Tamoxifen Hexal, pills 20mg, 30pcs

Composition

1 tablet contains:

Active ingredients:

tamoxifen citrate is 30.4 mg, which corresponds to a tamoxifen content of 20 mg.

Auxiliary substances:

lactose monohydrate – 142.6 mg,

sodium starch glycolate-20 mg,

povidone-5 mg,

microcrystalline cellulose-49.6 mg,

magnesium stearate-2.4 mg.

Shell composition:

white opadray dye – 5 mg (lactose-1.8 mg, titanium dioxide-1.3 mg, hypromellose-1.4 mg, polyethylene glycol 4000-0.5 mg).

Pharmacological action

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

Tamoxifen, as well as some of its metabolites, compete with estradiol for binding sites to cytoplasmic estrogen receptors in breast, uterine, vaginal, anterior pituitary, and tumors with a high content of estrogen receptors.

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

• Estrogen-dependent breast cancer in women (especially in menopause) and breast cancer in men.

The drug can be used to treat:

• ovarian cancer:
• endometrial cancer;
• kidney cancer;
• melanoma;
• soft tissue sarcoma in the presence of estrogen receptors in the tumor;
• prostate cancer with resistance to other drugs.

Contraindications

• Pregnancy;
• lactation (breast-feeding);
• hypersensitivity to tamoxifen and / or any other ingredient of the drug.

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

Side effects

When treated with tamoxifen, the most common side effects are associated with its anti-estrogenic effect, manifested in the form of paroxysmal sensations of heat (hot flashes), vaginal bleeding or discharge, itching in the genital area, alopecia, pain in the area of the lesion, ossalgia, weight gain.

The following adverse reactions were less common or rare: fluid retention, anorexia, nausea, vomiting, constipation, fatigue, depression, confusion, headache, dizziness, drowsiness, fever, skin rash, visual impairment, including corneal changes, cataracts, retinopathy, and retrobulbar neuritis. At the beginning of treatment, local exacerbation of the disease is possible – an increase in the size of soft tissue formations, sometimes accompanied by severe erythema of the affected areas and adjacent areas – which usually passes within 2 weeks.

The risk of thrombophlebitis and thromboembolism may increase.

Transient leukopenia and thrombocytopenia can sometimes occur, as well as an increase in liver enzymes, very rarely accompanied by more severe liver function disorders, such as fatty liver infiltration, cholestasis and hepatitis.

Some patients with bone metastases experienced hypercalcemia at the beginning of treatment.

Tamoxifen causes amenorrhea or irregular menstruation in women in the pre-menopausal period, as well as the reversible development of cystic ovarian tumors.

With long-term treatment with tamoxifen, endometrial changes may occur, including hyperplasia, polyps and, in some cases, endometrial cancer, as well as the development of uterine fibroids.

Interaction

Concomitant use of tamoxifen and cytostatics increases the risk of blood clots.

Antacids, histamine_H2-receptor blockers and other drugs of similar action, increasing the pH value in the stomach, can cause premature dissolution and loss of the protective effect of the enteric tablet. The interval between taking tamoxifen and these drugs should be 1-2 hours.

Tamoxifen has been reported to enhance the anticoagulant effect of coumarin-type drugs (for example, warfarin).

Medications that reduce the excretion of calcium (for example, thiazide-type diuretics) may increase the risk of hypercalcemia.

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

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

How to take, course of use and dosage

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

The daily dose is 20-40 mg. As a standard dose, it is recommended to take 20 mg of tamoxifen orally daily for a long time. If signs of disease progression appear, the drug is discontinued.

Tablets should be taken without chewing, washed down with a small amount of liquid, in 1 reception in the morning, or by dividing the required dose into 2 doses in the morning and evening.

Overdose

No acute tamoxifen overdose has been observed in humans. It should be expected that an overdose may cause an increase in the above-described adverse reactions.

There are no specific antidotes, and treatment should be symptomatic.

Special instructions

Women receiving tamoxifen should undergo regular gynecological examinations. If there is a bloody discharge from the vagina or vaginal bleeding, the drug should be discontinued.

In patients with bone metastases, serum calcium concentrations should be measured periodically during the initial treatment period. In case of severe violations, tamoxifen should be temporarily discontinued.

If there are signs of venous thrombosis of the lower extremities (leg pain or swelling), pulmonary embolism (shortness of breath), the drug should be discontinued. Tamoxifen can cause ovulation, which increases the risk of pregnancy, and therefore women who are sexually active are recommended to use a mechanical or non-hormonal contraceptive during (and for about 3 months after) treatment with tamoxifen. During therapy, it is necessary to periodically monitor blood clotting parameters, calcium content in the blood, blood picture (white blood cells, platelets), liver function indicators, blood pressure, and conduct an examination by an optometrist.

In patients with hyperlipidemia, it is necessary to monitor the concentration of cholesterol and triglycerides in the blood serum during treatment.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Keep out of reach of children at a temperature not exceeding 25°C.

Shelf

life is 5 years.

Active ingredient

Tamoxifen

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Breast Cancer, Cancer