Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
BICALUTAMIDE
Actavis Group PTC ehf
L02BB03
BICALUTAMIDE
50 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Anti-androgens
Authorised
2014-11-07
BICALUTAMIDE ACTAVIS 50 MG FILM-COATED TABLETS PA1380/153/1 IE-PIL-V002 CRN: 2169445 PACKAGE LEAFLET: INFORMATION FOR THE USER BICALUTAMIDE ACTAVIS 50 MG FILM-COATED TABLETS bicalutamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Bicalutamide Actavis is and what it is used for 2. What you need to know before you use Bicalutamide Actavis 3. How to use Bicalutamide Actavis 4. Possible side effects 5. How to store Bicalutamide Actavis 6. Contents of the pack and other information 1. WHAT BICALUTAMIDE ACTAVIS IS AND WHAT IT IS USED FOR The growth of prostatic tumours is dependent on stimulation by male hormones (androgens). Bicalutamide Actavis contains the active substance bicalutamide, which prevents this stimulation. Bicalutamide Actavis is used in adult males in the treatment of advanced prostate cancer in combination with a type of medicine called LHRH analogues or surgical castration. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE ACTAVIS DO NOT USE BICALUTAMIDE ACTAVIS - if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6). - if you are a woman or a child - if you are already taking any medicine containing te Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bicalutamide Actavis 50mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 50 mg bicalutamide. Excipient with known effect: One tablet contains 56.56 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Bicalutamide Actavis 50 mg film-coated tablets are round, biconvex, white, 7 mm in diameter, with “B 50” printed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in combination with LHRH analogue therapy or surgical castration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult males including the elderly: one film-coated tablet (50 mg) daily with or without food. Treatment with Bicalutamide Actavis should be started at least 3 days before commencing treatment with an LHRH analogue, or at the same time as surgical castration. _Paediatric population_ Bicalutamide is not indicated in children and adolescents _Renal impairment_ No dose adjustment is necessary for patients with renal impairment. _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 Actavis is contraindicated in females and children (see section 4.6). Bicalutamide Actavis must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients listed in section 6.1. Co-administration of terfenadine, astemizole or cisapride with Bicalutamide Actavis is contraindicated (see section 4.5). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Прочитайте повний документ