SERACTIL Film-coated tablet

Active ingredients: Dexibuprofen

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 (= S(+)-ibuprofen) is considered to be the pharmacologically active enantiomer of racemic ibuprofen. Racemic ibuprofen is a non-steroidal substance with antiinflammatory and analgesic effects. Its mechanism of action is thought to be due to inhibition of prostaglandin synthesis.

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
Austria, Spain, Poland