Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bicalutamide
Zentiva Pharma UK Ltd
L02BB03
Bicalutamide
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030402; GTIN: 5000283653226
PACKAGE LEAFLET: INFORMATION FOR THE USER CASODEX ® BICALUTAMIDE 50MG TABLETS 50MG TABLETS / (BICALUTAMIDE) This product is available using any of the above names but will be referred to as Casodex throughout the following: 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 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 condit Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bicalutamide 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg bicalutamide Excipient(s) with known effect: Each tablet contains 56.6 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, 7mm diameter. Marked ‘B 50’ on one side. 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 Bicalutamide 50 mg 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 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 is contraindicated for use in children (see section 4.3). 4.3 CONTRAINDICATIONS Bicalutamide 50 mg is contraindicated in females and children (see section 4.6). Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration of terfenadine, astemizole or cisapride with bicalutamide 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. Bicalutamide 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 increased accumulation of bicalutamide. Therefore, bicalutamide should be used with caution in patients with moderate to severe hepatic impairment. Periodic liver Læs hele dokumentet