SERACTIL Film-coated tablet Ref.[2735] Active ingredients: Dexibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2004  Publisher: Gebro Pharma GmbH, A-6391, Fieberbrunn, Austria

Product name and form

Seractil 400 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, oblong, both-sided scored film-coated tablet.

Qualitative and quantitative composition

Each film-coated tablet contains 400 mg of dexibuprofen.

For excipients, see 6.1.

Active Ingredient
Description
Dexibuprofen
List of Excipients

Tablet core:

Hypromellose
Microcrystalline cellulose
Carmellose calcium
Colloidal anhydrous silica
Talc

Film-coating material:

Hypromellose
Titanium dioxide (E171)
Glycerol triacetate
Talc
Macrogol 6000

Pack sizes and marketing

10, 20, 30, 50, 60, 90, 100, 100x1 and 500x1 film-coated tablets in PVC/PVDC/aluminium blisters.

150 film-coated tablets in PE jars with dosing hole and hinged closure.

Not all pack sizes may be marketed.

Marketing authorization holder

Gebro Pharma GmbH, A-6391, Fieberbrunn, Austria

Marketing authorization dates and numbers

PL 04536/0007

31 October 2000

Drugs

Drug
Countries
SERACTIL
Austria, Spain, Poland, Romania
 
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