FLUTAN Tablet Ref.[28303] Active ingredients: Flutamide

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Flutan 250mg tablets.

Pharmaceutical Form

Tablets.

The tablets are light yellow, round, convex, scored tablets with 12 mm diameter.

Qualitative and quantitative composition

Each tablet contains 250mg of flutamide.

Excipient with known effect: lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Flutamide

Flutamide is a non-steroidal, highly specific, orally active anti-androgenic agent. The pharmacologically active metabolite, hydroxyflutamide, is believed to exert an anti-androgenic effect directly on the target tissues, either by inhibiting androgen uptake or by blocking cytoplasmic and nuclear binding of androgen. Flutamide is indicated for the treatment of advanced prostatic carcinoma in which suppression of testosterone effects is indicated.

List of Excipients

Croscarmellose sodium
Povidone
Lactose spray dried
Microcrystalline cellulose
Sodium lauryl sulphate
Magnesium stearate
Colloidal anhydrous silica

Pack sizes and marketing

The tablets are packed in aluminium foil and polyvinylchloride blisters with a patient information leaflet, in a card carton. Packs containing 20 and 100 tablets are available. Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

13410

25.06.1991 / 30.07.2013

Drugs

Drug Countries
FLUTAN Cyprus, Hong Kong, Malta, Romania

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