מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bicalutamide
Relonchem Ltd
L02BB03
Bicalutamide
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030402; GTIN: 5055144200835
Package leaflet: Information for the user BICALUTAMIDE 50 MG 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 I N THIS LEAFLET: 1. What Bicalutamide 50 mg Tablets are and what they are used for 2. What you need to know before you take Bicalutamide 50 mg Tablets 3. How to take Bicalutamide 50 mg Tablets 4. Possible side effects 5. How to store Bicalutamide 50 mg Tablets 6. Contents of the pack and other information 1. WHAT BICALUTAMIDE 50 MG TABLETS ARE AND WHAT THEY ARE USED FOR Bicalutamide 50 mg Tablets contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens’. • Bicalutamide 50 mg Tablets are 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 50 MG TABLETS DO NOT TAKE BICALUTAMIDE 50 MG TABLETS: • 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 50 mg Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide 50 mg Tablets. Bicalutamide must not be given to children. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Bicalutamide 50 mg Tablets: • if you have any of the following: any heart or blood vessel condi קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bicalutamide 50 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50mg bicalutamide. Excipient with known effect: Each 50 mg tablet contains 69.26 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White round, bi-convex, film-coated tablet with ‘BIC 50’ on one side and ‘G’ on the other. 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 Posology Adult males including older people: one tablet (50mg) once a day. Treatment with Bicalutamide tablets 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 contraindicated in children (see section 4.3). _ _ _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). Method of administration For oral use. 4.3 CONTRAINDICATIONS Bicalutamide is contraindicated in females (see section 4.6) and children. 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. Androgen deprivation therapy may prolong the QT interval. In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio includ קרא את המסמך השלם