FEMOSTON 1/10 instructions for use, description of the medicinal product FEMOSTON 1/10: contraindications, side effects, dosages, composition - tablets, coating. shell in the directory of medicinal

Instructions for use FEMOSTON® 1/10 (FEMOSTON® 1/10)

Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history, conduct a general and gynecological examination in order to identify possible contraindications and conditions requiring precautions. During treatment with Femoston® 1/10, it is recommended to conduct periodic examinations (the frequency and nature of the examinations are determined individually). In addition, it is advisable to conduct breast examination (including mammography) in accordance with accepted standards, taking into account clinical indications.

Risk factors for thrombosis and thromboembolism during HRT are a history of thromboembolic complications, severe forms of obesity (body mass index more than 30 kg/m2) and systemic lupus erythematosus. There is no generally accepted opinion regarding the role of varicose veins in the development of thromboembolism.

The risk of developing deep vein thrombosis of the lower extremities may temporarily increase with prolonged immobilization, major trauma, or surgery. In cases where prolonged immobilization is necessary after surgery, temporary cessation of HRT should be considered 4-6 weeks before surgery.

When deciding on HRT in patients with recurrent deep vein thrombosis or thromboembolism receiving anticoagulant treatment, the benefits and risks of HRT must be carefully assessed.

If thrombosis develops after starting HRT, Femoston® 1/10 should be discontinued.

The patient should be informed of the need to consult a doctor if the following symptoms occur:

painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, blurred vision.

After consultation with the doctor, the patient should stop taking the drug if jaundice appears or deterioration of liver function, a pronounced increase in blood pressure, a newly diagnosed migraine-like attack, pregnancy, or the manifestation of any contraindication.

There is research data demonstrating a slight increase in the incidence of breast cancer detection in women receiving HRT for a long time (more than 10 years). The likelihood of being diagnosed with breast cancer increases with the duration of treatment and returns to normal 5 years after stopping HRT.

Patients who have previously received HRT using only estrogen drugs should be especially carefully examined before starting treatment with Femoston® 1/10 in order to identify possible endometrial hyperstimulation.

Breakthrough uterine bleeding and mild menstrual-like bleeding may occur in the first months of treatment with the drug. If, despite dose adjustment, such bleeding does not stop, the drug should be discontinued until the cause of the bleeding is determined. If bleeding recurs after a period of amenorrhea or continues after discontinuation of treatment, its etiology should be determined. This may require an endometrial biopsy.

The patient should inform the doctor about the medications she is currently taking or was taking before prescribing Femoston® 1/10.

The use of estrogens may affect the results of the following laboratory tests:

determination of glucose tolerance, study of thyroid and liver functions.

To treat symptoms of estrogen deficiency in postmenopausal women, HRT is prescribed only if symptoms of estrogen deficiency negatively affect quality of life. A thorough assessment of the benefits and disadvantages of HRT should be carried out regularly, at least once a year, and treatment should only be continued if the benefits of therapy outweigh the disadvantages.

Femoston® 1/10 is not a contraceptive. Perimenopausal patients are advised to use non-hormonal contraceptives.

Impact on the ability to drive vehicles and operate machinery

Femoston® 1/10 does not affect the ability to drive vehicles and operate machinery.

special instructions

The drug is prescribed only in the presence of symptoms that adversely affect the quality of life.
All patients receiving HRT are required to assess the benefit/risk ratio at least once a year. Therapy should be continued until the benefits of taking the drug outweigh the risk of side effects.

Experience with the drug in women over 65 years of age is limited.

Information about the risks associated with HRT in cases of premature menopause is limited.

Due to the lower absolute risk in younger women, their benefit/risk ratio may favor HRT compared with older women.

Medical examination

Before prescribing or resuming therapy with Femoston® conti, it is necessary to collect a complete medical and family history and conduct a general and gynecological examination (including the mammary glands) of the patient in order to identify possible contraindications and conditions requiring precautions. During treatment with Femoston® conti, it is recommended to conduct periodic examinations, the frequency and nature of which are determined individually, but not less than once every 6 months. It is advisable to perform mammography for additional examination of the mammary glands. Women should be informed about those possible changes in the mammary glands that need to be reported to their doctor.

The use of estrogens may affect the results of the following laboratory tests: determination of glucose tolerance, study of thyroid and liver functions.

Endometrial hyperplasia

The risk of developing endometrial hyperplasia and cancer when patients use only estrogens depends on the dose and duration of treatment and increases from 2 to 12 times compared with patients not receiving therapy; the risk may remain elevated for 10 years after stopping therapy.

In women with a preserved uterus, HRT with estrogens alone is not recommended due to the increased risk of developing endometrial cancer. Cyclic use of progestogen (at least 12 days of a 28-day cycle), or use of a continuous combined HRT regimen in women with a preserved uterus, may prevent the estrogen-increased risk of endometrial hyperplasia and cancer.

In women, the use of combined HRT for 5 years did not lead to an increased risk of developing endometrial cancer.

For the purpose of timely diagnosis, it is advisable to conduct ultrasound (US) screening and, if necessary, conduct a histological (cytological) examination.

Bloody vaginal discharge

In the first months of treatment with the drug, breakthrough bleeding and/or scanty spotting from the vagina may occur. If such bleeding appears some time after the start of therapy or continues after cessation of treatment, its cause should be determined. An endometrial biopsy may be performed to rule out malignancy.

Venous thromboembolism

HRT is associated with a 1.3-3-fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. The development of this phenomenon is most likely during the first year of HRT.

If there are thromboembolic complications in first-degree relatives at a young age, as well as with a history of recurrent miscarriage, it is necessary to conduct a hemostasis study (during screening, only some disorders of the blood coagulation system are detected).

If the patient is taking anticoagulants, it is necessary to carefully consider the prescription of Femoston® conti from the point of view of the benefit/risk ratio. Until a thorough assessment of the factors for the possible development of thromboembolism or the initiation of anticoagulant therapy is completed, Femoston® conti is not prescribed.

If a thrombophilic condition is detected in a family member and/or in case of seriousness or severity of the defect (for example, deficiency of antithrombin III, protein S or C, as well as a combination of defects), Femoston® conti is contraindicated.

Since patients with diagnosed thrombophilic conditions have an increased risk of developing venous thromboembolism, the use of Femoston® conti, which increases this risk, is contraindicated.

In most cases, risk factors for developing VTE include: estrogen use, older age, major surgery, prolonged immobilization, obesity (body mass index > 30 kg/m2), pregnancy or the postpartum period, systemic lupus erythematosus and cancer. There is no consensus on the possible role of varicose veins in the development of VTE.

To prevent VTE after surgery, prophylactic measures should be considered in all postoperative patients.

In case of prolonged immobilization after surgery, it is recommended to stop taking Femoston® conti 4-6 weeks before, and treatment should not be resumed until the woman has completely recovered mobility.

If VTE develops after initiation of therapy, the drug should be discontinued and patients should be informed that they should contact their physician immediately if they experience any potential thromboembolic symptoms (eg, tenderness or swelling of the lower extremities, sudden pain in the chest, shortness of breath).

Mammary cancer

In women receiving long-term HRT using estrogen alone or in combination with estrogen and progestogen, the incidence of breast cancer diagnosis increases, which returns to the original level within 5 years after cessation of therapy.

The increase in risk depends on the duration of HRT use. In women taking combined HRT for more than 5 years, the risk of developing breast cancer can increase up to 2 times.

Combination therapy with estrogen and progestogen

Results from a randomized, placebo-controlled trial (Women's Health Initiative (WHI)) and epidemiological studies have shown an increased risk of breast cancer in women taking combined estrogen and progestogen HRT. This increase becomes noticeable after approximately three years of therapy.

Estrogen-only therapy

According to the WHI study, there was no increased risk of breast cancer in women with a previous hysterectomy who received estrogen-only HRT.

Most observational studies showed a small increase in the risk of breast cancer, but the risk was markedly lower in women taking combined estrogen and progestogen therapy.

The increase in risk becomes noticeable after several years of using HRT drugs, and after stopping therapy it returns to the original level within several (maximum five) years.

While taking HRT medications, there may be an increase in the density of breast tissue during mammography, which can make it difficult to diagnose breast cancer.

Ovarian cancer

Ovarian cancer is much less common than breast cancer. Epidemiological data obtained from a large meta-analysis suggest a small increase in the risk of developing ovarian cancer for women receiving HRT as estrogen monotherapy or combination therapy with estrogens and progestogens.

These studies (increased risk) become more apparent when therapy lasts more than five years, and after discontinuation, the risk gradually decreases over time. Findings from a number of other studies, including the WHI, indicate that combined HRT is associated with a similar or slightly lower risk of ovarian cancer.

Risk of ischemic stroke

Combination therapy with estrogen and progestogen or therapy with estrogen alone is associated with a 1.5-fold increase in the relative risk of ischemic stroke. The risk of hemorrhagic stroke does not increase when receiving HRT.

The relative risk does not depend on age, time of menopause, or duration of therapy. However, the baseline risk is highly dependent on age, so the overall risk of stroke in women taking HRT will increase with age.

Coronary heart disease (CHD)

Randomized controlled clinical trials provided no evidence of a protective effect of HRT against myocardial infarction in women with or without CAD who received combined estrogen and progestogen HRT or estrogen monotherapy.

Combination therapy with estrogen and progestogen

The relative risk of coronary heart disease during the use of combined estrogen and progestogen HRT is slightly increased. Because the absolute risk of CAD is highly dependent on age, the number of additional cases of CAD due to combined HRT use in healthy premenopausal women is very small, but increases with age. The risk is slightly higher in women over 60 years of age.

Estrogen-only therapy

Based on data from randomized controlled trials, there was no increased risk of coronary artery disease in women with a previous hysterectomy who received estrogen monotherapy.

Other states

Estrogens can cause fluid retention, which may adversely affect patients with impaired renal or cardiac function. This group of patients should be under medical supervision.

Patients with hypertriglyceridemia while taking HRT medications should also be under medical supervision, because There are reports of very rare cases of significant increases in the concentration of triglycerides in the blood plasma, which contributes to the development of pancreatitis.

Estrogens increase the concentration of thyroxine-binding globulin, which leads to an overall increase in the concentration of circulating thyroid hormones, as measured by determination of plasma protein-bound iodine, thyroxine (T4) concentration - chromatographic or radioimmunoassay, or triiodothyronine (T3) - radioimmunoassay. A labeled triiodothyronine uptake test shows elevated levels of thyroxine-binding globulin. The concentrations of free hormones T3 and T4 usually do not change.

Plasma concentrations of other binding proteins (eg, transcortin and sex hormone-binding globulin) may also be increased, resulting in increased concentrations of circulating corticosteroids and sex hormones.

The concentrations of free or biologically active hormones do not change.

It is possible to increase the concentration of other plasma proteins (angiotensinogen/renin system, α-1-antitrypsin, ceruloplasmin).

The use of HRT does not improve cognitive function. There are reports of an increased risk of developing dementia in women who start using HRT (combined or estrogen-containing only) after 65 years.

Femoston® conti is not a contraceptive.

Femoston conti 1/5 tablets ppo No. 28

Compound

Active ingredients: estradiol - 1 mg, dydrogesterone - 5 mg. Excipients: lactose monohydrate - 114.7 mg, hypromellose (HPMC 2910) - 2.8 mg, corn starch - 14.4 mg, colloidal silicon dioxide - 1.4 mg, magnesium stearate - 0.7 mg.

Pharmacokinetics

Estradiol

Suction

The absorption of estradiol depends on the particle size; micronized estradiol is rapidly absorbed from the gastrointestinal tract.

Distribution

Estrogen can be found in both bound and free states. About 98-99% of a dose of estradiol is bound to plasma proteins, of which 30-52% is bound to albumin and about 46-69% is bound to sex hormone-binding globulin (SHBG).

When taking Femoston® conti daily, the concentration of estradiol in the blood plasma reaches a constant value after about 5 days. Typically, this indicator is achieved within 8-11 days after the start of therapy.

Estrogens are excreted in breast milk.

Metabolism

Estradiol is actively metabolized in the liver. The main unconjugated and conjugated metabolites are estrone and estrone sulfate, which have estrogenic activity. Estrone sulfate may undergo enterohepatic recirculation.

Removal

Estrone and estradiol are excreted in a state conjugated with glucuronic acid mainly by the kidneys. T1/2 is 10-16 hours.

Dydrogesterone

Suction

After oral administration, it is quickly absorbed and completely metabolized. Tmax values for dydrogesterone vary from 30 minutes to 2.5 hours. The absolute bioavailability of dydrogesterone is 28%.

Distribution

More than 90% of dydrogesterone and 20α-dihydrodydrogesterone (DHD) are bound to plasma proteins.

The drug is characterized by linear pharmacokinetics with single and repeated oral administration in the dose range from 2/5 mg to 10 mg. A comparison of the kinetics of single and multiple doses shows that the pharmacokinetic properties of dydrogesterone and DHD do not change when taking multiple doses.

Css of dydrogesterone is achieved 3 days after treatment.

Metabolism

The main metabolite of dydrogesterone is DHD. Cmax of DHD in blood plasma is achieved approximately 1.5 hours after taking the drug. The concentration of DHD in the blood plasma significantly exceeds the initial concentration of dydrogesterone; the ratios of the AUC and Cmax values of DHD to dydrogesterone are about 40 and 25, respectively.

A common characteristic feature of all dydrogesterone metabolites is the preservation of the 4,6-dien-3-one configuration of the original substance and the absence of 17α-hydroxylation, which determines the absence of estrogenic and androgenic activity.

Removal

T1/2 is 5-7 hours for dydrogesterone, 14-17 hours for DGD. Dydrogesterone is completely eliminated after 72 hours. On average, 63% of the dose taken is excreted by the kidneys. Total plasma clearance - 6.4 l/min. DHD is detected in urine primarily as a glucuronic acid conjugate.

Indications for use

hormone replacement therapy for disorders caused by estrogen deficiency in postmenopausal women (no earlier than 12 months after the last menstruation);
prevention of postmenopausal osteoporosis in women at high risk of fractures with intolerance or contraindications to the use of other medications.

Contraindications

diagnosed or suspected breast cancer;
diagnosed or suspected estrogen-dependent malignancies (for example, endometrial cancer);
diagnosed or suspected progestogen-dependent neoplasms (for example, meningioma);
bleeding from the vagina of unknown etiology;
untreated endometrial hyperplasia;
thrombosis (arterial and venous) and thromboembolism currently or in history (including thrombosis, deep vein thrombosis; pulmonary embolism, myocardial infarction, ischemic or hemorrhagic cerebrovascular disorders);
multiple or pronounced factors of arterial or venous thrombosis, angina pectoris, prolonged immobilization, severe forms of obesity (BMI more than 30 kg/m2), diseases of the cerebral vessels or coronary arteries, transient ischemic attacks, complicated lesions of the valvular apparatus of the heart, atrial fibrillation;
identified hereditary or acquired predisposition to arterial or venous thrombosis/thromboembolism (for example, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
acute or chronic liver diseases currently or in history (before normalization of liver function tests), incl. malignant liver tumors;
porphyria;
pregnancy;
breastfeeding period;
galactose intolerance, lactase deficiency, glucose/galactose malabsorption syndrome;
hypersensitivity to dydrogesterone, estradiol and/or to any excipient in the drug.

The use of Femoston® conti should be discontinued if the following conditions occur:

jaundice and/or liver dysfunction;
uncontrolled arterial hypertension;
migraine-like headache that first appeared during the use of drugs for HRT.

Carefully

The use of drugs for HRT, incl. Femoston® conti requires precautions in the presence of any of the following diseases/conditions and risk factors::

uterine leiomyoma, endometriosis;
the presence of risk factors for the occurrence of estrogen-dependent tumors (for example, 1st degree relatives with breast cancer);
arterial hypertension;
benign liver tumors;
diabetes mellitus, both in the presence of vascular complications and in cases of their absence;
cholelithiasis;
migraine or severe headache;
systemic lupus erythematosus;
history of endometrial hyperplasia;
epilepsy;
bronchial asthma;
otosclerosis.

Use of the drug with caution is required:

in patients with chronic heart failure and/or renal failure;
if there are risk factors for the development of thrombosis or thromboembolism in a family history - thrombosis or thromboembolic complications in first-degree relatives aged less than 50 years (such patients should be screened, having previously been notified that screening can only identify a part of thrombophilic disorders) .

Directions for use and doses

The drug is taken orally daily for 28 days, continuously, 1 tablet/day (preferably at the same time of day), regardless of meals.

Treatment should continue without interruption, and the next treatment cycle should begin immediately after the end of the 28-day cycle.

To initiate and maintain HRT treatment for estrogen deficiency disorders, the combination of dydrogesterone + estradiol should be used at the lowest effective dose and for the shortest period of time. Depending on the clinical response, the dose can be further adjusted.

When switching from another continuous sequential or cyclic regimen of taking the drug, you should finish the current cycle and then switch to Femoston® conti.

Women who have not previously received HRT, or when switching from another continuous combined HRT regimen, should start taking Femoston® conti on any day.

If the patient misses the next dose, the tablet must be taken within 12 hours after the usual dosing time. If more than 12 hours have passed, the missed tablet should not be taken; the next day you should take the tablet at the usual time. Skipping a dose may increase the likelihood of breakthrough uterine bleeding or spotting.

Storage conditions

The drug should be stored out of the reach of children, at a temperature not exceeding 30°C.

Best before date

3 years. Do not use after the expiration date.

special instructions

The drug is prescribed only in the presence of symptoms that adversely affect the quality of life. All patients receiving HRT at least once a year require a benefit/risk assessment. Therapy should be continued until the benefits of taking the drug outweigh the risk of adverse reactions.

Experience with the drug in women over 65 years of age is limited.

Information about the risks associated with HRT in cases of premature menopause is limited. Due to the lower absolute risk in younger women, their benefit/risk ratio may be more favorable than in older women.

Medical examination

Before starting or resuming taking Femoston® conti, it is necessary to collect a complete medical and family history and conduct a general and gynecological examination (including mammary glands) of the patient in order to identify possible contraindications and conditions requiring precautions. While taking Femoston® conti, it is recommended to conduct periodic examinations, the frequency and nature of which are determined individually, but not less than once every 6 months. It is advisable to perform mammography for additional examination of the mammary glands. Women should be informed about those possible changes in the mammary glands that need to be reported to their doctor.

The use of estrogens may affect the results of the following laboratory tests: determination of glucose tolerance, study of thyroid and liver functions.

Hyperplasia and endometrial cancer

The risk of developing endometrial hyperplasia and cancer when using drugs containing only estrogen depends on the dose and duration of treatment and increases from 2 to 12 times compared with patients not receiving therapy; the risk may remain elevated for 10 years after stopping therapy.

In women with a preserved uterus, the use of HRT drugs containing only estrogen is not recommended due to the increased risk of developing endometrial cancer.

Cyclic use of progestogen (at least 12 days of a 28-day cycle), or use of a continuous combined HRT regimen in women with a preserved uterus, prevents the increased risk of endometrial hyperplasia and cancer associated with estrogen use.

For the purpose of timely diagnosis, it is advisable to conduct ultrasound (US) screening and, if necessary, conduct a histological (cytological) examination.

Bloody vaginal discharge

In the first months of taking the drug, there may be bleeding and/or scanty spotting from the vagina. If such bleeding appears some time after the start of therapy or continues after cessation of treatment, its cause should be determined. An endometrial biopsy may be performed to rule out malignancy.

Venous thromboembolism

If there is a family history of thrombosis/thromboembolism in first-degree relatives under the age of 50 years, as well as a history of recurrent miscarriage, it is necessary to conduct a hemostasis study (during screening, only some disorders of the blood coagulation system are detected). If the patient is taking anticoagulants, it is necessary to carefully assess the benefit/risk ratio when using Femoston® conti. Until a thorough assessment of the factors for the possible development of thromboembolism or the initiation of anticoagulant therapy is completed, Femoston® conti is not prescribed.

If a thrombophilic condition is detected in a family member and/or in the case of the seriousness or severity of the defect (for example, antithrombin III deficiency, protein S or C deficiency, as well as a combination of defects), Femoston® conti is contraindicated.

Since patients with diagnosed thrombophilic conditions have an increased risk of developing venous thromboembolism, the use of Femoston® conti, which increases this risk, is contraindicated.

In most cases, risk factors for developing VTE include: estrogen use, older age, major surgery, prolonged immobilization, obesity (BMI>30 kg/m2), pregnancy or the postpartum period, systemic lupus erythematosus and cancer. There is no consensus on the possible role of varicose veins in the development of VTE.

To prevent VTE after surgery, prophylactic measures should be considered in all postoperative patients.

If VTE develops after initiation of therapy, the drug should be discontinued and patients should be informed that they should contact their physician immediately if any of the symptoms indicating possible thrombosis or thromboembolism occur (eg, tenderness or swelling of the lower extremities, sudden chest pain, shortness of breath).

Mammary cancer

In women who have been receiving HRT for a long time containing only estrogen or combined (estrogen + progestogen) drugs, the incidence of breast cancer diagnosis increases, which returns to the original level within 5 years after cessation of therapy.

The increase in risk depends on the duration of HRT use. In women taking combined HRT drugs for more than 5 years, the risk of developing breast cancer can increase up to 2 times.

Combination therapy with estrogen and progestogen. The results of a randomized placebo-controlled trial (Women's Health Initiative (WHI)) and epidemiological studies showed an increased risk of developing breast cancer in women taking combined drugs for HRT (estrogen + progestogen). This increase becomes noticeable after approximately three years of therapy.

Estrogen-only therapy. According to the WHI study, there was no increased risk of breast cancer in women with a previous hysterectomy who received estrogen-only HRT.

Most observational studies showed a small increase in the risk of breast cancer, although this risk was markedly lower in women taking combined estrogen and progestogen therapy.

The increase in risk becomes noticeable after several years of using HRT drugs, and after stopping therapy it returns to the original level within several (maximum five) years.

While taking HRT medications, there may be an increase in the density of breast tissue during mammography, which can make it difficult to diagnose breast cancer.

Ovarian cancer

Ovarian cancer is much less common than breast cancer. Epidemiological data from a large meta-analysis suggest a small increase in the risk of developing ovarian cancer for women receiving combined or estrogen-only HRT.

These studies (increased risk) become more obvious when therapy lasts more than 5 years, and after discontinuation, the risk gradually decreases over time. The results of a number of other studies, incl. WHI indicate that combined HRT is associated with a similar or slightly lower risk of ovarian cancer.

Risk of ischemic stroke

Coronary heart disease (CHD)

Combination therapy with estrogen and progestogen. The relative risk of coronary heart disease during the use of combined estrogen and progestogen HRT is slightly increased. Because the absolute risk of CAD is highly dependent on age, the number of additional cases of CAD due to combined HRT use in healthy premenopausal women is very small, but increases with age. The risk is slightly higher in women over 60 years of age.

Estrogen-only therapy. Based on data from randomized controlled trials, there was no increased risk of coronary artery disease in women with a previous hysterectomy who received estrogen monotherapy.

Other states

Estrogens can cause fluid retention, which may adversely affect patients with impaired renal or cardiac function. This group of patients should be under medical supervision.

Estrogens increase the concentration of thyroxine-binding globulin, which leads to an overall increase in the concentration of circulating thyroid hormones (measured by determination of iodine bound to plasma proteins), the concentration of thyroxine (T4) - chromatographic or radioimmunoassay, or triiodothyronine (T3) - radioimmunoassay. The labeled triiodothyronine uptake test shows an increased concentration of thyroxine-binding globulin. The concentrations of free hormones T3 and T4 usually do not change. Plasma concentrations of other binding proteins (eg, transcortin and sex hormone-binding globulin) may also be increased, resulting in increased concentrations of circulating glucocorticoids and sex hormones.

The concentrations of free or biologically active hormones do not change. It is possible to increase the concentration of other plasma proteins (angiotensinogen/renin system, α-1-antitrypsin, ceruloplasmin).

The use of HRT does not improve cognitive function. There are reports of an increased risk of developing dementia in women who start using HRT (combined or estrogen-containing only) after 65 years.

Femoston® conti is not a contraceptive.

Description

Antimenopausal agent (estrogen + progestogen).

Dosage form

Orange-pink, round, biconvex, film-coated tablets, engraved “379” on one side; cross-sectional appearance of the tablets: white, rough surface.

Use in children

Contraindicated in children.

Action

Estradiol

, which is part of the drug Femoston® conti, is identical to endogenous human estradiol, which is the most active estrogen.

Estradiol compensates for the deficiency of estrogen in the female body in women at menopausal age and reduces menopausal symptoms during the first weeks of treatment.

Hormone replacement therapy (HRT) with Femoston® conti prevents bone loss in the postmenopausal period or after oophorectomy.

Dydrogesterone

- a progestogen that is effective when taken orally and has activity similar to parenterally administered progesterone.

When carrying out HRT, the inclusion of dydrogesterone ensures complete secretory transformation of the endometrium, thereby reducing the risk of developing endometrial hyperplasia, increased under the influence of estrogen.

Side effects

In clinical studies, the most common symptoms reported in patients treated with the estradiol/dydrogesterone combination were headache, abdominal pain, breast tenderness/tenderness, and back pain.

In clinical studies (n=4929), the following undesirable effects were observed with the incidence indicated below (number of reported cases/number of patients): very common (≥1/10); often (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000).

Infectious and parasitic diseases: often - vaginal candidiasis; infrequently - cystitis.

Benign, malignant and unspecified neoplasms: uncommon - increase in the size of fibroids.

From the blood and lymphatic system: rarely - hemolytic anemia*.

On the part of the immune system: rarely - hypersensitivity to the active and auxiliary substances in the drug.

Mental disorders: often - depression, nervousness; infrequently - changes in libido.

From the nervous system: very often - headache; often - migraine, dizziness; rarely - meningioma*.

On the part of the organ of vision: rarely - increased corneal curvature*, intolerance to contact lenses*.

From the cardiovascular system: uncommon - venous thromboembolism*, arterial hypertension, peripheral vascular disease, varicose veins; rarely - stroke*.

From the digestive system: very often - abdominal pain; often - nausea, vomiting, flatulence; infrequently - dyspepsia.

From the liver and biliary tract: uncommon - impaired liver function (sometimes in combination with jaundice, asthenia or malaise and abdominal pain), gallbladder disease.

From the skin and subcutaneous tissues: often - allergic skin reactions (including skin rash, urticaria, itching); rarely - angioedema, erythema nodosum*, vascular purpura; chloasma or melasma, which may persist after stopping the drug*.

From the musculoskeletal system: very often - back pain.

From the genital organs and mammary glands: very often - tension/pain in the mammary glands; often - menstrual irregularities (including spotting in postmenopause, metrorrhagia, menorrhagia, oligo-/amenorrhea, irregular menstruation, dysmenorrhea), pain in the lower abdomen, changes in vaginal secretion; uncommon - breast enlargement, premenstrual syndrome.

General disorders and disorders at the injection site: often - asthenic conditions (weakness, malaise, fatigue), peripheral edema.

Laboratory and instrumental data: often - increase in body weight; infrequently - weight loss.

*Adverse effects reported spontaneously but not observed in clinical studies.

Other adverse reactions caused by the use of a combination of estrogen and progestogen (including estradiol + dydrogesterone)

Benign, malignant and unspecified neoplasms: estrogen-dependent benign and malignant neoplasms, incl. endometrial cancer and ovarian cancer; increase in the size of meningioma.

From the immune system: systemic lupus erythematosus.

Metabolism: hypertriglyceridemia.

From the nervous system: the likelihood of developing dementia, chorea, provoking epilepsy attacks.

Vascular disorders: arterial thromboembolism.

From the digestive system: pancreatitis (in patients with hypertriglyceridemia).

From the skin and subcutaneous tissues: erythema multiforme.

From the kidneys and urinary tract: urinary incontinence.

From the genital organs and mammary gland: fibrocystic mastopathy, cervical erosion.

Congenital and hereditary disorders: worsening of the course of concomitant porphyria.

Laboratory and instrumental data: increased concentration of thyroid hormones in blood plasma

Use during pregnancy and breastfeeding

The use of Femoston® conti during pregnancy and breastfeeding is contraindicated.

If pregnancy occurs while taking the drug, you should immediately stop using it.

The drug Femoston® conti is not used in women of reproductive age.

Interaction

Decreased effectiveness of estrogen and progestogen

The metabolism of estrogen and progestogen can be enhanced when taken simultaneously with drugs that induce microsomal liver enzymes of the cytochrome P450 system (isoenzymes CYP2B6, 3A4, 3A5, 3A7): anticonvulsants (phenobarbital, carbamazepine, phenytoin) and antimicrobial drugs (rifampicin, rifabutin, nevirapine, efavirenz) .

Herbal preparations containing St. John's wort (Hypericum perforatum) may enhance the metabolism of estrogen and progestogen through the CYP3A4 isoenzyme.

Ritonavir and nelfinavir, although known as strong inhibitors of CYP3A4, A5, A7, when used simultaneously with sex hormones, can enhance their metabolism.

Increased metabolism of estrogens and gestagens can be clinically manifested by a decrease in the effect of the drug and a change in the intensity of bleeding from the vagina.

The effect of estrogens on the metabolism of other drugs

Estrogens can affect the metabolism of other drugs through competitive binding to enzymes (CYP450) involved in their breakdown. This must be taken into account for drugs with a narrow therapeutic action, such as tacrolimus and cyclosporine A (CYP3A4, 3A3), fentanyl (CYP3A4) and theophylline (CYP1A2), because this type of interaction can lead to an increase in the plasma concentration of the above drugs to a toxic level. This may require careful monitoring of medications over a long period of time and possibly a reduction in the dose of tacrolimus, fentanyl, cyclosporine A and theophylline.

No studies have been conducted to study interactions with other drugs.

Overdose

Estradiol and dydrogesterone are substances with low toxicity.

Symptoms: nausea, vomiting, breast tension, dizziness, abdominal pain, drowsiness/weakness, withdrawal bleeding may occur.

Treatment: symptomatic therapy.

Impact on the ability to drive vehicles and operate machinery

Care should be taken when operating vehicles and machinery, taking into account the risk of adverse reactions from the nervous system.

Use of the drug Femoston

To initiate and maintain treatment of postmenopausal symptoms, the minimum effective dose should be prescribed for the minimum period of time. Femoston is taken daily in the first 14 days of a 28-day cycle, 1 tablet containing 1 or 2 mg of estradiol, and in the remaining 14 days - daily, 1 tablet containing 1 mg of estradiol and 10 mg of dydrogesterone or 2 mg of estradiol and 10 mg of dydrogesterone. After the end of the 28-day cycle, a new cycle should begin. Treatment must be continuous. The tablets should be taken in the order indicated on the package. Treatment of postmenopausal symptoms Usually begins with taking the drug Femoston, containing 1 mg of estradiol and 10 mg of dydrogesterone. Depending on the clinical effect, the dose is then selected individually. If the severity of symptoms associated with estrogen deficiency does not decrease, the dose can be increased by prescribing a drug that contains 2 mg of estradiol and 10 mg of dydrogesterone. Prevention of osteoporosis When hormone replacement therapy is used, it is necessary to take into account individual tolerance to treatment and that the expected effect of the drug on bone tissue is dose-dependent. Femoston Conti 1 tablet 1 time per day daily, without breaks, regardless of meals. Prevention of osteoporosis When hormone replacement therapy is used, it is necessary to take into account individual tolerance to treatment and that the expected effect of the drug on bone tissue is dose-dependent.

Interactions of the drug Femoston

The metabolism of estrogens can be enhanced when used simultaneously with substances that activate enzymes (cytochrome P450 systems) that are involved in the metabolism of drugs. These substances include anticonvulsants (eg, phenobarbital, carbamazepine, phenytoin) and antimicrobials (eg, rifampicin, rifabutin, nevirapine, efavirens). Ritonavir and nelvinavir, when used simultaneously with steroid hormones, activate the above enzymes. Herbal preparations, the component of which is St. John's wort (Hypericum perforatum), increase the metabolism of estrogens and progestogens, which can lead to a weakening of their effect and a change in the profile of uterine bleeding. There is no information on the interaction of dydrogesterone with other drugs.