Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Tamoxifen citrate 30.4mg equivalent to tamoxifen 20 mg;
Sandoz New Zealand Limited
Tamoxifen citrate 30.4 mg (=tamoxifen 20 mg)
20 mg
Film coated tablet
Active: Tamoxifen citrate 30.4mg equivalent to tamoxifen 20 mg Excipient: Hypromellose Lactose monohydrate Macrogol 4000 Magnesium stearate Microcrystalline cellulose Povidone Sodium starch glycolate Titanium dioxide
Blister pack, PVC/PVDC/Al x 30's (not marketed), 30 tablets
Prescription
Prescription
Chemische Fabrik Berg GmbH
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
1998-11-16
TAMOXIFEN SANDOZ ® 1 TAMOXIFEN SANDOZ ® _tamoxifen citrate tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions 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 has 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 treat breast cancer. It contains the active ingredient tamoxifen citrate. Tamoxifen citrate is an anti-oestrogen which blocks the effect of oestrogen. Oestrogen is a natural female sex hormone. In some types of breast cancer, oestrogen can help cancer cells to grow. By blocking its effect Tamoxifen Sandoz stops or slows the growth of cancer cells. Your doctor will have explained why you are being treated with Tamoxifen Sandoz and told you what dose to take. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR. They may differ from the information contained in this leaflet. Your doctor may have prescribed Tamoxifen Sandoz for another reason. Ask your doctor if you have any questions about why this medicine was prescribed for you. There is no evidence that Tamoxifen Sandoz is addictive. BEFORE YOU TAKE TAMOXIFEN SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT USE TAMOXIFEN SANDOZ IF YOU ARE PREGNANT, TRYING TO BECOME PREGNANT OR ARE BREASTFEEDING. We do not know if it is safe for your to take it while you are pregnant. It may affect your baby if you take it at any time during pregnancy. DISCUSS CONTRACEPTION WITH YOUR DOCTOR. Although Tamoxifen Sandoz blocks female hormones, it is not a contraceptive. Tamoxifen Sandoz should not be used during pregnancy as birth defects can result. A nine month interval is recommended between Olvassa el a teljes dokumentumot
230320-Tamoxifen Sandoz-ds Page 1 of 9 NEW ZEALAND DATA SHEET TAMOXIFEN SANDOZ (TAMOXIFEN CITRATE) FILM-COATED TABLETS 1. PRODUCT NAME Tamoxifen Sandoz _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tamoxifen Sandoz 10 mg: Each tablet contains tamoxifen citrate equivalent to tamoxifen 10 mg. Tamoxifen Sandoz 20 mg: Each tablet contains tamoxifen citrate equivalent to tamoxifen 20 mg. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM 10 MG: Tablet, film coated, 7 mm round, white, biconvex, plain both sides. 20 MG: Tablet, film coated, 9 mm round, white, biconvex, plain one side and scored on the other. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Tamoxifen Sandoz is indicated for the treatment of breast cancer; the response is similar to that seen with either estrogens or androgens but tamoxifen appears to produce less marked side- effects and to be more acceptable to the patient. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS (INCLUDING THE ELDERLY) _ _Breast cancer _ The dosage range is 20 to 40 mg daily given either in divided doses twice daily or as a single dose once daily. In early disease, it is currently recommended that treatment is given for not less than 5 years. The optimal duration of tamoxifen therapy remains to be determined. _CHILDREN _ Tamoxifen is not indicated for use in children. METHOD OF ADMINISTRATION For oral administration. 4.3. C ONTRAINDICATIONS Tamoxifen must not be administered during pregnancy. Premenopausal patients must be carefully examined before treatment for breast cancer to exclude the possibility of pregnancy. There have been a small number of reports of spontaneous abortions, birth defects and foetal 230320-Tamoxifen Sandoz-ds Page 2 of 9 deaths after women have taken tamoxifen, although no causal relationship has been established (refer to Section 4.4 Special warnings and precautions for use). Tamoxifen should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients. 4. Olvassa el a teljes dokumentumot