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BETAHISTINE DIHYDROCHLORIDE Tablets (2018)

Product Name and Form

Betahistine Dihydrochloride 8mg Tablets.

Pharmaceutical form

Tablet.

Betahistine Dihydrochloride 8mg Tablets are white, circular, flat, bevelled edged tablets marked B8 on one side.

Qualitative and Quantitative Composition

Each tablet contains 8mg betahistine dihydrochloride.

Excipient(s) with known effect: lactose monohydrate.

For the full list of excipients, see section 6.1.

List of excipients

Povidone K90
Microcrystalline cellulose
Lactose monohydrate
Colloidal anhydrous silica
Crospovidone
Stearic acid

Pack sizes and Marketing

Blister strips consisting of 250 µm transparent PVC, a 60 g/m² PVDC layer and 20µm hard temper aluminium foil, contained in a carton.

Pack sizes: 60, 84, 90, 100 and 120 tablets.

Marketing authorization holder
Authorization dates

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

23/03/2000

Marketing authorization number:

PL 30464/0019