Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
TAMOXIFEN CITRATE
Relon Chem Limited
TAMOXIFEN CITRATE
10 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Package Leaflet: Information for the User Tamoxifen 10mg Tablets Tamoxifen Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others, it may harm them, even if their symptoms are the same as yours. If any side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: What Tamoxifen 10mg Tablets are and what they are used for Before you take Tamoxifen 10mg Tablets Special precautions How to take Tamoxifen 10mg Tablets Possible side effects How to store Tamoxifen 10mg Tablets Further information 1. What Tamoxifen is and what it is used for Tamoxifen belongs to a group of medicines known as anti-oestrogens. Tamoxifen is used to treat breast cancer. 2. Before you take Tamoxifen 10mg Tablets Do not take Tamoxifen 10mg Tablets if you are pregnant are breast-feeding are taking anticoagulant tablets? have ever had an allergic reaction to tamoxifen or to any of its ingredients. Tamoxifen should not be taken by women who are pregnant or breast feeding. Taking other medicines Tamoxifen 10mg Tablets can interact with certain types of anticoagulant medicine and a drug called rifampicin (for tuberculosis). Please inform your doctor if you are taking, or have recently taken any other medicines, even those you have bought without prescription. In particular, you should inform your doctor if you are taking: paroxetine, fluoxetine (e.g. antidepressants) bupropion (antidepressant or aid to smoking cessation) quinidine (for example used in Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15.2mg tamoxifen citrate equivalent to 10mg tamoxifen. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, white, biconvex tablets with a score line and ‘TN10’ embossed on one side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tamoxifen 10mg Tablets are indicated for the treatment of breast cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: ORAL 1. BREAST CANCER ADULTS The recommended daily dose of tamoxifen is normally 20mg. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with higher doses. Substantive evidence supporting the use of treatment with 30-40 mg per day is not available, although these doses have been used in some patients with advanced disease ELDERLY PATIENTS Similar dosing regimens of Tamoxifen 10mg Tablets have been used in elderly patients with breast cancer and in some of these patients it has been used as sole therapy 4.3 CONTRAINDICATIONS Tamoxifen 10mg Tablets must not be given during pregnancy. Pre-menopausal patients must be carefully examined before treatment for breast cancer or infertility to exclude the possibility of pregnancy (see also Section 4.6). Tamoxifen 10mg Tablets should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients. Treatment for infertility: Patients with a personal or family history of confirmed idiopathic venous thromboembolic events or a known genetic defect. IRISH MEDICINES BOARD _____________________________________________________________________________________________ Διαβάστε το πλήρες έγγραφο