Monotherapy of focal seizures with or without secondary generalisation

Child 16–17 years: Initially 250 mg once daily for 1 week, then increased to 250 mg twice daily, then increased in steps of 250 mg twice daily (max. per dose 1.5 g twice daily), adjusted according to response, dose to be increased every 2 weeks

Adult: Initially 250 mg once daily for 1–2 weeks, then increased to 250 mg twice daily, then increased in steps of 250 mg twice daily (max. per dose 1.5 g twice daily), adjusted according to response, dose to be increased every 2 weeks.

Adjunctive therapy of focal seizures with or without secondary generalisation

Child 1–5 months: Initially 7 mg/kg once daily, then increased in steps of up to 7 mg/kg twice daily (max. per dose 21 mg/kg twice daily), dose to be increased every 2 weeks Child 6 months–17 years (body-weight up to 50 kg): Initially 10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose 30 mg/kg twice daily), dose to be increased every 2 weeks

Child 12–17 years (body-weight 50 kg and above): Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2–4 weeks

Adult: Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2–4 weeks

Adjunctive therapy of myoclonic seizures and tonic-clonic seizures

Child 12–17 years (body-weight up to 50 kg): Initially 10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose 30 mg/kg twice daily), dose to be increased every 2 weeks

Child 12–17 years (body-weight 50 kg and above): Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2 weeks

Adult: Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2–4 weeks.

• Hepatic Impairment
• Renal Impairment

Pregnancy: Monitoring Clinical Response Should Be Monitored During Pregnancy—plasma Concentrations Decrease During Pregnancy (by up To 60% in The Third Trimester).

Breast Feeding present in Milk— Advise to Avoid.

Hepatic Impairment caution in Severe Impairment.

Dose Adjustments maintenance Dose Reduction of 50% in Severe Impairment if Creatinine Clearance Is Less than 60 ml/minute/1.73m2

Renal Impairment

Dose Adjustments

In Children reduce Dose if Estimated Glomerular Filtration Rate Less than 80m L/minute/1.73m²

In Adults maximum 2 g Daily if egfr 50–80 ml/minute/1.73m². Maximum 1.5 g Daily if egfr 30–50 ml/minute/1.73m². Maximum 1 g Daily if egfr Less than 30 ml/minute/1.73m²

Common or very common: Anxiety, Decreased appetite, Asthenia, Abnormal behavior cough, Depression, Diarrhoea, Dizziness, Drowsiness, Gastrointestinal discomfort, Headache, Increased risk of infection, Insomnia, Altered mood, Movement disorders, Nausea, Skin reactions, Vertigo, Vomiting

Uncommon Alopecia, Concentration impaired, Confusion, Hallucination, Leukopenia, Muscle weakness, Myalgia, Paranesthesia, Psychotic disorder, Suicidal behaviors, Thrombocytopenia vision disorders, Weight changes

Rare or very rare acute kidney injury, Agranulocytosis, hepatic disorders, Hyponatremia, Neutropenia, pancreatitis, Pancytopenia, Personality disorder, rhabdomyolysis, Severe cutaneous adverse reactions (SCARs), Thinking abnormal

Store in a cool and dry place

10×10 Tablets