Basic Information
EPILIM CHRONO TABLET 200 mg
TABLET, FILM COATED
Regulatory Information
SIN08537P
February 5, 1996
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
XN03AG01
Company Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Active Ingredients
Strength: 58 mg
Strength: 133.2 mg
Detailed Information
Contraindications
**Contra-indications** Epilim is contraindicated in the following situations: - Active liver disease - Personal or family history of severe hepatic dysfunction, especially drug related - Hypersensitivity to sodium valproate - Porphyria - Known urea cycle disorders - Patients with known systemic primary carnitine deficiency with uncorrected hypocarnitinemia (see section Special warnings and special precautions for use _Patients at risk of hypocarnitinemia_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Patients known to have mitochondrial disorders caused by mutations in the nuclear gene encoding mitochondrial enzyme polymerase γ (POLG, e.g. Alpers-Huttenlocher Syndrome) and in children under two years of age who are suspected of having a POLG-related disorder ( _see Special warnings_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **Treatment of epilepsy** - in pregnancy unless there is no suitable alternative treatment (see Special Warnings and Precautions for Use and Pregnancy – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - in women of childbearing potential, unless there is no other alternative treatment and unless the conditions of the pregnancy prevention program are fulfilled (see Special Warnings and Precautions for Use and Pregnancy – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **Treatment of bipolar disorder** - in pregnancy (see Special Warnings and Precautions for Use and Pregnancy – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - in women of childbearing potential, unless there is no other alternative treatment and unless the conditions of the pregnancy prevention program are fulfilled (see Special Warnings and Precautions for Use and Pregnancy – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**Therapeutic Indications** **Epilepsy** For oral administration in the treatment of generalized, partial or other epilepsy with the following patterns of seizures: - absence - myoclonic - tonic-clonic - atonic - mixed As well as, for partial epilepsy: - simple or complex seizures - secondary generalized seizures - specific syndromes (West, Lennox-Gastaut) **Mania** For treatment of mania where other therapy has proved inadequate or is inappropriate.