| Product Name: | Betahistine Mesilates Tablet IP |
| Brand Name: | Generic |
| Strength: | 6mg, 12mg |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP, |
| Therapeutic use: | Antihistamine |
| Indication: | Betahistine is indicated for treating Ménière’s syndrome, which may include vertigo, tinnitus, hearing loss and nausea. Initial oral treatment is 8 to 16 mg three times daily, taken preferably with meals. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Betahistine Mesilates Tablet IP 6mg
- Betahistine Mesilates Tablet IP 12mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Betahistine Mesilates Tablet IP 6mg
Each Un-coated tablet contains:
Betahistine Mesilates IP.………..……..6mg
Excipients ………………………….…….…..q.s - Betahistine Mesilates Tablet IP 12mg
Each Un-coated tablet contains:
Betahistine Mesilates IP.………..……..12mg
Excipients ……………………..………….…..q.s
THERAPEUTIC INDICATIONS:
Betahistine is indicated for treating Ménière’s syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea. Initial oral treatment is 8 to 16 mg three times daily, preferably with meals.
CAUTION & SCHEDULE:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Store in cool, dry & dark place
Protect from Light & moisture.
Dosage: As directed by the Physician.