Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
TAMOXIFEN CITRATE EQV TAMOXIFEN
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
L02BA01
20 mg
TABLET, FILM COATED
TAMOXIFEN CITRATE EQV TAMOXIFEN 20 mg
ORAL
Prescription Only
TEVA PHARMACEUTICAL INDUSTRIES LTD
ACTIVE
1992-07-03
73426_s1 - P: Tamoxifen (as citrate) (Tamoxifen), SG, Tablets, SMPC 06 23.02.2023 YG 05.07.2023 YG 160x560mm Kfar Saba 9 pt Profile Black Tamoxifen / Singapore / 160 x 560 mm Side A 322K08282-03 TAMOXIFEN TABLET 20 MG 1. NAME OF THE MEDICINAL PRODUCT Tamoxifen Tablet 20mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30.4 mg of tamoxifen citrate equivalent to 20 mg of tamoxifen. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet Round, white, biconvex tablets, engraved: `20’ above score line and `T’ below on one side, and plain on the reverse. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Tamoxifen is used for the treatment of breast cancer. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. ADULTS (INCLUDING ELDERLY) The dosage range is 20 to 40 mg daily, given either in divided doses twice daily or as a single dose once daily. USE IN CHILDREN The use of Tamoxifen is not recommended in children, as safety and efficacy have not been established (see Pharmacodynamic and Pharmacokinetics properties). 4.3. CONTRAINDICATIONS Tamoxifen must not be given during pregnancy. Pre-menopausal patients must be carefully examined before treatment for breast cancer or infertility to exclude the possibility of pregnancy (see section 4.6.). Tamoxifen should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Menstruation is suppressed in a proportion of pre-menopausal women receiving tamoxifen for the treatment of breast cancer An increased incidence of endometrial changes including hyperplasia, polyps, cancer and uterine sarcoma (mostly malignant mixed Mullerian tumours), has been reported in association with tamoxifen treatment. The underlying mechanism is unknown but may be related to the oestrogen-like effect properties of tamoxifen. Any patient receiving or having previously received tamoxifen who reports abnormal gynaecological symptoms, especially vaginal bleeding, or who pre Lees het volledige document