Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BICALUTAMIDE;
Pharmathen S.A.
L02BB03
BICALUTAMIDE;
Filmomhulde tablet
Oraal gebruik
Bicalutamide
Hulpstoffen: HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOLEN; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); POLYDEXTROSE (E 1200); POVIDON (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);
PACKAGE LEAFLET: INFORMATION FOR THE USER BICALUTAMIDE PHARMATHEN 50 MG, FILMOMHULDE TABLETTEN 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 onto 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 sec- tion 4. WHAT IS IN THIS LEAFLET 1. What [nationally completed name] 50 mg is and what it is used for 2. What you need to know before you take [nationally completed name] 50 mg 3. How to take [nationally completed name] 50 mg 4. Possible side effects 5. How to store [nationally completed name] 50 mg 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] 50 MG IS AND WHAT IT IS USED FOR [nationally completed name] 50 mg is one of a group of drugs called anti-androgens. It interferes with some of the actions of the male sex hormones. [nationally completed name] 50 mg is used to treat prostate cancer. It is used as combination therapy in tumor stages called “advanced” together with other treatments such as surgical castration or drugs which reduce the levels of androgens in the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] 50 DO NOT TAKE [NATIONALLY COMPLETED NAME] 50 MG − if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6). − if you are a woman, a child or an adolescent. − if you are taking any medications containing terfenadine, astemizole or cisapride (see ‘Other medicines and [nationally completed name] 50 mg’, below). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking [nationally completed name] 50 mg: − if you have any liver problem Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bicalutamide Pharmathen 50 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 50 mg bicalutamide. Excipient with known effect: lactose monohydrate 58.56 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White film-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 surgi- cal castration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adult males including the elderly: one tablet (50 mg) daily with or without food. Treatment with bicalutamide should be commenced at least 3 days before commencing treatment with an LHRH analogue, or at the same time as surgical castration. _Paediatric population_ Bicalutamide is not indicated in children. Patients with renal impairment: No dosage adjustment is necessary for patients with renal impairment. Patients with hepatic impairment: No dosage adjustment is necessary in patients with mild hepatic impairment. Increased accu- mulation may occur in patients with moderate to severe hepatic impairment (see section 4.4). 4.3 CONTRAINDICATIONS Bicalutamide is contra-indicated in females and children (see section 4.6). Bicalutamide must not be given to any patient who has shown a hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Coadministration 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 accumula- tion of bicalutamide. Therefore, bicalutamide should be used with caution in patients with moderate to severe hepatic impairment. P Leggi il documento completo