Betahistine Hydrochloride Tablet BP 24mg Technical Specification:
| Product Name: | Betahistine Hydrochloride Tablet BP 24mg |
| Brand Name: | Generic |
| Strength: | 8mg, 16mg, 24mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 20s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Antivertigo |
| Indication: | To treat Meniere’s disease |
| Storage: | Store below 30 ˚C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Betahistine Hydrochloride Tablet BP 8mg
Betahistine Hydrochloride Tablet BP 16mg
Betahistine Hydrochloride Tablet BP 24mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Betahistine Hydrochloride Tablet BP 24mg
Each Uncoated Tablet Contains:
Betahistine Dihydrochloride BP ………….24mg
Excipients…………………………….……….……Q.S.
Colour: Sunset Yellow Lake
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 & WARNING:
Keep out of reach of children.
Prescription medicine only.
Please read the enclosed leaflet carefully before administration.
STORAGE & DOSAGE:
Storage: Store protected from light and moisture at a temperature not exceeding 30˚C.
Dosage: As directed by the Physician.