Instruction for use: Vero-Tamoxifen

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)

C43 Malignant melanoma of the skin

Malignant melanoma, Localized malignant melanoma, Localized form of malignant melanoma, Melanoma, Melanoma after surgical resection, Metastatic melanoma, Common metastatic malignant melanoma, Metastasizing form of malignant melanoma, Disseminated malignant melanoma

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

C64 Malignant neoplasm of kidney, except for renal pelvis

Wilms swelling, Kidney Cancer, Metastatic Renal Cell Carcinoma, Renal carcinoma, Inoperable kidney carcinomas, Metastatic kidney carcinoma, Metastatic Renal Cell Carcinoma, Wilms tumor, Wilms swelling, Adenomyosarcoma, Adenomyocystosarcoma, Adenosarcoma of the kidney, Kidney Cancer, Common renal cell carcinoma, Nephroblastoma, Nephroma, Embryonal nephroma, Recurrent carcinoma of the kidney, Birch-Hirschfeld Tumor, Common renal cell carcinoma, Tumors of the kidney

Composition and form of release

1 tablet contains tamoxifen 0.01 g; In a contour acheikova packing 10 pcs., In a cardboard pack of 3 or 5 packages.

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

Under the usual scheme of administration (20 mg twice a day), the concentration of tamoxifen in the body stabilizes to 5 weeks.

Indications for Vero-Tamoxifen

Breast cancer, kidney cancer, melanoma.

Contraindications

Hypersensitivity, pregnancy, breast-feeding.

pregnancy and lactation

Contraindicated. At the time of treatment should stop breastfeeding.

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, changes in the conjunctiva and retina, bone pain in the presence of metastases in them, cystoid ovarian changes (in women in the premenopausal period), menstrual cycle suppression.

Interaction

Incompatible with preparations containing estrogens; Combination with cytostatics increases the risk of thrombosis.

Dosing and Administration

The dosage regimen is set individually, depending on the indications.

Inside, not liquid, squeezed a small amount of liquid in the morning or, dividing the required dose into 2 doses, in the morning and in the evening. The daily dose is 0.02-0.04 g. The standard dose is 0.02 g daily until signs of disease progression appear.

special instructions

Patients in the premenopausal period need to exclude a possible pregnancy. Adequate methods of contraception should be used during treatment.

storage Conditions

In a dry place protected from light.

Keep out of the reach of children.

Shelf life of Vero-Tamoxifen

Tablets 10 mg - 2 years.

Tablets 10 mg - 5 years.

Tablets 20 mg - 2 years.

Tablets 20 mg - 5 years.

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