Tegretol Tablets 100mg, 200mg, 400mg Ref.[2613] Active ingredients: Carbamazepine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Novartis Pharmaceuticals UK Limited Trading as Geigy Pharmaceuticals Frimley Business Park Frimley Camberley Surrey GU16 7SR England

Product name and form

Tegretol 100mg, 200mg and 400mg Tablets.

Pharmaceutical Form

100mg Tablets: The tablets are white, round, flat, uncoated tablets with bevelled edges, having one side impressed “GEIGY”, the other “B/W” and a score.

200mg Tablets: The tablets are white, round, flat, uncoated tablets with bevelled edges, having one side impressed “CG”, the other “G/K” and a score.

400mg Tablets: The tablets are white, flat, rod-shaped tablets with bevelled edges. One side bears the imprint “CG/CG”, the other “LR/LR” and both sides are scored.

Qualitative and quantitative composition

The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide.

Each tablet contains 100mg / 200mg / 400mg carbamazepine Ph.Eur.

Active Ingredient Description
Carbamazepine

Carbamazepine is a derivative of dibenzazepine. It belongs to the pharmaceutical class of antiepileptic, neurotropic and psychotropic drugs. Carbamazepine helps control the transmission of messages from the brain to the muscles.

List of Excipients

Tegretol Tablets:

Each uncoated tablet contains aerosil 200 standard
Microcrystalline cellulose
Nymcel ZSB-10
Magnesium stearate

Pack sizes and marketing

Tegretol 100mg come in PVC/PE/PVDC blister packs of 84 and 100 tablets.

Tegretol 200mg come in PVC/PE/PVDC blister packs of 84 and 100 tablets.

Tegretol 400mg come in PVC/PE/PVDC blister packs of 56.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited
Trading as Geigy Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
England

Marketing authorization dates and numbers

Tegretol 100mg Tablets: PL 00101/0461

Tegretol 200mg Tablets: PL 00101/0462

Tegretol 400mg Tablets: PL 00101/0463

4 July 1997 / 8 December 2008

Drugs

Drug Countries
TEGRETOL Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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