Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tamoxifen citrate
Arrow Generics Ltd
L02BA01
Tamoxifen citrate
40mg
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 Tablets BP 40 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablets contains 60.80 mg of tamoxifen citrate. Excipient with known effect: Each tablet contains 519.20 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, normal convex tablets printed with the company logo on one face and A390 on the other face . 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tamoxifen Tablets BP 40 mg is indicated for: 1. The treatment of breast cancer. 2. The treatment of anovulatory infertility. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1. Breast Cancer _Adults_ 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. _Elderly_ Similar dosing regimens of tamoxifen have been used in elderly with breast cancer and in some of these patients it has been used as sole therapy. 2. _Anovulatory_ _infertility_ The possibility of pregnancy must be excluded before commencing any course of treatment whether initial or subsequent. The initial course of treatment in women menstruating regularly but with anovular cycles, consists of 20 mg of tamoxifen daily on the second, third, fourth and fifth days of the menstrual cycle. If unsatisfactory basal temperature 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 the dosage to 40 mg and then 80 mg daily. In women with irregular menstrual cycle, the initial course of treatment may begin on any day. If no signs of ovulation are demonstrable, then a subsequent course of treatment may begin 45 days later with dosa Read the complete document