País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
tamoxifen citrate, Quantity: 30.4 mg (Equivalent: tamoxifen, Qty 20 mg)
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; titanium dioxide; microcrystalline cellulose; povidone; hypromellose; macrogol 4000; magnesium stearate; sodium starch glycollate
Oral
Treatment of breast cancer. ? TAMOXIFEN SANDOZ is indicated for the treatment of breast cancer.,Primary reduction of breast cancer risk ? TAMOXIFEN SANDOZ is indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).
Visual Identification: White, round, biconvex tablets with a score notch on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2001-09-26
TAMOXIFEN SANDOZ ® 1 TAMOXIFEN SANDOZ ® _tamoxifen citrate tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about TAMOXIFEN SANDOZ. It does not contain all the information that is known about TAMOXIFEN SANDOZ. 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 TAMOXIFEN SANDOZ 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 TAMOXIFEN SANDOZ IS USED FOR TAMOXIFEN SANDOZ is used to either treat breast cancer or reduce the risk of breast cancer occurring if you are at increased risk of breast cancer. If you and your healthcare professional are considering using TAMOXIFEN SANDOZ for reducing the risk of breast cancer occurring, your knowledge of treatment risks becomes more important because you don't currently have breast cancer. TAMOXIFEN SANDOZ therapy may be uncommonly associated with serious side effects such as deep vein thrombosis (DVT - blood clots in veins of your leg), pulmonary embolus (blood clots in your lungs) and uterine cancer. In some women, these events were fatal. Less serious side effects such as hot flushes, vaginal discharge, menstrual irregularities and gynaecological conditions may also occur. Whether the benefits of treatment outweigh the risks depends on your age, health history, your level of breast cancer risk and on your personal judgement. TAMOXIFEN SANDOZ therapy to reduce the risk of breast cancer may not be appropriate for all women at increased risk for breast cancer. An assessment with your healthcare professional of the potential benefits and risks prior to starting therapy for reduction in breast cancer risk is essential. You should understand that TAMOXIFEN SANDOZ reduces, but does not eliminate, the risk of breast cancer. TAMOXIFEN S Leer el documento completo
211116-tamoxifen sandoz-pi Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION TAMOXIFEN SANDOZ ® (TAMOXIFEN CITRATE) TABLETS 1. NAME OF THE MEDICINE Tamoxifen citrate. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tamoxifen Sandoz 10 mg tablet contains 10 mg tamoxifen citrate. Each Tamoxifen Sandoz 20 mg tablet contains 20 mg tamoxifen citrate. _List of excipients with known effect:_ Lactose monohydrate. _ _ For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tamoxifen Sandoz 10 mg tablets: white, round, biconvex, film coated tablets in blisters. Tamoxifen Sandoz 20 mg tablets: white, round, biconvex, with a score notch, film coated tablets in blisters. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS _TREATMENT OF BREAST CANCER _ Tamoxifen Sandoz is indicated for the treatment of breast cancer. _PRIMARY REDUCTION OF BREAST CANCER RISK _ Tamoxifen Sandoz is indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average). 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE _Adults _ _TREATMENT OF BREAST CANCER _ The initial dose is 20 mg once daily. In advanced breast cancer, if no response is seen, dosage may be increased to 40 mg once daily. _PRIMARY REDUCTION OF BREAST CANCER RISK _ The recommended maximum dose is 20 mg daily for 5 years. There are insufficient data to support a higher dose or longer period of use. An assessment of the potential benefits and risks prior to starting therapy for reduction in breast cancer risk is essential. Validated algorithms are available that calculate breast cancer risk based on features such as age, family history, genetic factors, reproductive factors, and history of breast disease. 211116-tamoxifen sandoz-pi Page 2 of 15 Tamoxifen Sandoz reduces, but does not eliminate, the risk of breast cancer. In clinical trials, Tamoxifen Sandoz decreased th Leer el documento completo