Tamoximed

Tamoxifenum

Tamoximed 10 mg tablets: each tablet contains tamoxifen 10 mg as tamoxifen citrate. Tamoximed 20 mg tablets: each tablet contains tamoxifen 20 mg as tamoxifen citrate. Excipient with known effect: lactose monohydrate.

Indication: Tamoximed is indicated for the adjuvant treatment of early breast cancer in women with oestrogen-receptor-positive tumours. Tamoximed is indicated for the treatment of women with locally advanced/metastatic hormone-dependent breast cancer.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance or to any of the excipients listed in sec. 6.1; − patients with a history of stroke, deep vein thrombosis or pulmonary embolism; − patients at increased risk of developing endometrial cancer; − pregnancy.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use In cases of severe thrombocytopenia, leucopenia or hypercalcaemia, an individual risk/benefit analysis and close medical monitoring are required. During treatment with tamoxifen, blood counts (particularly platelets), liver function and plasma calcium concentrations should be monitored at regular intervals. Serum triglyceride levels should also be assessed. Tamoxifen may suppress menstruation in premenopausal women receiving tamoxifen for the treatment of breast cancer (see sec. 4.8). An increased incidence of endometrial carcinoma and uterine sarcoma (particularly malignant mixed Müllerian tumours) has been reported in association with tamoxifen treatment. The underlying mechanism is unknown but may be related to the oestrogenic action