Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Bicalutamide
Teva Pharma B.V.
L02BB; L02BB03
Bicalutamide
50 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Anti-androgens; bicalutamide
Marketed
2007-05-18
BICALUTAMIDE 50MG FILM-COATED TABLETS CZ/H/133/01/MR ie-pil-clean-bicalutamide-teva-pa0749-032-001 1 PATIENT LEAFLET: INFORMATION FOR THE USER BICALUTAMIDE TEVA 50 MG FILM-COATED TABLETS Bicalutamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Teva is and what it is used for 2. What you need to know before you take Bicalutamide Teva 3. How to take Bicalutamide Teva 4. Possible side effects 5. How to store Bicalutamide Teva 6. Contents of the pack and other information 1. WHAT BICALUTAMIDE TEVA IS AND WHAT IT IS USED FOR Bicalutamide contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens’. • Bicalutamide Teva is used to treat prostate cancer. • It works by blocking the effects of male hormones such as testosterone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE TEVA DO NOT TAKE BICALUTAMIDE TEVA • if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6) • if you are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole). • if you are a woman. Do not take Bicalutamide if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide. Bicalutamide must not be given to children. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Bicalutamide Teva: • if you have any of the following: any heart or blood vessel conditions, including heart rhythm Pročitajte cijeli dokument
Health Products Regulatory Authority 25 May 2022 CRN00CMF4 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bicalutamide Teva 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg bicalutamide Excipient with known effect: Each tablet contains 33.25 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet White to off-white biconvex film-coated tablets, debossed with "93" on one side and "220" on the other. 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 Posology Adult males including the elderly: one tablet (50 mg) once daily a day. Treatment with Bicalutamide Teva should be started the same time as treatment with an LHRH analogue or surgical castration. _ _ _Renal impairment_ No dosage adjustment is necessary for patients with renal impairment. _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). _Paediatric population _ Bicalutamide Teva is contraindicated for use in children (see section 4.3). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Bicalutamide Teva is contraindicated in females and children (see section 4.6). Co-administration of terfenadine, astemizole or cisapride with Bicalutamide Teva is contraindicated (see section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Initiation of treatment should be under the direct supervision of a specialist. Health Products Regulatory Authority 25 May 2022 CRN00CMF4 Page 2 of 6 Bicalutamide is extensively metabolised in the liver. Data suggest that its elimination may be slower in subjects with severe hepatic impairment, and this could lead to i Pročitajte cijeli dokument