Basic Information
Topiron film-coated tablets 50mg
TABLET, FILM COATED
Regulatory Information
SIN14131P
April 9, 2012
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XN03AX11
Company Information
NOVEM PHARMA PRIVATE LIMITED
NOVEM PHARMA PRIVATE LIMITED
Active Ingredients
Strength: 50mg
Detailed Information
Contraindications
**4.3. Contraindications** Migraine prophylaxis: in pregnancy and in women of childbearing potential if not using a highly effective method of contraception. Hypersensitivity to the active substance or to any of the excipients.
Indication Information
**4.1. Therapeutic indications** Topiramate is indicated as monotherapy in adults and children with partial onset seizures and generalised seizures including tonic-clonic seizures. Topiramate is indicated as adjunctive therapy for adults and children with partial onset seizures or generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. Topiramate is also indicated in adults for the prophylaxis of migraine headache. The usefulness of Topiramate in the acute treatment of migraine headache has not been studied.