Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BICALUTAMIDE
Farmaprojects S.A.
50 Milligram
Film Coated Tablet
2008-07-04
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 impairment (creatinine clearance < 30 ml/min). (See section 4.4.) Hepatic impairment: no dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (see Section 4.4). 4.3 CONTRAINDICATIONS Bicalutamide is contraindicated in females and children. Bicalutamide is contraindicated in patients with hypersensitivity to the active substance or any of the excipients (see section 4.4). Concomitant administration of terfenadine, astemizole or cisapride with Bicalutamide is contraindicat Read the complete document