BICALUTAMIDE FARMAPROJECTS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-04-2023
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Active ingredient:
BICALUTAMIDE
Available from:
Farmaprojects S.A.
Dosage:
50 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2008-07-04
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Bicalutamide Farmaprojects 50 mg, film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of bicalutamide.
Each tablet contains 56 mg of lactose monohydrate as an excipient.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Treatment of advanced prostate cancer in combination with luteinising hormone-releasing hormone (LHRH) analogue
therapy or surgical castration.
4.2 Posology and method of administration
Adult males including the elderly: one tablet once daily at the same time each day (usually in the morning or in the
evening), with or without food.
Treatment with bicalutamide should be started at least 3 days prior to the administration of an LHRH analogue or at the
same time as surgical castration.
Children and adolescents: There is no relevant indication for the use of bicalutamide in children and adolescents.
Renal impairment: no dosage adjustment is necessary for patients with renal impairment. There is no experience with
the use of bicalutamide in patients with severe renal&#
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