Details

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• Marketing Authorisation (MAL): MAL19860953AZ.

• Manufacturer: Sanofi Winthrop Industrie, France.

Content

• Active Ingredients: Each tablet contains 333 mg sodium valproate and 145 mg valproic acid, equivalent to 500 mg sodium valproate.

• Formulation: Prolonged-release tablets designed to release the active ingredient gradually over time.

• Pack Size: 30 tablets per pack.

Indications

Epilim Chrono is indicated for the treatment of:

• Epilepsy: Including generalized and partial seizures, such as myoclonic, simple or complex partial, secondary generalized, and specific syndromes like West syndrome and Lennox-Gastaut syndrome.

• Bipolar Disorder: For the treatment and prevention of manic episodes associated with bipolar disorder.

Instructions

Dosage & Administration:

• Adults: Start with 600 mg daily, increasing by 200 mg every 3 days until control is achieved. The usual dose ranges from 1000 mg to 2000 mg per day, equivalent to 20–30 mg/kg body weight. If adequate control is not achieved within this range, the dose may be further increased up to 2500 mg per day.

• Children Over 20 kg: Initial dosage should be 500 mg/day, with gradual increases until control is achieved; the usual dose is within the range of 20–30 mg/kg body weight per day. The dose may be further increased up to 35 mg/kg/day depending on the child's condition.

• Administration: Take the tablet orally, swallowing it whole with water. Do not chew, crush, or break the tablet. Epilim Chrono may be taken once or twice daily, preferably at the same time each day. It can be taken with or without food.

Precautions:

• Epilim Chrono is contraindicated in pregnancy unless two specialists independently consider and document that there is no other effective or tolerated treatment. It is also contraindicated in women of childbearing potential aged under 55 years unless the conditions of the pregnancy prevention programme are fulfilled.

• Regular monitoring of liver function and blood counts is recommended during treatment.

• Avoid alcohol consumption while taking Epilim Chrono, as it can enhance side effects like dizziness and drowsiness.

Side Effects:

• Common side effects may include nausea, vomiting, abdominal pain, diarrhea, tremor, headache, somnolence, and weight gain.

• Serious side effects are rare but can include liver injury, blood disorders, and pancreatitis.

Storage:

• Store at room temperature, away from moisture and heat.

• Keep out of reach of children.