Levetiracetam Actavis Group

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis Group 100 mg/ml oral solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains 100 mg levetiracetam. 
 
Excipients with known effect:  
Each ml contains 1.50 mg of methyl parahydroxybenzoate (E218), 0.15 mg of propyl 
parahydroxybenzoate (E216), 290 mg of maltitol liquid (E965), 3,26 mg propylene glycol (E 1520) 
and 0.25 mg of sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Oral solution. 
Clear, faint yellowish-brown solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial onset seizures 
with or without secondary generalisation in adults and adolescents from 16 years of age with newly 
diagnosed epilepsy. 
 
Levetiracetam Actavis Group is indicated as adjunctive therapy 
• in the treatment of partial onset seizures with or without secondary generalisation in adults, 

adolescents, children and infants from 1 month of age with epilepsy. 
• in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with 

Juvenile Myoclonic Epilepsy. 
• in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 

12 years of age with Idiopathic Generalised Epilepsy. 
 
4.2 Posology and method of administration 
 
Posology 
 
Monotherapy for adults and adolescents from 16 years of age 
 
The recommended starting dose is 250 mg twice daily which should be increased to an initial 
therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg 
twice daily every two weeks depending upon the clinical response. The maximum dose is 1,500 mg 
twice daily. 
 
Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more 
 
The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of 
treatment. 
Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg 
twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four 
weeks. 



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Discontinuation 
 
If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and 
adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in 
infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should 
not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease 
should not exceed 7 mg/ kg twice daily every two weeks). 
 
Special populations 
 
Elderly (65 years and older) 
 
Adjustment of the dose is recommended in elderly patients with compromised renal function (see 
“Renal impairment” below). 
 
Renal impairment 
 
The daily dose must be individualised according to renal function. 
 
For adult patients, refer to the following table and adjust the dose as indicated. To use this dosing 
table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr in ml/min 
may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents 
weighing 50 kg or more, the following formula:  
 

[140-age (years)] x weight (kg) 
CLcr (ml/min) =  -----------------------------------------  (x 0.85 for women) 

72 x serum creatinine (mg/dl) 
 
Then CLcr is adjusted for body surface area (BSA) as follows: 
 

CLcr (ml/min)  
CLcr (ml/min/1.73 m2) = ----------------------------  x 1.73 

BSA subject (m2) 
 
Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal 
function: 
 
Group  Creatinine clearance 

(ml/min/1.73m2)  
Dose and frequency  

Normal  ≥ 80  500 to 1,500 mg twice daily  
Mild  50-79  500 to 1,000 mg twice daily  
Moderate  30-49  250 to 750 mg twice daily  
Severe  < 30  250 to 500 mg twice daily  
End-stage renal disease patients 
undergoing dialysis (1)  - 500 to 1,000 mg once daily (2)  
(1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam. 
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended. 
 
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal 
function as levetiracetam clearance is related to renal function. This recommendation is based on a 
study in adult renally impaired patients. 
 
The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination using, for 
young adolescents, children and infants, using the following formula (Schwartz formula): 
 



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Height (cm) x ks 
CLcr (ml/min/1.73 m2) = ------------------------------------ 

Serum Creatinine (mg/dl) 
 
ks= 0.45 in term infants to 1 year old; ks= 0.55 in children to less than 13 years and in adolescent 
female; ks= 0.7 in adolescent male 
 
Dosing adjustment for infants, children and adolescent patients weighing less than 50 kg with 
impaired renal function: 
 

Group  
Creatinine 
clearance 
(ml/min/1.73m2)  

Dose and frequency (1) 
Infants 1 to less than 
6 months  

Infants 6 to 23 months, children 
and adolescents weighing less 
than 50 kg  

Normal  ≥ 80  7 to 21 mg/kg (0.07 to 
0.21 ml/kg) twice daily  

10 to 30 mg/kg (0.10 to 
0.30 ml/kg) twice daily  

Mild  50-79  7 to 14 mg/kg (0.07 to 
0.14 ml/kg) twice daily  

10 to 20 mg/kg (0.10 to 
0.20 ml/kg) twice daily  

Moderate  30-49  3.5 to 10.5 mg/kg (0.035 
to 0.105 ml/kg) twice 
daily  

5 to 15 mg/kg (0.05 to 
0.15 ml/kg) twice daily  

Severe  < 30  3.5 to 7 mg/kg (0.035 to 
0.07 ml/kg) twice daily  

5 to 10 mg/kg (0.05 to 
0.10 ml/kg) twice daily  

End-stage renal 
disease patients 
undergoing dialysis   

-- 
7 to 14 mg/kg (0.07 to 
0.14 ml/kg) once daily (2) 

(4)  

10 to 20 mg/kg (0.10 to 
0.20 ml/kg) once daily (3) (5)  

(1) Levetiracetam Actavis Group oral solution should be used for doses under 250 mg, for doses not 
multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for 
patients unable to swallow tablets. 
(2) A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with 
levetiracetam.  
(3) A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with 
levetiracetam.  
(4) Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.  
(5) Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.  
 
Hepatic impairment 
 
No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with 
severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. 
Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine 
clearance is < 60 ml/min/1.73 m2. 
 
Paediatric population 
 
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength 
according to age, weight and dose. 
 
The oral solution is the preferred formulation for use in infants and children under the age of 6 years. 
In addition, the oral solution should be used for initial treatment in children weighing less than 25 kg, 
for patients unable to swallow tablets or for the administration of doses below 250 mg. 
 



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Monotherapy 
 
The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy 
treatment have not been established. 
No data are available. 
 
Add-on therapy for infants aged 6 to 23 months, children (2 to 11 years) and adolescents (12 to 
17 years) weighing less than 50 kg 
 
The initial therapeutic dose is 10 mg/kg twice daily. 
Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice 
daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two 
weeks. The lowest effective dose should be used. 
Dose in children 50 kg or greater is the same as in adults. 
 
Dose recommendations for infants from 6 months of age, children and adolescents: 
 
Weight  Starting dose:  

10 mg/kg twice daily  
Maximum dose: 
30 mg/kg twice daily  

6 kg (1)  60 mg (0.6 ml) twice daily  180 mg (1.8 ml) twice daily  
10 kg (1)  100 mg (1 ml) twice daily  300 mg (3 ml) twice daily  
15 kg (1)  150 mg (1.5 ml) twice daily  450 mg (4.5 ml) twice daily  
20 kg (1) 200 mg (2 ml) twice daily  600 mg (6 ml) twice daily  
25 kg  250 mg twice daily  750 mg twice daily  
From 50 kg (2)  500 mg twice daily  1,500 mg twice daily  
(1) Children 25 kg or less should preferably start the treatment with Levetiracetam Actavis Group 
100 mg/ml oral solution.  
(2) Dose in children and adolescents 50 kg or more is the same as in adults.  
 
Add-on therapy for infants from 1 month to less than 6 months 
 
The initial therapeutic dose is 7 mg/kg twice daily. 
Depending upon the clinical response and tolerability, the dose can be increased up to 21 mg/kg twice 
daily. Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks. 
The lowest effective dose should be used. 
Infants should start the treatment with Levetiracetam Actavis Group 100 mg/ml oral solution. 
 
Dose recommendations for infants aged from 1 month to less than 6 months: 
 
Weight  Starting dose:  

7 mg/kg twice daily  
Maximum dose:  
21 mg/kg twice daily  

4 kg  28 mg (0.3 ml) twice daily  84 mg (0.85 ml) twice daily  

5 kg  35 mg (0.35 ml) twice daily  105 mg (1.05 ml) twice daily  

7 kg  49 mg (0.5 ml) twice daily  147 mg (1.5 ml) twice daily  

 
Three presentations are available: 

- A 300 ml bottle with a 10 ml oral syringe (delivering up to 1,000 mg levetiracetam) graduated 
every 0.25 ml (corresponding to 25 mg). This presentation should be prescribed for children 
aged 4 years and older, adolescents and adults. 

 



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- A 300 ml bottle with a 3 ml oral syringe (delivering up to 300 mg levetiracetam) graduated 
every 0.1 ml (corresponding to 10 mg). In order to ensure the accuracy of the dosing, this 
presentation should be prescribed for infants and young children aged from 6 months to less 
than 4 years. 

 
- A 300 ml bottle with a 1 ml oral syringe (delivering up to 100 mg levetiracetam) graduated 

every 0.05 ml (corresponding to 5 mg). In order to ensure the accuracy of the dosing, this 
presentation should be prescribed for infants aged 1 month to less than 6 months. 

 
Method of administration 
 
The oral solution may be diluted in a glass of water or baby’s bottle and may be taken with or without 
food. After oral administration the bitter taste of levetiracetam may be experienced. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients 
listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Renal impairment 
 
The administration of levetiracetam to patients with renal impairment may require dose adjustment. In 
patients with severely impaired hepatic function, assessment of renal function is recommended before 
dose selection (see section 4.2). 
 
Acute kidney injury 
 
The use of levetiracetam has been very rarely associated with acute kidney injury, with a time to onset 
ranging from a few days to several months. 
 
Blood cell counts 
 
Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, 
thrombocytopenia and pancytopenia) have been described in association with levetiracetam 
administration, generally at the beginning of the treatment. Complete blood cell counts are advised in 
patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders 
(section 4.8). 
 
Suicide 
 
Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with 
anti-epileptic agents (including levetiracetam). A meta-analysis of randomized placebo-controlled 
trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and 
behaviour. The mechanism of this risk is not known. 
 
Therefore, patients should be monitored for signs of depression and/or 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 depression and/or suicidal ideation or 
behaviour emerge. 
 
Abnormal and aggressive behaviours  
Levetiracetam may cause psychotic symptoms and behavioural abnormalities including irritability and 
aggressiveness. Patients treated with levetiracetam should be monitored for developing psychiatric 
signs suggesting important mood and/or personality changes. If such behaviours are noticed, treatment 



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adaptation or gradual discontinuation should be considered. If discontinuation is considered, please 
refer to section 4.2. 
 
Worsening of seizures 
 
As with other types of antiepileptic drugs, levetiracetam may rarely exacerbate seizure frequency or 
severity. This paradoxical effect was mostly reported within the first month after levetiracetam 
initiation or increase of the dose, and was reversible upon drug discontinuation or dose decrease. 
Patients should be advised to consult their physician immediately in case of aggravation of epilepsy. 
 
Electrocardiogram QT interval prolongation 
 
Rare cases of ECG QT interval prolongation have been observed during the post-marketing 
surveillance. Levetiracetam should be used with caution in patients with QTc-interval prolongation, in 
patients concomitantly treated with drugs affecting the QTc-interval, or in patients with relevant pre-
existing cardiac disease or electrolyte disturbances. 
 
Paediatric population 
 
Available data in children did not suggest impact on growth and puberty. However, long term effects 
on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children 
remain unknown. 
 
Excipients 
 
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) 
Levetiracetam Actavis Group 100 mg/ml oral solution contains methyl parahydroxybenzoate (E218) 
and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).  
 
Maltitol liquid 
Levetiracetam Actavis Group 100 mg/ml oral solution contains maltitol liquid. Patients with rare 
hereditary problems of fructose intolerance should not take this medicinal product. 
 
Propylene glycol (E1520) 
Levetiracetam Actavis Group 100 mg/ml oral solution contains 3,26 mg propylene glycol (E1520) in 
each ml.  
Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious 
adverse effects in neonates. 
 
Sodium  
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Antiepileptic medicinal products 
 
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not 
influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, 
carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these 
antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam. 
 
As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric 
patients receiving up to 60 mg/kg/day levetiracetam.  
A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy 
(4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not 
influence the steady-state serum concentrations of concomitantly administered carbamazepine and 



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valproate. However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme-
inducing antiepileptic medicinal products. Dose adjustment is not required. 
 
Probenecid 
 
Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to 
inhibit the renal clearance of the primary metabolite, but not of levetiracetam. Nevertheless, the 
concentration of this metabolite remains low. 
 
Methotrexate 
 
Concomitant administration of levetiracetam and methotrexate has been reported to decrease 
methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to 
potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in 
patients treated concomitantly with the two drugs. 
 
Oral contraceptives and other pharmacokinetics interactions 
 
Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinyl-
estradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not 
modified. Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and 
warfarin; prothrombin times were not modified. Co-administration with digoxin, oral contraceptives 
and warfarin did not influence the pharmacokinetics of levetiracetam. 
 
Laxatives 
 
There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative 
macrogol has been concomitantly administered with oral levetiracetam. Therefore, macrogol should 
not be taken orally for one hour before and for one hour after taking levetiracetam. 
 
Food and alcohol 
 
The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was 
slightly reduced.  
No data on the interaction of levetiracetam with alcohol are available. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of child bearing potential  
 
Specialist advice should be given to women who are of childbearing potential. Treatment with 
levetiracetam should be reviewed when a woman is planning to become pregnant. As with all 
antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to 
breakthrough seizures that could have serious consequences for the woman and the unborn child. 
Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic 
medicines AEDs could be associated with a higher risk of congenital malformations than 
monotherapy, depending on the associated antiepileptics. 
 
Pregnancy 
 
A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy 
(more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not 
suggest an increase in the risk for major congenital malformations. Only limited evidence is available 
on the neurodevelopment of children exposed to levetiracetam monotherapy in utero. However, 
current epidemiological studies (on about 100 children) do not suggest an increased risk of 
neurodevelopmental disorders or delays.  



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Levetiracetam can be used during pregnancy, if after careful assessment it is considered clinically 
needed. In such case, the lowest effective dose is recommended.  
Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in 
levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more 
pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy). 
Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.  
 
Breastfeeding 
 
Levetiracetam is excreted in human breast milk. Therefore, breast-feeding is not recommended.  
However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment 
should be weighed considering the importance of breastfeeding. 
 
Fertility 
 
No impact on fertility was detected in animal studies (see section 5.3). No clinical data are available, 
potential risk for human is unknown. 
 
4.7 Effects on ability to drive and use machines 
 
Levetiracetam has minor or moderate influence on the ability to drive and use machines. Due to 
possible different individual sensitivity, some patients might experience somnolence or other central 
nervous system related symptoms, especially at the beginning of treatment or following a dose 
increase. Therefore, caution is recommended in those patients when performing skilled tasks, e.g.  
driving vehicles or operating machinery. Patients are advised not to drive or use machines until it is 
established that their ability to perform such activities is not affected. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue 
and dizziness. The adverse reaction profile presented below is based on the analysis of pooled 
placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with 
levetiracetam. These data are supplemented with the use of levetiracetam in corresponding open-label 
extension studies, as well as post-marketing experience. The safety profile of levetiracetam is 
generally similar across age groups (adult and paediatric patients) and across the approved epilepsy 
indications. 
 
Tabulated list of adverse reactions 
 
Adverse reactions reported in clinical studies (adults, adolescents, children and infants> 1 month) and 
from post-marketing experience are listed in the following table per System Organ Class and per 
frequency. Adverse reactions are presented in the order of decreasing seriousness and their frequency 
is defined as follows: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to 
<1/100); rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000). 
 

MedDRA SOC 
Frequency category 

Very common Common Uncommon  Rare 
Infections and 
infestations 

Nasopharyngitis    Infection 

Blood and 
lymphatic system 
disorders 

  Thrombocytopenia, 
leukopenia 

Pancytopenia, 
neutropenia, 
agranulocytosis 

Immune system 
disorders 

   Drug reaction 
with eosinophilia 



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MedDRA SOC 
Frequency category 

Very common Common Uncommon  Rare 
and systemic 
symptoms 
(DRESS), 
Hypersensitivity 
(including 
angioedema and 
anaphylaxis) 

Metabolism and 
nutrition 
disorders 

 Anorexia Weight decreased , 
weight increase 

Hyponatraemia 

Psychiatric 
disorders 

 Depression, hostility/ 
aggression, anxiety,  
insomnia, 
nervousness/irritability 

Suicide attempt, 
suicidal ideation, 
psychotic disorder, 
abnormal behaviour, 
hallucination, anger, 
confusional state , 
panic attack, affect 
lability/mood swings, 
agitation 

Completed 
suicide, 
personality 
disorder, thinking 
abnormal, 
delirium 

Nervous system 
disorders 

Somnolence, 
headache 

Convulsion, balance 
disorder, dizziness, 
lethargy, tremor 

Amnesia, memory 
impairment, 
coordination 
abnormal/ataxia, 
paraesthesia, 
disturbance in attention 

Choreoathetosis, 
dyskinesia, 
hyperkinesia, gait 
disturbance, 
encephalopathy, 
seizures 
aggravated 

Eye disorders   Diplopia, vision 
blurred 

 

Ear and labyrinth 
disorders 

 Vertigo   

Cardiac disorders    Electrocardiogram 
QT prolonged 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Cough   

Gastrointestinal 
disorders 

 Abdominal pain, 
diarrhoea, dyspepsia, 
vomiting, nausea 

 Pancreatitis 

Hepatobiliary 
disorders 

  Liver function test 
abnormal 

Hepatic failure, 
hepatitis 

Renal and 
Urinary disorders 

   Acute kidney 
injury 

Skin and 
subcutaneous 
tissue disorders 

 Rash Alopecia, eczema, 
pruritus,  

Toxic epidermal 
necrolysis, 
Stevens-Johnson 
syndrome, 
erythema 
multiforme 

Musculoskeletal 
and connective 
tissue disorders 

  Muscular weakness, 
myalgia 

Rhabdomyolysis 
and blood creatine 
phosphokinase 
increased* 



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MedDRA SOC 
Frequency category 

Very common Common Uncommon  Rare 
General disorders 
and 
administration 
site conditions 

 Asthenia/fatigue   

Injury, poisoning 
and procedural 
complications 

  Injury  

 
* Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.  
 
Description of selected adverse reactions 
 
The risk of anorexia is higher when levetiracetam is coadministered with topiramate.  
In several cases of alopecia, recovery was observed when levetiracetam was discontinued.  
Bone marrow suppression was identified in some of the cases of pancytopenia. 
 
Cases of encephalopathy generally occurred at the beginning of the treatment (few days to a few 
months) and were reversible after treatment discontinuation. 
 
Paediatric population 
 
In patients aged 1 month to less than 4 years, a total of 190 patients have been treated with 
levetiracetam in placebo-controlled and open label extension studies. Sixty of these patients were 
treated with levetiracetam in placebo-controlled studies.  In patients aged 4-16 years, a total of 645 
patients have been treated with levetiracetam in placebo-controlled and open label extension studies.  
233 of these patients were treated with levetiracetam in placebo-controlled studies. In both these 
paediatric age ranges, these data are supplemented with the post-marketing experience of the use of 
levetiracetam. 
 
In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety 
study. No new safety concerns for levetiracetam were identified for infants less than 12 months of age 
with epilepsy. 
 
The adverse reaction profile of levetiracetam is generally similar across age groups and across the 
approved epilepsy indications.  Safety results in paediatric patients in placebo-controlled clinical 
studies were consistent with the safety profile of levetiracetam in adults except for behavioural and 
psychiatric adverse reactions which were more common in children than in adults.  In children and 
adolescents aged 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood 
swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal 
behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other 
age ranges or in the overall safety profile.  In infants and children aged 1 month to less than 4 years, 
irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more 
frequently than in other age groups or in the overall safety profile. 
 
A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed 
the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with 
partial onset seizures. It was concluded that levetiracetam was not different (non inferior) from 
placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory 
Screen Composite score in the per-protocol population. Results related to behavioral and emotional 
functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as 
measured in a standardised and systematic way using a validated instrument (CBCL – Achenbach 
Child Behaviour Checklist). However subjects, who took levetiracetam in the long-term open label 
follow-up study, did not experience a worsening, on average, in their behavioural and emotional 
functioning; in particular measures of aggressive behavior were not worse than baseline. 



12 

 
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 
 
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma 
were observed with levetiracetam overdoses. 
 
Management of overdose 
 
After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. 
There is no specific antidote for levetiracetam. Treatment of an overdose will be symptomatic and may 
include haemodialysis. The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the 
primary metabolite.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14 
 
The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-
pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances. 
 
Mechanism of action 
 
The mechanism of action of levetiracetam still remains to be fully elucidated. In vitro and in vivo 
experiments suggest that levetiracetam does not alter basic cell characteristics and normal 
neurotransmission. 
In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type 
Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores. In addition it partially 
reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines. 
Furthermore, levetiracetam has been shown in in vitro studies to bind to a specific site in rodent brain 
tissue. This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion 
and neurotransmitter exocytosis. Levetiracetam and related analogs show a rank order of affinity for 
binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure 
protection in the mouse audiogenic model of epilepsy. This finding suggests that the interaction 
between levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic 
mechanism of action of the medicinal product. 
 
Pharmacodynamic effects 
 
Levetiracetam induces seizure protection in a broad range of animal models of partial and primary 
generalised seizures without having a pro-convulsant effect. The primary metabolite is inactive. In 
man, an activity in both partial and generalised epilepsy conditions (epileptiform 
discharge/photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of 
levetiracetam. 
 
Clinical efficacy and safety 
 



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Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation 
in adults, adolescents, children and infants from 1 month of age with epilepsy: 
 
In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies 
at 1,000 mg, 2,000 mg, or 3,000 mg/day, given in 2 divided doses, with a treatment duration of up to 
18 weeks. In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from 
baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7%, 
31.6% and 41.3% for patients on 1,000, 2,000 or 3,000 mg levetiracetam respectively and of 12.6% 
for patients on placebo. 
 
Paediatric population 
 
In paediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, 
placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks. In 
this study, the patients received levetiracetam as a fixed dose of 60 mg/kg/day (with twice a day 
dosing). 
44.6% of the levetiracetam treated patients and 19.6% of the patients on placebo had a 50% or greater 
reduction from baseline in the partial onset seizure frequency per week. With continued long-term 
treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for 
at least 1 year. 
 
In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a 
double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 
5 days. In this study, patients were prescribed 20 mg/kg, 25 mg/kg, 40 mg/kg or 50 mg/kg daily dose 
of oral solution based on their age titration schedule. A dose of 20 mg/kg/day titrating to 40 mg/kg/day 
for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for 
infants and children 6 months to less than 4 years old, was use in this study. The total daily dose was 
administered twice daily. 
The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50% reduction 
from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader 
using a 48-hour video EEG. The efficacy analysis consisted of 109 patients who had at least 24 hours 
of video EEG in both baseline and evaluation periods. 43.6% of the levetiracetam treated patients and 
19.6% of the patients on placebo were considered as responders. The results are consistent across age 
group. With continued long-term treatment, 8.6% of the patients were seizure-free for at least 
6 months and 7.8 % were seizure-free for at least 1 year. 
35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control 
clinical studies of which only 13 were aged < 6 months. 
 
Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in 
patients from 16 years of age with newly diagnosed epilepsy. 
 
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, non-
inferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or 
older with newly or recently diagnosed epilepsy. The patients had to present with unprovoked partial 
seizures or with generalized tonic-clonic seizures only. The patients were randomized to 
carbamazepine CR 400 – 1,200 mg/day or levetiracetam 1,000 – 3,000 mg/day, the duration of the 
treatment was up to 121 weeks depending on the response. 
Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of 
carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% 
(95 % CI: -7.8 8.2). More than half of the subjects remained seizure free for 12 months (56.6% and 
58.5% of subjects on levetiracetam and on carbamazepine CR respectively). 
 
In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in 
a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out 
of 69).  
 



14 

Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of 
age with Juvenile Myoclonic Epilepsy.  
 
Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks 
duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with 
myoclonic seizures in different syndromes. The majority of patients presented with juvenile myoclonic 
epilepsy. 
In this study, levetiracetam, dose was 3,000 mg/day given in 2 divided doses. 
58.3% of the levetiracetam treated patients and 23.3% of the patients on placebo had at least a 50% 
reduction in myoclonic seizure days per week. With continued long-term treatment, 28.6% of the 
patients were free of myoclonic seizures for at least 6 months and 21.0% were free of myoclonic 
seizures for at least 1 year. 
 
Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and 
adolescents from 12 years of age with idiopathic generalised epilepsy.  
 
Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study which 
included adults, adolescents and a limited number of children suffering from idiopathic generalized 
epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile 
myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand 
Mal seizures on awakening). In this study, levetiracetam dose was 3,000 mg/day for adults and 
adolescents or 60 mg/kg/day for children, given in 2 divided doses.  
72.2% of the levetiracetam treated patients and 45.2% of the patients on placebo had a 50% or greater 
decrease in the frequency of PGTC seizures per week. With continued long-term treatment, 47.4% of 
the patients were free of tonic-clonic seizures for at least 6 months and 31.5% were free of tonic-clonic 
seizures for at least 1 year. 
 
5.2 Pharmacokinetic properties 
 
Levetiracetam is a highly soluble and permeable compound. The pharmacokinetic profile is linear with 
low intra- and inter-subject variability. There is no modification of the clearance after repeated 
administration. There is no evidence for any relevant gender, race or circadian variability. The 
pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy. 
 
Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of 
levetiracetam expressed as mg/kg bodyweight. Therefore there is no need for plasma level monitoring 
of levetiracetam. 
A significant correlation between saliva and plasma concentrations has been shown in adults and 
children (ratio of saliva/plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and 
after 4 hours post-dose for oral solution formulation). 
 
Adults and adolescents 
 
Absorption 
 
Levetiracetam is rapidly absorbed after oral administration. Oral absolute bioavailability is close to 
100 %. 
Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing. Steady-state is achieved after 
two days of a twice daily administration schedule. 
Peak concentrations (Cmax) are typically 31 and 43 µg/ml following a single 1,000 mg dose and 
repeated 1,000 mg twice daily dose, respectively. 
The extent of absorption is dose-independent and is not altered by food. 
 
Distribution 
 
No tissue distribution data are available in humans. 
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10%).  



15 

The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/kg, a value close to the total 
body water volume. 
 
Biotransformation 
 
Levetiracetam is not extensively metabolised in humans. The major metabolic pathway (24% of the 
dose) is an enzymatic hydrolysis of the acetamide group. Production of the primary metabolite, ucb 
L057, is not supported by liver cytochrome P450 isoforms. Hydrolysis of the acetamide group was 
measurable in a large number of tissues including blood cells. The metabolite ucb L057 is 
pharmacologically inactive. 
 
Two minor metabolites were also identified. One was obtained by hydroxylation of the pyrrolidone 
ring (1.6% of the dose) and the other one by opening of the pyrrolidone ring (0.9% of the dose). 
Other unidentified components accounted only for 0.6% of the dose. 
 
No enantiomeric interconversion was evidenced in vivo for either levetiracetam or its primary 
metabolite. 
 
In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human 
liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl 
transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities. In addition, levetiracetam 
does not affect the in vitro glucuronidation of valproic acid.  
In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or 
UGT1A1. Levetiracetam caused mild induction of CYP2B6 and CYP3A4. The in vitro data and in 
vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme 
induction is expected in vivo. Therefore, the interaction of levetiracetam with other substances, or vice 
versa, is unlikely. 
 
Elimination 
 
The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration 
or repeated administration. The mean total body clearance was 0.96 ml/min/kg. 
 
The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 
93% of the dose was excreted within 48 hours). Excretion via faeces accounted for only 0.3% of the 
dose.  
The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66% and 
24% of the dose, respectively during the first 48 hours.  
The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/min/kg respectively indicating 
that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that 
the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration. 
Levetiracetam elimination is correlated to creatinine clearance. 
 
Elderly 
 
In the elderly, the half-life is increased by about 40% (10 to 11 hours). This is related to the decrease 
in renal function in this population (see section 4.2). 
 
Renal impairment 
 
The apparent body clearance of both levetiracetam and of its primary metabolite is correlated to the 
creatinine clearance. It is therefore recommended to adjust the maintenance daily dose of 
Levetiracetam Actavis Group, based on creatinine clearance in patients with moderate and severe renal 
impairment (see section 4.2). 
 
In anuric end-stage renal disease adult subjects the half-life was approximately 25 and 3.1 hours 
during interdialytic and intradialytic periods, respectively. 



16 

The fractional removal of levetiracetam was 51% during a typical 4-hour dialysis session. 
 
Hepatic impairment 
 
In subjects with mild and moderate hepatic impairment, there was no relevant modification of the 
clearance of levetiracetam. In most subjects with severe hepatic impairment, the clearance of 
levetiracetam was reduced by more than 50% due to a concomitant renal impairment (see section 4.2). 
 
Paediatric population 
 
Children (4 to 12 years) 
 
Following single oral dose administration (20 mg/kg) to epileptic children (6 to 12 years), the half-life 
of levetiracetam was 6.0 hours. The apparent body weight adjusted clearance was approximately 30% 
higher than in epileptic adults. 
 
Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), 
levetiracetam was rapidly absorbed. Peak plasma concentration was observed 0.5 to 1.0 hour after 
dosing. Linear and dose proportional increases were observed for peak plasma concentrations and area 
under the curve. The elimination half-life was approximately 5 hours. The apparent body clearance 
was 1.1 ml/min/kg. 
 
Infants and children (1 month to 4 years) 
 
Following single dose administration (20 mg/kg) of a 100 mg/ml oral solution to epileptic children 
(1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were 
observed approximately 1 hour after dosing.  The pharmacokinetic results indicated that half-life was 
shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults 
(0.96 ml/min/kg). 
 
In the population pharmacokinetic analysis conducted in patients from 1 month to 16 years of age, 
body weight was significantly correlated to apparent clearance (clearance increased with an increase in 
body weight) and apparent volume of distribution. Age also had an influence on both parameters. This 
effect was pronounced for the younger infants, and subsided as age increased, to become negligible 
around 4 years of age. 
 
In both population pharmacokinetic analyses, there was about a 20% increase of apparent clearance of 
levetiracetam when it was co-administered with an enzyme-inducing antiepileptic medicinal product. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, genotoxicity and carcinogenic potential. 
Adverse effects not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at 
exposure levels similar to human exposure levels and with possible relevance for clinical use were 
liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, 
fatty infiltration and increased liver enzymes in plasma. 
 
No adverse reactions on male or female fertility or reproduction performance were observed in rats at 
doses up to 1,800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 
generation. 
 
Two embryo-foetal development (EFD) studies were performed in rats at 400, 1,200 and 
3,600 mg/kg/day. At 3,600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in 
foetal weight associated with a marginal increase in skeletal variations/minor anomalies. There was no 
effect on embryomortality and no increased incidence of malformations. The NOAEL (No Observed 



17 

Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a 
mg/m2 basis) and 1,200 mg/kg/day for fetuses. 
 
Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 
1,200 and 1,800 mg/kg/day. The dose level of 1,800 mg/kg/day induced a marked maternal toxicity 
and a decrease in foetal weight associated with increased incidence of fetuses with 
cardiovascular/skeletal anomalies. The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day 
for the fetuses (equal to the MRHD on a mg/m2 basis). 
 
A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 
and 1,800 mg/kg/day. The NOAEL was ≥ 1,800 mg/kg/day for the F0 females, and for the survival, 
growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis). 
 
Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects 
seen in any of the standard developmental or maturation endpoints at doses up to 1,800 mg/kg/day 
(x 6- 17 the MRHD on a mg/m2 basis). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium citrate   
Citric acid monohydrate  
Methyl parahydroxybenzoate (E218)  
Propyl parahydroxybenzoate (E216)  
Ammonium glycyrrhizate 
Glycerin  
Glycerol (E422)  
Maltitol liquid (E965)  
Acesulfame potassium (E950)  
Grape flavour (contains propylene glycol) 
Purified water  
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
After first opening: 7 months 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard 
box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene). 
  
300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard 
box also containing a 3 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the 
syringe (polyethylene). 
  



18 

300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard 
box also containing a 1 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the 
syringe (polyethylene). 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
Reykjavíkurvegur 76-78 
220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/738/001 
EU/1/11/738/002 
EU/1/11/738/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 5 December 2011 
Date of latest renewal: 08 August 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
 
Detailed information on this product is available on the website of the European Medicines Agency 
http://www.ema.europa.eu 
 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 

 
 
 



20 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Balkanpharma – Troyan AD 
1 Krayrechna Str. 
BG-5600 Troyan 
Bulgaria 
 
 
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 report 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) 
 
Not applicable. 
 
 

  



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

 
  



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Bottle of 300 ml with 1 ml syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis Group 100 mg/ml oral solution 
Levetiracetam 
For children aged 1 month to less than 6 months. 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains 100 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains E216, E218,  maltitol liquid (E965) and propylene glycol (E1520). See leaflet for further 
information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 ml oral solution with a 1 ml oral syringe and an adaptor. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
Use the 1 ml syringe and adaptor included in the package. 
 
 
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 
Do not use after 7 months of first opening the bottle. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



24 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/738/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis Group 100 mg/ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
 
  



25 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label for Bottle of 300 ml with 1 ml syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis Group 100 mg/ml oral solution 
Levetiracetam 
For children aged 1 month to less than 6 months. 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains 100 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 ml oral solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
Use the 1 ml syringe and adaptor included in the package. 
 
 
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 
Do not use after 7 months of first opening the bottle. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
 



26 

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 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/738/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Bottle of 300 ml with 3 ml syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis Group 100 mg/ml oral solution 
Levetiracetam 
For children aged 6 months to less than 4 years 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains 100 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520). See leaflet for further 
information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 ml oral solution with a 3 ml oral syringe and an adaptor. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
Use the 3 ml syringe and adaptor included in the package. 
 
 
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 
Do not use after 7 months of first opening the bottle. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



28 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/738/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis Group 100 mg/ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



29 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label for Bottle of 300 ml with 3 ml syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis Group 100 mg/ml oral solution 
Levetiracetam 
For children aged 6 months to less than 4 years 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains 100 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 ml oral solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
Use the 3 ml oral syringe and adaptor included in the package 
 
 
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 
Do not use after 7 months of first opening the bottle. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



30 

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 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/738/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



31 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Bottle of 300 ml with 10 ml syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis Group 100 mg/ml oral solution 
Levetiracetam 
For adults and children aged 4 years and older 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains 100 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520). See leaflet for further 
information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 ml oral solution with a 10 ml oral syringe. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
Use the 10 ml syringe included in the package. 
 
 
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 
Do not use after 7 months of first opening the bottle. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



32 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/738/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis Group 100 mg/ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
 
  



33 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label for Bottle of 300 ml with 10 ml syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis Group 100 mg/ml oral solution 
Levetiracetam 
For adults and children aged 4 years and older 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains 100 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains E216, E218,  maltitol liquid (E965) and propylene glycol (E1520). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 ml oral solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
Use the 10 ml oral syringe included in the package 
 
 
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 
Do not use after 7 months of first opening the bottle. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



34 

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 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/738/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



35 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
B. PACKAGE LEAFLET 



36 

Package Leaflet: Information for the patient 
 

Levetiracetam Actavis Group 100 mg/ml oral solution  
Levetiracetam 

 
 
Read all of this leaflet carefully before you or your child 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 Levetiracetam Actavis Group is and what it is used for 
2. What you need to know before you take Levetiracetam Actavis Group 
3. How to take Levetiracetam Actavis Group 
4. Possible side effects 
5. How to store Levetiracetam Actavis Group 
6. Contents of the pack and other information 
 
 
1. What Levetiracetam Actavis Group is and what it is used for 
 
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). 
 
Levetiracetam Actavis Group is used: 

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to 
treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits 
(seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only 
one side of the brain, but could thereafter extend to larger areas on both sides of the brain 
(partial onset seizure with or without secondary generalisation). Levetiracetam has been 
given to you by your doctor to reduce the number of fits. 

• as an add-on to other antiepileptic medicines to treat: 
• partial onset seizures with or without generalisation in adults, adolescents, children 

and infants from one month of age 
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults 

and adolescents from 12 years of age with juvenile myoclonic epilepsy 
• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) 

in adults and adolescents from 12 years of age with idiopathic generalised epilepsy 
(the type of epilepsy that is thought to have a genetic cause). 

 
 
2. What you need to know before you take Levetiracetam Actavis Group 
 
Do not take Levetiracetam Actavis Group 
• If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this 

medicine (listed in section 6). 
 
Warnings and precautions 
Talk to your doctor before taking Levetiracetam Actavis Group 
• If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your 

dose should be adjusted. 
• If you notice any slow down in the growth or unexpected puberty development of your child, 

please contact your doctor. 



37 

• A small number of people being treated with anti-epileptics such as levetiracetam have had 
thoughts of harming or killing themselves. If you have any symptoms of depression and/or 
suicidal ideation, please contact your doctor. 

• If you have a family or medical history of irregular heart rhythm (visible on an 
electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to 
heartbeat irregularities or salt imbalances.  

 
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few 
days: 
• Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or 

your family and friends notice important changes in mood or behaviour. 
• Aggravation of epilepsy 

Your seizures may rarely become worse or happen more often, mainly during the first month 
after the start of the treatment or increase of the dose. If you experience any of these new 
symptoms while taking Levetiracetam Actavis Group, see a doctor as soon as possible. 

 
Children and adolescents 
Levetiracetam Actavis Group is not indicated in children and adolescents below 16 years on its own 
(monotherapy). 
 
Other medicines and Levetiracetam Actavis Group 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking 
levetiracetam as this may result in a reduction of its effect. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only 
if after careful assessment it is considered necessary by your doctor. 
You should not stop your treatment without discussing this with your doctor.A risk of birth defects for 
your unborn child cannot be completely excluded.  
Breast-feeding is not recommended during treatment. 
 
Driving and using machines 
Levetiracetam Actavis Group may impair your ability to drive or operate any tools or machinery, as it 
may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the 
dose. You should not drive or use machines until it is established that your ability to perform such 
activities is not affected. 
 
Levetiracetam Actavis Group contains methyl parahydroxybenzoate, propyl 
parahydroxybenzoate, maltitol, propylene glycol and sodium. 
Levetiracetam Actavis Group oral solution includes methyl parahydroxybenzoate (E218) and propyl 
parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). 
Levetiracetam Actavis Group oral solution also contains maltitol. If you have been told by your doctor 
that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Levetiracetam Actavis Group oral solution contains propylene glycol (E1520). If your baby is less 
than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if 
the baby is given other medicines that contain propylene glycol or alcohol. 
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-
free’. 
 
3. How to take Levetiracetam Actavis Group 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 



38 

Levetiracetam Actavis Group must be taken twice a day, once in the morning and once in the evening, 
at about the same time each day. 
Take the oral solution following your doctor’s instructions. 
 
Monotherapy  
 
Dose in adults and adolescents from 16 years of age: 
Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years 
and above. 
General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each 
individual dose being measured between 5 ml (500 mg) and 15 ml (1,500 mg).  
When you will first start taking Levetiracetam Actavis Group, your doctor will prescribe you a 
lower dose during 2 weeks before giving you the lowest general dose. 
 
Add-on therapy 
 
Dose in adults and adolescents (12 to 17 years): 
Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years 
and above. 
General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each 
individual dose being measured between 5 ml (500 mg) and 15 ml (1,500 mg). 
 
Dose in children 6 months and older: 
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to 
the age, weight and dose. 
For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in 
the package. 
For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the 
package. 
General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each 
individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of 
the child. (see table below for dose examples). 
 
Dose in children 6 months and older: 
Weight  Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily 
6 kg  0.6 ml twice daily  1.8 ml twice daily  
8 kg  0.8 ml twice daily  2.4 ml twice daily  
10 kg  1 ml twice daily  3 ml twice daily  
15 kg  1.5 ml twice daily  4.5 ml twice daily  
20 kg  2 ml twice daily  6 ml twice daily  
25 kg  2.5 ml twice daily  7.5 ml twice daily  
From 50 kg   5 ml twice daily  15 ml twice daily  
 
Dose in infants (1 month to less than 6 months): 
For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe 
included in the package. 
General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each 
individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of 
the infant. (see table below for dose examples). 
 
Dose in infants (1 month to less than 6 months): 
Weight  Starting dose: 0.07 ml/kg twice daily  Maximum dose: 0.21 ml/kg twice daily  
4 kg  0.3 ml twice daily  0.85 ml twice daily  
5 kg  0.35 ml twice daily  1.05 ml twice daily  
6 kg  0.45 ml twice daily  1.25 ml twice daily  



39 

7 kg  0.5 ml twice daily  1.5 ml twice daily  
 
Method of administration: 
After measuring the correct dose with an appropriate syringe, Levetiracetam Actavis Group oral 
solution may be diluted in a glass of water or baby’s bottle. You may take Levetiracetam Actavis 
Group with or without food. After oral administration the bitter taste of levetiracetam may be 
experienced. 
 
Instruction for use: 
 
Instruction for use for 10 ml syringes 
 

 
 
Open the bottle. Before starting the measuring procedure make sure that the transparent dosing body 
of the syringe as well as the white plunger are in the bottom most position. To measure the dosing 
quantity, use one hand to hold the dosing body and the other hand to pull up the plunger until you 
reach the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor 
(Figure 1). 
 

 
 
Pull the syringe by the dosing body out of the bottle (Figure 2). 
 

 



40 

 
Empty the contents of the syringe in a glass of water by pushing down the plunger. Be sure to drink 
the whole contents of the glass. The contents of the syringe can also be given directly from the syringe 
into the mouth or emptied onto a spoon (Figure 3). 
 

 
 
Wash the syringe with water after use and close the bottle with the plastic screw cap (Figure 4). 
 
Instruction for use for 1 ml and 3 ml syringes with an adaptor 
 

 
 
Open the bottle and push the syringe adaptor firmly into the bottle neck (Figure 1). 
 

 
 
Take the syringe and pull back the plunger a little way (Figure 2). 
 



41 

 
 
Push the tip of the syringe into the adaptor opening. Push the plunger down slowly to introduce air 
inside the bottle (Figure 3). 
 

 
 
Turn the bottle upside down with the syringe still in place (Figure 4). 
 

 
 
Pull the plunger down and fill the syringe with a quantity of solution slightly beyond the prescribed 
dose (Figure 5). 
 

 
 
If any bubbles appear in the syringe keep the bottle upside down and slightly push in the plunger and 
pull it back again. Repeat until there are no bubbles in the syringe (Figure 6). 
 



42 

 
 
Push the plunger in slowly to the graduation mark corresponding to the quantity in milliliters (ml) 
prescribed by your doctor (Figure 7). 
 

 
 
Turn the bottle the right way up and remove the syringe (Figure 8). 
 

 
 
For young children gently put the tip of the syringe into the child´s mouth to the inside of the cheek. 
Push the plunger in slowly and allow the child to swallow the content of the syringe. The content of 
the syringe can also be emptied in a glass of water or baby´s bottle. Be sure to drink the whole 
contents of the glass (Figure 9). 
 

 
 
Wash the syringe with water after use and close the bottle with the plastic screw cap (Figure 10). 
 



43 

Duration of treatment: 
• Levetiracetam Actavis Group is used as a chronic treatment. You should continue 

Levetiracetam Actavis Group treatment for as long as your doctor has told you. 
• Do not stop your treatment without your doctor’s advice as this could increase your seizures. 
 
If you take more Levetiracetam Actavis Group than you should 
The possible side effects of an overdose of Levetiracetam Actavis Group are sleepiness, agitation, 
aggression, decrease of alertness, inhibition of breathing and coma. 
Contact your doctor if you took more Levetiracetam Actavis Group than you should. Your doctor will 
establish the best possible treatment of overdose. 
 
If you forget to take Levetiracetam Actavis Group 
Contact your doctor if you have missed one or more doses. 
Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Levetiracetam Actavis Group 
If stopping treatment, Levetiracetam Actavis Group should be discontinued gradually to avoid an 
increase of seizures. Should your doctor decide to stop your Levetiracetam Actavis Group treatment, 
he/she will instruct you about the gradual withdrawal of Levetiracetam Actavis Group. 
 
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. 
 
Tell your doctor immediately, or go to your nearest emergency department, if you experience: 
 
• weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a 

serious allergic (anaphylactic) reaction; 
• swelling of the face, lips, tongue and throat (Quincke’s oedema); 
• flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, 

increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell 
(eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic 
Symptoms [DRESS]); 

• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the 
legs, ankles or feet, as this may be a sign of sudden decrease of kidney function; 

• a skin rash which may form blisters and look like small targets (central dark spots surrounded by a 
paler area, with a dark  ring around the edge) (erythema multiforme); 

• a widespread  rash with  blisters and peeling skin, particularly around the mouth, nose, eyes and 
genitals (Stevens-Johnson  syndrome); 

• a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic  
epidermal necrolysis); 

• signs of serious mental changes or if someone around you notices signs of confusion, somnolence 
(sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour 
or other neurological signs including involuntary or uncontrolled movements. These could be 
symptoms of an encephalopathy. 

 
The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), 
headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like 
sleepiness, tiredness and dizziness may be more common. These effects should however decrease over 
time.  
 
Very common: may affect more than 1 in 10 people 
• nasopharyngitis; 
• somnolence (sleepiness), headache. 



44 

 
Common: may affect up to 1 in 10 people 
• anorexia (loss of appetite); 
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability; 
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), 

lethargy (lack of energy and enthusiasm), tremor (involuntary trembling); 
• vertigo (sensation of rotation); 
• cough; 
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea; 
• rash; 
• asthenia/fatigue (tiredness). 
 
Uncommon: may affect up to 1 in 100 people 
• decreased number of blood platelets, decreased number of white blood cells;  
• weight decrease, weight increase; 
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, 

confusion, panic attack, emotional instability/mood swings, agitation; 
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia 

(impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of 
concentration); 

• diplopia (double vision), vision blurred; 
• elevated/abnormal values in a liver function test; 
• hair loss, eczema, pruritus;  
• muscle weakness, myalgia (muscle pain); 
• injury. 
 
Rare: may affect up to 1 in 1,000 people 
• infection; 
• decreased number of all blood cell types; 
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], 

Quincke’s oedema [swelling of the face, lips, tongue and throat]); 
• decreased blood sodium concentration; 
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable 

to concentrate); 
• delirium; 
• encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of 

symptoms); 
• seizures may become worse or happen more often;  
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling 

movements, hyperkinesia (hyperactivity); 
• change of the heart rhythm (Electrocardiogram);  
• pancreatitis; 
• liver failure, hepatitis; 
• sudden decrease in kidney function; 
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded 

by a paler area, with a dark ring around the edge) (erythema multiforme), 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). 

• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase 
increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese 
patients. 

• limp or difficulty walking. 
 
Reporting of side effects 



45 

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 Levetiracetam Actavis Group 

 
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 cardboard box and bottle after 
EXP:. 
The expiry date refers to the last day of that month. 
Do not use after 7 months of first opening the bottle.  
 
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 Levetiracetam Actavis Group contains 
The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam. 
 
The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate 
(E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerin, glycerol (E422), 
maltitol liquid (E965), acesulfame potassium (E950), grape flavour (contains propylene glycol), 
purified water. 
 
What Levetiracetam Actavis Group looks like and contents of the pack 
 
Levetiracetam Actavis Group 100 mg/ml oral solution is a clear, faint yellowish-brown solution. 
 
The 300 ml glass bottle of Levetiracetam Actavis Group (for children aged 4 years and above, 
adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 
0.25 ml). 
The 300 ml glass bottle of Levetiracetam Actavis Group (for infants and young children aged from 6 
months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated 
every 0.1 ml) and an adaptor for the syringe. 
The 300 ml glass bottle of Levetiracetam Actavis Group (for infants aged 1 month to less than 
6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and 
an adaptor for the syringe. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Balkanpharma-Troyan AD 
1 Krayrechna Str, 
Troyan 5600 



46 

Bulgaria 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland / Islande / Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 52660203 
 

България 
Тева ФармаЕАД 
Teл.: +359 24899585 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande / Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Actavis Group PTC ehf. 
Iceland 
Tel: +354 5503300 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Actavis Group PTC ehf. 
Ijsland 
Tel: +354 5503300 
 

Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 

Ελλάδα 
Specifar A.B.E.E. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070  
 

España 
Actavis Group PTC ehf. 
Islandia 
Tel: +354 5503300 
 

Polska 
Teva Pharmaceuticals Polska Sp. Z o.o. 
Tel: +48 223459300 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 19127700 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 



47 

Ísland 
Teva Pharma Iceland ehf. 
Sími: +354 5503300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
A. Potamitis Medicare Ltd 
Τηλ: +357 22583333 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 

Latvija 
UAB Teva Baltics filiāle Latvijā  
Tel: +371 67323666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271385257 
 

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


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