Tamoxifen 20 mg 20 tablets

Tamoxifen 20 mg 20 tablets

Composition:

Each tablet contains:
Tamoxifen citrate (equivalent to tamoxifen) — 20 mg.
Excipients:
Corn starch, lactose monohydrate, povidone K30, magnesium stearate, sodium starch glycolate.

Product Description:

• Tamoxifen is an antineoplastic agent and a selective estrogen receptor modulator (antiestrogen).
• Competitively blocks estrogen receptors in target tissues (including breast tissue), thereby inhibiting the stimulating effect of estrogens on the growth and progression of hormone-dependent tumors.
• Well absorbed from the gastrointestinal tract, with peak plasma concentrations reached within 4–7 hours.
  It is metabolized in the liver and excreted mainly via the intestines (as metabolites).
  The elimination half-life ranges from 5 to 7 days.

Indications for Use:

Breast cancer (especially in postmenopausal women, as well as in the presence of estrogen-receptor-positive tumors).
Treatment of anovulatory infertility.

Method of Administration and Dosage:

• Method of Administration: Oral use, swallowed whole with a small amount of liquid, without chewing.
• Breast Cancer:
  Adults: The standard recommended daily dose is 20 mg (taken once daily or divided into two doses).
  Prescribing higher doses (30–40 mg per day) has not demonstrated additional benefits in terms of reducing relapse risk or improving survival.
  Elderly Patients: A similar dosing regimen is applied (including as monotherapy).
• Anovulatory Infertility:
  Pregnancy must be fully ruled out before starting each course of therapy.
  Women with regular anovulatory cycles: The initial dose is 20 mg daily on days 2, 3, 4, and 5 of the menstrual cycle.
  In case of unsatisfactory basal body temperature or inadequate pre-ovulatory cervical mucus, the dose in subsequent cycles may be increased to 40 mg, and then to 80 mg daily.
• Women with irregular menstrual cycles (or amenorrhea): The initial course can be started on any day. In the absence of signs of ovulation, a repeated course with an increased dose is started 45 days after completion of the previous treatment.
• Discontinuation of Treatment: Duration of therapy is determined individually by the physician (in breast cancer, the course can last up to 5 years).

Contraindications:

Hypersensitivity to tamoxifen or any of the excipients.
Pregnancy and lactation.
Severe thrombophlebitis, history of venous thromboembolism.

Precautions:

• Laboratory and Medical Monitoring: Peripheral blood counts (especially platelet levels), as well as serum calcium and glucose levels, must be monitored regularly during treatment.
• Ophthalmological Control: Regular ophthalmic examination (every 3 months) is indicated during prolonged use for timely detection of visual organ changes.
• Conditions Requiring Caution: Use with extreme caution in leukopenia, thrombocytopenia, hypercalcemia, cataracts, and hyperlipidemia.
• Drug Interactions: Do not combine with hormonal medications containing estrogens (reduces the efficacy of both agents). When used concurrently with anticoagulants and drugs affecting the blood coagulation system, dose adjustment and constant INR / prothrombin time monitoring are required.
• Gynecological Control: Given the risk of endometrial hyperplasia and polyps, women must undergo regular gynecological examinations. If vaginal bleeding occurs, consult a physician immediately.
• Carcinogenicity: Experimental animal studies have established a carcinogenic effect of tamoxifen (increased formation of liver and uterine tumors).

Adverse Reactions / Side Effects:

• Digestive System: Nausea, vomiting, altered liver transaminase activity; rare cases of fatty liver infiltration, cholestasis, hepatitis.
• Endocrine System and Reproductive System:
  In women: Hot flashes, vaginal bleeding, endometrial hyperplasia, body weight changes.
  In men: Decreased libido, impotence.
• Cardiovascular System: Peripheral edema, thrombophlebitis, thromboembolism (including pulmonary embolism).
• Organ of Vision: Rarely — retinopathy, keratopathy, cataracts.
• CNS and Psychiatric Disorders: Rarely — depression, dizziness, headache, retrobulbar neuritis.
• Hematopoietic System: Rarely — thrombocytopenia, leukopenia.
• Dermatological Reactions: Alopecia (hair loss), rash, skin itching.
• Others: Bone pain and pain in affected areas (flare reactions), increased body temperature.

Pregnancy and Lactation:

• Strictly contraindicated.
• Pregnancy must be ruled out before starting therapy. 
• Women of childbearing potential must use reliable non-hormonal contraception during treatment and for at least 9 months after its completion.
• Contraindicated during breastfeeding (if administration is necessary, treatment should be combined with discontinuation of lactation).

Storage Conditions:

Store in a dry, light-protected place at a temperature not exceeding 30 °C.
Keep out of reach of children.

Packaging:

20 tablets in blisters together with a patient instruction leaflet in a cardboard box.