Details

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• Marketing Authorisation (MAL): MAL19860953AZ.

• Manufacturer: Sanofi-Aventis, S.A., Spain.

Content

• Active Ingredient: Each tablet contains 200 mg sodium valproate.

• Formulation: Enteric-coated tablets designed to release the active ingredient in the intestines, reducing stomach irritation.

• Pack Size: 100 tablets per pack.

Indications

Epilim is indicated for the treatment of:

• Generalized epilepsy

• Partial epilepsy

• Other types of epilepsy, including absence, myoclonic, tonic-clonic, atonic, and mixed seizures

• Specific syndromes such as West syndrome and Lennox-Gastaut syndrome

• Treatment and prevention of mania associated with bipolar disorder

Instructions

Dosage & Administration:

• Epilim tablets should be swallowed whole with a glass of water.

• Do not chew, crush, or break the tablets, as this may damage the enteric coating and increase the risk of side effects.

• The dosage varies based on age, body weight, and medical condition. Your doctor will determine the appropriate dose for you.

Warnings & Precautions:

• Epilim can cause serious harm to an unborn child when taken during pregnancy. If you are a female able to have a baby, you must use at least one effective method of contraception during your entire treatment with Epilim. Your doctor should discuss with you the most appropriate method of contraception. Schedule an urgent appointment with your doctor if you want to become pregnant or think you are pregnant.

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

• Avoid alcohol consumption while taking Epilim, 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.

For more detailed information, please refer to the Patient Information Leaflet or consult your healthcare provider.