Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tamoxifen citrate
Relonchem Ltd
L02BA01
Tamoxifen citrate
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030401; GTIN: 05055144200897
TAMOXIFEN 20MG TABLETS Tamoxifen PACKAGE LEAFLET: INFORMATION FOR THE USER 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. WHAT IS IN THIS LEAFLET: 1. WHAT TAMOXIFEN 20MG TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMOXIFEN 20MG TABLETS 3. HOW TO TAKE TAMOXIFEN 20MG TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TAMOXIFEN 20MG TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TAMOXIFEN 20MG TABLETS ARE AND WHAT THEY ARE USED FOR Tamoxifen belongs to a group of medicines called 'anti-oestrogens'. Oestrogen is a natural substance in your body known as a 'sex hormone'. Some breast cancers need oestrogen to grow and Tamoxifen works by blocking the effects of oestrogen. WHAT TAMOXIFEN IS USED FOR • Tamoxifen is used to treat breast cancer • It is also used to treat infertility in women caused by a failure to produce and release eggs (ovulate) properly. • 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 Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains 30.4mg tamoxifen citrate (equivalent to 20mg tamoxifen). 3 PHARMACEUTICAL FORM Tablets Round, white, biconvex tablets with a score line and ‘20’ embossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tamoxifen 20mg Tablets are indicated for: 1. The treatment of breast cancer. 2. The treatment of anovulatory infertility. 3. 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 trails so the efficacy and safety of tamoxifen treatment in these younger women is unknown. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY 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 Similar dosing regimens of Tamoxifen 20mg Tablets have been used in elderly patients with breast cancer and in some of these patients it has been used as sole therapy. 2. 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 20mg daily in single or divided doses, given on the second, third, fourth and fifth days of menstrual cycle. If unsatisfactory basal temperature records or poor pre-ovulatory cervical mucus indicate that this initial course of treatment has been unsuccessful, further courses may be given during subsequent menstrual periods, increasing the dosage to 40mg and then to 80 mg daily in single or divided doses. In women who are no Lire le document complet