Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
bicalutamide, Quantity: 50 mg
Aspen Pharma Pty Ltd
Bicalutamide
Tablet, film coated
Excipient Ingredients: magnesium stearate; lactose monohydrate; povidone; sodium starch glycollate; titanium dioxide; hypromellose; macrogol 400
Oral
28 tablets
(S4) Prescription Only Medicine
Treatment of advanced prostate cancer in combination with LHRH agonist therapy. Prevention of disease flare associated with the use of LHRH agonists.
Visual Identification: White, biconvex tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2007-12-20
Calutex – Consumer Medicine Information Page 1 of 4 CALUTEX _ _ _bicalutamide 50 mg tablets _ CONSUMER MEDICINE INFORMATION (CMI) _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Calutex. It does not contain all the information and does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you taking Calutex against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CALUTEX IS USED FOR Calutex is used in combination with other medicines to treat advanced prostate cancer. Calutex contains bicalutamide as the active ingredient. Bicalutamide belongs to a group of medicines called anti- androgens. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens may help the cancer cells to grow. Calutex interferes with some of the actions of these hormones. Calutex should only be taken by men. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR. They may differ from the information in this leaflet. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. Calutex is only available with a doctor’s prescription. It is not addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CALUTEX IF YOU ARE A WOMAN. DO NOT GIVE THIS MEDICINE TO CHILDREN. There is no experience of its use in children. DO NOT TAKE CALUTEX IF YOU ARE ALLERGIC TO BICALUTAMIDE OR ANY OF THE OTHER TABLET INGREDIENTS LISTED AT THE END OF THE LEAFLET. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other part of the body; rash, itching or hives on the skin. DO NOT TAKE CALUTEX IF YOU ARE TAKING CISAPRIDE OR THE ANTIHISTAMINES, TERFENADINE AND ASTEMIZOL Lesen Sie das vollständige Dokument
Calutex (bicalutamide) – Product Information Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION CALUTEX (BICALUTAMIDE) TABLETS 1. NAME OF THE MEDICINE Bicalutamide. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Calutex tablets contain bicalutamide 50 mg as the active ingredient. Excipients with known effect include lactose monohydrate. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Calutex is a white, film coated biconvex tablet containing bicalutamide 50 mg as the active ingredient. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in combination with LHRH agonist therapy. Prevention of disease flare associated with the use of LHRH agonists. 4.2 DOSE AND METHOD OF ADMINISTRATION Adult males, including the elderly One tablet (50 mg) once a day. Treatment with Calutex 50 mg should be started at the same time as treatment with a LHRH agonist. 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: Special warnings and precautions for use). In such cases, a lower or less frequent dose may be considered. 4.3 CONTRAINDICATIONS Females; children; known hypersensitivity to bicalutamide or any other constituents of the formulation. Calutex (bicalutamide) – Product Information Page 2 of 9 Coadministration of terfenadine, astemizole or cisapride with Calutex is contraindicated (see section 4.5: Interactions with other medicines and other forms of interactions). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hyperglycaemia A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes. Consideration should therefore be given to monitoring blood glucose in pa Lesen Sie das vollständige Dokument