Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
bicalutamide, Quantity: 50 mg
Strides Pharma Science Pty Ltd
Bicalutamide
Tablet, film coated
Excipient Ingredients: povidone; lactose monohydrate; magnesium stearate; sodium starch glycollate type A; titanium dioxide; hypromellose; macrogol 400
Oral
98 tablets, 56 tablets, 28 tablets
(S4) Prescription Only Medicine
Treatment of advanced prostate cancer in combination with LHRH agonist therapy.
Visual Identification: A white to off-white, round, film-coated, biconvex tablet, engraved with 'BC 50' on one face and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2007-05-24
BICALOX™ CONSUMER MEDICINE INFORMATION Bicalutamide 50 mg film-coated tablets WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about BICALOX. It does not contain all the information that is known about BICALOX. 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 BICALOX 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 BICALOX IS USED FOR BICALOX is used in combination with other medicines to treat locally advanced prostate cancer. BICALOX is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens can help the cancer cells to grow. Bicalutamide interferes with some of the actions of these hormones. BICALOX SHOULD ONLY BE TAKEN BY MEN. YOU MUST FOLLOW ALL THE 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. ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION. BICALOX is not addictive. BICALOX is only available with a doctor’s prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE BICALOX IF YOU ARE A WOMAN. Women are not normally treated with BICALOX. DO NOT GIVE BICALOX TO CHILDREN. There is no experience of its use in children. DO NOT TAKE BICALOX IF YOU ARE ALLERGIC TO BICALUTAMIDE OR ANY OF THE OTHER INGREDIENTS IN BICALOX. DO NOT TAKE BICALOX IF YOU ARE TAKING CISAPRIDE OR THE ANTIHISTAMINES, TERFENADINE AND ASTEMIZOLE. DO NOT TAKE BICALOX 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 TAKE BICALOX IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. DO NOT USE IT TO TREAT ANY OTHER COMPLAINTS UNLESS YOUR DOC read_full_document
1 AUSTRALIAN PRODUCT INFORMATION – BICALOX (BICALUTAMIDE) 1 NAME OF THE MEDICINE Bicalutamide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each BICALOX tablet contains 50 mg bicalutamide. Bicalutamide is a white to almost white powder. Practically insoluble in water, freely soluble in acetone, slightly soluble in anhydrous ethanol and in methylene chloride. Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM A white to off-white, round, film-coated, biconvex tablet, engraved with 'BC 50' on one face and plain on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in combination with LHRH agonist therapy. 4.2 D OSE AND METHOD OF ADMINISTRATION ADULT MALES, INCLUDING THE ELDERLY One tablet (50 mg), once a day. Treatment with bicalutamide 50 mg should be started at the same time as treatment with a LHRH agonist. 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 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). In such cases, a lower or less frequent dose may be considered. 4.3 C ONTRAINDICATIONS BICALOX is contraindicated in females and children; also in case of known hypersensitivity to bicalutamide or any other constituents of the formulation. 2 Co-administration of terfenadine, astemizole or cisapride with bicalutamide is contraindicated (see section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). 4.4 S PECIAL 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 patients receiving bic read_full_document