BETAHISTINE DIHYDROCHLORIDE Tablets

Active ingredients: Betahistine

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.

Active Ingredient
Description

Betahistine dihydrochloride is a histamine-like drug in which pharmacological activity can be attributed to a specific effects and/or more direct influences on recovery mechanisms the vestibular nuclei. It has weak agonist activity at histamine H1 receptors and moderate antagonist activity at H3 receptors. Betahistine may increase blood flow to the cochlear region as well as to the whole brain.

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

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Marketing authorization dates and numbers

PL 30464/0019

23/03/2000