Femoston 2/10 tablets p/o No. 28x1

Name

Femoston tablet 2/10 No. 28

Description

Tablets 2 mg estradiol/10 mg dydrogesterone: round, biconvex, light yellow film-coated, embossed with an “S” above the “6” on one side and “379” on the other side. The tablet core is white.

Main active ingredient

Estradiol, Dydrogesterone.

Release form

Pills.

Dosage

2/10 №28.

special instructions

Before prescribing or restarting HRT, it is necessary to obtain a complete medical and family history and conduct a general and gynecological examination to identify possible contraindications and conditions requiring precautions. During treatment with the drug, it is recommended to periodically examine women (the frequency and nature of the studies are determined individually). In addition, it is advisable to conduct breast examination and/or mammography in accordance with accepted standards, taking into account clinical indications. The use of estrogens may affect the results of the following laboratory tests: glucose tolerance testing, thyroid and liver function tests. Generally recognized risk factors for thrombosis and thromboembolism while taking 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, the drug 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. There is data demonstrating a slight increase in the detection rate of breast cancer in women who received 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 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. Femoston® is not a contraceptive. Perimenopausal patients are advised to use non-hormonal contraceptives. It does not affect the ability to drive a car or use other mechanisms.

pharmachologic effect

Pharmacological action: estrogen-progestogen. Estradiol is an estrogen that is part of the drug Femoston®, identical to endogenous human estradiol. Estradiol replenishes the deficiency of estrogen in the female body after menopause and provides effective treatment of psycho-emotional and vegetative menopausal symptoms: hot flashes, increased sweating, sleep disturbances, increased nervous excitability, dizziness, headache, involution of the skin and mucous membranes, especially the mucous membranes of the genitourinary system (dryness and irritation of the vaginal mucosa, pain during sexual intercourse). Hormone replacement therapy (HRT) with Femoston® prevents bone loss in the postmenopausal period caused by estrogen deficiency. Taking Femoston® leads to a change in the lipid profile towards a decrease in the level of total cholesterol and LDL and an increase in HDL. Dydrogesterone is a progestogen, effective when taken orally, which completely ensures the onset of the secretion phase in the endometrium, thereby reducing the risk of developing endometrial hyperplasia and/or carcinogenesis, which increases against the background of estrogens. Dydrogesterone does not have estrogenic, androgenic, anabolic or glucocorticosteroid activity. The combination of 1 mg estradiol with dydrogesterone is a modern low-dose HRT regimen.

Pharmacokinetics

After oral administration, micronized estradiol is easily absorbed. Metabolized in the liver to estrone and estrone sulfate, which also undergoes hepatic biotransformation. Glucuronides of estrone and estradiol are excreted primarily in the urine. Dydrogesterone after oral administration is quickly absorbed from the gastrointestinal tract. Metabolized completely. The main metabolite is 20-dihydrodydrogesterone, present in urine mainly in the form of a glucuronic acid conjugate. Complete elimination of dydrogesterone occurs after 72 hours.

Indications for use

HRT for disorders caused by natural or surgical menopause; prevention of postmenopausal osteoporosis.

Directions for use and doses

Inside, preferably at the same time of day, regardless of food intake - 1 tablet. per day without a break. Femoston® 1/10 is taken according to the following scheme: in the first 14 days of a 28-day cycle, take 1 white tablet daily (from half the package with an arrow marked with the number “1”) containing 1 mg of estradiol, in the remaining 14 days - daily 1 gray tablet (from half the package with the arrow marked "2") containing 1 mg estradiol and 10 mg dydrogesterone. Femoston® 2/10 is taken according to the following regimen: in the first 14 days of a 28-day cycle, take 1 tablet daily. pink (from half of the package with an arrow marked with the number “1”) containing 2 mg estradiol, and in the remaining 14 days - 1 light yellow tablet daily (from half of the package with an arrow marked with the number “2”) containing 2 mg estradiol and 10 mg dydrogesterone. For patients whose menstruation has not stopped, it is recommended to begin treatment on the first day of the menstrual cycle (1st day of the onset of menstruation). For patients with irregular menstrual cycles, it is advisable to begin treatment after 10–14 days of monotherapy with a progestogen. Patients whose last menstruation was observed more than 1 year ago can begin treatment at any time.

Use during pregnancy and lactation

Contraindicated during pregnancy and breastfeeding.

Precautionary measures

Caution - Patients receiving HRT who have the following conditions (currently or in the past) should be closely monitored by a physician:

Interaction with other drugs

Drugs that are inducers of microsomal liver enzymes (barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine) can weaken the estrogenic effect of Femoston®. Ritonavir and nelfinavir, although known as inhibitors of microsomal metabolism, may act as inducers when taken concomitantly with steroid hormones. Herbal preparations containing St. John's wort can stimulate the exchange of estrogens and progestogens. The interactions of dydrogesterone with other drugs are unknown. The patient should inform the doctor about the medications she is currently taking or was taking before prescribing Femoston®.

Contraindications

established or suspected pregnancy; breastfeeding period; diagnosed or suspected breast cancer, history of breast cancer; diagnosed or suspected estrogen-dependent malignancies; vaginal bleeding of unknown etiology; previous idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism); active or recent arterial thromboembolism; acute liver diseases, as well as a history of liver diseases (until normalization of laboratory parameters of liver function); untreated endometrial hyperplasia; hypersensitivity to any of the components of the drug; porphyria. With caution - patients receiving HRT and having the following conditions (currently or in the past) should be under close medical supervision: uterine leiomyoma, endometriosis; history of thrombosis or its risk factors; risk factors for estrogen-dependent tumors (for example, breast cancer in the patient’s mother); arterial hypertension; benign liver tumor; diabetes; cholelithiasis; epilepsy; migraine or intense headache; history of endometrial hyperplasia; systemic lupus erythematosus; bronchial asthma; renal failure; otosclerosis. After consultation with the doctor, the drug should be discontinued in cases such as: the appearance of jaundice or deterioration of liver function; strong rise in blood pressure; newly diagnosed migraine-like attack; pregnancy; manifestation of any contraindication.

Compound

1 pink tablet estradiol 2 mg 1 light yellow tablet estradiol 2 mg dydrogesterone 10 mg excipients: lactose monohydrate; hypromellose; corn starch; colloidal silicon dioxide; magnesium stearate; Opadry OY-6957 pink (only for pink tablets), Opadry OY-02B22764 yellow (only for light yellow tablets)

Overdose

Symptoms: nausea, vomiting, drowsiness, dizziness. Treatment: symptomatic.

Side effect

From the blood and lymphatic system: very rarely (

Storage conditions

At a temperature not exceeding 30 °C. Keep out of the reach of children. Do not use after the expiration date stated on the package.

Buy Femoston 2/10 tablet p/pl.ob. in bl. in pack No. 28x1 in the pharmacy

Price for Femoston 2/10 tablet p/pl.ob. in bl. in pack No. 28x1

Instructions for use for Femoston 2/10 tablet p/pl.ob. in bl. in pack No. 28x1

Femoston® 1 (Femoston® 1)

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 3HT 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® 1, 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. While taking Femoston® 1, 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.

If there is a family history of thrombosis or thromboembolism in first-degree relatives under the age of 50 years while taking the drug for HRT, careful medical supervision is necessary.

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

Reasons for immediate discontinuation of therapy:

Therapy should be discontinued if contraindications are established, as well as in the following cases:

-Jaundice or deterioration of liver function

- Significant increase in blood pressure

-Onset of migraine-type headaches

-Pregnancy

Hyperplasia and endometrial cancer

The risk of developing endometrial hyperplasia and cancer when using HRT drugs containing only estrogen depends on the dose and duration of treatment and increases from 2 to 12 times compared to 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

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® 1 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 1 is not prescribed.

If a hereditary or acquired predisposition to arterial or venous thrombosis is identified (for example, hyperhomocysteinemia, protein C deficiency, protein S deficiency, antithrombin III deficiency, etc., as well as their combination) and/or the presence of such conditions in the family history (in relatives 1st degree of relationship) taking Femoston® 1 is contraindicated due to the increased risk of thrombosis and thromboembolism, including venous.

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, you should stop taking Femoston® 1 4-6 weeks before and not resume taking the drug until the woman’s motor activity is completely restored.

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 (for example, pain 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.

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 ovarian cancer for women receiving combined or estrogen-only HRT.

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 alone.

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.

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 (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 increase, 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® 1 is not a contraceptive.

special instructions

The drug is prescribed only in the presence of symptoms that adversely affect the quality of life.
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® 1/10, 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® 1/10, 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.

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 no treatment; the risk may remain elevated for 10 years after stopping therapy.

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.

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

Bloody issues

In the first months of treatment with 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

HRT is associated with a 1.3 to 3-fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. 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. If the patient is taking anticoagulants, it is necessary to carefully consider the prescription of Femoston® 1/10 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® 1/10 is not prescribed.

When a thrombophilic condition is identified in a family member and/or when the defect is serious or severe (eg, antithrombin III, protein S or C deficiency, or

combinations of defects), Femoston® 1/10 is contraindicated.

Since patients with diagnosed thrombophilic conditions have an increased risk of developing venous thromboembolism, the use of Femoston 1/10, which increases this risk, is contraindicated.

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® 1/10 4-6 weeks before, and treatment should not be resumed until the woman’s mobility is completely restored. 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).

Breast cancer and ovarian cancer

In women receiving long-term HRT using estrogen alone or the estrogen-progestogen complex, 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 estrogen-progestogen HRT for more than 5 years, the risk of developing breast cancer can increase up to 2 times.

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 is much less common than breast cancer. Long-term use (at least 5-10 years) of estrogens in monotherapy during HRT is associated with a slight increase in the risk of developing ovarian cancer. Data from some studies, including the WHI, indicate that combined HRT may increase the risk of developing this pathology to the same or slightly lesser extent.

Risk of ischemic stroke

The relative risk is not affected by age or duration of therapy, but the baseline risk is highly dependent on age, such that the overall risk of stroke in women receiving HRT will increase with age.

Coronary heart disease (CHD)

The relative risk of coronary heart disease during the use of combined estrogen + progestogen HRT increases slightly. 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.

Other states

Estrogens can cause fluid retention, which may adversely affect patients with impaired renal or cardiac function.

In women with hypertriglyceridemia, while taking drugs for HRT, in very rare cases, the concentration of triglycerides in the blood plasma can significantly increase, which contributes to the development of pancreatitis.

Estrogens increase the concentration of thyroid binding globulin, which leads to a general increase in the concentration of circulating thyroid hormones (the concentrations of free hormones T3 (triiodothyronine) and T4 (thyroxine) usually do not change). Plasma concentrations of other binding proteins (transcortin, sex hormone binding globulin) may also increase, 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® 1/10 is not a contraceptive.