 mg) 

3 ml  
(30 mg) 

4 ml  
(40 mg) 

5 ml  
(50 mg) 

6 ml  
(60 mg) 

15 kg 1.5 ml  
(15 mg) 

3 ml  
(30 mg) 

4.5 ml  
(45 mg) 

6 ml  
(60 mg) 

7.5 ml  
(75 mg) 

9 ml  
(90 mg) 

20 kg 2 ml  
(20 mg) 

4 ml  
(40 mg) 

6 ml  
(60 mg) 

8 ml  
(80 mg) 

10 ml  
(100 mg) 

12 ml  
(120 mg) 

25 kg 2.5 ml  
(25 mg) 

5 ml  
(50 mg) 

7.5 ml  
(75 mg) 

10 ml  
(100 mg) 

12.5 ml  
(125 mg) 

15 ml  
(150 mg) 

30 kg 3 ml  
(30 mg) 

6 ml  
(60 mg) 

9 ml  
(90 mg) 

12 ml  
(120 mg) 

15 ml  
(150 mg) 

18 ml  
(180 mg) 

35 kg 3.5 ml  
(35 mg) 

7 ml  
(70 mg) 

10.5 ml  
(105 mg) 

14 ml  
(140 mg) 

17.5 ml  
(175 mg) 

21 ml  
(210 mg) 

(1) Children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup. Lacosamide 
UCB 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible. 

 
Monotherapy doses to be taken twice daily for children and adolescents from 4 years of age 
weighing 40 kg to under 50 kg(1) (2): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting dose 

0.2 ml/kg  
(2 mg/kg) 
 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg) 

0.5 ml/kg 
(5 mg/kg)  
Maximum 
recommended 
dose 

40 kg 4 ml  
(40 mg) 

8 ml  
(80 mg) 

12 ml  
(120 mg) 

16 ml  
(160 mg) 

20 ml  
(200 mg) 

45 kg 4.5 ml  
(45 mg) 

9 ml  
(90 mg) 

13.5 ml  
(135 mg) 

18 ml  
(180 mg) 

22.5 ml  
(225 mg) 

(1) Children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup. Lacosamide 
UCB 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible. 
(2) Dosage in adolescents 50 kg or more is the same as in adults. 

 

Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary 

generalised tonic-clonic seizures) 

The recommended starting dose is 2 mg/kg/day which should be increased to an initial therapeutic 
dose of 4 mg/kg/day after one week. 
Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day 
every week. The dose should be gradually adjusted until the optimum response is obtained. In children 



59 

weighing less than 20 kg, due to an increased clearance compared to adults, a maximum dose of up to 
12 mg/kg/day is recommended. In children weighing from 20 to under 30 kg, a maximum dose of 
10 mg/kg/day is recommended and in children weighing from 30 to under 50 kg a maximum dose of 
8 mg/kg/day is recommended, although in open-label studies (see sections 4.8 and 5.2), a dose up to 
12 mg/kg/day has been used by a small number of these children.  
 
The following table below summarises the recommended posology in adjunctive therapy for children 
and adolescents weighing less than 50 kg. 

Starting dose 
 

2 mg/kg/day  

Single loading dose  Not recommended 
Titration (incremental steps) 2 mg/kg/day every week 
Maximum recommended dose in patients 
< 20 kg 

up to 12 mg/kg/day 

Maximum recommended dose in patients ≥ 20 kg 
to < 30 kg 

up to 10 mg/kg/day 

Maximum recommended dose in patients ≥ 30 kg 
to < 50 kg  

up to 8 mg/kg/day  

 
The tables below provide guidance on the volume of solution for infusion per administration 
depending on prescribed dose and body weight. The precise volume of solution for infusion is to be 
calculated according to the exact body weight of the child. 
 
Adjunctive therapy doses to be taken twice daily for children from 4 years of age weighing less than 
20 kg(1): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting 
dose 

0.2 ml/kg  
(2 mg/kg) 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg) 

0.5 ml/kg 
(5 mg/kg) 

0.6 ml/kg 
(6 mg/kg) 
Maximum 
recommended 
dose 

10 kg 1 ml  
(10 mg) 

2 ml  
(20 mg) 

3 ml  
(30 mg) 

4 ml  
(40 mg) 

5 ml  
(50 mg) 

6 ml  
(60 mg) 

15 kg 1.5 ml  
(15 mg) 

3 ml  
(30 mg) 

4.5 ml  
(45 mg) 

6 ml  
(60 mg) 

7.5 ml  
(75 mg) 

9 ml  
(90 mg) 

(1) Children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup. Lacosamide 
UCB 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible. 

 
Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age 
weighing 20 kg to under 30 kg(1): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting dose 

0.2 ml/kg  
(2 mg/kg) 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg)  
 

0.5 ml/kg 
(5 mg/kg)  
Maximum 
recommended 
dose 

20 kg 2 ml  
(20 mg) 

4 ml  
(40 mg) 

6 ml  
(60 mg) 

8 ml  
(80 mg) 

10 ml  
(100 mg) 

25 kg 2.5 ml  
(25 mg) 

5 ml  
(50 mg) 

7.5 ml  
(75 mg) 

10 ml  
(100 mg) 

12.5 ml  
(125 mg) 

(1) Children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup. Lacosamide 
UCB 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible. 

 



60 

Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age 
weighing 30 kg to under 50 kg(1): 

Weight 0.1 ml/kg 
(1 mg/kg) 
Starting dose 

0.2 ml/kg  
(2 mg/kg) 

0.3 ml/kg 
(3 mg/kg) 

0.4 ml/kg 
(4 mg/kg)  
Maximum 
recommended dose 

30 kg 3 ml (30 mg) 6 ml (60 mg) 9 ml (90 mg) 12 ml (120 mg) 
35 kg 3.5 ml (35 mg) 7 ml (70 mg) 10.5 ml (105 mg) 14 ml (140 mg) 
40 kg 4 ml (40 mg) 8 ml (80 mg) 12 ml (120 mg) 16 ml (160 mg) 
45 kg 4.5 ml (45 mg) 9 ml (90 mg) 13.5 ml (135 mg) 18 ml (180 mg) 
(1) Children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup. Lacosamide 
UCB 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible. 

 
Loading dose 

Administration of a loading dose has not been studied in children. Use of a loading dose is not 
recommended in adolescents and children weighing less than 50 kg. 
 
Children less than 4 years 

The safety and efficacy of lacosamide in children aged below 4 years have not yet been established. 
No data are available. 
 
Method of administration 
 
The solution for infusion is infused over a period of 15 to 60 minutes twice a day. An infusion 
duration of at least 30 minutes for administration > 200 mg per infusion (i.e. > 400 mg/day) is 
preferred. 
Lacosamide UCB solution for infusion can be administered intravenously without further dilution or 
can be diluted with sodium chloride 9 mg/ml (0.9 %) solution for injection, glucose 50 mg/ml (5 %) 
solution for injection or lactated Ringer’s solution for injection. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Known second- or third-degree atrioventricular (AV) block.  
 
4.4 Special warnings and precautions for use 
 
Suicidal ideation and behaviour 
 
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal 
products in several indications. A meta-analysis of randomised placebo-controlled studies of 
antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and 
behaviour. The mechanism of this risk is not known and the available data do not exclude the 
possibility of an increased risk for lacosamide. 
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate 
treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical 
advice should signs of suicidal ideation or behaviour emerge (see section 4.8). 
 
Cardiac rhythm and conduction 
 
Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies. 
Lacosamide should be used with caution in patients with underlying proarrhythmic conditions such as 
patients with known cardiac conduction problems or severe cardiac disease (e.g. myocardial 
ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or 
patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and 



61 

sodium channel blocking antiepileptic medicinal products (see section 4.5), as well as in elderly 
patients. 
In these patients it should be considered to perform an ECG before a lacosamide dose increase above 
400 mg/day and after lacosamide is titrated to steady-state. 
 
In the placebo-controlled studies of lacosamide in epilepsy patients, atrial fibrillation or flutter were 
not reported; however, both have been reported in open-label epilepsy studies and in post-marketing 
experience. 
 
In post-marketing experience, AV block (including second degree or higher AV block) has been 
reported. In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In 
rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying 
proarrhythmic conditions. 
 
Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular 
pulse, palpitations, shortness of breath, feeling lightheaded, fainting). Patients should be counselled to 
seek immediate medical advice if these symptoms occur. 
 
Dizziness 
 
Treatment with lacosamide has been associated with dizziness which could increase the occurrence of 
accidental injury or falls. Therefore, patients should be advised to exercise caution until they are 
familiar with the potential effects of the medicine (see section 4.8). 
 
Excipients 
 
This medicinal product contains 59.8 mg sodium per vial, equivalent to 3% of the WHO 
recommended maximum daily intake of 2 g sodium for an adult. 
 
Potential for new onset or worsening of myoclonic seizures 
 
New onset or worsening of myoclonic seizures has been reported in both adult and paediatric patients 
with PGTCS, in particular during titration. In patients with more than one seizure type, the observed 
benefit of control for one seizure type should be weighed against any observed worsening in another 
seizure type. 
 
Potential for electro-clinical worsening in specific paediatric epilepsy syndromes 
 
The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal 
and generalised seizures may coexist have not been determined. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Lacosamide should be used with caution in patients treated with medicinal products known to be 
associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) 
and in patients treated with antiarrhythmics. However, subgroup analysis in clinical studies did not 
identify an increased magnitude of PR prolongation in patients with concomitant administration of 
carbamazepine or lamotrigine. 
 
In vitro data 
 
Data generally suggest that lacosamide has a low interaction potential. In vitro studies indicate that the 
enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, 
CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP2E1 are not inhibited by lacosamide at plasma 
concentrations observed in clinical studies. An in vitro study indicated that lacosamide is not 
transported by P-glycoprotein in the intestine. In vitro data show that CYP2C9, CYP2C19 and 
CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite. 



62 

 

In vivo data 
 
Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent. 
Lacosamide did not affect the AUC of midazolam (metabolised by CYP3A4, lacosamide given 
200 mg twice a day) but Cmax of midazolam was slightly increased (30 %). Lacosamide did not affect 
the pharmacokinetics of omeprazole (metabolised by CYP2C19 and CYP3A4, lacosamide given 
300 mg twice a day).  
The CYP2C19 inhibitor omeprazole (40 mg once daily) did not give rise to a clinically significant 
change in lacosamide exposure. Thus, moderate inhibitors of CYP2C19 are unlikely to affect systemic 
lacosamide exposure to a clinically relevant extent. 
Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (e.g. 
fluconazole) and CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead 
to increased systemic exposure of lacosamide. Such interactions have not been established in vivo but 
are possible based on in vitro data. 
 
Strong enzyme inducers such as rifampicin or St. John’s wort (Hypericum perforatum) may 
moderately reduce the systemic exposure of lacosamide. Therefore, starting or ending treatment with 
these enzyme inducers should be done with caution. 
 
Antiepileptic medicinal products 
 
In interaction studies lacosamide did not significantly affect the plasma concentrations of 
carbamazepine and valproic acid. Lacosamide plasma concentrations were not affected by 
carbamazepine and by valproic acid. Population pharmacokinetic analyses in different age groups 
estimated that concomitant treatment with other antiepileptic medicinal products known to be enzyme 
inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic 
exposure of lacosamide by 25 % in adults and 17 % in paediatric patients.  
 
Oral contraceptives 
 
In an interaction study there was no clinically relevant interaction between lacosamide and the oral 
contraceptives ethinylestradiol and levonorgestrel. Progesterone concentrations were not affected 
when the medicinal products were co-administered. 
 
Others 
 
Interaction studies showed that lacosamide had no effect on the pharmacokinetics of digoxin. There 
was no clinically relevant interaction between lacosamide and metformin.  
Co-administration of warfarin with lacosamide does not result in a clinically relevant change in the 
pharmacokinetics and pharmacodynamics of warfarin. 
Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available, a 
pharmacodynamic effect cannot be excluded. 
Lacosamide has a low protein binding of less than 15 %. Therefore, clinically relevant interactions 
with other medicinal products through competition for protein binding sites are considered unlikely. 
 
4.6 Fertility, pregnancy and lactation 
 

Pregnancy 
 
Risk related to epilepsy and antiepileptic medicinal products in general  

For all antiepileptic medicinal products, it has been shown that in the offspring of treated women with 
epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 
3 % in the general population. In the treated population, an increase in malformations has been noted 
with polytherapy, however, the extent to which the treatment and/or the illness is responsible has not 
been elucidated. 
Moreover, effective antiepileptic therapy must not be interrupted, since the aggravation of the illness is 



63 

detrimental to both the mother and the foetus. 
 
Risk related to lacosamide 

There are no adequate data from the use of lacosamide in pregnant women. Studies in animals did not 
indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits 
at maternal toxic doses (see section 5.3). The potential risk for humans is unknown. 
Lacosamide should not be used during pregnancy unless clearly necessary (if the benefit to the mother 
clearly outweighs the potential risk to the foetus). If women decide to become pregnant, the use of this 
product should be carefully re-evaluated. 
 
Breastfeeding 
 
It is unknown whether lacosamide is excreted in human breast milk. A risk to the newborns/infants 
cannot be excluded. Animal studies have shown excretion of lacosamide in breast milk. For 
precautionary measures, breast-feeding should be discontinued during treatment with lacosamide. 
 
Fertility 
 
No adverse reactions on male or female fertility or reproduction were observed in rats at doses 
producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the 
maximum recommended human dose (MRHD). 
 
4.7 Effects on ability to drive and use machines 
 
Lacosamide has minor to moderate influence on the ability to drive and use machines. Lacosamide 
treatment has been associated with dizziness or blurred vision.  
Accordingly, patients should be advised not to drive or to operate other potentially hazardous 
machinery until they are familiar with the effects of lacosamide on their ability to perform such 
activities. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Based on the analysis of pooled placebo-controlled clinical studies in adjunctive therapy in 
1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomised to lacosamide and 
35.2 % of patients randomised to placebo reported at least 1 adverse reaction. The most frequently 
reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and 
diplopia. They were usually mild to moderate in intensity. Some were dose-related and could be 
alleviated by reducing the dose. Incidence and severity of central nervous system (CNS) and 
gastrointestinal (GI) adverse reactions usually decreased over time. 
In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for 
patients randomised to lacosamide and 1.6 % for patients randomised to placebo. The most common 
adverse reaction resulting in discontinuation of lacosamide therapy was dizziness.  
Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. 
 
Based on the analysis of data from a non-inferiority monotherapy clinical study comparing lacosamide 
to carbamazepine controlled release (CR), the most frequently reported adverse reactions (≥ 10 %) for 
lacosamide were headache and dizziness. The discontinuation rate due to adverse reactions was 
10.6 % for patients treated with lacosamide and 15.6 % for patients treated with carbamazepine CR.  
 
The safety profile of lacosamide reported in a study conducted in patients aged 4 years and older with 
idiopathic generalised epilepsy with primary generalised tonic-clonic seizures (PGTCS) was consistent 
with the safety profile reported from the pooled placebo-controlled clinical studies in partial-onset 
seizures. Additional adverse reactions reported in PGTCS patients were myoclonic epilepsy (2.5 % in 
the lacosamide-group and 0 % in the placebo-group) and ataxia (3.3 % in the lacosamide-group and 
0 % in the placebo-group). The most frequently reported adverse reactions were dizziness and 



64 

somnolence. The most common adverse reactions resulting in discontinuation of lacosamide therapy 
were dizziness and suicidal ideation. The discontinuation rate due to adverse reactions was 9.1 % in 
the lacosamide group and 4.1 % in the placebo group. 
 
Tabulated list of adverse reactions 
 
The table below shows the frequencies of adverse reactions which have been reported in clinical 
studies and post-marketing experience. The frequencies are defined as follows: very common (≥ 1/10), 
common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be 
estimated from available data). Within each frequency grouping, undesirable effects are presented in 
order of decreasing seriousness. 
 

System organ 
class 

Very 
common 

Common Uncommon Not known 

Blood and 
lymphatic 
disorders 

   Agranulocytosis(1) 

Immune system 
disorders 

  Drug 
hypersensitivity(1) 

Drug reaction with 
eosinophilia and 
systemic symptoms 
(DRESS)(1,2) 

Psychiatric 
disorders 

 Depression 
Confusional state  
Insomnia(1) 

Aggression 
Agitation(1)  
Euphoric mood(1) 

Psychotic 
disorder(1) 

Suicide attempt (1) 
Suicidal ideation 

Hallucination (1) 

 

Nervous system 
disorders 

Dizziness 
Headache 
 

Myoclonic 
seizures(3) 

Ataxia 
Balance disorder  
Memory 
impairment  
Cognitive disorder  
Somnolence 
Tremor  
Nystagmus 
Hypoesthesia 

Dysarthria 
Disturbance in 
attention 

Paraesthesia 

Syncope(2) 
Coordination 
abnormal 
 

Convulsion 

Eye disorders Diplopia Vision blurred   
Ear and labyrinth 
disorders 

 Vertigo 
Tinnitus 

  

Cardiac disorders   Atrioventricular 
block(1,2) 
Bradycardia(1,2) 

Atrial Fibrillation 
(1,2) 

Atrial Flutter (1,2) 

Ventricular 
tachyarrhythmia(1) 

Gastrointestinal 
disorders 

Nausea 
 

Vomiting  
Constipation 
Flatulence  
Dyspepsia 

  



65 

System organ 
class 

Very 
common 

Common Uncommon Not known 

Dry mouth 

Diarrhoea 
Hepatobiliary 
disorders 

  Liver function test 
abnormal(2)  
Hepatic enzyme 
increased 
(> 2x ULN)(1) 

 

Skin and 
subcutaneous 
tissue disorders 

 Pruritus 
Rash(1) 

Angioedema(1)  
Urticaria(1) 

Stevens-Johnson 
syndrome(1) 
Toxic epidermal 
necrolysis(1) 

Musculoskeletal 
and connective 
tissue disorders 

 Muscle spasms   

General disorders 
and administration 
site conditions  

 Gait disturbance 
Asthenia  
Fatigue 
Irritability 

Feeling drunk 
Injection site pain 
or discomfort(4) 
Irritation(4) 

Erythema(4)  

Injury, poisoning 
and procedural 
complications 

 Fall  
Skin laceration 
Contusion 

  

(1) Adverse reactions reported in post marketing experience.  
(2) See Description of selected adverse reactions.  
(3) Reported in PGTCS studies. 
(4) Local adverse reactions associated with intravenous administration. 
 
Description of selected adverse reactions 
 
The use of lacosamide is associated with dose-related increase in the PR interval. Adverse reactions 
associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur.  
In adjunctive clinical studies in epilepsy patients the incidence rate of reported first-degree AV Block 
is uncommon, 0.7 %, 0 %, 0.5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, 
respectively. No second- or higher degree AV Block was seen in these studies. However, cases with 
second- and third-degree AV Block associated with lacosamide treatment have been reported in post-
marketing experience. In the monotherapy clinical study comparing lacosamide to carbamazepine CR 
the extent of increase in PR interval was comparable between lacosamide and carbamazepine. 
The incidence rate for syncope reported in pooled adjunctive therapy clinical studies is uncommon and 
did not differ between lacosamide (n=944) treated epilepsy patients (0.1 %) and placebo (n=364) 
treated epilepsy patients (0.3 %). In the monotherapy clinical study comparing lacosamide to 
carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) 
carbamazepine CR patients. 
Atrial fibrillation or flutter were not reported in short term clinical studies; however, both have been 
reported in open-label epilepsy studies and in post-marketing experience. 
 
Laboratory abnormalities 

Abnormalities in liver function tests have been observed in placebo-controlled studies with lacosamide 
in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic medicinal 
products. Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide UCB patients and 
0 % (0/356) of placebo patients. 
 



66 

Multiorgan hypersensitivity reactions 

Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic 
Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products. 
These reactions are variable in expression but typically present with fever and rash and can be 
associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is 
suspected, lacosamide should be discontinued. 
 
Paediatric population 
 
The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in open-
label studies (n=408) in adjunctive therapy in children from 4 years of age with partial-onset seizures 
was consistent with the safety profile observed in adults although the frequency of some adverse 
reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions 
(nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have 
been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence 
(14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), 
pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %). 
A total of 67.8 % of patients randomised to lacosamide and 58.1 % of patients randomised to placebo 
reported at least 1 adverse reaction. 
Behavioural, cognition and emotional functioning were measured by the questionnaires Achenbach 
CBCL and BRIEF that were applied at baseline and throughout the studies and were mainly stable 
during the course of the studies. 
 
Elderly population  
 
In the monotherapy study comparing lacosamide to carbamazepine CR, the types of adverse reactions 
related to lacosamide in elderly patients (≥ 65 years of age) appear to be similar to that observed in 
patients less than 65 years of age. However, a higher incidence (≥ 5 % difference) of fall, diarrhoea 
and tremor has been reported in elderly patients compared to younger adult patients. The most 
frequent cardiac-related adverse reaction reported in elderly compared to the younger adult population 
was first-degree AV block. This was reported with lacosamide in 4.8 % (3/62) in elderly patients 
versus 1.6 % (6/382) in younger adult patients. The discontinuation rate due to adverse events 
observed with lacosamide was 21.0 % (13/62) in elderly patients versus 9.2 % (35/382) in younger 
adult patients. These differences between elderly and younger adult patients were similar to those 
observed in the active comparator group. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Symptoms 
 

Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated 
with CNS and gastrointestinal system. 

 The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 
800 mg were not clinically different from those of patients administered recommended doses 
of lacosamide. 

 Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, 
seizures (generalised tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, 
shock and coma have also been observed. Fatalities have been reported in patients following 
an intake of acute single overdose of several grams of lacosamide. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


67 

Management 
 
There is no specific antidote for overdose with lacosamide. Treatment of lacosamide overdose should 
include general supportive measures and may include haemodialysis if necessary (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18  
 
Mechanism of action 
 
The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a 
functionalised amino acid. 
The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be 
fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances 
slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable 
neuronal membranes.  
 
Pharmacodynamic effects 
 
Lacosamide protected against seizures in a broad range of animal models of partial and primary 
generalised seizures and delayed kindling development.  
In non-clinical experiments lacosamide in combination with levetiracetam, carbamazepine, phenytoin, 
valproate, lamotrigine, topiramate or gabapentin showed synergistic or additive anticonvulsant effects. 
 
Clinical efficacy and safety (partial-onset seizures) 
Adult population 
 

Monotherapy 

Efficacy of lacosamide as monotherapy was established in a double-blind, parallel group, non-
inferiority comparison to carbamazepine CR in 886 patients 16 years of age or older with newly or 
recently diagnosed epilepsy. The patients had to present with unprovoked partial-onset seizures with 
or without secondary generalisation. The patients were randomised to carbamazepine CR or 
lacosamide, provided as tablets, in a 1:1 ratio. The dose was based on dose-response and ranged from 
400 to 1,200 mg/day for carbamazepine CR and from 200 to 600 mg/day for lacosamide. The duration 
of the treatment was up to 121 weeks depending on the response. 
The estimated 6-month seizure freedom rates were 89.8 % for lacosamide-treated patients and 91.1 % 
for carbamazepine CR treated patients using the Kaplan-Meier survival analysis method. The adjusted 
absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8). The Kaplan-Meier estimates 
of 12-month seizure freedom rates were 77.8 % for lacosamide-treated patients and 82.7 % for 
carbamazepine CR treated patients. 
The 6-month seizure freedom rates in elderly patients of 65 and above (62 patients in lacosamide, 
57 patients in carbamazepine CR) were similar between both treatment groups. The rates were also 
similar to those observed in the overall population. In the elderly population, the maintenance 
lacosamide dose was 200 mg/day in 55 patients (88.7 %), 400 mg/day in 6 patients (9.7 %) and the 
dose was escalated to over 400 mg/day in 1 patient (1.6 %). 
 
Conversion to monotherapy 

The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historical-
controlled, multicentre, double-blind, randomised trial. In this study, 425 patients aged 16 to 70 years 
with uncontrolled partial-onset seizures taking stable doses of 1 or 2 marketed antiepileptic medicinal 
products were randomised to be converted to lacosamide monotherapy (either 400 mg/day or 
300 mg/day in a 3:1 ratio). In treated patients who completed titration and started withdrawing 
antiepileptic medicinal products (284 and 99 respectively), monotherapy was maintained in 71.5 % 



68 

and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation 
period of 70 days. 
 
Adjunctive therapy 

The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) 
was established in 3 multicenter, randomised, placebo-controlled clinical studies with a 12-week 
maintenance period. Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive 
therapy studies, although the efficacy was similar to 400 mg/day and patients were less likely to 
tolerate this dose because of CNS- and gastrointestinal-related adverse reactions. Thus, the 
600 mg/day dose is not recommended. The maximum recommended dose is 400 mg/day. These 
studies, involving 1,308 patients with a history of an average of 23 years of partial-onset seizures, 
were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly 
with 1-3 antiepileptic medicinal products in patients with uncontrolled partial-onset seizures with or 
without secondary generalisation. Overall the proportion of subjects with a 50 % reduction in seizure 
frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 
400 mg/day.  
 
The pharmacokinetics and safety of a single loading dose of intravenous lacosamide were determined 
in a multicenter, open-label study designed to assess the safety and tolerability of rapid initiation of 
lacosamide using a single intravenous loading dose (including 200 mg) followed by twice daily oral 
dosing (equivalent to the intravenous dose) as adjunctive therapy in adult subjects 16 to 60 years of 
age with partial-onset seizures.  
 
Paediatric population 
 
Partial-onset seizures have a similar clinical expression in children from 4 years of age and in adults. 
The efficacy of lacosamide in children aged 4 years and older has been extrapolated from data of 
adolescents and adults with partial-onset seizures, for whom a similar response was expected provided 
the paediatric dose adaptations are established (see section 4.2) and safety has been demonstrated (see 
section 4.8). 
The efficacy supported by the extrapolation principle stated above was confirmed by a double-blind, 
randomised, placebo-controlled study. The study consisted of an 8-week baseline period followed by a 
6-week titration period. Eligible patients on a stable dose regimen of 1 to ≤ 3 antiepileptic medicinal 
products, who still experienced at least 2 partial-onset seizures during the 4 weeks prior to screening 
with seizure-free phase no longer than 21 days in the 8-week period prior to entry into the baseline 
period, were randomised to receive either placebo (n=172) or lacosamide (n=171).  
Dosing was initiated at a dose of 2 mg/kg/day in subjects weighing less than 50 kg or 100 mg/day in 
subjects weighing 50 kg or more in 2 divided doses. During the titration period, lacosamide doses 
were adjusted in 1or 2 mg/kg/day increments in subjects weighing less than 50 kg or 50 or 100 mg/day 
in subjects weighing 50 kg or more at weekly intervals to achieve the target maintenance period dose 
range. 
Subjects must have achieved the minimum target dose for their body weight category for the final 
3 days of the titration period to be eligible for entry into the 10-week maintenance period. Subjects 
were to remain on stable lacosamide dose throughout the maintenance period or were withdrawn and 
entered in the blinded taper period. 
Statistically significant (p=0.0003) and clinically relevant reduction in partial-onset seizure frequency 
per 28 days from baseline to the maintenance period was observed between the lacosamide and the 
placebo group. The percent reduction over placebo based on analysis of covariance was 31.72 % 
(95 % CI: 16.342,44.277). 
Overall, the proportion of subjects with at least a 50 % reduction in partial-onset seizure frequency per 
28 days from baseline to the maintenance period was 52.9 % in the lacosamide group compared with 
33.3 % in the placebo group. 
The quality of life assessed by the Pediatric Quality of Life Inventory indicated that subjects in both 
lacosamide and placebo groups had a similar and stable health-related quality of life during the entire 
treatment period. 
 



69 

Clinical efficacy and safety (primary generalized tonic-clonic seizures) 
 
The efficacy of lacosamide as adjunctive therapy in patients 4 years of age and older with idiopathic 
generalized epilepsy experiencing primary generalized tonic-clonic seizures (PGTCS) was established 
in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study. The 
study consisted of a 12-week historical baseline period, a 4-week prospective baseline period and a 24-
week treatment period (which included a 6-week titration period and an 18-week maintenance period). 
Eligible patients on a stable dose of 1 to 3 antiepileptic drugs experiencing at least 3 documented 
PGTCS during the 16-week combined baseline period were randomized 1 to 1 to receive lacosamide 
or placebo (patients in the full analysis set: lacosamide n=118, placebo n=121; of them 8 patients in 
the ≥ 4 to < 12 years age group and 16 patients in the ≥ 12 to < 18 years range were treated with LCM 
and 9 and 16 patients, respectively with placebo).  
Patients were titrated up to the target maintenance period dose of 12 mg/kg/day in patients weighing 
less than 30 kg, 8 mg/kg/day in patients weighing from 30 to less than 50 kg or 400 mg/day in patients 
weighing 50 kg or more.  
 

Efficacy variable 
Parameter 

Placebo 
N=121 

Lacosamide 
N=118 

Time to second PGTCS 
Median (days) 77.0 - 
95 % CI 49.0, 128.0 - 
Lacosamide – Placebo  
Hazard Ratio 0.540 
95 % CI 0.377, 0.774 
p-value < 0.001 

Seizure freedom   
Stratified Kaplan-Meier estimate (%) 17.2 31.3 
95 % CI 10.4, 24.0 22.8, 39.9 
Lacosamide – Placebo 14.1 
95 % CI 3.2, 25.1 
p-value 0.011 

Note: For the lacosamide group, the median time to second PGTCS could not be estimated by Kaplan-
Meier methods because ˃ 50% of patients did not experience a second PGTCS by Day 166. 
 
The findings in the pediatric subgroup were consistent with the results of the overall population for the 
primary, secondary and other efficacy endpoints.  
 
5.2 Pharmacokinetic properties 
 
Absorption  
 
After intravenous administration, Cmax is reached at the end of infusion. The plasma concentration 
increases proportionally with dose after oral (100-800 mg) and intravenous (50-300 mg) 
administration. 
 
Distribution 
 
The volume of distribution is approximately 0.6 L/kg. Lacosamide is less than 15 % bound to plasma 
proteins. 
 
Biotransformation 
 
95 % of the dose is excreted in the urine as lacosamide and metabolites. The metabolism of 
lacosamide has not been completely characterised.  
The major compounds excreted in urine are unchanged lacosamide (approximately 40 % of the dose) 
and its O-desmethyl metabolite less than 30 %.  



70 

A polar fraction proposed to be serine derivatives accounted for approximately 20 % in urine, but was 
detected only in small amounts (0-2 %) in human plasma of some subjects. Small amounts (0.5-2 %) 
of additional metabolites were found in the urine.  
In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of 
the O-desmethyl metabolite but the main contributing isoenzyme has not been confirmed in vivo. No 
clinically relevant difference in lacosamide exposure was observed comparing its pharmacokinetics in 
extensive metabolisers (EMs, with a functional CYP2C19) and poor metabolisers (PMs, lacking a 
functional CYP2C19). Furthermore an interaction study with omeprazole (CYP2C19-inhibitor) 
demonstrated no clinically relevant changes in lacosamide plasma concentrations indicating that the 
importance of this pathway is minor. The plasma concentration of O-desmethyl-lacosamide is 
approximately 15 % of the concentration of lacosamide in plasma. This major metabolite has no 
known pharmacological activity. 
 
Elimination 
 
Lacosamide is primarily eliminated from the systemic circulation by renal excretion and 
biotransformation. After oral and intravenous administration of radiolabeled lacosamide, 
approximately 95 % of radioactivity administered was recovered in the urine and less than 0.5 % in the 
faeces. The elimination half-life of lacosamide is approximately 13 hours. The pharmacokinetics is 
dose-proportional and constant over time, with low intra- and inter-subject variability. Following twice 
daily dosing, steady state plasma concentrations are achieved after a 3 day period. The plasma 
concentration increases with an accumulation factor of approximately 2. 
 
A single loading dose of 200 mg approximates steady-state concentrations comparable to 100 mg 
twice daily oral administration. 
 
Pharmacokinetics in special patient groups 
 
Gender 

Clinical studies indicate that gender does not have a clinically significant influence on the plasma 
concentrations of lacosamide. 
 
Renal impairment 

The AUC of lacosamide was increased by approximately 30 % in mildly and moderately and 60 % in 
severely renal impaired patients and patients with end-stage renal disease requiring haemodialysis 
compared to healthy subjects, whereas Cmax was unaffected.  
Lacosamide is effectively removed from plasma by haemodialysis. Following a 4-hour haemodialysis 
treatment, AUC of lacosamide is reduced by approximately 50 %. Therefore, dosage supplementation 
following haemodialysis is recommended (see section 4.2). The exposure of the O-desmethyl 
metabolite was several-fold increased in patients with moderate and severe renal impairment. In 
absence of haemodialysis in patients with end-stage renal disease, the levels were increased and 
continuously rising during the 24-hour sampling. It is unknown whether the increased metabolite 
exposure in end-stage renal disease subjects could give rise to adverse effects but no pharmacological 
activity of the metabolite has been identified. 
 
Hepatic impairment 

Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of 
lacosamide (approximately 50 % higher AUCnorm). The higher exposure was partly due to a reduced 
renal function in the studied subjects. The decrease in non-renal clearance in the patients of the study 
was estimated to give a 20 % increase in the AUC of lacosamide. The pharmacokinetics of lacosamide 
has not been evaluated in severe hepatic impairment (see section 4.2). 
 
Elderly (over 65 years of age) 

In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 
50 % increased compared to young men, respectively. This is partly related to lower body weight. The 
body weight normalized difference is 26 and 23 %, respectively. An increased variability in exposure 



71 

was also observed. The renal clearance of lacosamide was only slightly reduced in elderly subjects in 
this study.  
A general dose reduction is not considered to be necessary unless indicated due to reduced renal 
function (see section 4.2). 
 
Paediatric population 
The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic 
analysis using sparse plasma concentration data obtained in one placebo-controlled randomised study 
and three open-label studies in 414 children with epilepsy aged 6 months to 17 years. The 
administered lacosamide doses ranged from 2 to 17.8 mg/kg/day in twice daily intake, with a 
maximum of 600 mg/day for children weighing 50 kg or more. 
The typical plasma clearance was estimated to be 1.04 L/h, 1.32 L/h and 1.86 L/h for children 
weighing 20 kg, 30 kg and 50 kg respectively. In comparison, plasma clearance was estimated at 
1.92 L/h in adults (70 kg body weight). 
Population pharmacokinetic analysis using sparse pharmacokinetic samples from PGTCS study 
showed a similar exposure in patients with PGTCS and in patients with partial-onset seizures. 
 
5.3 Preclinical safety data 
 
In the toxicity studies, the plasma concentrations of lacosamide obtained were similar or only 
marginally higher than those observed in patients, which leaves low or non-existing margins to human 
exposure. 
A safety pharmacology study with intravenous administration of lacosamide in anesthetised dogs 
showed transient increases in PR interval and QRS complex duration and decreases in blood pressure 
most likely due to a cardiodepressant action. These transient changes started in the same concentration 
range as after maximum recommended clinical dosing. In anesthetised dogs and Cynomolgus 
monkeys, at intravenous doses of 15-60 mg/kg, slowing of atrial and ventricular conductivity, 
atrioventricular block and atrioventricular dissociation were seen. 
In the repeated dose toxicity studies, mild reversible liver changes were observed in rats starting at 
about 3 times the clinical exposure. These changes included an increased organ weight, hypertrophy of 
hepatocytes, increases in serum concentrations of liver enzymes and increases in total cholesterol and 
triglycerides. Apart from the hypertrophy of hepatocytes, no other histopathologic changes were 
observed. 
In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but an 
increase in numbers of stillborn pups and pup deaths in the peripartum period, and slightly reduced 
live litter sizes and pup body weights were observed at maternal toxic doses in rats corresponding to 
systemic exposure levels similar to the expected clinical exposure. Since higher exposure levels could 
not be tested in animals due to maternal toxicity, data are insufficient to fully characterise the 
embryofetotoxic and teratogenic potential of lacosamide. 
Studies in rats revealed that lacosamide and/or its metabolites readily crossed the placental barrier. 
In juvenile rats and dogs, the types of toxicity do not differ qualitatively from those observed in adult 
animals. In juvenile rats, a reduced body weight was observed at systemic exposure levels similar to 
the expected clinical exposure. In juvenile dogs, transient and dose-related CNS clinical signs started 
to be observed at systemic exposure levels below the expected clinical exposure. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
water for injections 
sodium chloride 
hydrochloric acid (for pH adjustment) 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 



72 

section 6.6. 
 
6.3 Shelf life 
 
3 years. 
 
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C 
for product mixed with the diluents mentioned in 6.6 and stored in glass or PVC bags. 
From a microbiological point of view, the product should be used immediately. If not used 
immediately, in-use storage times and conditions prior to use are the responsibility of the user and 
would not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and 
validated aseptic conditions. 
 
6.4 Special precautions for storage 
 
Do not store above 25°C. 
For storage conditions after dilution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
Colourless type I glass vial with a chlorobutyl rubber closure coated with a fluoropolymer.  
Packs of 1x20 ml and 5x20 ml.  
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Product with particulate matter or discolouration should not be used. 
This medicinal product is for single use only, any unused solution should be discarded. Any unused 
medicinal product or waste material should be disposed of in accordance with local requirements. 
Lacosamide UCB solution for infusion was found to be physically compatible and chemically stable 
when mixed with the following diluents for at least 24 hours and stored in glass or PVC bags at 
temperatures up to 25°C. 
Diluents:  
sodium chloride 9 mg/ml (0.9 %) solution for injection 
glucose 50 mg/ml (5 %) solution for injection 
lactated Ringer’s solution for injection. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/001 
EU/1/19/1383/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 26 August 2019 
Date of latest renewal:  



73 

 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
  

http://www.ema.europa.eu/


74 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX II 

 
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



75 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Aesica Pharmaceuticals GmbH 
Alfred Nobel Strasse 10 
40789 Monheim am Rhein 
GERMANY 
 
UCB Pharma S.A. 
Chemin du Foriest 
B-1420 Braine-L'Alleud 
BELGIUM 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT  
 
 Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing 
authorisation and any agreed subsequent updates of the RMP.  
 
An updated RMP should be submitted 

 At the request of the European Medicines Agency 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result  
of an important (pharmacovigilance or risk minimisation) milestone being reached 

 
  



76 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

  



77 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



78 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 50 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 50 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
14 x 1 film-coated tablet 
28 film-coated tablets 
56 film-coated tablets 
56 x 1 film-coated tablet 
168 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



79 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/004 14 film-coated tablets 
EU/1/19/1383/005 14 x 1 film-coated tablet 
EU/1/19/1383/006 28 film-coated tablets 
EU/1/19/1383/007 56 film-coated tablets 
EU/1/19/1383/008 56 x 1 film-coated tablet 
EU/1/19/1383/009 168 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 50 mg 
<Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  
  



80 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister label 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 50 mg film-coated tablets 
<For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 50 mg tablets  
lacosamide 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 



81 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 100 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 100 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
14 x 1 film-coated tablet 
28 film-coated tablets 
56 film-coated tablets 
56 x 1 film-coated tablet 
168 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



82 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/010 14 film-coated tablets 
EU/1/19/1383/011 14 x 1 film-coated tablet 
EU/1/19/1383/012 28 film-coated tablets 
EU/1/19/1383/013 56 film-coated tablets 
EU/1/19/1383/014 56 x 1 film-coated tablet 
EU/1/19/1383/015 168 film-coated tablets  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 100 mg 
<Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  
  



83 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister label 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 100 mg film-coated tablets 
<For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 100 mg tablets  
lacosamide 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 



84 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 150 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 150 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
14 x 1 film-coated tablet 
28 film-coated tablets 
56 film-coated tablets 
56 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



85 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/016 14 film-coated tablets 
EU/1/19/1383/017 14 x 1 film-coated tablet 
EU/1/19/1383/018 28 film-coated tablets 
EU/1/19/1383/019 56 film-coated tablets 
EU/1/19/1383/020 56 x 1 film-coated tablet  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 150 mg 
<Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  



86 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
MULTIPACKS ONLY 
Carton of 168 film-coated tablets containing 3 Cartons of 56 film-coated tablets (with Blue box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 150 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 150 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 168 (3 packs of 56) film-coated tablets. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



87 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/021 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 150 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  
 
  



88 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
MULTIPACKS ONLY 
Intermediate Carton  
Carton of 56 film-coated tablets 150 mg (without Blue Box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 150 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 150 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 film-coated tablets. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



89 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/021 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 150 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
 
  



90 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister label 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 150 mg film-coated tablets 
<For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 150 mg tablets  
lacosamide 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
  



91 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 200 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 200 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
14 x 1 film-coated tablet  
28 film-coated tablets 
56 film-coated tablets 
56 x 1 film-coated tablet 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



92 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/022 14 film-coated tablets 
EU/1/19/1383/023 14 x 1 film-coated tablet 
EU/1/19/1383/024 28 film-coated tablets 
EU/1/19/1383/025 56 film-coated tablets 
EU/1/19/1383/026 56 x 1 film-coated tablet  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 200 mg 
<Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  
  



93 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
MULTIPACKS ONLY 
Carton of 168 film-coated tablets containing 3 Cartons of 56 film-coated tablets (with Blue box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 200 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 200 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 168 (3 packs of 56) film-coated tablets  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



94 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/027 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 200 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  
  



95 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
MULTIPACKS ONLY 
Intermediate Carton  
Carton of 56 film-coated tablets 200 mg (without Blue Box) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 200 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 200 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
56 film-coated tablets. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



96 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/027 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 200 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
 
  



97 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister label 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 200 mg film-coated tablets 
<For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 200 mg tablets  
lacosamide 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
  



98 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
TREATMENT INITIATION PACK ONLY 
 
Outer carton - treatment initiation pack containing 4 cartons of 14 film-coated tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 50 mg 
Lacosamide UCB 100 mg 
Lacosamide UCB 150 mg 
Lacosamide UCB 200 mg 
film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Lacosamide UCB 50 mg 
1 film-coated tablet contains 50 mg lacosamide. 
Lacosamide UCB 100 mg 
1 film-coated tablet contains 100 mg lacosamide. 
Lacosamide UCB 150 mg 
1 film-coated tablet contains 150 mg lacosamide. 
Lacosamide UCB 200 mg 
1 film-coated tablet contains 200 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Treatment initiation pack  
Each pack of 56 film-coated tablets for a 4-week treatment schedule contains: 
14 film-coated tablets of Lacosamide UCB 50 mg 
14 film-coated tablets of Lacosamide UCB 100 mg 
14 film-coated tablets of Lacosamide UCB 150 mg 
14 film-coated tablets of Lacosamide UCB 200 mg 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



99 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/028 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 50 mg 
Lacosamide UCB 100 mg 
Lacosamide UCB 150 mg 
Lacosamide UCB 200 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 



100 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  
  



101 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
TREATMENT INITIATION PACK ONLY 
 
Intermediate Carton  
Carton 14 tablets – week 1 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 50 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 50 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
Week 1 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



102 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/028 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 50 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
 
  



103 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TREATMENT INITIATION PACK ONLY 
 
Blister label – week 1 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 50 mg film-coated tablets 
lacosamide 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
Week 1 



104 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
TREATMENT INITIATION PACK ONLY  
 
Intermediate Carton  
Carton 14 tablets – week 2 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 100 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 100 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
Week 2 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



105 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/028 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
 
  



106 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TREATMENT INITIATION PACK ONLY 
 
Blister label – week 2 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 100 mg film-coated tablets 
lacosamide 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
Week 2 



107 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
TREATMENT INITIATION PACK ONLY 
 
Intermediate Carton  
Carton 14 tablets – week 3 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 150 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 150 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
Week 3 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



108 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/028 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 150 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
 
  



109 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TREATMENT INITIATION PACK ONLY 
 
Blister label – week 3 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 150 mg film-coated tablets 
lacosamide 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
Week 3 



110 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
TREATMENT INITIATION PACK ONLY  
 
Intermediate Carton  
Carton 14 tablets – week 4 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 200 mg film-coated tablets 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 film-coated tablet contains 200 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
Week 4 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



111 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/028 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 200 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
 
  



112 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TREATMENT INITIATION PACK ONLY 
 
Blister label – week 4 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 200 mg film-coated tablets 
lacosamide 
 
 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 

3. EXPIRY DATE 
 
EXP 
 
 

4. BATCH NUMBER 
 
Lot 
 
 

5. OTHER 
 
Week 4 
  



113 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
Outer carton / bottle  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 10 mg/ml syrup 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml of syrup contains 10 mg lacosamide. 
1 bottle of 200 ml contains 2,000 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol (E420), sodium methyl parahydroxybenzoate (E219), propylene glycol (E1520), 
sodium and aspartame (E951). See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
200 ml syrup with measuring cup and oral syringe 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. (only for the outer carton) 
Oral use 
Shake well before use. 
Children from 4 years and adolescents under 50 kg: use the oral syringe.  
Patients weighing 50 kg or more: use the measuring cup. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
After first opening, bottle may be used for up to 2 months.  
Opening date (only for the outer carton) 
 
 



114 

9. SPECIAL STORAGE CONDITIONS 
 
Do not refrigerate.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lacosamide UCB 10 mg/ml (only for the outer carton) 

 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. (only for the outer carton) 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  
 
(only for the outer carton)  



115 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer carton  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 10 mg/ml solution for infusion 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml of solution for infusion contains 10 mg lacosamide. 
1 vial of 20 ml contains 200 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sodium chloride, hydrochloric acid, water for injections.  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 x 20 ml solution for infusion 
200 mg/20 ml 
5 x 20 ml solution for infusion 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

Read the package leaflet before use. 
Intravenous use 
For single use only 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C.  
 
 



116 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution should be discarded.  
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
Allée de la Recherche 60 
B-1070 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/001 
EU/1/19/1383/002 
 
 
13. BATCH NUMBER 
 

Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
PC  
SN  
NN  
 



117 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING  
 
Vial 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lacosamide UCB 10 mg/ml infusion 
lacosamide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml of solution contains 10 mg lacosamide. 
1 vial of 20 ml contains 200 mg lacosamide. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sodium chloride, hydrochloric acid, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
200 mg/20 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 

For single use only. Read the package leaflet before use. 
IV use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 



118 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
UCB Pharma S.A. 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1383/001 
EU/1/19/1383/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 
 
  



119 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
B. PACKAGE LEAFLET 



120 

Package leaflet: Information for the patient 
 

Lacosamide UCB 50 mg film-coated tablets 
Lacosamide UCB 100 mg film-coated tablets 
Lacosamide UCB 150 mg film-coated tablets 
Lacosamide UCB 200 mg film-coated tablets 

lacosamide 
 

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Lacosamide UCB is and what it is used for 
2. What you need to know before you take Lacosamide UCB  
3. How to take Lacosamide UCB 
4. Possible side effects 
5. How to store Lacosamide UCB  
6. Contents of the pack and other information 
 
 
1. What Lacosamide UCB is and what it is used for 
 
What Lacosamide UCB is 
Lacosamide UCB contains lacosamide. This belongs to a group of medicines called “antiepileptic 
medicines”. These medicines are used to treat epilepsy. 
 You have been given this medicine to lower the number of fits (seizures) you have. 
 
What Lacosamide UCB is used for 
 Lacosamide UCB is used in adults, adolescents and children aged 4 years and older.  
 It is used: 

 on its own and in association with other antiepileptic medicines to treat a certain type 
of epilepsy characterised by the occurrence of partial-onset seizure with or without 
secondary generalisation. In this type of epilepsy, fits first affect only one side of your 
brain. However, these may then spread to larger areas on both sides of your brain; 

 in association with other antiepileptic medicines to treat primary generalised tonic-
clonic seizures (major fits, including loss of consciousness) in patients with idiopathic 
generalised epilepsy (the type of epilepsy that is thought to have a genetic cause). 

 
 
2.  What you need to know before you take Lacosamide UCB 
 
Do not take Lacosamide UCB 
 if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in 

section 6). If you are not sure whether you are allergic, please discuss with your doctor. 
 if you have a certain type of heart beat problem called second- or third-degree AV block. 
 
Do not take Lacosamide UCB if any of the above applies to you. If you are not sure, talk to your 
doctor or pharmacist before taking this medicine. 
 



121 

Warnings and precautions 
Talk to your doctor before taking Lacosamide UCB if: 
 you have thoughts of harming or killing yourself. A small number of people being treated with 

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing 
themselves. If you have any of these thoughts at any time, tell your doctor straight away. 

 you have a heart problem that affects the beat of your heart and you often have a particulary 
slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).  

 you have severe heart disease such as heart failure or have had a heart attack.  
 you are often dizzy or fall over. Lacosamide UCB may make you dizzy - this could increase 

the risk of accidental injury or a fall. This means that you should take care until you are used 
to the effects of this medicine. 

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 
Lacosamide UCB. 
If you are taking Lacosamide UCB, talk to your doctor if you are experiencing a new type of seizure 
or worsening of existing seizures. 
If you are taking Lacosamide UCB and you are experiencing symptoms of abnormal heartbeat (such as 
slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek 
medical advice immediately (see section 4). 
 
Children under 4 years 
Lacosamide UCB is not recommended for children aged under 4 years. This is because we do not yet 
know whether it will work and whether it is safe for children in this age group.  
  
Other medicines and Lacosamide UCB 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect 
your heart - this is because Lacosamide UCB can also affect your heart: 
 medicines to treat heart problems;  
 medicines which can increase the “PR interval” on a scan of the heart (ECG or 

electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine 
or pregabalin;  

 medicines used to treat certain types of irregular heart beat or heart failure.  
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 
Lacosamide UCB.  
 
Also tell your doctor or pharmacist if you are taking any of the following medicines - this is because 
they may increase or decrease the effect of Lacosamide UCB on your body: 
 medicines for fungal infections called fluconazole, itraconazole or ketoconazole;  
 a medicine for HIV called ritonavir; 
 medicines used to treat bacterial infections called clarithromycin or rifampicin;  
 a herbal medicine used to treat mild anxiety and depression called St. John’s wort. 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 
Lacosamide UCB.  
 
Lacosamide UCB with alcohol 
As a safety precaution do not take Lacosamide UCB with alcohol. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your 
doctor or pharmacist for advice before taking this medicine. 
 
It is not recommended to take Lacosamide UCB if you are pregnant or breast-feeding, as the effects of 
Lacosamide UCB on pregnancy and the unborn baby or the new-born child are not known. Also, it is 
not known whether Lacosamide UCB passes into breast milk. Seek advice immediately from your 



122 

doctor if you get pregnant or are planning to become pregnant. They will help you decide if you 
should take Lacosamide UCB or not. 
 
Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A 
worsening of your disease can also harm your baby. 
 
Driving and using machines 
Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is 
because Lacosamide UCB may make you feel dizzy or cause blurred vision.  
 
 
3. How to take Lacosamide UCB 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
Taking Lacosamide UCB 
 Take Lacosamide UCB twice each day - once in the morning and once in the evening. 
 Try to take it at about the same time each day.  
 Swallow the Lacosamide UCB tablet with a glass of water. 
 You may take Lacosamide UCB with or without food. 
 
You will usually start by taking a low dose each day and your doctor will slowly increase this over a 
number of weeks. When you reach the dose that works for you, this is called the “maintenance dose”, 
you then take the same amount each day. Lacosamide UCB is used as a long term treatment. You 
should continue to take Lacosamide UCB until your doctor tells you to stop. 
 
How much to take 
Listed below are the normal recommended doses of Lacosamide UCB for different age groups and 
weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with 
your liver. 
 
Adolescents and children weighing 50 kg or more and adults 
When you take Lacosamide UCB on its own 
The usual starting dose of Lacosamide UCB is 50 mg twice a day. 
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice a day. 
 
Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a 
maintenance dose between 100 mg and 300 mg twice a day. 
 
When you take Lacosamide UCB with other antiepileptic medicines 
The usual starting dose of Lacosamide UCB is 50 mg twice a day.  
 
Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a 
maintenance dose between 100 mg and 200 mg twice a day. 
 
If you weigh 50 kg or more, your doctor may decide to start Lacosamide UCB treatment with a single 
“loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later. 
 
Children and adolescent weighing less than 50 kg 
The dose depends on their body weight. They usually start treatment with the syrup and only change to 
tablets if they are able to take tablets and get the correct dose with the different tablet strengths. The 
doctor will prescribe the formulation that is best suited to them. 
 
If you take more Lacosamide UCB than you should  
If you have taken more Lacosamide UCB than you should, contact your doctor immediately. Do not 
try to drive. 



123 

You may experience:  
 dizziness;  
 feeling sick (nausea) or being sick (vomiting);  
 fits (seizures), heart beat problems such a slow, fast or irregular heart beat, coma or a fall in 

blood pressure with rapid heartbeat and sweating. 
 
If you forget to take Lacosamide UCB  
 If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you 

remember.  
 If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the 

missed tablet anymore. Instead take Lacosamide UCB at the next time that you would 
normally take it.  

 Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Lacosamide UCB 

 Do not stop taking Lacosamide UCB without talking to your doctor, as your epilepsy may 
come back again or become worse.  

 If your doctor decides to stop your treatment with Lacosamide UCB, they will tell you how to 
decrease the dose step by step. 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Nervous system side effects such as dizziness may be higher after a single “loading” dose. 
 
Talk to your doctor or pharmacist if you get any of the following: 
 
Very common: may affect more than 1 in 10 people 
 Headache; 
 Feeling dizzy or sick (nausea); 
 Double vision (diplopia). 
 
Common: may affect up to 1 in 10 people 
 Short jerks of a muscle or group of muscles (myoclonic seizures); 
 Difficulties in coordinating your movements or walking; 
 Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, 

falling easily and getting bruises; 
 Troubles with your memory, thinking or finding words, confusion; 
 Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;  
 A spinning sensation (vertigo), feeling drunk; 
 Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or 

bowel, diarrhoea;  
 Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention; 
 Noise in the ear such as buzzing, ringing or whistling; 
 Irritability, trouble sleeping, depression; 
 Sleepiness, tiredness or weakness (asthenia);  
 Itching, rash. 
 
Uncommon: may affect up to 1 in 100 people 
 Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your 

heart (conduction disorder); 
 Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there; 



124 

 Allergic reaction to medicine intake, hives; 
 Blood tests may show abnormal liver function, liver injury; 
 Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away; 
 Feeling angry or agitated; 
 Abnormal thinking or losing touch with reality; 
 Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower 

legs; 
 Fainting.  
 
Not known: frequency cannot be estimated from available data 
 Abnormal rapid heartbeat (ventricular tachyarrhythmia);  
 A sore throat, high temperature and getting more infections than usual. Blood tests may show 

a severe decrease in a specific class of white blood cells (agranulocytosis); 
 A serious skin reaction which may include a high temperature and other flu-like symptoms, a 

rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show 
increased levels of liver enzymes and a type of white blood cell (eosinophilia);  

 A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes 
and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in 
more than 30 % of the body surface (toxic epidermal necrolysis); 

 Convulsion. 
 
Additional side effects in children  
 
Common: may affect up to 1 in 10 children 
 Runny nose (nasopharyngitis); 
 Fever (pyrexia); 
 Sore throat (pharyngitis); 
 Eating less than usual. 

 
Uncommon: may affect up to 1 in 100 children 
 Feeling sleepy or lacking in energy (lethargy). 
 
Not known: frequency cannot be estimated from available data 
 Changes in behaviour, not acting like themselves. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Lacosamide UCB  
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


125 

6. Contents of the pack and other information 
 
What Lacosamide UCB contains 
 The active substance is lacosamide. 

One tablet of Lacosamide UCB 50 mg contains 50 mg lacosamide. 
One tablet of Lacosamide UCB 100 mg contains 100 mg lacosamide. 
One tablet of Lacosamide UCB 150 mg contains 150 mg lacosamide. 
One tablet of Lacosamide UCB 200 mg contains 200 mg lacosamide. 

 
 The other ingredients are: 

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low 
substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10 Pharmaceutical 
Grade), magnesium stearate. 
Film-coat: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*.  
* The colourants are: 
50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake 
(E132). 
100 mg tablet: yellow iron oxide (E172). 
150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). 
200 mg tablet: indigo carmine aluminium lake (E132). 

 
What Lacosamide UCB looks like and contents of the pack 
 Lacosamide UCB 50 mg are pinkish, oval film-coated tablets of approximately 10.4 mm x 

4.9 mm with a debossed ‘SP’ on one side and ‘50’ on the other side. 
 Lacosamide UCB 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm 

x 6.1 mm with a debossed ‘SP’ on one side and ‘100’ on the other side. 
 Lacosamide UCB 150 mg are salmon, oval film-coated tablets of approximately 15.1 mm x 

7.0 mm with a debossed ‘SP’ on one side and ‘150’ on the other side. 
 Lacosamide UCB 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 

7.8 mm with a debossed ‘SP’ on one side and ‘200’ on the other side. 
 
Lacosamide UCB is available in packs of 14, 28, 56, 14 x 1 and 56 x 1 film-coated tablets. 
Lacosamide UCB 50 mg and Lacosamide UCB 100 mg are available in packs of 168 film-coated 
tablets and Lacosamide UCB 150 mg and Lacosamide UCB 200 mg are available in multipacks 
comprising 3 cartons, each containing 56 tablets. The 14 x 1 and 56 x 1 film-coated tablet packs are 
available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, all other packs are 
available with standard PVC/PVDC blisters sealed with an aluminium foil. Not all pack sizes may be 
marketed. 
 
Marketing Authorisation Holder 
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium. 
 
Manufacturer 
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium. 
or  
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Suomija) 
 



126 

България 
Ю СИ БИ България ЕООД 
Teл.: + 359 (0) 2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: + 420 221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: + 36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: + 356 / 21 37 64 36 
 

Deutschland 
UCB Pharma GmbH 
Tel: + 49 /(0) 2173 48 4848 
 

Nederland 
UCB Pharma B.V. 
Tel.: + 31 / (0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland  
Tel: + 358 9 2514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: + 30 / 2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: + 43 (0)1 291 80 00 

España 
UCB Pharma, S.A. 
Tel: + 34 / 91 570 34 44 
 

Polska 

UCB Pharma Sp. z o.o. 
Tel: + 48 22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: + 33 / (0)1 47 29 44 35 

Portugal 
Bial – Portela & Cª, S.A. 
Tel: + 351 22 986 6100 
 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385 (0) 1 230 34 46 
 

România 
UCB Pharma Romania S.R.L. 
Tel: + 40 21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: + 353 / (0)1-46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: + 386 1 589 69 00 
 

Ísland 
Vistor hf. 
Simi: + 354 535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: + 421 (0) 2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: + 39 / 02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: + 358 9 2514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: + 357 22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: + 46 / (0) 40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel: + 44 / (0)1753 534 655 

 



127 

This leaflet was last revised in {month/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 

http://www.ema.europa.eu/


128 

Package leaflet: Information for the patient 
 

Lacosamide UCB 50 mg film-coated tablets 
Lacosamide UCB 100 mg film-coated tablets 
Lacosamide UCB 150 mg film-coated tablets 
Lacosamide UCB 200 mg film-coated tablets 

lacosamide 
 
The treatment initiation pack is only suitable in adolescents and children weighing 50 kg or 
more and in adults. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet  
1. What Lacosamide UCB is and what it is used for 
2. What you need to know before you take Lacosamide UCB 
3. How to take Lacosamide UCB 
4. Possible side effects 
5. How to store Lacosamide UCB 
6. Contents of the pack and other information 
 
 
1. What Lacosamide UCB is and what it is used for 
 
What Lacosamide UCB is 
Lacosamide UCB contains lacosamide. This belongs to a group of medicines called “antiepileptic 
medicines”. These medicines are used to treat epilepsy. 
 You have been given this medicine to lower the number of fits (seizures) you have. 
 
What Lacosamide UCB is used for 
 Lacosamide UCB is used in adolescents and children aged 4 years and older weighing 50 kg 

or more and in adults. 
 It is used: 

 on its own and in association with other antiepileptic medicines to treat a certain type of 
epilepsy characterised by the occurrence of partial-onset seizure with or without 
secondary generalisation. In this type of epilepsy, fits first affect only one side of your 
brain. However, these may then spread to larger areas on both sides of your brain;  

 in association with other antiepileptic medicines to treat primary generalised tonic-
clonic seizures (major fits, including loss of consciousness) in patients with idiopathic 
generalised epilepsy (the type of epilepsy that is thought to have a genetic cause). 

 
 
2. What you need to know before you take Lacosamide UCB  
 
Do not take Lacosamide UCB 
 if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in 

section 6). If you are not sure whether you are allergic, please discuss with your doctor. 
 if you have a certain type of heart beat problem called second- or third-degree AV block. 
 



129 

Do not take Lacosamide UCB if any of the above applies to you. If you are not sure, talk to your 
doctor or pharmacist before taking this medicine. 
 
Warnings and precautions 
Talk to your doctor before taking Lacosamide UCB if: 
 you have thoughts of harming or killing yourself. A small number of people being treated with 

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing 
themselves. If you have any of these thoughts at any time, tell your doctor straight away. 

 you have a heart problem that affects the beat of your heart and you often have a particulary 
slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter). 

 you have severe heart disease such as heart failure or have had a heart attack. 
 you are often dizzy or fall over. Lacosamide UCB may make you dizzy - this could increase 

the risk of accidental injury or a fall. This means that you should take care until you are used 
to the effects of this medicine. 

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 
Lacosamide UCB. 
If you are taking Lacosamide UCB, talk to your doctor if you are experiencing a new type of seizure 
or worsening of existing seizures. 
If you are taking Lacosamide UCB and you are experiencing symptoms of abnormal heartbeat (such as 
slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek 
medical advice immediately (see section 4). 
 
Children under 4 years 
Lacosamide UCB is not recommended for children aged under 4 years. This is because we do not yet 
know whether it will work and whether it is safe for children in this age group.  
 
Other medicines and Lacosamide UCB 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.  
 
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect 
your heart - this is because Lacosamide UCB can also affect your heart: 
 medicines to treat heart problems; 
 medicines which can increase the “PR interval” on a scan of the heart (ECG or 

electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine 
or pregabalin; 

 medicines used to treat certain types of irregular heart beat or heart failure. 
If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before taking 
Lacosamide UCB.  
 
Also tell your doctor or pharmacist if you are taking any of the following medicines - this is because 
they may increase or decrease the effect of Lacosamide UCB on your body: 
 medicines for fungal infections called fluconazole, itraconazole or ketoconazole; 
 a medicine for HIV called ritonavir; 
 medicines for bacterial infections called clarithromycin or rifampicin; 
 a herbal medicine used to treat mild anxiety and depression called St. John’s wort. 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 
Lacosamide UCB.  
 
Lacosamide UCB with alcohol 
As a safety precaution do not take Lacosamide UCB with alcohol. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 



130 

It is not recommended to take Lacosamide UCB if you are pregnant or breast-feeding, as the effects of 
Lacosamide UCB on pregnancy and the unborn baby or the new-born child are not known. Also, it is 
not known whether Lacosamide UCB passes into the breast milk. Seek advice immediately from your 
doctor if you get pregnant or are planning to become pregnant. They will help you decide if you 
should take Lacosamide UCB or not. 
 
Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A 
worsening of your disease can also harm your baby. 
 
Driving and using machines 
Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is 
because Lacosamide UCB may make you feel dizzy or cause blurred vision.  
 
 
3. How to take Lacosamide UCB  
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
Taking Lacosamide UCB 
 Take Lacosamide UCB twice each day - once in the morning and once in the evening. 
 Try to take it at about the same time each day.  
 Swallow the Lacosamide UCB tablet with a glass of water.  
 You may take Lacosamide UCB with or without food. 
 
You will usually start by taking a low dose each day and your doctor will slowly increase this over a 
number of weeks. When you reach the dose that works for you, this is called the “maintenance dose”, 
you then take the same amount each day. Lacosamide UCB is used as a long term treatment. You 
should continue to take Lacosamide UCB until your doctor tells you to stop. 
 
How much to take 
Listed below are the normal recommended doses of Lacosamide UCB for different age groups and 
weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with 
your liver. 
 
Adolescents and children weighing 50 kg or more and adults only 
When you take Lacosamide UCB on its own 
The usual starting dose of Lacosamide UCB is 50 mg twice a day. 
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice a day. 
 
Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a 
maintenance dose between 100 mg and 300 mg twice a day. 
 
When you take Lacosamide UCB with other antiepileptic medicines 
- Start of the treatment (the first 4 weeks) 
This pack (treatment initiation pack) is used when you start your treatment with Lacosamide UCB. 
The pack contains 4 different packages for the first 4 weeks of treatment, one package for each week. 
Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.  
Each package contains a different dosage strength of Lacosamide UCB, so you will increase your dose 
gradually.  
You will start your treatment with a low dose of Lacosamide UCB, usually 50 mg twice a day, and 
increase it week by week. The usual dose that may be taken per day for each of the first 4 weeks of 
treatment is shown in the following table. Your doctor will tell you whether you need all 4 packages. 
 



131 

Table: Start of the treatment (the first 4 weeks) 
Week  
 

Package to be 
used 

First dose (in the 
morning) 

Second dose (in the 
evening) 

TOTAL 
daily dose 

Week 1  Package marked 
"Week 1" 

50 mg 
(1 tablet Lacosamide UCB 
50 mg) 

50 mg 
(1 tablet Lacosamide UCB 
50 mg) 

100 mg 

Week 2  Package marked 
"Week 2"  

100 mg 
(1 tablet Lacosamide UCB 
100 mg) 

100 mg 
(1 tablet Lacosamide UCB 
100 mg) 

200 mg 

Week 3 Package marked 
"Week 3" 

150 mg 
(1 tablet Lacosamide UCB 
150 mg) 

150 mg 
(1 tablet Lacosamide UCB 
150 mg) 

300 mg 

Week 4 Package marked 
"Week 4"  

200 mg 
(1 tablet Lacosamide UCB 
200 mg) 

200 mg 
(1 tablet Lacosamide UCB 
200 mg) 

400 mg 

 
- Maintenance treatment (after the first 4 weeks) 
After the first 4 weeks of treatment, your doctor may adjust the dose with which you will continue 
your long term treatment. This dose is called a maintenance dose and will depend on how you respond 
to Lacosamide UCB. For most patients the maintenance dose is between 200 mg and 400 mg per day. 
 
Children and adolescents below 50 kg 
The treatment initiation pack is not suitable for children and adolescents weighing less than 50 kg.  
 
If you take more Lacosamide UCB than you should  
If you have taken more Lacosamide UCB than you should, contact your doctor immediately. Do not 
try to drive. 
You may experience:  
 dizziness; 
 feeling sick (nausea) or being sick (vomiting); 
 fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a fall in 

blood pressure with rapid heartbeat and sweating. 
 
If you forget to take Lacosamide UCB  
 If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you 

remember.  
 If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the 

missed tablet anymore. Instead take Lacosamide UCB at the next time that you would 
normally take it.  

 Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Lacosamide UCB 

 Do not stop taking Lacosamide UCB without talking to your doctor, as your epilepsy may 
come back again or become worse.  

 If your doctor decides to stop your treatment with Lacosamide UCB, they will tell you how to 
decrease the dose step by step. 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 



132 

Talk to your doctor or pharmacist if you get any of the following: 
 
Very common: may affect more than 1 in 10 people 
 Headache; 
 Feeling dizzy or sick (nausea); 
 Double vision (diplopia). 
 
Common: may affect up to 1 in 10 people 
 Short jerks of a muscle or group of muscles (myoclonic seizures); 
 Difficulties in coordinating your movements or walking; 
 Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, 

falling easily and getting bruises; 
 Troubles with your memory, thinking or finding words, confusion; 
 Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;  
 A spinning sensation (vertigo), feeling drunk; 
 Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or 

bowel, diarrhoea;  
 Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention; 
 Noise in the ear such as buzzing, ringing or whistling; 
 Irritability, trouble sleeping, depression; 
 Sleepiness, tiredness, or weakness (asthenia);  
 Itching, rash. 
 
Uncommon: may affect up to 1 in 100 people 
 Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your 

heart (conduction disorder); 
 Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there; 
 Allergic reaction to medicine intake, hives; 
 Blood tests may show abnormal liver function, liver injury; 
 Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away; 
 Feeling angry or agitated; 
 Abnormal thinking or losing touch with reality; 
 Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower 

legs; 
 Fainting. 
 
Not known: frequency cannot be estimated from available data 
 Abnormal rapid heartbeat (ventricular tachyarrhythmia);  
 A sore throat, high temperature and getting more infections than usual. Blood tests may show 

a severe decrease in a specific class of white blood cells (agranulocytosis); 
 A serious skin reaction which may include a high temperature and other flu-like symptoms, a 

rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show 
increased levels of liver enzymes and a type of white blood cell (eosinophilia);  

 A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes 
and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in 
more than 30 % of the body surface (toxic epidermal necrolysis); 

 Convulsion. 
 
Additional side effects in children  
 
Common: may affect up to 1 in 10 children 
 Runny nose (nasopharyngitis); 
 Fever (pyrexia); 
 Sore throat (pharyngitis); 
 Eating less than usual. 



133 

 
Uncommon: may affect up to 1 in 100 children 
 Feeling sleepy or lacking in energy (lethargy). 
 
Not known: frequency cannot be estimated from available data 
 Changes in behaviour, not acting like themselves. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Lacosamide UCB 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Lacosamide UCB contains 
 The active substance is lacosamide. 

One tablet of Lacosamide UCB 50 mg contains 50 mg lacosamide. 
One tablet of Lacosamide UCB 100 mg contains 100 mg lacosamide. 
One tablet of Lacosamide UCB 150 mg contains 150 mg lacosamide. 
One tablet of Lacosamide UCB 200 mg contains 200 mg lacosamide. 

 
 The other ingredients are: 

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low 
substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10 Pharmaceutical 
Grade), magnesium stearate. 
Film-coat: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*. 
* The colourants are: 
50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake 
(E132). 
100 mg tablet: yellow iron oxide (E172). 
150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). 
200 mg tablet: indigo carmine aluminium lake (E132). 

 
What Lacosamide UCB looks like and contents of the pack 
 Lacosamide UCB 50 mg are pinkish, oval film-coated tablets of approximately 10.4 mm x 

4.9 mm with a debossed ‘SP’ on one side and ‘50’ on the other side. 
 Lacosamide UCB 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm 

x 6.1 mm with a debossed ‘SP’ on one side and ‘100’ on the other side. 
 Lacosamide UCB 150 mg are salmon, oval film-coated tablets of approximately 15.1 mm x 

7.0 mm with a debossed ‘SP’ on one side and ‘150’ on the other side. 
 Lacosamide UCB 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 

7.8 mm with a debossed ‘SP’ on one side and ‘200’ on the other side. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


134 

 

The treatment initiation pack contains 56 film-coated tablets in 4 packages:  
 the package marked ‘Week 1’contains 14 tablets of 50 mg,  
 the package marked ‘Week 2’ contains 14 tablets of 100 mg,  
 the package marked ‘Week 3’ contains 14 tablets of 150 mg,  
 the package marked ‘Week 4’ contains 14 tablets of 200 mg. 
 
Marketing Authorisation Holder  
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium. 
 
Manufacturer  
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium. 
or  
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Suomija) 
 

България 
Ю СИ БИ България ЕООД 
Teл.: + 359 (0) 2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: + 420 221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: + 36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: + 356 / 21 37 64 36 
 

Deutschland 
UCB Pharma GmbH 
Tel: + 49 /(0) 2173 48 4848 
 

Nederland 
UCB Pharma B.V. 
Tel.: + 31 / (0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland  
Tel: + 358 9 2514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: + 30 / 2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: + 43 (0)1 291 80 00 

España 
UCB Pharma, S.A. 
Tel: + 34 / 91 570 34 44 
 

Polska 

UCB Pharma Sp. z o.o. 
Tel: + 48 22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: + 33 / (0)1 47 29 44 35 

Portugal 
Bial – Portela & Cª, S.A. 
Tel: + 351 22 986 6100 
 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385 (0) 1 230 34 46 

România 
UCB Pharma Romania S.R.L. 
Tel: + 40 21 300 29 04 



135 

  
Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: + 353 / (0)1-46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: + 386 1 589 69 00 
 

Ísland 
Vistor hf. 
Simi: + 354 535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: + 421 (0) 2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: + 39 / 02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: + 358 9 2514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: + 357 22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: + 46 / (0) 40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel: + 44 / (0)1753 534 655 

 
This leaflet was last revised in {month/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 
  

http://www.ema.europa.eu/


136 

Package leaflet: Information for the patient 
 

Lacosamide UCB 10 mg/ml syrup 
lacosamide 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet  
1. What Lacosamide UCB is and what it is used for 
2. What you need to know before you take Lacosamide UCB 
3. How to take Lacosamide UCB 
4. Possible side effects 
5. How to store Lacosamide UCB 
6. Contents of the pack and other information 
 
 
1. What Lacosamide UCB is and what it is used for 
 
What Lacosamide UCB is 
Lacosamide UCB contains lacosamide. This belongs to a group of medicines called “antiepileptic 
medicines”. These medicines are used to treat epilepsy. 
 You have been given this medicine to lower the number of fits (seizures) you have. 
 
What Lacosamide UCB is used for 
 Lacosamide UCB is used in adults, adolescents and children aged 4 years and older.  
 It is used: 

 on its own and in association with other antiepileptic medicines to treat a certain type of 
epilepsy characterised by the occurrence of partial-onset seizure with or without 
secondary generalisation. In this type of epilepsy, fits first affect only one side of your 
brain. However, these may then spread to larger areas on both sides of your brain;  

 in association with other antiepileptic medicines to treat primary generalised tonic-
clonic seizures (major fits, including loss of consciousness) in patients with idiopathic 
generalised epilepsy (the type of epilepsy that is thought to have a genetic cause). 

 
 
2. What you need to know before you take Lacosamide UCB  
 
Do not take Lacosamide UCB 
 if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in 

Section 6). If you are not sure whether you are allergic, please discuss with your doctor. 
 if you have a certain type of heart beat problem called second- or third-degree AV block. 
 
Do not take Lacosamide UCB if any of the above applies to you. If you are not sure, talk to your 
doctor or pharmacist before taking this medicine. 



137 

Warnings and precautions 
Talk to your doctor before taking Lacosamide UCB if: 
 you have thoughts of harming or killing yourself. A small number of people being treated with 

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing 
themselves. If you have any of these thoughts at any time, tell your doctor straight away. 

 you have a heart problem that affects the beat of your heart and you often have a particulary 
slow, fast or irregular heart beat (such as AV block, atrial fibrillation or atrial flutter).  

 you have severe heart disease such as heart failure or have had a heart attack. 
 you are often dizzy or fall over. Lacosamide UCB may make you dizzy – this could increase 

the risk of accidental injury or a fall. This means that you should take care until you are used 
to the effects of this medicine. 

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 
Lacosamide UCB. 
If you are taking Lacosamide UCB, talk to your doctor if you are experiencing a new type of seizure 
or worsening of existing seizures. 
If you are taking Lacosamide UCB and you are experiencing symptoms of abnormal heartbeat (such as 
slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek 
medical advice immediately (see section 4). 
 
Children under 4 years 
Lacosamide UCB is not recommended for children aged under 4 years. This is because we do not yet 
know whether it will work and whether it is safe for children in this age group. 
 
Other medicines and Lacosamide UCB 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.  
 
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect 
your heart - this is because Lacosamide UCB can also affect your heart: 
 medicines to treat heart problems; 
 medicines which can increase the “PR interval” on a scan of the heart (ECG or 

electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine 
or pregabalin; 

 medicines used to treat certain types of irregular heart beat or heart failure. 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 
Lacosamide UCB.  
 
Also tell your doctor or pharmacist if you are taking any of the following medicines - this is because 
they may increase or decrease the effect of Lacosamide UCB on your body: 
 medicines for fungal infections called fluconazole, itraconazole or ketoconazole; 
 a medicine for HIV called ritonavir; 
 medicines for bacterial infections called clarithromycin or rifampicin; 
 a herbal medicine used to treat mild anxiety and depression called St. John’s wort. 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 
Lacosamide UCB.  
 
Lacosamide UCB with alcohol 
As a safety precaution do not take Lacosamide UCB with alcohol. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
It is not recommended to take Lacosamide UCB if you are pregnant or breast-feeding, as the effects of 
Lacosamide UCB on pregnancy and the unborn baby or the new-born child are not known. Also, it is 
not known whether Lacosamide UCB passes into the breast milk. Seek advice immediately from your 



138 

doctor if you get pregnant or are planning to become pregnant. They will help you decide if you 
should take Lacosamide UCB or not. 
 
Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A 
worsening of your disease can also harm your baby. 
 
Driving and using machines 
Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is 
because Lacosamide UCB may make you feel dizzy or cause blurred vision. 
 
Lacosamide UCB contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame 
and propylene glycol 
 Sorbitol (a type of sugar): This medicine contains 187 mg sorbitol in each ml. Sorbitol is a 

source of fructose. If your doctor has told you that you (or your child) have an intolerance to 
some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare 
genetic disorder in which a person cannot break down fructose, talk to your doctor before you 
(or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort 
and mild laxative effect.  

 Sodium (salt): This medicine contains 1.42  mg sodium (main component of cooking/table 
salt) in each ml. This is equivalent to 0.07 % of the recommended maximum daily dietary 
intake of sodium for an adult. 

 Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).  
 Aspartame (E951): This medicine contains 0.032 mg aspartame in each ml. Aspartame is a 

source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic 
disorder in which phenylalanine builds up because the body cannot remove it properly.  

 Propylene glycol (E1520): This medicine contains 2.14 mg propylene glycol in each ml. 
 
 
3. How to take Lacosamide UCB  
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
Taking Lacosamide UCB 
 Take Lacosamide UCB twice each day - once in the morning and once in the evening. 
 Try to take it at about the same time each day. 
 You may take Lacosamide UCB with or without food.  
 
You will usually start by taking a low dose each day and your doctor will slowly increase this over a 
number of weeks. When you reach the dose that works for you, this is called the “maintenance dose”, 
you then take the same amount each day. Lacosamide UCB is used as a long term treatment. You 
should continue to take Lacosamide UCB until your doctor tells you to stop. 
 
How much to take 
Listed below are the normal recommended doses of Lacosamide UCB for different age groups and 
weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with 
your liver. 
 
Adolescents and children weighing 50 kg or more and adults 
 Use the measuring cup provided in the carton box. 
 
When you take Lacosamide UCB on its own 
The usual starting dose of Lacosamide UCB is 50 mg (5 ml) twice a day. 
Your doctor may also prescribe a starting dose of 100 mg (10 ml) of Lacosamide UCB twice a day. 
 
Your doctor may increase your twice daily dose every week by 50 mg (5 ml). This will be until you 
reach a maintenance dose of between 100 mg (10 ml) and 300 mg (30 ml) twice a day.  



139 

 
When you take Lacosamide UCB with other antiepileptic medicines 
The usual starting dose of Lacosamide UCB is 50 mg (5 ml) twice a day.  
 
Your doctor may increase your twice daily dose every week by 50 mg (5 ml). This will be until you 
reach a maintenance dose of between 100 mg (10 ml) and 200 mg (20 ml) twice a day.  
 
If you weigh 50 kg or more, your doctor may decide to start Lacosamide UCB treatment with a single 
“loading” dose of 200 mg (20 ml). You would then start your ongoing maintenance dose 12 hours 
later.  
 
Children and adolescents weighing less than 50 kg 
 Use the oral syringe provided in the carton box. 
 
When you take Lacosamide UCB on its own 
 
Your doctor will decide the dose of Lacosamide UCB based on your body weight. 
 
The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.  
 
Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of your 
body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 
6 mg (0.6 ml) for each kg of body weight, twice a day, for children weighing under 40 kg. The 
maximum recommended dose is 5 mg (0.5 ml) for each kg of body weight, twice a day, for children 
weighing from 40 kg to under 50 kg. Dosing charts are provided below: 
 
Taking Lacosamide UCB on its own – This is for information only. Your doctor will work out the 
right dose for you:  
 
To be taken twice daily for children from 4 years of age weighing less than 40 kg 

Weight Starting 
dose:  
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

0.4 ml/kg 
 

0.5 ml/kg 
 

Maximum 
recommended 
dose: 0.6 ml/kg 
 

10 kg 1 ml  2 ml  3 ml  4 ml  5 ml  6 ml  
15 kg 1.5 ml  3 ml  4.5 ml  6 ml  7.5 ml  9 ml  
20 kg 2 ml  4 ml  6 ml  8 ml  10 ml  12 ml  
25 kg 2.5 ml  5 ml  7.5 ml  10 ml  12.5 ml  15 ml  
30 kg 3 ml  6 ml  9 ml  12 ml  15 ml  18 ml  
35 kg 3.5 ml  7 ml  10.5 ml  14 ml  17.5 ml  21 ml  

 
To be taken twice daily for children and adolescents from 4 years of age weighing 40 kg to under 
50 kg: 

Weight Starting dose: 
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

0.4 ml/kg 
 

Maximum 
recommended 
dose: 0.5 ml/kg 
 

40 kg 4 ml  8 ml  12 ml  16 ml  20 ml  
45 kg 4.5 ml  9 ml  13.5 ml  18 ml  22.5 ml  

 
When you take Lacosamide UCB with other antiepileptic medicines 
 
Your doctor will decide the dose of Lacosamide UCB based on your body weight. 
 
In children from 4 years of age with a body weight of under 20 kg: 
 the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.  



140 

 
Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body 
weight. This will be until you reach a maintenance dose. The maximum recommended dose is 6 mg 
(0.6 ml), for each kg of body weight, twice a day. A dosing chart is provided below. 
  
Taking Lacosamide UCB with other antiepileptic medicines - Children above 4 years of age 
weighing less than 20 kg - This is for information only. Your doctor will work out the right dose for 
you:  
 
To be taken twice daily for children from 4 years of age weighing less than 20 kg 

Weight Starting 
dose:  
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

0.4 ml/kg 
 

0.5 ml/kg 
 

Maximum 
recommended 
dose: 
0.6 ml/kg 
 

10 kg 1 ml  2 ml  3 ml  4 ml  5 ml  6 ml  
15 kg 1.5 ml  3 ml  4.5 ml  6 ml  7.5 ml  9 ml  

 
In children from 4 years of age with a body weight of 20 to under 30 kg: 
 the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.  
 
Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body 
weight. This will be until you reach a maintenance dose. The maximum recommended dose is 5 mg 
(0.5 ml), for each kg of body weight, twice a day. A dosing chart is provided below. 
 
Taking Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body 
weight of 20 kg to under 30 kg - This is for information only. Your doctor will work out the right 
dose for you:  
 
To be taken twice daily for children and adolescents from 4 years of age weighing 20 kg to under 
30 kg: 

Weight Starting dose: 
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

0.4 ml/kg 
 

Maximum 
recommended 
dose: 0.5 ml/kg 
 

20 kg 2 ml  4 ml  6 ml  8 ml  10 ml 
25 kg 2.5 ml  5 ml  7.5 ml  10 ml  12.5 ml 

 
In children from 4 years of age with a body weight of 30 to under 50 kg: 
 the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.  
 
Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body 
weight. This will be until you reach a maintenance dose. The maximum recommended dose is 4 mg 
(0.4 ml), for each kg of body weight, twice a day. A dosing chart is provided below. 
 
Taking Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body 
weight of 30 kg to under 50 kg - This is for information only. Your doctor will work out the right 
dose for you: 
 
To be taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under 
50 kg: 

Weight Starting dose:  
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

Maximum 
recommended dose: 
0.4 ml/kg 
 

30 kg 3 ml  6 ml  9 ml  12 ml  



141 

35 kg 3.5 ml  7 ml  10.5 ml  14 ml  
40 kg 4 ml  8 ml  12 ml  16 ml  
45 kg 4.5 ml  9 ml  13.5 ml  18 ml  

 
 
Instructions for use: measuring cup 
 
Adolescents and children weighing 50 kg or more and adults 
 Use the measuring cup provided in this pack. 
1. Shake the bottle well before use.  
2. Fill the measuring cup to the millilitre (ml) dose marker prescribed by your doctor.  
3. Swallow the dose of syrup.  
4. Then drink some water.  
 
Instructions for use: oral syringe 
 
Your doctor will show you how to use the oral syringe, before you use it for the first time. If you have 
any questions, please go back to your doctor or pharmacist.  
 
Children and adolescents weighing less than 50 kg  
 Use the oral syringe and the adaptor provided in this pack.  
 
Shake the bottle well before use. 
Open the bottle by pressing the cap while turning it anti-clockwise (figure 1). 
 

 
 
Follow these steps the first time you take Lacosamide UCB:  
 Take off the adaptor from the oral syringe (figure 2). 
 Put the adaptor into the top of the bottle (figure 3). Make sure it is fixed well in place. You do 

not need to remove the adaptor after use. 
 

 
 
Follow these steps each time you take Lacosamide UCB: 
 Put the oral syringe into the adaptor opening (figure 4). 
 Turn the bottle upside down (figure 5). 
 



142 

 
 
 Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.  
 Pull the piston down to fill the oral syringe with a small amount of solution (figure 6). 
 Push the piston up to get rid of any bubbles (figure 7).  
 Pull the piston down to the millilitre (ml) dose marker prescribed by your doctor (figure 8). 
 

  
 
 Turn the bottle the right way up (figure 9).  
 Take the oral syringe out of the adaptor (figure 10). 
 

 
 
There are two ways in which you can choose to drink the medicine: 
 empty the contents of the oral syringe into a little water by pushing the piston to the bottom of 

the oral syringe (figure 11) – you will then need to drink all of the water (add just enough to 
make it easy to drink) or  

 drink the solution directly from the oral syringe without water (figure 12) – drink the whole 
contents of the oral syringe. 

 



143 

 
 
 Close the bottle with the plastic screw cap (you do not need to remove the adaptor).  
 Wash the oral syringe with water only (figure 13). 
  

 
 
If you take more Lacosamide UCB than you should  
If you have taken more Lacosamide UCB than you should, contact your doctor immediately. Do not 
try to drive. 
You may experience:  
 dizziness;  
 feeling sick (nausea) or being sick (vomiting);  
 fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a fall in 

blood pressure with rapid heartbeat and sweating. 
 
If you forget to take Lacosamide UCB  
 If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you 

remember.  
 If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the 

missed syrup anymore. Instead take Lacosamide UCB at the next time that you would 
normally take it.  

 Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Lacosamide UCB 

 Do not stop taking Lacosamide UCB without talking to your doctor, as your epilepsy may 
come back again or become worse.  

 If your doctor decides to stop your treatment with Lacosamide UCB, they will tell you how to 
decrease the dose step by step. 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Nervous system side effects such as dizziness may be higher after a single “loading” dose. 
 



144 

Talk to your doctor or pharmacist if you get any of the following: 
 
Very common: may affect more than 1 in 10 people 
 Headache; 
 Feeling dizzy or sick (nausea); 
 Double vision (diplopia). 
 
Common: may affect up to 1 in 10 people 
 Short jerks of a muscle or group of muscles (myoclonic seizures); 
 Difficulties in coordinating your movements or walking; 
 Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, 

falling easily and getting bruises;  
 Trouble with your memory, thinking or finding words, confusion; 
 Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;  
 A spinning sensation (vertigo), feeling drunk;  
 Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or 

bowel, diarrhoea;  
 Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention; 
 Noise in the ear such as buzzing, ringing or whistling; 
 Irritability, trouble sleeping, depression;  
 Sleepiness, tiredness or weakness (asthenia); 
 Itching, rash. 
 
Uncommon: may affect up to 1 in 100 people 
 Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your 

heart (conduction disorder); 
 Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there; 
 Allergic reaction to medicine intake, hives;  
 Blood tests may show abnormal liver function, liver injury;  
 Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away; 
 Feeling angry or agitated; 
 Abnormal thinking or losing of touch with reality; 
 Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower 

legs; 
 Fainting.  
 
Not known: frequency cannot be estimated from available data 
 Abnormal rapid heartbeat (ventricular tachyarrhythmia);  
 A sore throat, high temperature and getting more infections than usual. Blood tests may show 

a severe decrease in a specific class of white blood cells (agranulocytosis); 
 A serious skin reaction which may include a high temperature and other flu-like symptoms, a 

rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show 
increased levels of liver enzymes and a type of white blood cell (eosinophilia);  

 A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes 
and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in 
more than 30 % of the body surface (toxic epidermal necrolysis); 

 Convulsion. 
 
Additional side effects in children  
 
Common: may affect up to 1 in 10 children 
 Runny nose (nasopharyngitis); 
 Fever (pyrexia); 
 Sore throat (pharyngitis); 
 Eating less than usual. 



145 

 
Uncommon: may affect up to 1 in 100 children 
 Feeling sleepy or lacking in energy (lethargy). 
 
Not known: frequency cannot be estimated from available data 
 Changes in behaviour, not acting like themselves. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Lacosamide UCB  
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The 
expiry date refers to the last day of that month.  
 
Do not refrigerate.  
Once you have opened the syrup bottle, do not use beyond 2 months. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Lacosamide UCB contains 
 The active substance is lacosamide. 1 ml Lacosamide UCB syrup contains 10 mg lacosamide. 
 The other ingredients are glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) 

(E420), polyethylene glycol 4000, sodium chloride, citric acid anhydrous, acesulfame 
potassium (E950), sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains 
propylene glycol, maltol), masking flavour (contains propylene glycol, aspartame (E951), 
acesulfame potassium (E950), maltol, deionised water), purified water. 

 
What Lacosamide UCB looks like and contents of the pack 
 Lacosamide UCB 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown 

liquid. 
 Lacosamide UCB is available in a bottle of 200 ml.  
 
The carton boxes of Lacosamide UCB syrup contain a 30 ml measuring cup with graduation marks 
and a 10 ml oral syringe.  
 The measuring cup is suitable for adults, adolescents and children weighing 50 kg and above. 

Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg of lacosamide (for 
example 2 graduation marks correspond to 100 mg). 

 The oral syringe is suitable for children and adolescents below 50 kg. One full 10 ml oral 
syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 ml, 
which is 10 mg of lacosamide. After this, each graduation mark (0.25 ml) corresponds to 
2.5 mg of lacosamide (for example 4 graduation marks corresponds to 10 mg). 

 
Marketing Authorisation Holder  
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


146 

Manufacturer 
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany  
or 
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Suomija) 
 

България 
Ю СИ БИ България ЕООД 
Teл.: + 359 (0) 2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: + 420 221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: + 36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: + 356 / 21 37 64 36 
 

Deutschland 
UCB Pharma GmbH 
Tel: + 49 /(0) 2173 48 4848 
 

Nederland 
UCB Pharma B.V. 
Tel.: + 31 / (0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland  
Tel: + 358 9 2514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: + 30 / 2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: + 43 (0)1 291 80 00 

España 
UCB Pharma, S.A. 
Tel: + 34 / 91 570 34 44 
 

Polska 

UCB Pharma Sp. z o.o. 
Tel: + 48 22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: + 33 / (0)1 47 29 44 35 

Portugal 
Bial – Portela & Cª, S.A. 
Tel: + 351 22 986 6100 
 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385 (0) 1 230 34 46 
 

România 
UCB Pharma Romania S.R.L. 
Tel: + 40 21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: + 353 / (0)1-46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: + 386 1 589 69 00 
 

Ísland 
Vistor hf. 
Simi: + 354 535 7000 
 

Slovenská republika 
UCB s.r.o., organizačná zložka 
Tel: + 421 (0) 2 5920 2020 
 



147 

Italia 
UCB Pharma S.p.A. 
Tel: + 39 / 02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: + 358 9 2514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: + 357 22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: + 46 / (0) 40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel: + 44 / (0)1753 534 655 

 
This leaflet was last revised in {month/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
  

http://www.ema.europa.eu/


148 

Package leaflet: Information for the patient 
 

Lacosamide UCB 10 mg/ml solution for infusion 
lacosamide 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet  
1. What Lacosamide UCB is and what it is used for 
2. What you need to know before you use Lacosamide UCB 
3. How to use Lacosamide UCB 
4. Possible side effects 
5. How to store Lacosamide UCB 
6. Contents of the pack and other information 
 
 
1. What Lacosamide UCB is and what it is used for 
 
What Lacosamide UCB is 
Lacosamide UCB contains lacosamide. This belongs to a group of medicines called “antiepileptic 
medicines”. These medicines are used to treat epilepsy. 
 You have been given this medicine to lower the number of fits (seizures) you have. 
 
What Lacosamide UCB is used for 
 Lacosamide UCB is used in adults, adolescents and children aged 4 years and older.  
 It is used: 

 on its own and in association with other antiepileptic medicines to treat a certain type of 
epilepsy characterised by the occurrence of partial-onset seizure with or without 
secondary generalisation. In this type of epilepsy, fits first affect only one side of your 
brain. However, these may then spread to larger areas on both sides of your brain; 

 in association with other antiepileptic medicines to treat primary generalised tonic-
clonic seizures (major fits, including loss of consciousness) in patients with idiopathic 
generalised epilepsy (the type of epilepsy that is thought to have a genetic cause). 

 
 
2. What you need to know before you use Lacosamide UCB  
 
Do not use Lacosamide UCB 
 if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in 

section 6). If you are not sure whether you are allergic, please discuss with your doctor. 
 if you have a certain type of heart beat problem called second- or third-degree AV block.  
 
Do not use Lacosamide UCB if any of the above applies to you. If you are not sure, talk to your doctor 
or pharmacist before using this medicine. 
 
Warnings and precautions 
Talk to your doctor before using Lacosamide UCB if: 
 you have thoughts of harming or killing yourself. A small number of people being treated with 

antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing 
themselves. If you have any of these thoughts at any time, tell your doctor straight away. 

 you have a heart problem that affects the beat of your heart and you often have a particulary 
slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter). 



149 

 you have severe heart disease such as heart failure or have had a heart attack.  
 you are often dizzy or fall over. Lacosamide UCB may make you dizzy - this could increase 

the risk of accidental injury or a fall. This means that you should take care until you are used 
to the effects of this medicine. 

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using 
Lacosamide UCB. 
If you are taking Lacosamide UCB, talk to your doctor if you are experiencing a new type of seizure 
or worsening of existing seizures. 
If you are taking Lacosamide UCB and you are experiencing symptoms of abnormal heartbeat (such as 
slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek 
medical advice immediately (see section 4). 
 
Children under 4 years 
Lacosamide UCB is not recommended for children aged under 4 years. This is because we do not yet 
know whether it will work and whether it is safe for children in this age group. 
 
Other medicines and Lacosamide UCB 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.  
 
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect 
your heart - this is because Lacosamide UCB can also affect your heart: 
 medicines to treat heart problems; 
 medicines which can increase the “PR interval” on a scan of the heart (ECG or 

electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine 
or pregabalin; 

 medicines used to treat certain types of irregular heart beat or heart failure. 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using 
Lacosamide UCB.  
 
Also tell your doctor or pharmacist if you are taking any of the following medicines - this is because 
they may increase or decrease the effect of Lacosamide UCB on your body: 
 medicines for fungal infections called fluconazole, itraconazole or ketoconazole; 
 a medicine for HIV called ritonavir; 
 medicines for bacterial infections called clarithromycin or rifampicin; 
 a herbal medicine used to treat mild anxiety and depression called St. John’s wort. 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using 
Lacosamide UCB. 
 
Lacosamide UCB with alcohol 
As a safety precaution do not use Lacosamide UCB with alcohol. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before using this medicine. 
 
It is not recommended to use Lacosamide UCB if you are pregnant or breast feeding, as the effects of 
Lacosamide UCB on pregnancy and the unborn baby or the new-born child are not known. Also, it is 
not known whether Lacosamide UCB passes into breast milk. Seek advice immediately from your 
doctor if you get pregnant or are planning to become pregnant. They will help you decide if you 
should use Lacosamide UCB or not. 
 
Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A 
worsening of your disease can also harm your baby. 
 
Driving and using machines 
Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is 



150 

because Lacosamide UCB may make you feel dizzy or cause blurred vision.  
 
Lacosamide UCB contains sodium 
This medicine contains 59.8 mg sodium (main component of cooking/table salt) in each vial. This is 
equivalent to 3 % of the recommended maximum daily dietary intake of sodium for an adult. 
 
 
3. How to use Lacosamide UCB  
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
Using Lacosamide UCB 
 Lacosamide UCB can be started by: 

- taking the medicine by mouth or 
- by being given as an intravenous infusion (sometimes called an “IV infusion”) where the 

medicine is given into your vein by a doctor or nurse. It is given over 15 to 60 minutes. 
 The IV infusion is usually used for a short time when you cannot take the medicine by mouth. 
 Your doctor will decide for how many days you will have infusions. There is experience with 

twice daily infusions of Lacosamide UCB for up to 5 days. For longer term treatment 
Lacosamide UCB tablets and syrup are available. 

 
When you change from the infusion to taking the medicine by mouth (or the other way around) the 
total amount you take each day and how often you take it stays the same. 
 Use Lacosamide UCB twice each day – once in the morning and once in the evening. 
 Try to use it at about the same time each day. 
 
How much to use 
Listed below are the normal recommended doses of Lacosamide UCB for different age groups and 
weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with 
your liver. 
 
Adolescents and children weighing 50 kg or more and adults 
When you use Lacosamide UCB on its own 
The usual starting dose of Lacosamide UCB is 50 mg twice a day. 
The treatment with Lacosamide UCB may also start with a dose of 100 mg of Lacosamide UCB twice 
a day. 
 
Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a 
maintenance dose of between 100 mg and 300 mg twice a day. 
 
When you use Lacosamide UCB with other antiepileptic medicines 
The usual starting dose of Lacosamide UCB is 50 mg twice a day.  
 
Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a 
maintenance dose of between 100 mg and 200 mg twice a day. 
 
If you weigh 50 kg or more, your doctor may decide to start Lacosamide UCB treatment with a single 
“loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.  
 
Children and adolescents weighing less than 50 kg 
When you use Lacosamide UCB on its own 
Your doctor will decide the dose of Lacosamide UCB based on your body weight. 
 
The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.  
Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of your 
body weight. This will be until you reach a maintenance dose. The maximum recommended dose is 



151 

6 mg (0.6 ml) for each kg of body weight, twice a day, for children weighing under 40 kg. The 
maximum maintenance dose is 5 mg (0.5 ml) for each kg of body weight, twice a day, for children 
weighing from 40 kg to under 50 kg. Dosing charts are provided below: 

 
Using Lacosamide UCB on its own – This is for information only. Your doctor will work out the right 
dose for you:  
 
To be used twice daily for children from 4 years of age weighing less than 40 kg 

Weight Starting 
dose: 
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

0.4 ml/kg 
 

0.5 ml/kg 
 

Maximum 
recommended 
dose: 0.6 ml/kg 
 

10 kg 1 ml  2 ml  3 ml  4 ml  5 ml  6 ml  
15 kg 1.5 ml  3 ml  4.5 ml  6 ml  7.5 ml  9 ml  
20 kg 2 ml  4 ml  6 ml  8 ml  10 ml  12 ml  
25 kg 2.5 ml  5 ml  7.5 ml  10 ml  12.5 ml  15 ml  
30 kg 3 ml  6 ml  9 ml  12 ml  15 ml  18 ml  
35 kg 3.5 ml  7 ml  10.5 ml  14 ml  17.5 ml  21 ml  

 
To be used twice daily for children and adolescents from 4 years of age weighing 40 kg to under 
50 kg: 

Weight Starting dose: 
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

0.4 ml/kg 
 

Maximum 
recommended 
dose: 0.5 ml/kg 
 

40 kg 4 ml  8 ml  12 ml  16 ml  20 ml  
45 kg 4.5 ml  9 ml  13.5 ml  18 ml  22.5 ml  

 
When you use Lacosamide UCB with other antiepileptic medicines 
Your doctor will decide the dose of Lacosamide UCB based on your body weight. 
 
In children from 4 years of age with a body weight of under 20 kg: 
 the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.  
 
Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body 
weight. This will be until you reach a maintenance dose. The maximum recommended dose is 6 mg 
(0.6 ml), for each kg of body weight, twice a day. A dosing chart is provided below. 
 
Using Lacosamide UCB with other antiepileptic medicines - Children above 4 years of age weighing 
less than 20 kg – This is for information only. Your doctor will work out the right dose for you:  
 
To be used twice daily for children from 4 years of age weighing less than 20 kg 

Weight Starting 
dose: 
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

0.4 ml/kg 
 

0.5 ml/kg 
 

Maximum 
recommended 
dose: 
0.6 ml/kg 
 

10 kg 1 ml  2 ml  3 ml  4 ml  5 ml  6 ml  
15 kg 1.5 ml  3 ml  4.5 ml  6 ml  7.5 ml  9 ml  

 
In children from 4 years of age with a body weight of 20 kg to under 30 kg: 



152 

 the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.  
 
Your doctor may increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of body 
weight. This will be until you reach a maintenance dose. The maximum recommended dose is 5 mg 
(0.5 ml), for each kg of body weight, twice a day. A dosing chart is provided below. 
 
Using Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body 
weight of 20 to under 30 kg - This is for information only. Your doctor will work out the right dose 
for you:  
 
To be used twice daily for children and adolescents from 4 years of age weighing 20 kg to under 
30 kg: 

Weight Starting dose: 
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

0.4 ml/kg 
 

Maximum 
recommended 
dose: 0.5 ml/kg 
 

20 kg 2 ml  4 ml  6 ml  8 ml  10 ml 
25 kg 2.5 ml  5 ml  7.5 ml  10 ml  12.5 ml 

 
In children from 4 years of age with a body weight of 30 to under 50 kg: 
 the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.  
 
Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body 
weight. This will be until you reach a maintenance dose. The maximum recommended dose is 4 mg 
(0.4 ml), for each kg of body weight, twice a day. A dosing chart is provided below. 
 
Using Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body 
weight of 30 kg to under 50 kg - This is for information only. Your doctor will work out the right 
dose for you: 
 
To be used twice daily for children and adolescents from 4 years of age weighing 30 kg to under 
50 kg: 

Weight Starting dose: 
0.1 ml/kg 
 

0.2 ml/kg  
 

0.3 ml/kg 
 

Maximum 
recommended dose: 
0.4 ml/kg 
 

30 kg 3 ml  6 ml  9 ml  12 ml  
35 kg 3.5 ml  7 ml  10.5 ml  14 ml  
40 kg 4 ml  8 ml  12 ml  16 ml  
45 kg 4.5 ml  9 ml  13.5 ml  18 ml  

 
If you stop using Lacosamide UCB 
If your doctor decides to stop your treatment with Lacosamide UCB, they will decrease the dose step 
by step. This is to prevent your epilepsy from coming back again or becoming worse. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Nervous system side effects such as dizziness may be higher after a single “loading” dose. 
 



153 

Talk to your doctor or pharmacist if you get any of the following: 
 
Very common: may affect more than 1 in 10 people 
 Headache; 
 Feeling dizzy or sick (nausea); 
 Double vision (diplopia). 
 
Common: may affect up to 1 in 10 people 
 Short jerks of a muscle or group of muscles (myoclonic seizures); 
 Difficulties in coordinating your movements or walking; 
 Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, 

falling easily and getting bruises; 
 Troubles with your memory, thinking or finding words, confusion; 
 Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;  
 A spinning sensation (vertigo), feeling drunk; 
 Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or 

bowel, diarrhoea;  
 Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention; 
 Noise in the ear such as buzzing, ringing or whistling; 
 Irritability, trouble sleeping, depression; 
 Sleepiness, tiredness or weakness (asthenia); 
 Itching, rash. 
 
Uncommon: may affect up to 1 in 100 people 
 Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your 

heart (conduction disorder); 
 Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there; 
 Allergic reaction to medicine intake, hives; 
 Blood tests may show abnormal liver function, liver injury;  
 Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away; 
 Feeling angry or agitated; 
 Abnormal thinking or losing touch with reality; 
 Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower 

legs; 
 Fainting. 
 
Not known: frequency cannot be estimated from available data 
 Abnormal rapid heartbeat (ventricular tachyarrhythmia);  
 A sore throat, high temperature and getting more infections than usual. Blood tests may show 

a severe decrease in a specific class of white blood cells (agranulocytosis); 
 A serious skin reaction which may include a high temperature and other flu-like symptoms, a 

rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show 
increased levels of liver enzymes and a type of white blood cell (eosinophilia);  

 A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes 
and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in 
more than 30 % of the body surface (toxic epidermal necrolysis); 

 Convulsion. 
 
Additional side effects when given as an intravenous infusion 
There may be local side effects.  
 
Common: may affect up to 1 in 10 people 
 Injection site pain or discomfort or irritation.  
 



154 

Uncommon: may affect up to 1 in 100 people 
 Injection site redness. 
 
Additional side effects in children  
 
Common: may affect up to 1 in 10 children 
 Runny nose (nasopharyngitis); 
 Fever (pyrexia); 
 Sore throat (pharyngitis); 
 Eating less than usual. 

 
Uncommon: may affect up to 1 in 100 children 
 Feeling sleepy or lacking in energy (lethargy). 
 
Not known: frequency cannot be estimated from available data 
 Changes in behaviour, not acting like themselves. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Lacosamide UCB  
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25°C. 
 
Each vial of Lacosamide UCB solution for infusion must be used only once (single use). Any unused 
solution should be discarded. 
 
Only clear solution free from particles and discoloration should be used.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Lacosamide UCB contains 
 The active substance is lacosamide. 

1 ml Lacosamide UCB solution for infusion contains 10 mg lacosamide.  
1 vial contains 20 ml Lacosamide UCB solution for infusion equivalent to 200 mg lacosamide.  

 The other ingredients are: sodium chloride, hydrochloric acid, water for injections. 
 
What Lacosamide UCB looks like and contents of the pack 
 Lacosamide UCB 10 mg/ml solution for infusion is a clear, colourless solution. 
Lacosamide UCB solution for infusion is available in packages of 1 vial and 5 vials. Each vial 
contains 20 ml. 
Not all pack sizes may be marketed. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


155 

Marketing Authorisation Holder  
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium. 
 
Manufacturer 
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium. 
or  
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Lietuva 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Suomija) 
 

България 
Ю СИ БИ България ЕООД 
Teл.: + 359 (0) 2 962 30 49 

Luxembourg/Luxemburg 
UCB Pharma SA/NV 
Tél/Tel: + 32 / (0)2 559 92 00 
 

Česká republika 
UCB s.r.o. 
Tel: + 420 221 773 411 
 

Magyarország 
UCB Magyarország Kft. 
Tel.: + 36-(1) 391 0060 
 

Danmark 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Malta 
Pharmasud Ltd. 
Tel: + 356 / 21 37 64 36 
 

Deutschland 
UCB Pharma GmbH 
Tel: + 49 /(0) 2173 48 4848 
 

Nederland 
UCB Pharma B.V. 
Tel.: + 31 / (0)76-573 11 40 
 

Eesti 
UCB Pharma Oy Finland  
Tel: + 358 9 2514 4221 (Soome) 
 

Norge 
UCB Nordic A/S 
Tlf: + 45 / 32 46 24 00 
 

Ελλάδα 
UCB Α.Ε.  
Τηλ: + 30 / 2109974000 
 

Österreich 
UCB Pharma GmbH 
Tel: + 43 (0)1 291 80 00 

España 
UCB Pharma, S.A. 
Tel: + 34 / 91 570 34 44 
 

Polska 

UCB Pharma Sp. z o.o. 
Tel: + 48 22 696 99 20 
 

France 
UCB Pharma S.A. 
Tél: + 33 / (0)1 47 29 44 35 

Portugal 
Bial – Portela & Cª, S.A. 
Tel: + 351 22 986 6100 
 

Hrvatska 
Medis Adria d.o.o. 
Tel: +385 (0) 1 230 34 46 
 

România 
UCB Pharma Romania S.R.L. 
Tel: + 40 21 300 29 04 
 

Ireland 
UCB (Pharma) Ireland Ltd. 
Tel: + 353 / (0)1-46 37 395  
 

Slovenija 
Medis, d.o.o. 
Tel: + 386 1 589 69 00 
 

Ísland 
Vistor hf. 

Slovenská republika 
UCB s.r.o., organizačná zložka 



156 

Simi: + 354 535 7000 
 

Tel: + 421 (0) 2 5920 2020 
 

Italia 
UCB Pharma S.p.A. 
Tel: + 39 / 02 300 791 

Suomi/Finland 
UCB Pharma Oy Finland 
Puh/Tel: + 358 9 2514 4221 
 

Κύπρος 
Lifepharma (Z.A.M.) Ltd 
Τηλ: + 357 22 05 63 00 
 

Sverige 
UCB Nordic A/S 
Tel: + 46 / (0) 40 29 49 00 

Latvija 
UCB Pharma Oy Finland 
Tel: + 358 9 2514 4221 (Somija) 
 

United Kingdom 
UCB Pharma Ltd. 
Tel: + 44 / (0)1753 534 655 

 
This leaflet was last revised in {month/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 
The following information is intended for medical or healthcare professionals only. 
 
Each vial of Lacosamide UCB solution for infusion must be used only once (single use). Any unused 
solution should be discarded (see section 3). 
 
Lacosamide UCB solution for infusion can be administered without further dilution, or may be diluted 
with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) or lactated 
Ringer’s solution.  
 
From a microbiological point of view, the product should be used immediately. If not used 
immediately, in-use storage times and conditions prior to use are the responsibility of the user and 
would not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and 
validated aseptic conditions. 
 
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C 
for product mixed with these diluents and stored in glass or PVC bags. 
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET