Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BICALUTAMIDE
Avansor Pharma Oy
50 Milligram
Film Coated Tablet
2007-08-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bicalutamide Avansor 50mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of bicalutamide. Excipient: each tablet contains 60.44 mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, film-coated tablet, debossed with BCM 50 on one side. 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 elderly patients: the dosage is one 50 mg tablet to be taken orally once a day. Children and adolescents Bicalutamide is not indicated in children and adolescents. The tablets should be swallowed whole with liquid. Treatment with bicalutamide should be started at least 3 days before commencing treatment with an LHRH analogue, or at the same time as surgical castration. Renal impairment No dose adjustment is necessary in 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 dose adjustment is necessary for patients with mild hepatic impairment. The medicinal product may accumulate in patients with moderate to severe hepatic impairment (see section 4.4.). 4.3 CONTRAINDICATIONS Bicalutamide is contraindicated in females and children. Bicalutamide must not be given to any patient who has shown a hypersensitivity reaction to its use. Co-administration of terfenadine, astemizole or cisapride with bicalutamide is contra-indicated (see section 4.5). IRISH MEDICINES BOARD _________ Read the complete document