GABITRIL Film-coated tablet Ref.[8851] Active ingredients: Tiagabine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Product name and form

Gabitril 10 mg film-coated tablets.

Pharmaceutical Form

10 mg: Tablet. White, oval biconvex film-coated tablet embossed on one side with ‘252’.

Qualitative and quantitative composition

Each Gabitril 10 mg tablet contains: Tiagabine anhydrous, INN 10 mg (as hydrochloride monohydrate).

Excipient(s) with known effect: For the full list of excipients, see section 6.1.

Active Ingredient Description
Tiagabine

Tiagabine is an anti-epileptic drug. Tiagabine is a potent and selective inhibitor of both neuronal and glial GABA uptake, which results in an increase in GABAergic medicated inhibition in the brain.

List of Excipients

Tablet Core:

Cellulose, microcrystalline (E460)
Ascorbic acid (E300)
Lactose
Starch, pregelatinised (maize)
Crospovidone
Silica, colloidal anhydrous (E551)
Hydrogenated vegetable oil (Type 1)
Stearic acid
Magnesium stearate

Film-coating:

Hypromellose
Hydroxypropylcellulose (E463)
Titanium Dioxide (E171)

Pack sizes and marketing

Child resistant, white polyethylene bottles with white polypropylene screw closures with an embedded desiccant agent.

Packs containing 50 and 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

Marketing authorization dates and numbers

PL 16260/0010

Date of first authorisation: 30th September 2002
Date of latest renewal: 31th August 2006

Drugs

Drug Countries
GABITRIL Australia, Spain, France, Ireland, Lithuania, Poland, United Kingdom, United States

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