Tamoxifen Hexal, 20 mg 30 pcs

Tamoxifen is a non-steroidal anti-estrogenic drug that also has weak estrogenic properties. Its action is based on the ability to block estrogen receptors.

Tamoxifen and some of its metabolites compete with estradiol for binding sites with cytoplasmic estrogen receptors in breast, uterine, vaginal, anterior pituitary lobe tissues and tumors with high estrogen receptor content.

In contrast to the estrogen receptor complex, the tamoxifen receptor complex does not stimulate DNA synthesis in the nucleus but inhibits cell division, which leads to regression of tumor cells and their death.

Indications

The drug may be used to treat:

Active ingredient

Composition

1 tablet contains:

Active ingredients:

Tamoxifen citrate 30.4 mg, corresponding to a tamoxifen content of 20 mg.

Auxiliary Substances:

Lactose monohydrate – 142.6 mg,

Sodium starch glycolate – 20 mg,

p> povidone – 5 mg,

microcrystalline cellulose – 49.6 mg,

magnesium stearate – 2.4 mg.

Shell composition:

White opaque dye – 5 mg (lactose – 1.8 mg, titanium dioxide – 1.3 mg, hypromellose – 1.4 mg, polyethylene glycol 4000 – 0.5 mg).

How to take, the dosage

The dosing regimen is usually set individually depending on the indication.

The daily dose is 20-40 mg. As a standard dose, we recommend taking 20 mg of tamoxifen orally daily for a long time. If there are signs of disease progression, the drug should be discontinued.

The tablets should be taken without chewing, with a small amount of fluid, in 1 dose in the morning, or by dividing the required dose into 2 doses in the morning and in the evening.

Interaction

The simultaneous administration of tamoxifen and cytostatics increases the risk of thrombosis.

Antacids, histamine H2-receptor blockers and other drugs of similar action, by increasing the pH value in the stomach, may cause premature dissolution and loss of the protective effect of the enteric-soluble tablet. The interval between taking tamoxifen and these drugs should be 1-2 hours.

Tamoxifen has been reported to enhance the anticoagulation effect of coumarin drugs (e.g., warfarin).

Drugs that reduce calcium excretion (e.g., thiazide-type diuretics) may increase the risk of hypercalcemia.

The concomitant use of tamoxifen and tegafur may contribute to the development of active chronic hepatitis and cirrhosis of the liver.

The concomitant use of tamoxifen with other hormonal drugs (especially estrogen-containing contraceptives) leads to a weakening of the specific effects of both drugs.

Special Instructions

Women receiving tamoxifen should undergo regular gynecological examinations. If bleeding from the vagina or vaginal bleeding occurs, the drug should be discontinued.

In patients with bone metastases serum calcium concentration should be determined periodically during the initial period of treatment. In case of significant abnormalities, tamoxifen should be temporarily discontinued.

In case of signs of lower limb venous thrombosis (pain in the legs or swelling), pulmonary embolism (shortness of breath) the drug should be stopped. Tamoxifen can cause ovulation, which increases the risk of pregnancy, therefore, women who are sexually active are recommended to use mechanical or non-hormonal contraception during (and for about 3 months after) treatment with tamoxifen. During therapy it is necessary to periodically monitor blood clotting, blood calcium, blood picture (leukocytes, platelets), liver function, blood pressure, check-up with an ophthalmologist.

In patients with hyperlipidemia the serum cholesterol and triglyceride concentrations should be monitored during treatment.

Impact on ability to drive vehicles and other mechanisms requiring high concentration

At the time of treatment, it is necessary to refrain from potentially dangerous activities requiring high concentration and quick psychomotor reactions.

Contraindications

With caution: renal failure, diabetes, eye disease (including cataracts).including cataract, deep vein thrombosis and thromboembolic disease (including anamnesis), hyperlipidemia, leukopenia, thrombocytopenia, hypercalcemia, concomitant therapy with indirect anticoagulants.

Side effects

In tamoxifen treatment, the most common adverse reactions associated with its anti-estrogenic effects are fever attacks (hot flashes), vaginal bleeding or discharge, genital itching, alopecia, pain in the affected area, ossalgia, weight gain.

Less frequent or rare adverse reactions have been observed: fluid retention, anorexia, nausea, vomiting, constipation, increased fatigue, depression, confusion, headache, dizziness, somnolence, increased body temperature, skin rash, visual disturbances including corneal changes, cataracts, retinopathy and retrobulbar neuritis. At the beginning of treatment, a local exacerbation of the disease – an increase in the size of soft tissue masses, sometimes accompanied by marked erythema of the affected areas and adjacent areas – is possible, which usually subsides within 2 weeks.

The possibility of thrombophlebitis and thromboembolism may increase.

Transient leukopenia and thrombocytopenia and increased liver enzyme levels may occasionally be seen, very rarely accompanied by more severe liver function abnormalities such as fatty liver infiltration, cholestasis and hepatitis.

In some patients with bone metastases, hypercalcemia was observed at the beginning of treatment.

Tamoxifen causes amenorrhea or irregular menstruation in premenopausal women and the reversible development of cystic ovarian tumors.

Long-term treatment with tamoxifen may lead to changes in the endometrium, including hyperplasia, polyps, and, in isolated cases, endometrial cancer and the development of uterine fibroma.

Overdose

Acute overdose with tamoxifen has not been observed in humans. It should be expected that overdose may cause an exacerbation of the above described adverse reactions.

There are no specific antidotes; treatment should be symptomatic.