Land: Kypros
Språk: gresk
Kilde: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
BICALUTAMIDE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
L02BB03
BICALUTAMIDE
50MG
FILM COATED TABLETS
BICALUTAMIDE (8000001679) 50MG
ORAL USE
Εθνική Διαδικασία
BICALUTAMIDE
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027901) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027902) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 40 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027903) 40 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 90 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027904) 90 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 100 TABS IN BLISTER(S) PVC/PCTFE/ALU (300027905) 100 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) ALU/ALU (300027906) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) ALU/ALU (300027907) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 40 TABS IN BLISTER(S) ALU/ALU (300027908) 40 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 90 TABS IN BLISTER(S) ALU/ALU (300027909) 90 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 100 TABS IN BLISTER(S) ALU/ALU (300027910) 100 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
PATIENT INFORMATION LEAFLET TOSADEX 50 MG FILM-COATED TABLETS Bicalutamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. IN THIS LEAFLET: 1. What Tosadex is and what it is used for 2. Before you take Tosadex 3. How to take Tosadex 4. Possible side effects 5. How to store Tosadex 6. Further information What 1. WHAT TOSADEX IS AND WHAT IT IS USED FOR Tosadex contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens’. Tosadex is used to treat prostate cancer. It works by blocking effects of male hormones such as testosterone. 2. BEFORE YOU TAKE TOSADEX DO NOT TAKE TOSADEX IF: You are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in Section 6: Further information). You are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole). You are a woman. Do not take Tosadex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tosadex. Tosadex must not be given to children. TAKE SPECIAL CARE WITH TOSADEX Check with your doctor or pharmacist before taking Tosadex if: 1 You have problems with your liver. You have diabetes and are already taking an ‘LHRH analogue’. These include goserelin, buserelin, leuprorelin and triptorelin. If you go into hospital, tell the medical staff that you are taking Tosadex. TAKING OTHER MEDICINES Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you Les hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Tosadex 50 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of bicalutamide. Excipient(s) with known effect: 58.563 mg of lactose monohydrate per film-coated tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Round, white coated tablet, debossed with "BIC 50" 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 tablet (50 mg) once a day. Treatment with Tosadex should be started at least 3 days before commencing treatment with an LHRH analogue, or at the same time as surgical castration. Children: Tosadex is contraindicated in children. 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). 4.3 CONTRAINDICATIONS Tosadex is contraindicated in females and children (see section 4.6). 1 SUMMARY OF PRODUCT CHARACTERISTICS Tosadex must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients of this product. Co-administration of terfenadine, astemizole or cisapride with Tosadex 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, Tosadex should be used with caution in patients with moderate to severe hepatic impairment. Periodic liver function testing should be conside Les hele dokumentet