Instruction for use: Tamoxifen Lachema

Active substance Tamoxifen

ATX code L02BA01 Tamoxifen

Pharmacological groups

Estrogens, gestagens; Their homologues and antagonists

Antineoplastic hormonal agents and hormone antagonists

Nosological classification (ICD-10)

C50 Malignant neoplasm of breast

Cancer of the nipple and areola of the breast, Breast carcinoma, The hormone-dependent form of recurrent breast cancer in women in menopause, Hormone-dependent breast cancer, Disseminated breast carcinoma, Disseminated Breast Cancer, Malignant breast cancer, Malignant neoplasm of breast, Contralateral breast cancer, Locally advanced or metastatic breast cancer,Locally-distributed breast cancer, Locally-recurring breast cancer, Metastatic breast carcinoma, Metastasis of breast tumors, Metastatic breast carcinoma, Inoperable breast carcinoma, Incompatible breast cancer, Breast cancer in women with metastases, Breast cancer in men with metastases, Breast Cancer, Breast cancer in men, Mammary cancer, Breast cancer with distant metastases, Breast cancer in postmenopausal women, Breast cancer hormone-dependent, Breast cancer with local metastases, Breast cancer with metastases, Breast cancer with regional metastases,Breast cancer with metastases, Common hormone-dependent forms of breast cancer, Common Breast Cancer, Recurrent Breast Cancer, Recurrence of breast tumors, Breast cancer, Estrogen-dependent breast cancer, Estrogen-Dependent Breast Cancer, Disseminated breast cancer with overexpression of HER2, Tumors of the mammary glands

Composition and form of release

1 tablet contains tamoxifen citrate 10 mg; In a blister 10 pcs., In a box of 10 blisters.

pharmachologic effect

Pharmacological action - antitumor, antiestrogenic.

Competitively blocks estrogen receptors in target organs and inhibits tumor growth stimulated by estrogens.

Pharmacokinetics

Metabolised in the liver. The main products of metabolism - N-desmethyltamoxifen and 4-hydroxytamoxifen - are excreted mainly with feces in the form of conjugates.

Clinical Pharmacology

In the usual scheme of administration (20 mg 2 times / day), the concentration of tamoxifen in the body stabilizes to 5 weeks.

Indications

Breast carcinoma (late stage or postmenopausal); Postoperative therapy.

pregnancy and lactation

Contraindicated.

Side effects

Nausea, vomiting, hot flashes, itching of the skin, vaginal bleeding, swelling, thrombocytopenia (without a tendency to bleed). With prolonged therapy with high doses: visual disturbances, conjunctival and retinal changes, bone tenderness with metastasis, cystoid ovarian changes (in premenopausal women), menstrual cycle suppression.

Dosing and Administration

Inside. The dose is set individually. The optimal dosage for 20 mg twice a day for 2-3 years. It is possible to gradually reduce the daily dose to 30 mg. Combination with radiation or cytostatic therapy is allowed.

special instructions

Patients in pre-menopausal age should be carefully examined to exclude a possible pregnancy.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf Life

2 years.

Do not use after the expiry date printed on the package.