SERC Tablet Ref.[27765] Active ingredients: Betahistine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Serc-8.

Pharmaceutical Form

A round, flat, white to almost white tablet. Serc-8 is imprinted ‘256’ on one face of the tablet.

Qualitative and quantitative composition

Each tablet contains 8 mg betahistine dihydrochloride equivalent to 5.21 mg betahistine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Betahistine

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

Microcrystalline cellulose
Mannitol E421
Citric acid monohydrate
Colloidal anhydrous silica
Talc

Pack sizes and marketing

Blister strips of 30 tablets. The blister strips are made of PVC/PVdC film and aluminium foil. Each carton contains 120 tablets.

Grey polypropylene tablet container with white polypropylene tamper evident closure containing 500 or 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0049

7 October 98

Drugs

Drug Countries
SERC Austria, Canada, Spain, France, Ireland, Mexico, New Zealand, Tunisia, United Kingdom, South Africa

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