Keppra oral solution 100 mg/ml 300 ml bottle with measuring syringe No. 1

Instructions for Keppra oral solution 100 mg/ml 300 ml bottle with measuring syringe No. 1

Composition

active ingredient: levetiracetam;

1 ml of solution contains 100 mg of levetiracetam;

excipients: citric acid monohydrate, ammonium glycyrrhizinate, sodium citrate, methylparaben (E 218), propylparaben (E 216), glycerin 85% (E 422), liquid maltitol (E 965), acesulfame potassium (E 950), grape flavoring Firmenich 501040A, purified water.

Dosage form

Oral solution.

Main physicochemical properties: clear liquid.

Pharmacotherapeutic group

Antiepileptic drugs. Levetiracetam.

ATX code N03A X14.

Pharmacological properties

Pharmacodynamics.

Levetiracetam, an active substance derived from pyrrolidone (S-enantiomer of alpha-ethyl-2-oxo-1-pyrrolidine-acetamide), differs in chemical structure from known antiepileptic drugs.

Mechanism of action

The mechanism of action of levetiracetam is not well understood. Based on in vitro and in vivo studies, it is assumed that levetiracetam does not alter the basic characteristics of the nerve cell and normal neurotransmission. In vitro studies have shown that levetiracetam affects intracellular Ca2+ levels by partially inhibiting current through N-type Ca2+ channels and reducing the release of Ca2+ from intracellular depots. It also partially eliminates the inhibition of GABA- and glycine-gated currents caused by the action of zinc and β-carbolines. In addition, in vitro studies, levetiracetam has been shown to bind to specific sites in rodent brain tissue. The binding site is synaptic vesicle protein 2A, which is involved in vesicle fusion and neurotransmitter release. The affinity (ranked) of levetiracetam and its analogues for synaptic vesicle protein 2A correlated with their anticonvulsant potency in mouse models of audiogenic epilepsy. These results suggest that an interaction between levetiracetam and synaptic vesicle protein 2A may partially explain the mechanism of the drug's antiepileptic action.

Pharmacodynamic effects

Levetiracetam provides protection against seizures in a wide range of partial and primary generalized seizure models in animals without causing proconvulsant effects. The main metabolite is inactive.

In humans, the drug's activity has been confirmed against both partial and generalized epileptic seizures (epileptiform manifestations/photoparoxysmal response), indicating a broad spectrum of the pharmacological profile of levetiracetam.

Pharmacokinetics.

Levetiracetam is characterized by high solubility and permeability. The pharmacokinetics are linear and characterized by low inter- and intrasubject variability. Clearance does not change after repeated administration of the drug. There was no evidence of an effect of gender, race or circadian rhythm on pharmacokinetics. The pharmacokinetic profile was similar in healthy volunteers and patients with epilepsy.

Due to complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed in mg/kg body weight. Therefore, monitoring of levetiracetam plasma levels is not necessary.

In adults and children, a significant correlation was observed between saliva and plasma drug concentrations (saliva/plasma concentration ratios ranged from 1 to 1.7 after oral tablets and 4 hours after oral solution).

Adults and adolescents

Absorption.

Levetiracetam is rapidly absorbed after oral administration. Absolute oral bioavailability is close to 100%. Peak plasma concentrations (Cmax) are reached 1.3 hours after dosing. Steady state is reached after 2 days of twice daily dosing. Peak concentrations (Cmax) are typically 31 and 43 μg/ml after a single 1000 mg dose and a repeated 1000 mg dose twice daily, respectively. The extent of absorption is independent of dose and is not affected by food.

Distribution.

There are no data on the distribution of the drug in human tissues. Neither levetiracetam nor its main metabolite is significantly bound to plasma proteins (< 10%). The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/kg, which is approximately equal to the total body water volume.

Metabolism.

Levetiracetam metabolism in humans is negligible. The main metabolic pathway (24% of the dose) is enzymatic hydrolysis of the acetamide group. Hepatic cytochrome P450 isoforms are not involved in the formation of the main metabolite, ucb L057. Hydrolysis of the acetamide group has been observed in a large number of tissues, including blood cells. The metabolite ucb L057 is pharmacologically inactive.

Two minor metabolites were also identified. One was formed by hydroxylation of the pyrrolidone ring (1.6% of the dose), the other by opening of the pyrrolidone ring (0.9% of the dose).

Other unidentified components accounted for only 0.6% of the dose.

No interconversion of enantiomers of levetiracetam or its major metabolite was observed in vivo.

In human hepatocyte culture, levetiracetam had little or no effect on CYP1A1/2, SULT1E1 or UGT1A1. Levetiracetam induced a weak induction of CYP2B6 and CYP3A4. In vitro and in vivo data on interactions with oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected under in vivo conditions. Therefore, interactions of levetiracetam with other substances or vice versa are unlikely.

Breeding.

The plasma elimination half-life in adults was 7±1 h and was independent of dose, route of administration, or repeated administration. The mean total clearance was 0.96 mL/min/kg.

The main amount of the drug, on average 95% of the dose, was excreted in the urine (approximately 93% of the dose was excreted within 48 hours). Only 0.3% of the dose was excreted in the feces.

The cumulative urinary excretion of levetiracetam and its major metabolite was 66% and 24% of the dose, respectively, in 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 eliminated by glomerular filtration followed by tubular reabsorption and that the major metabolite is also eliminated by active tubular secretion in addition to glomerular filtration. Levetiracetam excretion correlates with creatinine clearance.

Elderly patients.

In elderly patients, the elimination half-life is increased by approximately 40% (10-11 hours). This is due to the deterioration of renal function in this population (see section "Method of administration and dosage").

Kidney dysfunction.

The apparent total clearance of levetiracetam and its main metabolite correlates with creatinine clearance. Therefore, in patients with moderate to severe renal impairment, it is recommended to adjust the maintenance daily dose of levetiracetam according to creatinine clearance (see section 4.2).

In anuric patients with end-stage renal disease, the elimination half-life was approximately 25 and 3.1 hours, respectively, between and during dialysis. 51% of levetiracetam was removed during a 4-hour fractional dialysis session.

Liver dysfunction.

No relevant changes in levetiracetam clearance were observed in patients with mild to moderate hepatic impairment. In most patients with severe hepatic impairment, levetiracetam clearance was reduced by more than 50% due to concomitant renal impairment (see section 4.2).

Pediatric population.

Children aged 4 to 12 years.

After a single dose (20 mg/kg) in epileptic children (6 to 12 years), the elimination half-life of levetiracetam was 6 hours. The apparent clearance, adjusted for body weight, was approximately 30% higher than in adult patients with epilepsy. After repeated oral administration (20–60 mg/kg/day) in epileptic children (4 to 12 years), levetiracetam was rapidly absorbed. Peak plasma concentrations were reached 0.5–1 hour after dosing. Peak concentrations and the area under the concentration-time curve increased linearly and were dose-dependent. The elimination half-life was approximately 5 hours; the apparent total clearance was 1.1 ml/min/kg.

Infants and children aged 1 month to 4 years.

After a single dose (20 mg/kg) of 100 mg/ml oral solution in pediatric epileptic patients (aged 1 month to 4 years), levetiracetam was rapidly absorbed, with peak plasma concentrations occurring approximately 1 hour after dosing. Pharmacokinetic parameters showed that the elimination half-life was shorter (5.3 hours) than in adults (7.2 hours) and the apparent clearance was faster (1.5 ml/min/kg) than in adults (0.96 ml/min/kg).

Another population pharmacokinetic analysis conducted in patients aged 1 month to 16 years showed a significant correlation between body weight and apparent clearance (clearance increased with increasing body weight) and apparent volume of distribution. Age also affected both parameters. This effect was more pronounced in younger infants, decreased with growth, and was negligible in children aged approximately 4 years.

Data from both population pharmacokinetic analyses indicated an increase in the apparent clearance of levetiracetam by approximately 20% with concomitant use of enzyme-inducing antiepileptic drugs.

Indication

Monotherapy (first-choice drug) in the treatment of:

partial seizures with or without secondary generalization in adults and adolescents aged 16 years and older with newly diagnosed epilepsy.

As an additional therapy in the treatment of:

partial seizures with or without secondary generalization in adults and children aged 1 month and older with epilepsy;

myoclonic seizures in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy;

primary generalized tonic-clonic seizures in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy.

Contraindication

Hypersensitivity to levetiracetam or other pyrrolidone derivatives, as well as to any of the excipients of the drug.

Interaction with other medicinal products and other types of interactions

Pre-marketing data from clinical studies in adult patients indicate that levetiracetam does not affect the serum concentrations of other antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone), which in turn do not affect the pharmacokinetics of levetiracetam.

There are no data on clinically significant drug interactions in pediatric patients, as well as in adults receiving up to 60 mg/kg/day of levetiracetam.

A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years of age) confirmed that adjunctive therapy with oral levetiracetam did not affect the steady-state serum concentrations of concomitantly administered carbamazepine and valproate. However, data suggest that the clearance of levetiracetam is 20% higher in children taking enzyme-inducing antiepileptic drugs. No dose adjustment is required.

Probenecid.

Probenecid (500 mg 4 times daily), a drug that blocks renal tubular secretion, inhibits renal clearance of the major metabolite, but not levetiracetam itself. However, concentrations of this metabolite remain low.

Methotrexate.

Concomitant use of levetiracetam and methotrexate has been reported to reduce the clearance of methotrexate, leading to increased/prolonged blood concentrations of methotrexate to potentially toxic levels. Methotrexate and levetiracetam blood levels should be closely monitored in patients receiving both drugs concurrently.

Oral contraceptives and pharmacokinetic interactions with other drugs.

Levetiracetam at a daily dose of 1000 mg does not change the pharmacokinetics of oral contraceptives (ethinyl estradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone levels) did not change. Levetiracetam at a daily dose of 2000 mg does not change the pharmacokinetics of digoxin and warfarin; prothrombin time values remained unchanged. Digoxin, oral contraceptives and warfarin, in turn, do not affect the pharmacokinetics of levetiracetam when used simultaneously.

Laxatives.

In isolated cases, reduced efficacy of levetiracetam has been reported when the osmotic laxative macrogol was used concomitantly with oral levetiracetam. Therefore, oral macrogol should not be taken within one hour before or one hour after taking levetiracetam.

Food and alcohol.

The extent of absorption of levetiracetam is independent of food, but the rate of absorption is slightly reduced when taken with food. There are no data on the interaction of levetiracetam with alcohol.

Application features

Kidney failure.

Patients with renal impairment may require dose adjustment of levetiracetam. In patients with severe hepatic impairment, it is recommended that renal function be assessed prior to administration (see section 4.2).

Acute kidney injury.

The use of levetiracetam has been very rarely associated with acute kidney injury, the time to onset of which ranged from a few days to several months.

Complete blood count.

Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leukopenia, thrombocytopenia and pancytopenia) have been reported in association with levetiracetam, usually at the start of treatment. A complete blood count is recommended in patients who experience significant weakness, fever, recurrent infections or coagulation disorders (see section 4.8).

Suicide.

Cases of suicide, suicide attempts, suicidal thoughts and behaviour have been reported in patients treated with antiepileptic drugs (including levetiracetam). A meta-analysis of randomised placebo-controlled trials of antiepileptic drugs has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known. In view of this risk, patients should be monitored for signs of depression and/or suicidal thoughts and behaviour and treatment should be adjusted as necessary. Patients (or their carers) should be advised to report any symptoms of depression and/or suicidal thoughts or behaviour to their doctor.

Unusual or aggressive behavior.

Levetiracetam may cause psychotic symptoms and behavioral disturbances, including irritability and aggression. Patients taking levetiracetam should be monitored for the development of psychiatric symptoms indicative of significant changes in mood and/or personality. If such behaviour occurs, it is recommended to adjust the treatment or gradually discontinue it. If treatment discontinuation is necessary, see the information in the section “Method of administration and dosage”.

As with other antiepileptic drugs, levetiracetam may occasionally increase the frequency or severity of seizures. This paradoxical effect has been reported most frequently within the first month of levetiracetam initiation or with dose increases. This effect was reversible upon discontinuation of the drug or dose reduction. Patients should be advised to seek immediate medical advice if their epilepsy worsens. For example, failure to respond to treatment or exacerbation of seizures has been reported in patients with epilepsy associated with mutations in the alpha subunit of voltage-gated sodium channels.

QT prolongation on the electrocardiogram (ECG).

During post-marketing surveillance, rare cases of QT prolongation on ECG have been reported. Levetiracetam should be used with caution in patients with QT prolongation, in patients taking concomitant medications that affect the QT interval, and in patients with underlying cardiac disease or electrolyte imbalance.

Children.

Available data in pediatric patients do not indicate any effects on growth and sexual maturation. However, long-term effects on learning ability, intelligence, growth, endocrine function, sexual maturation, and reproductive potential in children have not been studied.

Excipients.

The product contains methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions (possibly delayed). It also contains liquid maltitol, therefore patients with rare hereditary diseases associated with fructose intolerance should not use this medicine.

Use during pregnancy or breastfeeding

Women of reproductive age.

Special advice should be given to women of childbearing potential. Levetiracetam treatment should be reconsidered if a woman is planning to become pregnant. As with all antiepileptic drugs, abrupt withdrawal of levetiracetam should be avoided as this may lead to seizures, which may have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible, as treatment with multiple antiepileptic drugs may be associated with a higher risk of congenital malformations than monotherapy, depending on the combination of drugs.

Pregnancy.

A large amount of post-marketing data from pregnant women exposed to levetiracetam (more than 1800 women, including 1500 women exposed during the 1st trimester) does not indicate an increased risk of major birth defects. There are only limited data on the development of the nervous system in children exposed to Keppra® monotherapy in utero. However, available epidemiological studies (approximately 100 children) do not indicate an increased risk of disorders or delays in the development of the nervous system. Levetiracetam can be used during pregnancy if, after careful assessment, it is considered clinically necessary. In such cases, the lowest effective dose is recommended.

Physiological changes during pregnancy may affect levetiracetam concentrations. Decreases in plasma levetiracetam concentrations have been observed during pregnancy. This decrease is more pronounced in the third trimester (up to 60% of pre-pregnancy baseline concentrations). Pregnant women treated with levetiracetam should be given appropriate clinical monitoring.

Breast-feeding.

Levetiracetam is excreted in human milk. Breastfeeding is therefore not recommended. However, if levetiracetam must be used during breast-feeding, the benefits and risks of treatment should be weighed against the importance of breast-feeding.

Reproductive effects: No effects on reproductive function have been observed in animal studies. The potential risk for humans is unknown as no clinical data are available.

Ability to influence reaction speed when driving vehicles or other mechanisms

Levetiracetam has minor or moderate influence on the ability to drive and use machines. Due to possible individual sensitivity, some patients may experience drowsiness or other symptoms related to the effects on the central nervous system, especially at the beginning of treatment or during dose increases. Therefore, such patients should be careful when engaging in activities that require increased concentration, such as driving or operating machinery. Patients are advised to refrain from driving or operating machinery until it is established that their ability to perform such activities is not impaired.

Method of administration and doses

The drug should be taken orally, regardless of meals. The oral solution can be taken after dilution in a glass of water or a feeding bottle. After oral administration, a bitter taste of levetiracetam may be felt.

Partial seizures

The recommended dose for monotherapy (patients aged 16 years and over) and adjunctive therapy is the same and is listed below.

All indications

The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. However, a lower initial dose of 250 mg twice daily may be used by the physician based on an assessment of the reduction in seizure frequency compared to potential side effects. This dose may be increased to 500 mg twice daily after 2 weeks.

Depending on clinical response and tolerability, the daily dose may be increased to 1500 mg twice daily. The dose may be increased or decreased by 500 mg twice daily every 2–4 weeks.

Adolescents (12 to 17 years) weighing less than 50 kg and children from 1 month of age

The physician should prescribe the most appropriate dosage form, dosage and release form based on body weight, age and dose. For information on dose adjustment based on body weight, see the Children section.

Treatment discontinuation

If it is necessary to discontinue treatment with levetiracetam, it is recommended to discontinue it gradually (e.g., adults and adolescents weighing 50 kg or more should reduce the dose by 500 mg twice daily every 2–4 weeks; infants aged 6 months or more, children and adolescents weighing less than 50 kg should reduce the dose by no more than 10 mg/kg twice daily every two weeks; infants under 6 months should reduce the dose by no more than 7 mg/kg twice daily every two weeks).

Special patient groups

Elderly patients (≥ 65 years)

Dose adjustment in elderly patients is only necessary in case of renal impairment (see section “Patients with renal impairment” below).

Patients with renal impairment

The daily dose of levetiracetam must be selected individually.

For adult patients, the dose should be adjusted as shown in Table 1 below. To adjust the dose, the patient's creatinine clearance (CC) in ml/min should be determined.

In adults and adolescents weighing 50 kg or more, the creatinine clearance in ml/min can be calculated from the serum creatinine level (mg/dl) using the following formula:

[140 ─ age (in years)] × body weight (kg)

CC (ml/min) = -------------------------------------------------------------- × 0.85 (for women).

72 × serum creatinine (mg/dL)

Then adjust the CK according to body surface area (BSA) as shown below:

CC (ml/min)

CC (ml/min/1.7Zm2) = --------------------------- ×1.73.

Patient's PPT (m2)

Table 1

Dose adjustment recommendations for adult patients and adolescents weighing 50 kg or more with renal impairment

(1) A loading dose of 750 mg levetiracetam is recommended on the first day of treatment.

(2) After dialysis, an additional dose of 250–500 mg is recommended.

For children with renal impairment, the dose of levetiracetam should be adjusted according to renal function, as the clearance of levetiracetam is related to renal function. This recommendation is based on a study in adult patients with renal impairment.

For adolescents, children, and infants, the creatinine clearance in mL/min/1.73 m2 can be calculated from the serum creatinine level (mg/dL) using the following formula (Schwarz formula):

height (cm) × ks

CC (ml/min/1.73 m2) = --------------------------------- .

Serum creatinine (mg/dL)

In full-term infants under 1 year of age, ks = 0.45; in children under 13 years of age and adolescent girls, ks = 0.55; in adolescent boys, ks = 0.7.

Table 2

Dose adjustment recommendations for infants, children and adolescents weighing less than 50 kg with renal impairment

(2) A loading dose of 10.5 mg/kg (0.105 ml/kg) of levetiracetam is recommended on the first day of treatment.

(3) A loading dose of 15 mg/kg (0.15 ml/kg) of levetiracetam is recommended on the first day of treatment.

(4) After dialysis, an additional dose of 3.5–7 mg/kg (0.035–0.07 ml/kg) is recommended.

(5) After dialysis, an additional dose of 5–10 mg/kg (0.05–0.1 ml/kg) is recommended.

Patients with hepatic impairment

No dose adjustment is required for patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, creatinine clearance may not fully reflect the degree of renal impairment. Therefore, a 50% reduction in the daily maintenance dose is recommended for patients with creatinine clearance < 60 mL/min/1.73 m2.

Children

The doctor should prescribe the most appropriate dosage form, dosage and release form depending on age, body weight and dose.

Keppra® oral solution is preferred for infants and children under 6 years of age. In addition, the available tablet dosages are not suitable for initial treatment of children weighing less than 25 kg, for patients who cannot swallow tablets, or for doses up to 250 mg. In these cases, Keppra® oral solution should be used.

Monotherapy

The safety and efficacy of Keppra® as monotherapy in children and adolescents under 16 years of age have not been established.

Data is missing.

Adolescents (aged 16–17 years) weighing 50 kg or more with partial seizures with or without secondary generalization, who have been diagnosed with epilepsy for the first time

See above section “Adults (≥ 18 years) and adolescents (12–17 years) weighing 50 kg or more”.

Adjunctive therapy for infants aged 6–23 months, children (2–11 years) and adolescents (12–17 years) weighing less than 50 kg.

The initial therapeutic dose is 10 mg/kg twice daily.

Depending on clinical response and tolerability, the dose may be increased to 30 mg/kg twice daily. The dose should not be increased or decreased by more than 10 mg/kg twice daily every two weeks. The lowest effective dose should be used for all indications.

Children weighing 50 kg or more should use the same doses as adults for all indications.

For information on use in all indications, see above in the section “Adults (≥ 18 years) and adolescents (12–17 years) weighing 50 kg or more”.

Table 3

Recommended doses for infants aged 6 months and older, children and adolescents

(1) Children weighing 25 kg or less should be started on Keppra® 100 mg/ml oral solution.

(2) Children weighing 50 kg or more should use the same doses as adults.

Adjunctive therapy for infants aged 1 to < 6 months

The initial therapeutic dose is 7 mg/kg twice daily.

Depending on clinical response and tolerability, the dose may be increased to 21 mg/kg twice daily. The dose should not be increased or decreased by more than 7 mg/kg twice daily every two weeks. The lowest effective dose should be used.

Infants should be started on Keppra® 100 mg/mL oral solution.

Table 4

Recommended doses for infants aged 1 to 6 months

Method of administration of oral solution

Dose using the measuring syringe included in the package.

Three types of packaging are available:

300 ml bottle with a 10 ml oral syringe (corresponding to 1000 mg of levetiracetam) with a graduation of 0.25 ml (corresponding to 25 mg) - for children aged 4 years and over, adolescents and adults;

150 ml bottle with 3 ml oral syringe (corresponding to 300 mg of levetiracetam) with a graduation of 0.1 ml (corresponding to 10 mg) – for infants and young children from 6 months to < 4 years;

150 ml bottle with 1 ml oral syringe (corresponding to 100 mg of levetiracetam) with a graduation of 0.05 ml (corresponding to 5 mg) – for infants aged 1 to < 6 months.

Dilute the measured dose in a glass of water or in a feeding bottle.

Dosing the solution using a measuring syringe:

open the bottle by pressing the cap and turning it counterclockwise;

Separate the adapter from the syringe; insert the adapter into the neck of the vial. Make sure it is securely fastened;

insert the syringe into the open adapter (Fig. 4); turn the bottle upside down;

fill the syringe with the solution by pulling the piston to the mark corresponding to the required amount of solution in milliliters (ml) prescribed by the doctor;

Turn the bottle upside down. Remove the syringe from the adapter;

inject the contents of the syringe into a glass of water or a feeding bottle by pressing the piston to the bottom of the syringe;

drink the entire contents of the glass/feeding bottle;

close the bottle with a plastic cap;

Rinse the syringe with water.

Children.

Keppra®, an oral solution, can be prescribed to children from 1 month of age. The doctor selects the optimal dosage form, strength depending on age, body weight and dose. The drug is not recommended for use in children under 1 month of age due to the lack of data on the safety and efficacy of such use. It should be borne in mind that the drug should not be used in tablet form for the initial treatment of children weighing less than 25 kg in the case of high doses; for patients who cannot swallow tablets; for use in doses below 250 mg; in such cases, it should be used in the form of an oral solution.

The safety of the drug as monotherapy for children and adolescents under 16 years of age has not been established.

Overdose

Symptoms.

Overdose of Keppra® has been associated with drowsiness, agitation, aggression, respiratory depression, decreased consciousness, and coma.

Treatment.

In case of acute overdose, gastric lavage or induce vomiting is necessary. There is no specific antidote for levetiracetam. If necessary, symptomatic treatment should be carried out, including hemodialysis (60% of levetiracetam and 74% of the main metabolite are removed).

Side effects

The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness. The adverse event profile presented is based on a pooled analysis of placebo-controlled clinical trials involving a total of 3416 patients treated with levetiracetam. These data are supplemented by the use of levetiracetam in relevant open-label extension studies and post-marketing experience. The safety profile of levetiracetam is generally similar across age groups (adults and children) when used in the various established indications for epilepsy.

Adverse reactions reported in clinical trials (in adults, adolescents, children and infants from 1 month of age) and during the post-marketing period are listed in the following table by system organ class and their frequency. The 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).

Table 5

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