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Antiestrogen drug with antineoplastic action.
Active ingredient - Tamoxifen
Adjuvant therapy of early breast cancer with estrogen-receptor positive. Treatment of locally advanced or metastatic breast cancer with estrogen-receptor positive. Breast cancer (including men after castration). Tamoxifen can also be used in other solid tumors, refractory to standard treatments, in the presence of overexpression of estrogen receptors.
Adverse reactions associated with its anti-estrogenic action are most common when a patient is taking Tamoxifen. They manifested in the form of hot flashes ("hot flushes"), alopecia, pain in the area of the lesion, ossalgia, weight gain, vaginal bleeding or discharge, itching in the genital area.
Less frequently or infrequently observed the following side effects: water retention, anorexia, nausea, vomiting, constipation, fatigue, depression, confusion, headache, dizziness, drowsiness, fever, skin rashes (including isolated reports of erythema multiforme, syndrome Stevens-Johnson and bullous pemphigoid), impaired vision, including corneal changes, cataracts and retinopathy, optic neuritis, allergic reactions, including angioedema, decreased libido in men, impotence.
Interstitial pneumonitis is observed very rarely. At the beginning of the treatment there is capacity of local worsening of the disease – an increase in the size of soft tissue masses, sometimes accompanied by severe erythema of lesions and surrounding areas, which usually takes place within 2 weeks. It may increase the risk of thrombophlebitis and thromboembolism. Leg convulsions are frequently observed. Infrequently there may be transient leukopenia and thrombocytopenia, as well as increased activity of "liver" enzymes, rarely accompanied by severely impaired liver functions, such as fatty liver disease, cholestasis and hepatitis.
Rarely observed the increase in the concentration of serum triglyceride levels, in some cases combined with pancreatitis.
At the beginning of the treatment some patients with bone metastases had hypercalcemia. Tamoxifen causes amenorrhea or irregular menstruation in premenopausal patients, as well as the occurrence of reversible cystic ovarian tumors. Long-term treatment with Tamoxifen may cause endometrial changes including hyperplasia, polyps, development of uterine fibroids, and in rare cases – endometrial cancer, uterine sarcoma.
Store in dark dry place below 25°C.
Teva Pharmaceutical Industries Ltd., Israel.
License Number: 142 97 33083 00
Known as: Nolvadex-D, Tamoxifen Citrate, Tamoximed, Vero-Tamoxifen, Novofen, Zitazonium, Tamoxen, Tamoplex, Tamoxifen Lachema, Bilem, Cytotam, Tamilong, Tamfenax, Tamofar, TAM-20, Femoxtal, Taxus, Nolvanox
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