| Product Name: | Sodium Valproate and Valproic acid Controlled-Release Tablets |
| Brand Name: | Generic |
| Strength: | 500mg (333mg+145mg) |
| Dosage Form: | Tablets (Controlled Release) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiepileptic, Anticonvulsant |
| Indication: | Sodium Valproate + Valproic Acid is used in the treatment of epilepsy. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Sodium Valproate & Valproic acid Controlled Release Tablets 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Sodium Valproate & Valproic acid Controlled Release Tablets 500mg
Each Film Coated Controlled Release Tablet contains:
Sodium Valproate BP………………………………333 mg
Valproic Acid USP……………………………………145 mg
Excipients: ………………………………………q.s.
Color: Red oxide of Iron and Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Sodium valproate is used to treat epilepsy and bipolar disorder. It’s occasionally used to prevent migraine headaches.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.