Lacosamide Accord

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



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1. NAME OF THE MEDICINAL PRODUCT 
 

Lacosamide Accord 50 mg film-coated tablets 

Lacosamide Accord 100 mg film-coated tablets 

Lacosamide Accord 150 mg film-coated tablets 

Lacosamide Accord 200 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Lacosamide Accord 50 mg film-coated tablets 

 

One film-coated tablet contains 50 mg lacosamide. 

 

Lacosamide Accord 100 mg film-coated tablets 

 

One film-coated tablet contains 100 mg lacosamide. 

 

Lacosamide Accord 150 mg film-coated tablets 

 

One film-coated tablet contains 150 mg lacosamide. 

 

Lacosamide Accord 200 mg film-coated tablets 

 

One film-coated tablet contains 200 mg lacosamide. 

 

Excipient(s) with known effect: 

 

50 mg: Each film-coated tablet contains 0.105 mg of lecithin (soya) 

100 mg: Each film-coated tablet contains 0.210 mg of lecithin (soya) 

150 mg: Each film-coated tablet contains 0.315 mg of lecithin (soya) 

200 mg: Each film-coated tablet contains 0.420 mg of lecithin (soya) 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Film-coated tablet 

 

Lacosamide Accord 50 mg film-coated tablets 

 

Pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed “L” on one side and “50” on other 

side. 

 

Lacosamide Accord 100 mg film-coated tablets 

 

Dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets, debossed “L” on one side and “100” 

on other side. 

 

Lacosamide Accord 150 mg film-coated tablets 

 

Salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed “L” on one side and “150” on 

other side. 

 

Lacosamide Accord 200 mg film-coated tablets 

 



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Blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed “L” on one side and “200” on other 

side. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

Lacosamide Accord is indicated as monotherapy and 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. 

 

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 

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 

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).  

 



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Initiation of lacosamide treatment with a loading dose 

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). 

 

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 



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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.  

 

Monotherapy  

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  

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 



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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 film-coated tablets are for oral use. Lacosamide may be taken with or without food. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance, soya lecithin 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 trials 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 

400mg/day and after lacosamide is titrated to steady-state. 

 

In the placebo-controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not 

reported; however, both have been reported in open-label epilepsy trials 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 



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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 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 

 

Lacosamide Accord contains soya lecithin. Therefore, this medicinal product should be used with 

caution in patients allergic to peanut or soya. 

 

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 class I antiarrhythmics. However, subgroup analysis in clinical trials 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, CYP 2D6, and CYP2E1 are not inhibited by lacosamide at plasma 

concentrations observed in clinical trials. 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 trials 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 



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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 trial 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 trials 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 



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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 trials in adjunctive therapy in 

1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomized to lacosamide and 

35.2 % of patients randomized 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 randomized to lacosamide and 1.6 % for patients randomized 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 trial 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. 

 

Tabulated list of adverse reactions 

 

The table below shows the frequencies of adverse reactions which have been reported in clinical trials  

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 

 

Balance disorder  

Memory 

impairment  

Cognitive disorder  

Somnolence 

Tremor  

Nystagmus 

Syncope(2) 

Coordination 

abnormal 

 

 

Convulsion(3) 



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Hypoesthesia 

Dysarthria 

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 open-label 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 trials 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 trial 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 trials is uncommon and 

did not differ between lacosamide (n=944) treated epilepsy patients (0.1 %) and placebo (n=364) 



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treated epilepsy patients (0.3 %). In the monotherapy clinical trial 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 trials; however both have been 

reported in open-label epilepsy trials and in post-marketing experience. 

 

Laboratory abnormalities 

Abnormalities in liver function tests have been observed in placebo-controlled trials 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 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 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 

where mainly stable during the course of the trials.  
 

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 
 

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


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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 

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 randomized 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. 



13 

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, randomized 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 randomized to be converted to lacosamide monotherapy (either 400mg/day or 

300mg/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, randomized, placebo-controlled clinical trials with a 12-week 

maintenance period. Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive 

therapy trials, 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 trials, 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 



14 

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.  

 

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. 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 trial 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. 

 



15 

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 trials 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). 

 

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 anesthetized 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 



16 

range as after maximum recommended clinical dosing. In anesthetized 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 
 

Lacosamide Accord 50 mg film-coated tablets 

 

Tablet core 

 

Microcrystalline cellulose 

Hydroxy propyl cellulose-L 

Hydroxy propyl cellulose (low substituted) 

Silica, colloidal, anhydrous 

Crospovidone 

Magnesium stearate 

 

Tablet coat 

 

Polyvinyl alcohol 

Polyethylene glycol 

Talc 

Titanium dioxide (E171) 

Iron oxide red (E172) 

Iron oxide black (E172) 

Indigo carmine aluminum lake (E132) 

Lecithin (soya) 

 

Lacosamide Accord 100 mg film-coated tablets 

 

Tablet core 

 

Microcrystalline cellulose 

Hydroxy propyl cellulose-L 

Hydroxy propyl cellulose (low substituted) 

Silica, colloidal, anhydrous 

Crospovidone 

Magnesium stearate 



17 

 

Tablet coat 

 

Polyvinyl alcohol 

Polyethylene glycol 

Talc 

Titanium dioxide (E171) 

Lecithin (soya) 

Iron oxide yellow (E172) 

 

Lacosamide Accord 150 mg film-coated tablets 

 

Tablet core 

 

Microcrystalline cellulose 

Hydroxy propyl cellulose-L 

Hydroxy propyl cellulose (low substituted) 

Silica, colloidal, anhydrous 

Crospovidone 

Magnesium stearate 

 

Tablet coat 

 

Polyvinyl alcohol 

Polyethylene glycol 

Talc 

Titanium dioxide (E171) 

Lecithin (soya) 

Iron oxide red (E172) 

Iron oxide black (E172) 

Iron oxide yellow (E172) 

 

Lacosamide Accord 200 mg film-coated tablets 

 

Tablet core 

 

Microcrystalline cellulose 

Hydroxy propyl cellulose-L 

Hydroxy propyl cellulose (low substituted) 

Silica, colloidal, anhydrous 

Crospovidone 

Magnesium stearate 

 

Tablet coat 

 

Polyvinyl alcohol 

Polyethylene glycol 

Talc 

Titanium dioxide (E171) 

Lecithin (soya)  

Indigo carmine aluminum lake (E132) 

 

6.2 Incompatibilities 
 

Not applicable. 

 

6.3 Shelf life 



18 

 

2 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 Accord film-coated tablets are packed in PVC-PVDC/Aluminium blisters.  

Packs of 14, 56, 60 or 168 tablets  

Packs of 14 x 1 or 56 x 1 tablet in perforated unit dose blisters 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling 
 

No special requirements for disposal. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

Lacosamide Accord 50 mg film coated tablets: 

EU/1/17/1230/001-004 

EU/1/17/1230/017-018 

 

Lacosamide Accord 100 mg film coated tablets: 

EU/1/17/1230/005-008 

EU/1/17/1230/019-020 

 

Lacosamide Accord 150 mg film coated tablets: 

EU/1/17/1230/009-012 

EU/1/17/1230/021-022 

 

Lacosamide Accord 200 mg film coated tablets: 

EU/1/17/1230/013-016 

EU/1/17/1230/023-024 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 18 September 2017 

 

 

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/ 



19 

1. NAME OF THE MEDICINAL PRODUCT 
 

Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) 

Lacosamide Accord 50 mg film-coated tablets 

Lacosamide Accord 100 mg film-coated tablets 

Lacosamide Accord 150 mg film-coated tablets 

Lacosamide Accord 200 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Lacosamide Accord 50 mg film-coated tablets 

 

One film-coated tablet contains 50 mg lacosamide. 

 

Lacosamide Accord 100 mg film-coated tablets 

 

One film-coated tablet contains 100 mg lacosamide. 

 

Lacosamide Accord 150 mg film-coated tablets 

 

One film-coated tablet contains 150 mg lacosamide. 

 

Lacosamide Accord 200 mg film-coated tablets 

 

One film-coated tablet contains 200 mg lacosamide. 

 

Excipient(s) with known effect: 

 

50 mg: Each film-coated tablet contains 0.105 mg of lecithin (soya) 

100 mg: Each film-coated tablet contains 0.210 mg of lecithin (soya) 

150 mg: Each film-coated tablet contains 0.315 mg of lecithin (soya) 

200 mg: Each film-coated tablet contains 0.420 mg of lecithin (soya) 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Film-coated tablet 

 

Lacosamide Accord 50 mg film-coated tablets 

 

Pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed “L” on one side and “50” on other 

side. 

 

Lacosamide Accord 100 mg film-coated tablets 

 

Dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets, debossed “L” on one side and “100” 

on other side. 

 

Lacosamide Accord 150 mg film-coated tablets 

 

Salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed “L” on one side and “150” on 

other side. 

 

Lacosamide Accord 200 mg film-coated tablets 



20 

 

Blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed “L” on one side and “200” on other 

side. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

Lacosamide Accord is indicated as monotherapy and 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. 

 

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  

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 400mg/day and who need an additional antiepileptic 

medicinal product, the posology that is recommended for adjunctive therapy below should be 

followed. 

 

Adjunctive therapy 

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 Accord 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 Accord 50 mg tablets twice a day. 

During the second week, the patient takes Lacosamide Accord 100 mg tablets twice a day. 

Depending on response and tolerability, Lacosamide Accord 150 mg tablets may be taken twice a day 

during the third week and Lacosamide Accord 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 



21 

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). 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, soya lecithin or to any of the excipients listed in section 6.1. 



22 

 

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 trials 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 

400mg/day and after lacosamide is titrated to steady-state. 

 

In the placebo-controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not 

reported; however, both have been reported in open-label epilepsy trials 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 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 

 

Lacosamide Accord contains soya lecithin. Therefore, this medicinal product should be used with 

caution in patients allergic to peanut or soya. 

 



23 

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 trials 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 trials. 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 

 

Lacosomide 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 trials 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 trial 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 trials 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 



24 

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 trials in adjunctive therapy in 

1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomized to lacosamide and 

35.2 % of patients randomized 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 



25 

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 randomized to lacosamide and 1.6 % for patients randomized 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 trial 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. 

 

Tabulated list of adverse reactions 

 

The table below shows the frequencies of adverse reactions which have been reported in clinical trials 

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 

 

Balance disorder  

Memory 

impairment  

Cognitive disorder  

Somnolence 

Tremor  

Nystagmus 

Hypoesthesia 

Dysarthria 

Disturbance in 

attention 

Paraesthesia 

Syncope(2) 

Coordination 

abnormal 

 

 

Convulsion(3) 

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 

  



26 

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 open-label 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 trials 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 trial 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 trials 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 trial 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 trials; however, both have been 

reported in open-label epilepsy trials and in post-marketing experience. 

 

Laboratory abnormalities 

 

Abnormalities in liver function tests have been observed in placebo-controlled trials 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 patients and 0 % 
(0/356) of placebo patients. 

 

Multiorgan hypersensitivity reactions 

 



27 

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 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 where mainly stable 

during the course of the trials.  

 

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


28 

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 

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 randomized 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, randomized 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 randomized to be converted to lacosamide monotherapy (either 400mg/day or 



29 

300mg/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, randomized, placebo-controlled clinical trials with a 12-week 

maintenance period. Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive 

therapy trials, 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 trials, 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 

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.  

 

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 



30 

unchanged lacosamide increases rapidly and reaches Cmax about 0.5 to 4 hours post-dose. 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 trial 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 trials 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 



31 

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). 

 

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 anesthetized 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 anesthetized 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 

 



32 

6.1 List of excipients 
 

Lacosamide Accord 50 mg film-coated tablets 

 

Tablet core 

 

Microcrystalline cellulose 

Hydroxy propyl cellulose-L 

Hydroxy propyl cellulose (low substituted) 

Silica, colloidal, anhydrous 

Crospovidone 

Magnesium stearate 

 

Tablet coat 

 

Polyvinyl alcohol 

Polyethylene glycol 

Talc 

Titanium dioxide (E171) 

Iron oxide red (E172) 

Iron oxide black (E172) 

Indigo carmine aluminum lake (E132) 

Lecithin (soya) 

 

Lacosamide Accord 100 mg film-coated tablets 

 

Tablet core 

 

Microcrystalline cellulose 

Hydroxy propyl cellulose-L 

Hydroxy propyl cellulose (low substituted) 

Silica, colloidal, anhydrous 

Crospovidone 

Magnesium stearate 

 

Tablet coat 

 

Polyvinyl alcohol 

Polyethylene glycol 

Talc 

Titanium dioxide (E171) 

Lecithin (soya) 

Iron oxide yellow (E172) 

 

Lacosamide Accord 150 mg film-coated tablets 

 

Tablet core 

 

Microcrystalline cellulose 

Hydroxy propyl cellulose-L 

Hydroxy propyl cellulose (low substituted) 

Silica, colloidal, anhydrous 

Crospovidone 

Magnesium stearate 

 

Tablet coat 

 



33 

Polyvinyl alcohol 

Polyethylene glycol 

Talc 

Titanium dioxide (E171) 

Lecithin (soya) 

Iron oxide red (E172) 

Iron oxide black (E172) 

Iron oxide yellow (E172) 

 

Lacosamide Accord 200 mg film-coated tablets 

 

Tablet core 

 

Microcrystalline cellulose 

Hydroxy propyl cellulose-L 

Hydroxy propyl cellulose (low substituted) 

Silica, colloidal, anhydrous 

Crospovidone 

Magnesium stearate 

 

Tablet coat 

 

Polyvinyl alcohol 

Polyethylene glycol 

Talc 

Titanium dioxide (E171) 

Lecithin (soya)  

Indigo carmine aluminum lake (E132) 

 

6.2 Incompatibilities 
 

Not applicable. 

 

6.3 Shelf life 
 

2 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 Accord film-coated tablets are packed in PVC-PVDC/Aluminium blisters.  

The treatment initiation pack contains 4 cartons, each carton with 14 tablets of 50 mg, 100 mg, 150 mg 

and 200 mg.  

 

6.6 Special precautions for disposal and other handling 
 

No special requirements for disposal. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  



34 

08039 Barcelona,  

Spain 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/025 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 18 September 2017 

 

 

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/ 

  



35 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 
 

A. MANUFACTURERS 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   

 

 

 



36 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) responsible for batch release 

 

Accord Healthcare Ltd 

Sage House 

319 Pinner Road 

North Harrow 

Middlesex  

HA1 4HF 

UNITED KINGDOM 

 

Laboratori Fundacio Dau 

C/ C, 12-14 Pol. Ind. Zona Franca 

08040 Barcelona 

SPAIN 

 

Accord Healthcare B.V.,  

Winthontlaan 200,  

3526 KV Utrecht,  

The Netherlands 

 

Accord Healthcare Polska Sp.z o.o., 

ul. Lutomierska 50,95-200 Pabianice, Poland 

 

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  
 

The requirements for submission of periodic safety update reports 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 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  



37 

of an important (pharmacovigilance or risk minimisation) milestone being reached 

 

  



38 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



39 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

 



40 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

Outer carton 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 50 mg film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 50 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya). 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 film-coated tablets 

56 film-coated tablets 

60 film-coated tablets 

168 film-coated tablets 

14 x 1 film-coated tablet 

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 

 



41 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/001 

EU/1/17/1230/002 

EU/1/17/1230/003 

EU/1/17/1230/004 

EU/1/17/1230/017 

EU/1/17/1230/018 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 50 mg 

 

 

17. UNIQUE IDENTIFIER - 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: {number}  

SN: {number}  

NN: {number} 

  



42 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister label 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 50 mg film-coated tablets 

lacosamide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Accord 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. OTHER 

 



43 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

Outer carton 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 100 mg film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 100 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya). 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 film-coated tablets 

56 film-coated tablets 

60 film-coated tablets 

168 film-coated tablets 

14 x 1 film-coated tablet 

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 

 

 



44 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/005 

EU/1/17/1230/006 

EU/1/17/1230/007 

EU/1/17/1230/008 

EU/1/17/1230/019 

EU/1/17/1230/020 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 100 mg 

 

 

17. UNIQUE IDENTIFIER - 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: {number}  

SN: {number}  

NN: {number} 

 

  



45 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister label 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 100 mg film-coated tablets 

lacosamide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Accord 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. OTHER 

 



46 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

Outer carton 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 150 mg film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 150 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya). 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 film-coated tablets 

56 film-coated tablets 

60 film-coated tablets 

168 film-coated tablets 

14 x 1 film-coated tablet 

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 

 

 



47 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/009 

EU/1/17/1230/010 

EU/1/17/1230/011 

EU/1/17/1230/012 

EU/1/17/1230/021 

EU/1/17/1230/022 

 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 150 mg 

 

 

17. UNIQUE IDENTIFIER - 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: {number}  

SN: {number}  

NN: {number} 

 

 

 

 

 



48 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister label 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 150 mg film-coated tablets 

lacosamide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Accord 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. OTHER 

 

  



49 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

Outer carton 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 200 mg film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 200 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya). 

See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 film-coated tablets 

56 film-coated tablets 

60 film-coated tablets 

168 film-coated tablets 

14 x 1 film-coated tablet 

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 

 

 



50 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/013 

EU/1/17/1230/014 

EU/1/17/1230/015 

EU/1/17/1230/016 

EU/1/17/1230/023 

EU/1/17/1230/024 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 200 mg 

 

 

17. UNIQUE IDENTIFIER - 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: {number}  

SN: {number}  

NN: {number} 

  



51 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister label 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 200 mg film-coated tablets 

lacosamide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Accord 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. OTHER 

 

  



52 

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 Accord 50 mg 

Lacosamide Accord 100 mg 

Lacosamide Accord 150 mg 

Lacosamide Accord 200 mg 

film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Lacosamide Accord 50 mg 

1 film-coated tablet contains 50 mg lacosamide. 

Lacosamide Accord 100 mg 

1 film-coated tablet contains 100 mg lacosamide. 

Lacosamide Accord 150 mg 

1 film-coated tablet contains 150 mg lacosamide. 

Lacosamide Accord 200 mg 

1 film-coated tablet contains 200 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya). 

See leaflet for further information. 

 

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 Accord 50 mg 

14 film-coated tablets of Lacosamide Accord 100 mg 

14 film-coated tablets of Lacosamide Accord 150 mg 

14 film-coated tablets of Lacosamide Accord 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. 

 

 



53 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/025 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 50 mg 

Lacosamide Accord 100 mg 

Lacosamide Accord 150 mg 

Lacosamide Accord 200 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



54 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC:  

SN:  

NN: 

  



55 

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 Accord 50 mg film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

1 film-coated tablet contains 50 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya). 

See leaflet for further information. 

 

 

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 

 

 

 

 



56 

 

 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/025 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 50 mg 

 

 

17. UNIQUE IDENTIFIER - 2D BARCODE 

 

Not applicable 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

Not applicable   



57 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  

 

TREATMENT INITIATION PACK ONLY 

 

Blister label – week 1 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 50 mg film-coated tablets 

lacosamide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Accord 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. OTHER 

 

Week 1 

  



58 

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 Accord 100 mg film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

1 film-coated tablet contains 100 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya). 

See leaflet for further information. 

 

 

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 

 

 

 

 



59 

 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/025 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 100 mg 

 

 

17. UNIQUE IDENTIFIER - 2D BARCODE 

 

Not applicable 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

Not applicable 

  



60 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  

 

TREATMENT INITIATION PACK ONLY 

 

Blister label – week 2 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 100 mg film-coated tablets 

lacosamide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Accord 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. OTHER 

 

Week 2 

  



61 

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 Accord 150 mg film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

1 film-coated tablet contains 150 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya).  

See leaflet for further information. 

 

 

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 

 

 

 

 



62 

 

 

 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/025 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 150 mg 

 

 

17. UNIQUE IDENTIFIER - 2D BARCODE 

 

Not applicable 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

Not applicable 

  



63 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

TREATMENT INITIATION PACK ONLY 

 

Blister label – week 3 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 150 mg film-coated tablets 

lacosamide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Accord 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. OTHER 

 

Week 3 

  



64 

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 Accord 200 mg film-coated tablets 

lacosamide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

1 film-coated tablet contains 200 mg lacosamide. 

 

 

3. LIST OF EXCIPIENTS 

 

This medicinal product contains lecithin (soya). 

See leaflet for further information. 

 

 

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 

 

 

 

 



65 

 

 

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 

 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/17/1230/025 

 

 

13. BATCH NUMBER 

 

Lot: 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lacosamide Accord 200 mg 

 

 

17. UNIQUE IDENTIFIER - 2D BARCODE 

 

Not applicable 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

Not applicable 

  



66 

TREATMENT INITIATION PACK ONLY 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blister label – week 4 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lacosamide Accord 200 mg film-coated tablets 

lacosamide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Accord 

 

 

3. EXPIRY DATE 

 

EXP: 

 

 

4. BATCH NUMBER 

 

Lot: 

 

 

5. OTHER 

 

Week 4 

  



67 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



68 

Package leaflet: Information for the patient 

 

Lacosamide Accord 50 mg film-coated tablets 

Lacosamide Accord 100 mg film-coated tablets 

Lacosamide Accord 150 mg film-coated tablets 

Lacosamide Accord 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 Accord is and what it is used for 

2. What you need to know before you take Lacosamide Accord  

3. How to take Lacosamide Accord  

4. Possible side effects 

5. How to store Lacosamide Accord  

6. Contents of the pack and other information 

 

 

1. What Lacosamide Accord is and what it is used for 

 

What Lacosamide Accord is 

Lacosamide Accord 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 Accord is used for 

 Lacosamide Accord  is used in adults, adolescents and children aged 4 years and older. 

 It is used 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.  

 Lacosamide Accord may be used on its own or with other antiepileptic medicines. 
 

 

2.  What you need to know before you take Lacosamide Accord  

  

Do not take Lacosamide Accord  

 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 are allergic to peanut or soya. 

 if you have a certain type of heart beat problem called second- or third-degree AV block. 
 

Do not take Lacosamide Accord 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 
 

 



69 

Talk to your doctor before taking Lacosamide Accord 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 Accord 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 Accord. 

If you are taking Lacosamide Accord 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 Accord 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 Accord  

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 Accord 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 Accord.  

 

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 Accord 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 Accord. 

 

Lacosamide Accord with alcohol 
As a safety precaution do not take Lacosamide Accord 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 Accord if you are pregnant or breast-feeding, as the effects 



70 

of lacosamide on pregnancy and the unborn baby or the new-born child are not known. Also, it is not 

known whether Lacosamide Accord 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 take Lacosamide Accord 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 Accord may make you feel dizzy or cause blurred vision.  

 

Lacosamide Accord contains soya lecithin. 

If you are allergic to peanut or soya, do not use this medicinal product.  

 

 

3. How to take Lacosamide Accord  

 

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 Accord 

  Take Lacosamide Accord 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 Accord tablet with a glass of water. 

  You may take Lacosamide Accord 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 Accord is used as a long term treatment. You 

should continue to take Lacosamide Accord until your doctor tells you to stop. 

 

How much to take 

Listed below are the normal recommended doses of Lacosamide Accord 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 Accord on its own 

The usual starting dose of Lacosamide Accord is 50 mg twice a day.  

Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord 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 Accord with other antiepileptic medicines 

The usual starting dose of Lacosamide Accord 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 Accord 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 



71 

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 Accord than you should  
If you have taken more Lacosamide Accord 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 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 Accord 

  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 Accord 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 Accord 

 Do not stop taking Lacosamide Accord 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 Accord , 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 

 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. 
 



72 

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. 

 Difficulties in coordinating your movements or walking. 
 

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 Accord 
 

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. 

 

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


73 

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 Accord contains 

The active substance is lacosamide. 

One tablet of Lacosamide Accord 50 mg contains 50 mg lacosamide. 

One tablet of Lacosamide Accord 100 mg contains 100 mg lacosamide. 

One tablet of Lacosamide Accord 150 mg contains 150 mg lacosamide. 

One tablet of Lacosamide Accord 200 mg contains 200 mg lacosamide. 

 

The other ingredients are: 

Tablet core: Microcrystalline cellulose, hydroxy propyl cellulose-L, hydroxy propyl cellulose (low 

substituted), silica colloidal anhydrous, crospovidone and magnesium stearate. 

Film-coat: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), lecithin (soya) and 

colorants* 

* The colorants are 

50 mg tablet: Iron oxide red (E172), iron oxide black (E172), indigo carmine aluminum lake (E132) 

100 mg tablet: Iron oxide yellow (E172) 

150 mg tablet: Iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172) 

200 mg tablet: Indigo carmine aluminum lake (E132) 

 

What Lacosamide Accord looks like and contents of the pack 

Lacosamide Accord 50 mg are pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed “L” 

on one side and “50” on other side. 

Lacosamide Accord 100 mg are dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets, 

debossed “L” on one side and “100” on other side. 

Lacosamide Accord 150 mg are salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed 

“L” on one side and “150” on other side. 

Lacosamide Accord 200 mg are blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed “L” 

on one side and “200” on other side. 

 

Lacosamide Accord is available in packs of 14, 56, 60 or 168 film-coated tablets.  

 

The 14 x 1 or 56 x 1 tablet pack is available as perforated unit dose PVC-PVDC/Aluminium blisters 

sealed with an aluminium foil, all other packs are available with standard PVC-PVDC/Aluminium 

blisters sealed with an aluminium foil. 

  

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

Manufacturer 
Accord Healthcare Limited 

Sage House, 319 Pinner Road,  

North Harrow, Middlesex, HA1 4HF 

United Kingdom 

 



74 

or 

 

Accord Healthcare B.V.,  

Winthontlaan 200,  

3526 KV Utrecht,  

The Netherlands 

 

or 

 

LABORATORI FUNDACIÓ DAU 

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 

08040 Barcelona, Spain 

 

or 

 

Accord Healthcare Polska Sp.z o.o., 

ul. Lutomierska 50,95-200 Pabianice, Poland 

 

 

This leaflet was last revised in. 

 

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/


75 

Package leaflet: Information for the patient 

 

Lacosamide Accord 50 mg film-coated tablets 

Lacosamide Accord 100 mg film-coated tablets 

Lacosamide Accord 150 mg film-coated tablets 

Lacosamide Accord 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 Accord is and what it is used for 

2. What you need to know before you take Lacosamide Accord  

3. How to take Lacosamide Accord  

4. Possible side effects 

5. How to store Lacosamide Accord  

6. Contents of the pack and other information 

 

 

1. What Lacosamide Accord is and what it is used for 

 

What Lacosamide Accord is 

Lacosamide Accord 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 Accord is used for 

  Lacosamide Accord is used in adolescents and children aged 4 years and older weighing 50 kg 
or more and in adults.  

  It is used 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.  

  Lacosamide Accord may be used on its own or with other antiepileptic medicines. 
 

 

2. What you need to know before you take Lacosamide Accord 

 

Do not take Lacosamide Accord 

 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 are allergic to peanut or soya. 

 if you have a certain type of heart beat problem called second- or third-degree AV block. 
 



76 

Do not take Lacosamide Accord 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 Accord 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 Accord 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 Accord. 

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 Accord 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 Accord 
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 Accord 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 Accord.  

 

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 Accord 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 Accord. 

 

Lacosamide Accord with alcohol 
As a safety precaution do not take Lacosamide Accord 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 



77 

your doctor or pharmacist for advice before taking this medicine. 

 

It is not recommended to take Lacosamide Accord if you are pregnant or breast-feeding, as the effects 

of lacosamide on pregnancy and the unborn baby or the new-born child are not known.  

 

Also, it is not known whether Lacosamide Accord 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 Accord 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 Accord may make you feel dizzy or cause blurred vision  

Lacosamide Accord contains soya lecithin. 

If you are allergic to peanut or soya, do not use this medicinal product.  

 

 

3. How to take Lacosamide Accord 

 

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 Accord 

  Take Lacosamide Accord 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 Accord tablet with a glass of water.  

  You may take Lacosamide Accord 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 Accord is used as a long term treatment. 

 

You should continue to take Lacosamide Accord until your doctor tells you to stop. 

 

How much to take 

Listed below are the normal recommended doses of Lacosamide Accord 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 Accord on its own 

The usual starting dose of Lacosamide Accord is 50 mg twice a day.  

Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord 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 Accord 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 Accord.  

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 Accord, so you will increase your 

dose gradually.  

You will start your treatment with a low dose of Lacosamide Accord, usually 50 mg twice a day, and 



78 

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. 

 

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 

Accord 50 mg) 

50 mg 

(1 tablet Lacosamide 

Accord 50 mg) 

100 mg 

Week 2  Package marked 

"Week 2"  

100 mg 

(1 tablet Lacosamide 

Accord 100 mg) 

100 mg 

(1 tablet Lacosamide 

Accord 100 mg) 

200 mg 

Week 3 Package marked 

"Week 3" 

150 mg 

(1 tablet Lacosamide 

Accord 150 mg) 

150 mg 

(1 tablet Lacosamide 

Accord 150 mg) 

300 mg 

Week 4 Package marked 

"Week 4"  

200 mg 

(1 tablet Lacosamide 

Accord 200 mg) 

200 mg 

(1 tablet Lacosamide 

Accord 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 Accord. 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 Accord  than you should  
If you have taken more Lacosamide Accord 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 Accord 

 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 Accord 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 Accord 

  Do not stop taking Lacosamide Accord 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 Accord, 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.  



79 

 

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 

 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; 

 Difficulties in coordinating your movements or walking. 
 

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 



80 

 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 Accord 
 

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 Accord contains 

The active substance is lacosamide. 

One tablet of Lacosamide Accord 50 mg contains 50 mg lacosamide. 

One tablet of Lacosamide Accord 100 mg contains 100 mg lacosamide. 

One tablet of Lacosamide Accord 150 mg contains 150 mg lacosamide. 

One tablet of Lacosamide Accord 200 mg contains 200 mg lacosamide. 

 

The other ingredients are: 

Tablet core: Microcrystalline cellulose, hydroxy propyl cellulose-L, hydroxy propyl cellulose (low 

substituted), silica colloidal anhydrous, crospovidone and magnesium stearate. 

Film-coat: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), lecithin (soya) and 

colorants* 

* The colorants are 

50 mg tablet: Iron oxide red (E172), iron oxide black (E172), indigo carmine aluminum lake (E132) 

100 mg tablet: Iron oxide yellow (E172) 

150 mg tablet: Iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172) 

200 mg tablet: Indigo carmine aluminum lake (E132) 

 

What Lacosamide Accord looks like and contents of the pack 

Lacosamide Accord 50 mg are pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed “L” 

on one side and “50” on other side. 

Lacosamide Accord 100 mg are dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets, 

debossed “L” on one side and “100” on other side. 

Lacosamide Accord 150 mg are salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed 

“L” on one side and “150” on other side. 

Lacosamide Accord 200 mg are blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed “L” 

on one side and “200” on other side. 

 

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,  

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


81 

 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  

Accord Healthcare S.L.U.  

World Trade Center, Moll de Barcelona, s/n,  

Edifici Est 6ª planta,  

08039 Barcelona,  

Spain  

 

Manufacturer  
Accord Healthcare Limited 

Sage House, 319 Pinner Road,  

North Harrow, Middlesex, HA1 4HF 

United Kingdom  

 

or 

 

 

Accord Healthcare B.V.,  

Winthontlaan 200,  

3526 KV Utrecht,  

The Netherlands 

 

or 

 

LABORATORI FUNDACIÓ DAU 

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 

08040 Barcelona, Spain 

 

or 

 

Accord Healthcare Polska Sp.z o.o., 

ul. Lutomierska 50,95-200 Pabianice, Poland 

 

 

This leaflet was last revised in. 

 

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/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS 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
	LABELLING AND PACKAGE LEAFLET
	A. LABELLING
	B. PACKAGE LEAFLET