দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Bicalutamide
Laboratoires Juvise Pharmaceuticals
L02BB; L02BB03
Bicalutamide
50 milligram(s)
Film-coated tablet
Anti-androgens; bicalutamide
Marketed
2000-04-21
PACKAGE LEAFLET: INFORMATION FOR THE USER CASODEX 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 Casodex is and what it is used for 2. What you need to know before you take Casodex 3. How to take Casodex 4. Possible side effects 5. How to store Casodex 6. Contents of the pack and other information 1. WHAT CASODEX IS AND WHAT IT IS USED FOR Casodex contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens’. Casodex is used together with other treatments 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 CASODEX DO NOT TAKE CASODEX: 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 Casodex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Casodex. Casodex must not be given to children. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Casodex: if you have any of the following: any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Casodex. if you are taking blood সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 27 August 2021 CRN00C32R Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Casodex 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50mg of bicalutamide. Excipient(s) with known effect: 61 mg lactose monohydrate per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, white, biconvex tablet intagliated with “CDX50” on one face and a logo on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in combination with luteinizing-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 a day. Treatment with Casodex should be started at 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: Casodex 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. Casodex is contraindicated in females and children (see section 4.6). Co-administration of terfenadine, astemizole or cisapride with Casodex 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 27 August 2021 CRN00C32R Page 2 of 7 Casodex is extensively metabolised in the liver. Data suggests that its elimination may be slower in subjects with severe hepatic impairment and this could lead to increasedaccumulation of Casodex. Therefore, Caso সম্পূর্ণ নথি পড়ুন