Levetiracetam Actavis

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 250 mg film-coated tablets 
Levetiracetam Actavis 500 mg film-coated tablets 
Levetiracetam Actavis 750 mg film-coated tablets 
Levetiracetam Actavis 1,000 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Levetiracetam Actavis 250 mg film-coated tablets 
 
Each film-coated tablet contains 250 mg levetiracetam. 
 
Levetiracetam Actavis 500 mg film-coated tablets 
 
Each film-coated tablet contains 500 mg levetiracetam. 
 
Levetiracetam Actavis 750 mg film-coated tablets 
 
Each film-coated tablet contains 750 mg levetiracetam. 
 
Excipient with known effect: 
 
Each film-coated tablet contains 0.156 mg sunset yellow E110. 
 
Levetiracetam Actavis 1,000 mg film-coated tablets 
 
Each film-coated tablet contains 1,000 mg levetiracetam. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Levetiracetam Actavis 250 mg film-coated tablets 
 
Oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side. 
 
Levetiracetam Actavis 500 mg film-coated tablets 
 
Oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side. 
 
Levetiracetam Actavis 750 mg film-coated tablets 
 
Oval, orange 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side. 
 
Levetiracetam Actavis 1,000 mg film-coated tablets 
 
Oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side. 
 
 
4. CLINICAL PARTICULARS 
 



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4.1 Therapeutic indications 
 
Levetiracetam Actavis 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 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. 
 
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, using the following formula: 
 



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[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/1.73 m2) 
Dose and frequency 
 

Normal 
Mild 
Moderate 

≥ 80 
50-79 
30-49 

500 to 1,500 mg twice daily 
500 to 1,000 mg twice daily 
250 to 750 mg twice daily 

Severe 
End-stage renal disease patients 
undergoing dialysis (1) 

< 30 
- 

250 to 500 mg twice daily 
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, for young 
adolescents, children and infants, using the following formula (Schwartz formula):  
 
      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 adolescents patients weighing less than 50 kg with 
impaired renal function 
 
Group Creatinine 

clearance 
(ml/min/1.73 m2) 

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 



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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) An 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 tablet formulation is not adapted for use in infants and children under the age of 6 years. An oral 
solution is the preferred formulation for use in this population. In addition, the available dose strengths 
of the tablets are not appropriate 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. In all of the above cases an 
oral solution should be used. 
 
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 from 6 to 23 months, children (2 to 11 years) and adolescents (12 to 
17 years) weighing less than 50 kg 
 
An oral solution is the preferred formulation for use in infants and children under the age of 6 years. 
 
For children 6 years and above, an 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. 
The lowest effective dose should be used. The starting dose for a child or adolescent of 25 kg should 
be 250 mg twice daily with a maximum dose of 750 mg twice daily. 
Dose in children 50 kg or greater is the same as in adults. 
 
Add-on therapy for infants aged from 1 month to less than 6 months 
 
An oral solution is the formulation to use in infants. 
 
Method of administration 



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The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may 
be taken with or without food. After oral administration the bitter taste of levetiracetam may be 
experienced. The daily dose is administered in two equally divided doses. 
 
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 
adaptation or gradual discontinuation should be considered. If discontinuation is considered, please 
refer to section 4.2. 
 
Paediatric population 
 
The tablet formulation is not adapted for use in infants and children under the age of 6 years. 
 



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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. 
 
Levetiracetam Actavis 750 mg film-coated tablets 
 
Levetiracetam Actavis 750 mg contains colouring agent sunset yellow (E110) which may cause 
allergic reactions. 
 
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 
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 
(ethinylestradiol 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. 



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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. 
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 



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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 
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 

Eye disorders   Diplopia, vision 
blurred 

 

Ear and labyrinth 
disorders 

 Vertigo   

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Cough   

Gastrointestinal  Abdominal pain,  Pancreatitis 



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disorders diarrhoea, dyspepsia, 
vomiting, nausea 

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* 

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 



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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 behavioural 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 behaviour were not worse than baseline. 
 
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 



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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 
 
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 month and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for 
infants and children 6 month to less than 4 years old, was used 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. 
 



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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). 
 
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). 
 



14 

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%). 
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 Actavis 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 



15 

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, 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. 
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 
 



16 

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 
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 foetuses with 
cardiovascular/skeletal anomalies. The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day 
for the foetuses (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 
 
Levetiracetam Actavis 250 mg film-coated tablets 
 
Crospovidon 
Povidone 
Silica colloidal anhydrous 
Magnesium stearate 
Polyvinyl alcohol – part. hydrolyzed 
Macrogol 4000 
Talc 
Titanium dioxide (E171) 
Indigo carmine (E132) 
 
Levetiracetam Actavis 500 mg film-coated tablets 
 
Crospovidon 
Povidone 
Silica colloidal anhydrous 
Magnesium stearate 
Polyvinyl alcohol – part. hydrolyzed 
Macrogol 4000 



17 

Talc 
Titanium dioxide (E171) 
Iron oxide yellow (E172) 
Indigo carmine (E132) 
 
Levetiracetam Actavis 750 mg film-coated tablets 
 
Crospovidon 
Povidone 
Silica colloidal anhydrous 
Magnesium stearate 
Polyvinyl alcohol – part. hydrolyzed 
Macrogol 4000 
Talc 
Titanium dioxide (E171) 
Indigo carmine (E132) 
Sunset yellow (E110) 
Iron oxide red (E172) 
 
Levetiracetam Actavis 1,000 mg film-coated tablets 
 
Crospovidon 
Povidone 
Silica colloidal anhydrous 
Magnesium stearate 
Polyvinyl alcohol – part. hydrolyzed 
Macrogol 4000 
Talc 
Titanium dioxide (E171) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Aluminium/PVC blister packs. 
White tablet containers (HDPE) closed with snap-on cap (LDPE) with a tamper evident ring. 
 
Pack sizes: 
Levetiracetam Actavis 250 mg, 500 mg and 1,000 mg film-coated tablets 
 
Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets. 
Perforated unit dose blisters: 60 x 1 film-coated tablets. 
Tablet containers: 30, 100 and 200 film-coated tablets. 
 
Levetiracetam Actavis 750 mg film-coated tablets 
 



18 

Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets. 
Tablet containers: 30, 100 and 200 film-coated tablets. 
 
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.  
220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Levetiracetam Actavis 250 mg film-coated tablets 
 
EU/1/11/713/001 
EU/1/11/713/002 
EU/1/11/713/003 
EU/1/11/713/004 
EU/1/11/713/005 
EU/1/11/713/006 
EU/1/11/713/007 
EU/1/11/713/008 
EU/1/11/713/009 
EU/1/11/713/010 
EU/1/11/713/041 
 
Levetiracetam Actavis 500 mg film-coated tablets 
 
EU/1/11/713/011 
EU/1/11/713/012 
EU/1/11/713/013 
EU/1/11/713/014 
EU/1/11/713/015 
EU/1/11/713/016 
EU/1/11/713/017 
EU/1/11/713/018 
EU/1/11/713/019 
EU/1/11/713/020 
EU/1/11/713/042 
 
Levetiracetam Actavis 750 mg film-coated tablets 



19 

 
EU/1/11/713/021 
EU/1/11/713/022 
EU/1/11/713/023 
EU/1/11/713/024 
EU/1/11/713/025 
EU/1/11/713/026 
EU/1/11/713/027 
EU/1/11/713/028 
EU/1/11/713/029 
EU/1/11/713/030 
 
Levetiracetam Actavis 1,000 mg film-coated tablets 
 
EU/1/11/713/031 
EU/1/11/713/032 
EU/1/11/713/033 
EU/1/11/713/034 
EU/1/11/713/035 
EU/1/11/713/036 
EU/1/11/713/037 
EU/1/11/713/038 
EU/1/11/713/039 
EU/1/11/713/040 
EU/1/11/713/043 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 03 October 2011 
Date of latest renewal:08 September 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this product is available on the website of the European Medicines Agency 
http://www.ema.europa.eu 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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   

 

 
 
 



21 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Teva Operations Poland Sp. z. o. o. 
ul. Mogilska 80 
31-546 Kraków 
Poland 
 
Specifar S.A 
1, 28 Octovriou str. 
123 51 Ag. Varvara 
Athens 
Greece 
 
Tjoapack Netherlands B.V. 
Nieuwe Donk 9 
ETTEN-LEUR, 4879AC 
Netherlands 
 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 
 
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 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. 

 
 

  



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 

  



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton of 250 mg film-coated tablets in tablet containers 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 250 mg film-coated tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 250 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 film-coated tablets 
200 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



25 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/008 30 tablets 
EU/1/11/713/009 100 tablets 
EU/1/11/713/010 200 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis 250 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} 
 
 
  



26 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label of 250 mg film-coated tablets in tablet containers 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 250 mg tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 250 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
200 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



27 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/008 30 tablets 
EU/1/11/713/009 100 tablets 
EU/1/11/713/010 200 tablets 
 
 
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 
 
 
 
  



28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Aluminium/PVC blisters 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 250 mg film-coated tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 250 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
20 film-coated tablets 
30 film-coated tablets 
50 film-coated tablets 
60 film-coated tablets 
100 film-coated tablets 
120 film-coated tablets 
200 film-coated tablets 
60 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



29 

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/1/11/713/001 20 tablets 
EU/1/11/713/002 30 tablets 
EU/1/11/713/003 50 tablets 
EU/1/11/713/004 60 tablets 
EU/1/11/713/005 100 tablets 
EU/1/11/713/006 120 tablets 
EU/1/11/713/007 200 tablets 
 
Perforated unit dose blisters: 
EU/1/11/713/041 60 x 1 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis 250 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} 



30 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blisters for 250 mg film-coated tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 250 mg tablets 
Levetiracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 
 
 
 
  



31 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton of 500 mg film-coated tablets in tablet containers 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 500 mg film-coated tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 500 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 film-coated tablets 
200 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



32 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/018 30 tablets 
EU/1/11/713/019 100 tablets 
EU/1/11/713/020 200 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis 500 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} 
 
 
  



33 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label of 500 mg film-coated tablets in tablet containers 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 500 mg tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 500 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
200 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



34 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/018 30 tablets 
EU/1/11/713/019 100 tablets 
EU/1/11/713/020 200 tablets 
 
 
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 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Aluminium/PVC blisters 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 500 mg film-coated tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 500 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
20 film-coated tablets 
30 film-coated tablets 
50 film-coated tablets 
60 film-coated tablets 
100 film-coated tablets 
120 film-coated tablets 
200 film-coated tablets 
60 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



36 

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/1/11/713/011 20 tablets 
EU/1/11/713/012 30 tablets 
EU/1/11/713/013 50 tablets 
EU/1/11/713/014 60 tablets 
EU/1/11/713/015 100 tablets 
EU/1/11/713/016 120 tablets 
EU/1/11/713/017 200 tablets 
 
Perforated unit dose blisters: 
EU/1/11/713/042 60 x 1 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis 500 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} 



37 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blisters for 500 mg film-coated tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 500 mg tablets 
Levetiracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 
 
 
 
  



38 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton of 750 mg film-coated tablets in tablet containers 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 750 mg film-coated tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 750 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains colouring agent sunset yellow (E110). See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 film-coated tablets 
200 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



39 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/028 30 tablets 
EU/1/11/713/029 100 tablets 
EU/1/11/713/030 200 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis 750 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} 
 
 



40 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label of 750 mg film-coated tablets in tablet containers 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 750 mg tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 750 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains colouring agent sunset yellow (E110).  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
200 tablets 
  
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



41 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/028 30 tablets 
EU/1/11/713/029 100 tablets 
EU/1/11/713/030 200 tablets 
 
 
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 
 
 
 
 
 
 



42 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Aluminium/PVC blisters 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 750 mg film-coated tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 750 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains colouring agent sunset yellow (E110). See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
20 film-coated tablets 
30 film-coated tablets 
50 film-coated tablets 
60 film-coated tablets 
100 film-coated tablets 
120 film-coated tablets 
200 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



43 

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/1/11/713/021 20 tablets 
EU/1/11/713/022 30 tablets 
EU/1/11/713/023 50 tablets 
EU/1/11/713/024 60 tablets 
EU/1/11/713/025 100 tablets 
EU/1/11/713/026 120 tablets 
EU/1/11/713/027 200 tablets 
 
 
13. BATCH NUMBER 
 
Lot 

 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis 750 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} 



44 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blisters for 750 mg film-coated tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 750 mg tablets 
Levetiracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
 
 
 
  



45 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton of 1,000 mg film-coated tablets in tablet containers 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 1,000 mg film-coated tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 1,000 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
100 film-coated tablets 
200 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



46 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/038 30 tablets 
EU/1/11/713/039 100 tablets 
EU/1/11/713/040 200 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis 1,000 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} 
 
 
 



47 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label of 1,000 mg film-coated tablets in tablet containers 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 1,000 mg tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 1,000 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 tablets 
100 tablets 
200 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



48 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/038 30 tablets 
EU/1/11/713/039 100 tablets 
EU/1/11/713/040 200 tablets 
 
 
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 
 
 
 
 



49 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton for Aluminium/PVC blisters 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 1,000 mg film-coated tablets 
Levetiracetam 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 1,000 mg levetiracetam. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
20 film-coated tablets 
30 film-coated tablets 
50 film-coated tablets 
60 film-coated tablets 
100 film-coated tablets 
120 film-coated tablets 
200 film-coated tablets 
60 x 1 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/713/031 20 tablets 
EU/1/11/713/032 30 tablets 
EU/1/11/713/033 50 tablets 
EU/1/11/713/034 60 tablets 
EU/1/11/713/035 100 tablets 
EU/1/11/713/036 120 tablets 
EU/1/11/713/037 200 tablets 
 
Perforated unit dose blisters: 
EU/1/11/713/043 60 x 1 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levetiracetam Actavis 1,000 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 
 
Blisters for 1,000 mg film-coated tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levetiracetam Actavis 1,000 mg tablets 
Levetiracetam 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
  



52 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
  



53 

Package Leaflet: Information for the patient 
 

Levetiracetam Actavis 250 mg film-coated tablets 
Levetiracetam Actavis 500 mg film-coated tablets 
Levetiracetam Actavis 750 mg film-coated tablets 

Levetiracetam Actavis 1,000 mg film-coated tablets 
 

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 is and what it is used for 
2. What you need to know before you take Levetiracetam Actavis 
3. How to take Levetiracetam Actavis 
4. Possible side effects 
5. How to store Levetiracetam Actavis 
6. Contents of the pack and other information 
 
 
1. What Levetiracetam Actavis is and what it is used for 
 
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). 
 
Levetiracetam Actavis 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 
 
Do not take Levetiracetam Actavis 
• if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this 

medicine (listed in section 6). 
 



54 

Warnings and precautions 
Talk to your doctor before taking Levetiracetam Actavis 
• 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. 
• A small number of people being treated with anti-epileptics such as Levetiracetam Actavis have 

had thoughts of harming or killing themselves. If you have any symptoms of depression and/or 
suicidal ideation, please contact your doctor. 

 
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.  
 
Children and adolescents 
Levetiracetam Actavis is not indicated in children and adolescents below 16 years on its own 
(monotherapy). 
 
Other medicines and Levetiracetam Actavis 
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 loss of its effect. 
 
Pregnancy and breast-feeding 
If you are pregnant or breastfeeding, 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 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 750 mg tablets contain Sunset Yellow (E110) 
Sunset Yellow (E110) colouring agent may cause allergic reactions. 
 
 
3. How to take Levetiracetam Actavis 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Take the number of tablets following your doctor´s instructions. 
Levetiracetam Actavis must be taken twice a day, once in the morning and once in the evening, at 
about the same time each day. 
 
Monotherapy 
 
Dose in adults and adolescents (from 16 years of age): 
General dose: between 1,000 mg and 3,000 mg each day. 



55 

When you will first start taking Levetiracetam Actavis, your doctor will prescribe you a lower dose 
(500 mg each day) during 2 weeks before giving you the lowest general dose of 1,000 mg. 
 
Add-on therapy 
 
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: 
General dose: between 1,000 mg and 3,000 mg each day. 
Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 
2 tablets of 250 mg in the evening. 
 
Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) 
weighing less than 50 kg: 
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the 
age, weight and dose. 
An oral solution is a formulation more appropriate to infants and children under the age of 6 years and 
to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets do not 
allow accurate dosage. 
 
Method of administration 
Swallow Levetiracetam Actavis tablets with a sufficient quantity of liquid (e.g. a glass of water). You 
may take Levetiracetam Actavis with or without food. After oral administration the bitter taste of 
levetiracetam may be experienced. 
 
Duration of treatment 
• Levetiracetam Actavis is used as a chronic treatment. You should continue Levetiracetam 

Actavis 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 than you should 
The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease 
of alertness, inhibition of breathing and coma. 
Contact your doctor if you took more tablets than you should. Your doctor will establish the best 
possible treatment of overdose. 
 
If you forget to take Levetiracetam Actavis 
Contact your doctor if you have missed one or more doses. 
Do not take a double dose to make up for a forgotten tablet. 
 
If you stop taking Levetiracetam Actavis 
If stopping treatment, Levetiracetam Actavis should be discontinued gradually to avoid an increase of 
seizures. Should your doctor decide to stop your Levetiracetam Actavis treatment, he/she will instruct 
you about the gradual withdrawal of Levetiracetam Actavis. 
 
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 



56 

(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 side effects are 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. 
 
Common: may affect up to1 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); 



57 

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

symptoms); 
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling 

movements, hyperkinesia (hyperactivity); 
• 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 
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 
 
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, label or 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 Levetiracetam Actavis contains 
The active substance is called levetiracetam. 
One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam. 
One tablet of Levetiracetam Actavis 500 mg contains 500 mg of levetiracetam. 
One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam. 
One tablet of Levetiracetam Actavis 1,000 mg contains 1,000 mg of levetiracetam. 
 
The other ingredients are: 
Crospovidon, povidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol–part. 
hydrolyzed, macrogol 4000, talc, titanium dioxide (E171), colourants*. 
 
* The colourants are: 
250 mg tablet: Indigo carmine (E132). 
500 mg tablet: Iron oxide yellow (E172), indigo carmine (E132). 
750 mg tablet: Indigo carmine (E132), sunset yellow (E110), iron oxide red (E172). 
 
What Levetiracetam Actavis looks like and contents of the pack 



58 

Levetiracetam Actavis 250 mg film-coated tablets are oval, light blue, 13.6 x 6.4 mm marked with “L” 
on one side and “250” on the other side. 
Levetiracetam Actavis 500 mg tablets are oval, yellow, 17.1 x 8.1 mm marked with “L” on one side 
and “500” on the other side. 
Levetiracetam Actavis 750 mg tablets are oval, orange, 19.0 x 9.3 mm marked with “L” on one side 
and “750” on the other side. 
Levetiracetam Actavis 1,000 mg tablets are oval, white, 19.0 x 10.0 mm marked with “L” on one side 
and “1000” on the other side. 
 
Pack sizes 
Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets. 
Perforated unit dose blisters: 60 x 1 film-coated tablets (only available for 250 mg, 500 mg and 
1,000 mg tablets). 
Tablet containers: 30, 100 and 200 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland 
 
Manufacturer 
Specifar S.A 
1, 28 Octovriou str., 123 51 Ag. Varvara, Athens, Greece 
 
Teva Operations Poland Sp. z. o. o. 
ul. Mogilska 80, 31-546 Kraków, Poland 
 
Tjoapack Netherlands B.V. 
Nieuwe Donk 9, ETTEN-LEUR, 4879AC, Netherlands 
 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland 
 
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 
Актавис ЕАД 
Teл.: +359 24899585 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande / Island 
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 Ltd. 
Tel: +356 21693533 
 



59 

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 ABEE 
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 
Tel: +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 19630330 
 

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

Ísland 
Actavis Group PTC 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 {MM/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(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET