Betahistine Tablet Technical Specification:
| Product Name: | Betahistine Tablet IP 4mg |
| Brand Name: | Generic |
| Strength: | 4mg, 8mg, 16mg, 24mg |
| Dosage Form: | Tablets (Uncoated, Film Coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 50s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antivertigo |
| Indication: | To treat Meniere’s disease |
| Storage: | Store below 30 ˚C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Betahistine Tablet IP 4mg
Betahistine Tablet IP 8mg
Betahistine Tablet IP 16mg
Betahistine Tablet IP 24mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Betahistine Tablet IP 4mg
Each Uncoated Tablet Contains:
Betahistine Hydrochloride IP ………….4 mg
Excipients………………………………….……Q.S.
Colour: Quinoline Yellow WS
B. Betahistine Tablet IP 8mg
Each Uncoated Tablet Contains:
Betahistine Hydrochloride IP ………….4 mg
Excipients………………………………….……Q.S.
Colour: Red oxide of iron
THERAPEUTIC INDICATIONS:
This medication is used to prevent and treat a disorder of the inner ear known as Meniere’s disease. The symptoms include dizziness (vertigo), ringing in the ears (tinnitus), and loss of hearing, probably caused by fluid in the ear. This medicine helps relieve the symptoms by reducing the amount of fluid
CAUTION & SCHEDULE:
Keep out of reach of children.
Tablet should be swallowed whole; not to be chewed or crushed.
SCHEDULE: SCHEDULE H DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Must be stored in a cool, dry & dark place below 25°C.
Protect from light & moisture.
Dosage: As directed by the Physician.