দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
tamoxifen citrate
Aspen Pharmacare Australia Pty Ltd
Tamoxifen citrate
Registered
GENRX TAMOXIFEN 1 GENRX TAMOXIFEN _Contains the active ingredient, tamoxifen (as tamoxifen citrate) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE This leaflet answers some common questions about tamoxifen. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is GenRx Tamoxifen. It is used in the treatment of breast cancer. Although women have been helped by tamoxifen it is not a cure for breast cancer. Tamoxifen can be used in two ways. It can help treat a cancer which is in, or has spread from, the breast. It can also be used in women who have had a cancer lump removed. Tamoxifen may decrease or prevent the spread of cancer cells to other parts of the body. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ Tamoxifen acts mainly by blocking the effects of oestrogen, a female sex hormone found naturally in the body. In some types of breast cancer, oestrogen can help cancer cells grow. There is no evidence that this medicine is addictive. _USE IN CHILDRE সম্পূর্ণ নথি পড়ুন
Product Information – Australia GenRx Tamoxifen Tablets Page 1 GENRX TAMOXIFEN (TAMOXIFEN CITRATE) 1. NAME OF THE MEDICINE Tamoxifen citrate. 2.&3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each tablet contains tamoxifen citrate equivalent to 20 mg tamoxifen and the following inactive ingredients: lactose, magnesium stearate, povidone, sodium starch glycollate, and maize starch. For the full list of excipients, see Section 6.1 List of excipients White, round, convex tablets, 9 mm in diameter with 20 embossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Palliative treatment of breast cancer. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS The recommended daily dose of tamoxifen is 20 mg. A dose of 40 mg once a day may be used in patients with advanced breast cancer in which no response is seen with the minimal dose. Tamoxifen is not indicated for use in children. Response is usually not achieved until after a treatment period of 2 to 3 months. The current recommended treatment duration is five years; however the optimum duration has not been established. Older people Similar dosing regimens of tamoxifen have been used in older people with breast cancer and in some of these patients it has been used as sole therapy. CHILDREN Tamoxifen is not indicated for use in children. Method of administration For administration by the oral route. 4.3 CONTRAINDICATIONS Tamoxifen must not be given during pregnancy. Premenopausal patients must be carefully examined before treatment for breast cancer to exclude the possibility of pregnancy. Tamoxifen should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Product Information – Australia GenRx Tamoxifen Tablets Page 2 AN INCREASED INCIDENCE OF ENDOMETRIAL CHANGES INCLUDING HYPERPLASIA, ENDOMETRIAL POLYPS, CANCER AND UTERINE SARCOMA (MOSTLY MALIGNANT MIXED MULLERIAN TUMOURS) HAS BEEN REPORTED IN ASSOCIATION WITH TAMOXIFEN TREATMENT. THE INCI সম্পূর্ণ নথি পড়ুন