Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BICALUTAMIDE
Avansor Pharma Oy
BICALUTAMIDE
50 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
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 Excipients with known effect: each tablet contains 60.44 mg lactose monohydrate For the 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 (see section 4.6). Bicalutamide must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients of this product listed in section 6. IRISH MEDICINES BOARD __ Read the complete document