Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Bicalutamide 150mg
AstraZeneca Limited
Bicalutamide 150 mg
150 mg
Film coated tablet
Active: Bicalutamide 150mg Excipient: Hypromellose Lactose monohydrate Macrogol 300 Magnesium stearate Povidone Purified water Sodium starch glycolate Titanium dioxide
Blister pack, PVC/Al 28 tablets, 28 tablets
Prescription
Prescription
AstraZeneca UK Ltd
Package - Contents - Shelf Life: Blister pack, PVC/Al 28 tablets - 28 tablets - 48 months from date of manufacture stored at or below 30°C
2002-01-03
Cosudex® CMI 310717 Copyright 1(5) COSUDEX ® BICALUTAMIDE 50 MG TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about COSUDEX. It does not contain all the information that is known about COSUDEX. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking COSUDEX against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT COSUDEX IS USED FOR COSUDEX 50 mg is used to treat prostate cancer. COSUDEX is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens may help the cancer cells to grow. By blocking these hormones, COSUDEX may slow or stop the growth of cancer cells. COSUDEX 50 mg will be used in combination with other medicines to treat your cancer. COSUDEX should only be taken by men. Follow all directions given to you by your doctor. They may differ from the information in this leaflet. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. COSUDEX is not addictive. COSUDEX is only available with a doctor’s prescription. BEFORE YOU USE COSUDEX _WHEN YOU MUST NOT USE IT _ COSUDEX MUST NOT BE TAKEN BY WOMEN, INCLUDING PREGNANT WOMEN OR MOTHERS WHO ARE BREAST FEEDING. Women are not normally treated with COSUDEX. DO NOT TAKE COSUDEX IF YOU ARE ALLERGIC TO BICALUTAMIDE OR ANY OTHER INGREDIENTS IN COSUDEX. DO NOT GIVE COSUDEX TO CHILDREN. There is no experience of its use in children. DO NOT TAKE COSUDEX AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE PACK. It may have no effect at all or an unexpected effect if you take it after the expiry date. DO NOT USE COSUDEX IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. DO NOT USE IT TO TREAT ANY OTHER COMPLAINTS UNLESS Læs hele dokumentet
C OSUDEX Data Sheet 310717 Copyright DATA SHEET 1. PRODUCT NAME C OSUDEX 50 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 50 mg bicalutamide. C OSUDEX 50 mg is a white film-coated tablet impressed with CDX50 on one side and a logo on the other. 3. PHARMACEUTICAL FORM Film coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in combination with GnRH luteinizing-hormone releasing hormone (LHRH) agonist therapy or surgical castration. Prevention of disease flare associated with the use of LHRH agonists. 4.2 DOSE AND METHOD OF ADMINISTRATION AS COMBINATION THERAPY IN ADULT MALES INCLUDING THE ELDERLY One tablet (50 mg) once a day. Treatment with C OSUDEX should be started at the same time as treatment with a GnRH (LHRH) agonist or surgical castration. CHILDREN C OSUDEX is contraindicated in children. USE IN ADULT MALES WITH RENAL IMPAIRMENT No dosage adjustment is necessary for patients with renal impairment. USE IN ADULT MALES WITH 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 C OSUDEX is contraindicated in females and children. C OSUDEX must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients. C OSUDEX Data Sheet 310717 Copyright 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bicalutamide is extensively metabolised in the liver. Data suggest that its elimination may be slower in subjects with severe hepatic impairment and this could lead to increased accumulation of bicalutamide. Therefore, C OSUDEX 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. Severe hepatic changes and hepatic failure have been observed rarely with C OSUDEX , and fatal outcomes Læs hele dokumentet