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Seractil 400mg Film-Coated Tablets (2004)

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.

Chemical substance
Description
Dexibuprofen

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
Authorization dates

Gebro Pharma GmbH, A-6391, Fieberbrunn, Austria

31 October 2000

Marketing authorization number:

PL 04536/0007