Betahistine Hydrochloride Tablet Technical Specification:
| Product Name: | Betahistine Hydrochloride Tablet 8mg |
| Brand Name: | Generic |
| Strength: | 8mg, 16mg,24mg,48mg |
| Dosage Form: | Tablets (Uncoated, Orally Disintegrating) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 150s |
| 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 8mg Uncoated Tablet
Betahistine 8mg Orally Disintegrating Tablet
Betahistine 16mg Uncoated Tablet
Betahistine 16mg Uncoated Dispersible Tablet
Betahistine 24mg Uncoated Tablet
Betahistine 24mg Film Coated SR Tablet
Betahistine 24mg Uncoated Orally Disintegrating Tablet
Betahistine 48mg Film Coated SR Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Betahistine 8mg Uncoated Tablet
Each Uncoated Dispersible Tablet Contains:
Betahistine Hydrochloride IP ………….8mg
Excipients………………………………….……Q.S.
Colour: Quinoline Yellow WS
B. Betahistine 8mg Orally Disintegrating Tablet
Each Uncoated Orally Disintegrating Tablet Contains:
Betahistine Hydrochloride IP ………….8mg
Excipients………………………………….……Q.S.
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:
CAUTION:
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.