Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
BICALUTAMIDE
TARO INTERNATIONAL LTD, ISRAEL
L02BB03
TABLETS
BICALUTAMIDE 50 MG
PER OS
Required
CORDEN PHARMA GMBH, GERMANY
BICALUTAMIDE
BICALUTAMIDE
For the treatment of advanced prostate cancer in combination with LHRH analog therapy or surgical castration.
2021-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only Casodex ® 50 mg Tablets Composition: Each tablet contains: bicalutamide 50 mg Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Further information'. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. This medicine is not intended for women or children, including pregnant or breast-feeding women. 1. WHAT IS THE MEDICINE INTENDED FOR? For treatment of prostate cancer. Therapeutic group: An anti-androgenic agent that interferes with some of the activities of andro- gens (male hormones) within the body. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • you are sensitive (allergic) to the active ingredient bicalutamide or to any of the other ingredients of this medicine (please refer to section 6 - Further Information). • you are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine, astemizole). Special warnings regarding use of Casodex Before starting treatment with Casodex, tell the doctor if: • You are suffering from a heart or blood vessel problem, including heart rhythm disorders (arrhythmia), or if you are being treated with medi- cines for any of these problems. The risk of heart rhythm problems can increase when using Casodex. • You are taking blood thinners or medicines to prevent blood clots. • You are suffering from liver problems. • You are suffering from diabetes and are taking "LHRH analogs", including goserelin, buserelin, leuprorelin and triptorelin. If you go to the hospital, tell Izlasiet visu dokumentu
Page 1 of 8 CASODEX 50 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT Casodex 50 mg Tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg bicalutamide (INN). Excipient(s) with known effect: Each tablet contains 61 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White film-coated tablet. 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 the elderly: one tablet (50 mg) once a day. Treatment with Casodex should be started at least 3 days before commencing treatment with an LHRH analogue, or at the same time as surgical castration. Paediatric population: Casodex is contraindicated for use in children (see section 4.5) 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 Casodex is contra-indicated 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 Casodex is contra-indicated (see section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Initiation of treatment should be under the direct supervision of a specialist. Page 2 of 8 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 increased accumulation of Casodex. Therefore, Casodex should be used with caution in patients with moderate to severe hepatic impairment. Periodic liver function testing should be considered due to the possibility of hepatic changes. The majority of changes are expected to occur within Izlasiet visu dokumentu