FLUTAMIDE Tablet Ref.[9663] Active ingredients: Flutamide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts. EN6 lTL

Product name and form

Flutamide 250 mg Tablets.

Pharmaceutical Form

Tablets.

Yellow biconvex tablets marked ‘FT’ score ‘250’ on one side with a ‘G’ on the reverse.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 250 mg of flutamide.

Excipient of known effect: Each tablet contains 221.7 mg of lactose monohydrate.

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

Cellulose, microcrystalline
Lactose monohydrate
Maize starch, pregelatinised
Sodium laurilsulfate
Silica, colloidal anhydrous
Magnesium stearate

Pack sizes and marketing

Flutamide tablets are packaged either in PVC/aluminium blister packs or in polypropylene pots with polyethylene caps (with optional polyethylene ullage filler), containing 20, 21, 30 50, 60, 84, 100, 105, 250 or 10*21 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts. EN6 lTL

Marketing authorization dates and numbers

PL 04569/0338

22 December 1997 / December 2002

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