Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tamoxifen citrate
Actavis UK Ltd
L02BA01
Tamoxifen citrate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030401
Pharma code 760 ( 011111001 ) First bar is 105mm from the top edge of the leaflet. Top of page cut-off to middle of registration mark: 44 mm. WHAT IS IN THIS LEAFLET TAMOXIFEN 10 MG AND 20 MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 1. WHAT TAMOXIFEN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMOXIFEN 3. HOW TO TAKE TAMOXIFEN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TAMOXIFEN 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT TAMOXIFEN IS AND WHAT IT IS USED FOR • The name of your medicine is Tamoxifen Tablets and they belong to a group of drugs called anti-oestrogens. • Tamoxifen is used to treat: • breast cancer • certain forms of infertility • Tamoxifen can also reduce the risk of developing breast cancer occurring in those women who have an increased likelihood of developing breast cancer (your risk). It is important that your healthcare professional calculates your risk of developing breast cancer and discusses the result with you before commencing treatment. There are a number of specific tools available to calculate breast cancer risk, based on information such as your age, family history, genetics, reproductive factors (e.g. age when periods started and stopped, had children or not, taken or taking hormonal replacement therapy and/or oral contraceptive pill) and history of breast disease. Although the tools can estimate your risk, it doesn’t mean you will get breast cancer, being at increased risk means you have a higher chance of developing breast cancer. If Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen 10 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15.2 mg of tamoxifen citrate equivalent to 10 mg of tamoxifen. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Round biconvex white coated tablets 7 mm diameter with one face blank, the reverse face marked `10' and `T'. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Tamoxifen is used for the treatment of breast cancer and is also used to stimulate ovulation in the treatment of anovulatory infertility. Tamoxifen is also used in the primary prevention of breast cancer in women at moderate or high risk (see section 5.1). Women aged less than 30 years old were excluded from primary prevention trials so the efficacy and safety of tamoxifen treatment in these younger women is unknown. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults _ _ _ _Breast Cancer _ The recommended daily dose of tamoxifen is normally 20 mg. 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. _ _ _Anovulatory Infertility_ Before commencing any course of treatment, whether initial or subsequent, the possibility of pregnancy must be excluded. In women who are menstruating regularly, but with anovular cycles, the initial course of treatment consists of 20 mg daily in single or divided doses, given on the second, third, fourth and fifth days of the menstrual cycle. If unsatisfactory basal temperature records or poor pre-ovulatory cervical mucus indicates that this course of treatment has been unsuccessful, further courses may be given during subsequent menstrual periods, increasing the dose to 40 mg and then to 80 mg daily in single or divided doses. In women who are not menstruating regularly, the initia Baca dokumen lengkapnya