Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tamoxifen citrate
Waymade Healthcare Plc
L02BA01
Tamoxifen citrate
10mg
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 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 Lesen Sie das vollständige Dokument