Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tamoxifen citrate
Waymade Healthcare Plc
L02BA01
Tamoxifen citrate
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030401
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Tamoxifen Citrate 30.40mg (equivalent to 20mg tamoxifen) Excipient with known effect: Each tablet contains 259.60mg of lactose For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White, convex tablets with an approximate diameter of 9.5mm printed T20on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tamoxifen 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 trials 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 30-40mg per day is not available, although these doses have been used in some patients with advanced disease. Elderly people Similar dosing regimens of tamoxifen have been used in the elderly 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 given daily on the second, third, fourth and fifth days of the 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 of treatment may be given during subsequent menstrual periods, increasing Przeczytaj cały dokument