Why is femoston prescribed and how to take it. InternetAmbulanceMedical portal Reception of femoston 1 5

Femoston 1/5

P N014320/01-2002. INN Dydrogesterone + Estradiol &

Trade name Femoston 1/5
Registration number P N014320/01-2002
Date of registration 26.08.2002
Cancellation date
Manufacturer Solvay Pharmaceuticals B.V. - Netherlands

Packaging:
No. Packing ID EAN
1 film-coated tablets 28 pcs.
2 film-coated tablets 28 pcs.

Description (Vidal):

FEMOSTON® 1/5 (FEMOSTON® 1/5)

Representation:

SOLVAY PHARMA ATX code: G03FA14 Marketing authorization holder:

SOLVAY PHARMACEUTICALS, B.V.

estradiol + dydrogesterone

Release form, composition and packaging

Orange-pink, round, biconvex film-coated tablets, debossed with "379" on one side of the tablet and debossed with "S" above the badge? - another.

estradiol 1 mg

dydrogesterone 5 mg

Excipients: lactose monohydrate, methylhydroxypropyl cellulose, corn starch, colloidal anhydrous silicon dioxide, magnesium stearate, Opadry orange Y-8734 (macrogol 400, titanium dioxide (E171), iron oxide yellow and red (E172)).

28 pcs. - blisters (1) - packs of cardboard.

28 pcs. - blisters (3) - packs of cardboard.

Clinico-pharmacological group: Anticlimacteric drug

Registration Nos.:

# tab., cover film coating, 1 mg + 5 mg: 28 or 84 pcs. - P No. 014320 / 01-2002, 08.26.02 PPR

Description of the drug is based on officially approved instructions for use and approved by the manufacturer for the 2008 edition.

Pharmacological action | Pharmacokinetics | Indications | Dosing regimen | Side effect | Contraindications | Pregnancy and lactation | Special Instructions | Overdose | Drug interaction | Terms of dispensing from pharmacies | Storage conditions and expiration dates

pharmachologic effect

Monophasic drug for hormone replacement therapy with a low-dose content as an estrogen component - estradiol, as a progestogen component - dydrogesterone. Both components are chemically and biologically identical to the endogenous female sex hormones produced in the ovaries (estradiol and progesterone).

Estradiol compensates for the estrogen deficiency in the female body after menopause and provides effective relief of psycho-emotional and autonomic menopausal symptoms, such as hot flashes, increased sweating, sleep disturbances, increased nervous irritability, dizziness, headache, involution of the skin and mucous membranes, especially the genitourinary system (dryness and irritation of the vaginal mucosa, pain during intercourse).

Hormone replacement therapy (HRT) with Femoston 1/5 prevents bone loss in the postmenopausal period. Risk factors contributing to the development of postmenopausal osteoporosis include early onset of menopause, long-term use of corticosteroids in the recent past, and smoking.

Taking the drug Femoston 1/5 leads to a change in the lipid profile in the direction of lowering the level of total cholesterol and LDL and increasing HDL.

Dydrogesterone is an effective oral progestogen that completely ensures the onset of the secretion phase in the endometrium, thereby reducing the risk of endometrial hyperplasia and / or carcinogenesis (increased by the use of estrogens). Dydrogesterone does not have estrogenic, androgenic, anabolic or glucocorticosteroid activity.

To achieve the maximum effect, HRT should be started as soon as possible after menopause.

Pharmacokinetics

Estradiol

Suction

After taking the drug inside, estradiol is easily absorbed.

Metabolism and excretion

Estradiol undergoes standard metabolic conversion in the liver to estrone and estrone sulfate. Estrone sulfate undergoes intrahepatic metabolism.

Glucuronides of estrone and estradiol are excreted mainly in the urine.

Dydrogesterone

Suction

In the human body, dydrogesterone is rapidly absorbed from the gastrointestinal tract.

Metabolism

Metabolized completely. The main metabolite of dydrogesterone is 20-dihydrodydrogesterone (DHD), which is present in the urine mainly as a glucuronic acid conjugate.

breeding

T1 / 2 dydrogesterone is 5-7 hours, T1 / 2 DHD - 14-17 hours. After 72 hours, dydrogesterone is completely eliminated.

Indications

- hormone replacement therapy for disorders caused by estrogen deficiency in postmenopausal women;

- prevention of postmenopausal osteoporosis.

Dosing regimen

The drug is prescribed orally 1 tablet per day (preferably at the same time of day), without interruption.

Side effect

On the part of the reproductive system: acyclic menstrual-like bleeding in the first months of treatment, spotting bloody discharge from the vagina, vaginal candidiasis, soreness and engorgement of the mammary glands; rarely - a change in libido.

From the digestive system: nausea, vomiting, flatulence, abdominal pain, cholestatic jaundice are possible.

From the side of the central nervous system: rarely - headache, migraine, dizziness, depression, chorea.

Dermatological reactions: chloasma, melasma, which may persist after discontinuation of the drug, erythema nodosum, rash, itching.

From the side of the cardiovascular system: rarely - arterial hypertension, thrombosis, peripheral edema.

Other: rarely - cramps in the muscles of the lower extremities, intolerance to contact lenses, changes in body weight.

Contraindications

- diagnosed or suspected breast cancer (also a history of breast cancer);

- endometrial cancer or other hormone-dependent neoplasms;

- vaginal bleeding of unknown etiology;

- confirmed acute deep vein thrombosis or pulmonary embolism in history;

- violations of cerebral circulation;

- acute or chronic liver disease, as well as a history of liver disease (before normalization of laboratory parameters of liver function);

- established or suspected pregnancy;

- lactation period (breastfeeding);

- Hypersensitivity to the components of the drug.

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Application for violations of liver function

contraindicated in acute or chronic liver disease, as well as a history of liver disease (until normalization of laboratory parameters of liver function)

special instructions

Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history and conduct a general and gynecological examination in order to identify possible contraindications and conditions requiring precautions. During treatment with Femoston 1/5, it is recommended to periodically conduct an examination (the frequency and nature of the studies are determined individually). In addition, it is advisable to conduct a study of the mammary glands (including mammography) in accordance with accepted standards, taking into account clinical indications.

Femoston 1/5 is prescribed for women who have been postmenopausal for at least 1 year.

When switching from another estrogen-progestogen drug for HRT, Femoston 1/5 should be started at the end of the estrogen-progestogen phase without interruption in taking the tablets.

Patients receiving HRT and having the following conditions (currently or in history) should be under medical supervision: uterine leiomyoma, endometriosis, thrombosis and risk factors for their development in history, arterial hypertension, impaired renal function, diabetes mellitus with vascular complications, bronchial asthma, porphyria, cholelithiasis, epilepsy, hemoglobinopathies, otosclerosis, multiple sclerosis, migraine or severe headache.

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

The risk of developing deep vein thrombosis of the lower extremities may increase with prolonged immobilization, extensive trauma or surgery. In cases where prolonged immobilization is necessary after surgery, consideration should be given to temporarily stopping HRT 4-6 weeks before surgery.

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

If thrombosis develops after the start of HRT, Femoston 1/5 should be discontinued.

The patient should be informed about the need to consult a doctor in case of the following symptoms: painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, blurred vision.

There is evidence demonstrating a slight increase in the incidence of breast cancer detected in women who received long-term (more than 10 years) HRT. The detection of breast cancer may be due to early diagnosis, the biological effects of HRT, or a combination of both. The probability of diagnosing breast cancer increases with the duration of treatment and returns to normal five years after the cessation of HRT.

Patients who previously received HRT using only estrogenic drugs should be especially carefully examined before starting treatment with Femoston 1/5 in order to identify possible endometrial hyperstimulation.

Breakthrough uterine bleeding and mild menstrual-like bleeding may occur in the first months of drug treatment. 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 established. This may require an endometrial biopsy.

The drug Femoston 1/5 is not a contraceptive. Patients in perimenopause are advised to use non-hormonal contraceptives.

The patient should inform the doctor about the drugs that she is currently taking or took before prescribing Femoston 1/5.

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

Influence on the ability to drive vehicles and control mechanisms.

The drug does not affect the ability to drive vehicles and control mechanisms.

Overdose

To date, there have been no reports of overdose symptoms. It is possible to increase the side effects of the drug.

Treatment: There is no specific antidote. If necessary, carry out symptomatic therapy.

drug interaction

The simultaneous use of drugs that are inducers of microsomal liver enzymes (barbiturates, phenytoin, rifampicin, carbamazepine, oxcarbazepine, topiramate, felbamate) may weaken the estrogenic effect of Femoston 1/5.

Interactions of dydrogesterone, which is part of Femoston 1/5, with other drugs are not known.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. Shelf life - 3 years.

Compound

Active ingredients: 17-β-estradiol 1 mg (as hemihydrate), dydrogesterone 5 mg.

Excipients: lactose monohydrate 114.7 mg, hypromellose 2.8 mg, corn starch 14.4 mg, colloidal anhydrous silicon dioxide 1.4 mg, magnesium stearate 0.7 mg.

Film sheath: mixed film coating Orange I 4.0 mg (hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172)).

Description

Round, biconvex, orange-pink film-coated tablets, debossed with "379" on one side of the tablet.

Pharmacotherapeutic group

Progestogens and estrogens, fixed combinations. ATX: G03FA14.

Pharmacological properties

Pharmacodynamics

Estradiol

The active ingredient, synthetic 17-β-estradiol, is chemically and biologically identical to endogenous human estradiol. It compensates for the reduced level of estrogen in menopausal women, thus alleviating the symptoms of menopause.

Estrogens prevent bone loss that occurs during menopause or after oophorectomy.

Dydrogesterone

The activity of dydrogesterone for oral administration is comparable to the activity of parenterally administered progesterone.

Since estrogens promote endometrial growth, estrogen alone increases the risk of endometrial hyperplasia and cancer. The addition of progestogens significantly reduces the estrogen-induced risk of endometrial hyperplasia in non-hysterectomized women.

Clinical Study Data

Reducing the severity of symptoms of estrogen deficiency and improving the profile of men-strual-likebleeding.

Relief of menopausal symptoms occurs in the first weeks of treatment.

Amenorrhea (absence of menses or spotting) was observed in 88% of women during 10-12 months of treatment. Irregular bleeding and / or spotting was observed in 15% of women in the first 3 months of treatment and in 12% during 10-12 months of treatment.

Relief of menopausal symptoms occurs in the first weeks of treatment.

Prevention of osteoporosis.

Estrogen deficiency in menopause contributes to bone loss and a decrease in bone mass in a woman's body. The effect of estrogens on bone mass is dose-dependent.

The protective effect lasts as long as the treatment lasts. After the cessation of hormone replacement therapy (HRT), bone loss occurs at the same rate as in women who did not take estrogens. The Women's Health's Initiative (WHI) study and meta-analyzes of studies show that the current use of HRT alone or in combination with a progestogen, administered predominantly to healthy women, reduces the risk of hip, vertebral, and other fractures due to osteoporosis. HRT may also prevent fractures in women with low bone mineral density and/or established osteoporosis, but evidence to support this assumption is limited.

After 1 year of treatment with Femoston® 1/5 Conti, bone mineral density (BMD) in the lumbar spine increased by 4±3.4% (mean value ± standard deviation). During treatment, BMD in the lumbar spine increased or remained unchanged in 90% of women. Femoston® 1/5 conti affects the BMD of the femur. After 1 year of treatment, BMD of the femoral neck increased by 1.5±4.5%, by 3.7±6.0% in the area of ​​the trochanter and by 2.1±7.2% in the area of ​​Ward's triangle. BMD in three areas of the femur increased or remained unchanged after therapy with Femoston® 1/5 Conti and amounted to 71%, 66% and 81%, respectively.

Pharmacokinetics

Estradiol

Suction

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

Below is a table with mean steady state pharmacokinetic parameters for estradiol (E2), estrone (E1) and estrone sulfate (E1S) for each dose of micronized estradiol. Data are presented as mean value (SD). estradiol 1 mg:

Distribution

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

Metabolism

After oral administration, estradiol is rapidly metabolized. The main unconjugated and conjugated metabolites are estrone and estrone sulfate. These metabolites can exhibit estrogenic activity both on their own and after being converted to estradiol. Estrone sulfate undergoes intrahepatic metabolism.

breeding

Estrone and estradiol are excreted in the urine, mainly in the form of glucuronides. T1 / 2 is 10-16 hours. Estrogens are excreted in the milk of nursing mothers. With daily intake of Femoston, the equilibrium concentration of estradiol is reached after 5 days of administration, most often by 8-11 days.

Dydrogesterone

Suction

After oral administration, it is rapidly absorbed from the gastrointestinal tract. The time to reach Tmax is from 0.5 to 2.5 hours. The absolute bioavailability of dydrogesterone at a dose of 20 mg orally (compared to 7.8 mg IV) is 28%.

The table shows the average values ​​of the pharmacokinetic parameters of dydrogesterone (D) and dihydrodydrogesterone (DHD). Data are presented as mean value (SD). dydrogesterone 5 mg:

Distribution

With intravenous administration, the volume of distribution in the equilibrium state is about 1400 liters.

Dydrogesterone and DHD bind to plasma proteins by more than 90%.

Metabolism

After oral administration, dydrogesterone is rapidly metabolized to DHD. The concentration of the main metabolite 20-a-dihydro didrogesterone reaches a peak approximately 1.5 hours after a dose. The plasma concentration of DHD is much higher than that of dydrogesterone. The AUC and Cmax ratios of DHD and dydrogesterone are approximately 40 and 25, respectively. T1 / 2 of dydrogesterone and DHD averages 5-7 hours and 14-17 hours, respectively. A common characteristic feature of all dydrogesterone metabolites is the preservation of the 4,6-dien-3-one configuration of the parent substance and the absence of 17α-hydroxylation, which leads to the absence of estrogenic and androgenic activity.

breeding

After ingestion of labeled dydrogesterone, an average of 63% of the dose is excreted in the urine.

The total plasma clearance is 6.4 l / min. Complete excretion of dydrogesterone occurs after 72 hours. DHD is excreted in the urine mainly in the form of a glucuronic acid conjugate.

Pharmacokinetics is linear both with single and repeated use from 2.5 to 10 mg. Comparison of the kinetics of single and multiple doses shows that the pharmacokinetics of dydrogesterone and DHD do not change as a result of repeated doses. Stable concentration is reached after 3 days of treatment.

Indications for medical use

Hormone replacement therapy (HRT) for estrogen deficiency disorders in postmenopausal women who have stopped menstruating for at least 12 months. Prevention of postmenopausal osteoporosis in women at high risk of fractures who are intolerant to or contraindicated in the use of other drugs for the prevention of osteoporosis (see section "Precautions for medical use").

Experience in treating women over 65 years of age is limited.

Method of application and dosage

Femoston® 1/5 conti is a drug for continuous combined hormone replacement therapy for oral administration.

Estrogen and progestogen are given continuously on a daily basis.

Take 1 tablet daily for 28 days of the cycle.

Femoston® 1/5 conti should be taken consecutively and without interruption between packs. At the beginning or during the continuation of the treatment of menopausal symptoms, the minimum effective dose should be used for the shortest possible period.

A continuous combined regimen of treatment begins with Femoston 1/5 conti, depending on the time of menopause and the severity of symptoms. For women with natural menopause, treatment with Femoston® 1/5 Conti should be prescribed no earlier than 12 months after natural menstruation. In the case of surgically induced menopause, treatment can be started immediately.

Depending on the effectiveness of treatment in the future, the dose may be changed.

When switching from another estrogen-progestogen drug to a continuous sequential or cyclic regimen, patients should finish taking the current 28-day cycle and then start taking Femoston 1/5 conti without taking a break between cycles.

When switching from a combined estrogen-progestin preparation for a continuous regimen, patients can start taking Femoston 1/5 conti on any day.

If you miss the next pill, you should take the missed dose as soon as possible. If the time of missing the next tablet exceeded 12 hours, treatment should be continued with the next tablet, without taking the missed tablet. Skipping a dose may increase the chance of breakthrough bleeding and spotting.

Femoston® 1/5 conti can be taken with or without food.

Pediatric population

There are no reasonable indications for the use of Femoston® 1/5 conti in children and adolescents.

Side effect

The most common adverse reactions in patients treated with estradiol/dydrogesterone in clinical trials are headache, abdominal pain, breast pain/breast tenderness, and back pain.

*For more information, see below.

*Adverse reactions from spontaneous reports that were not observed in clinical studies were added to the frequency of "Rare (≥1/10000, but

Mammary cancer

In women who received combination therapy with estrogen and progestogen for 5 years or more, there was a two-fold increase in the risk of developing breast cancer. Any increase in risk in women who received estrogen-only HRT was less than in women who received combined estrogen and progestogen HRT. The level of risk depends on the duration of therapy (see section "Precautions for medical use").

The results of the largest randomized placebo controlled clinical trial (WHI) and the largest epidemiological study (MWS) are presented:

StudyMWS- Estimated additional risk of breast cancer after five years of therapy:

Age, years	Additional cases per 1000 women who never received HRT for more than 5 years	Risk ratio	Additional cases per 1000 women who received HRT for more than 5 years (95% CI)
HRT with estrogen only
50-65	9-12	1.2	1-2 (0-3)
HRT with a combination of estrogens and progestogens
50-65	9-12	1.7	6 (5-7)
# Overall risk ratio. The hazard ratio is not constant and increases with increasing duration of HRT. Note: Since the baseline incidence of breast cancer is different in different EU countries, the number of additional cases of breast cancer will also vary proportionally.

a Based on baseline frequency in developed countries

StudyWHI, USA - Additional risk of breast cancer after 5 years of therapy:

b W HI study in uterineless women showing no increased risk of breast cancer.

# When the analysis included only women who did not receive HRT before the start of the study, no increased risk was observed during the first 5 years: after 5 years, the risk was higher than in women who did not receive HRT.

Risk of developing endometrial cancer

Postmenopausal women with uterus.

The risk of developing endometrial cancer is approximately 5 cases per 1000 women with a uterus who do not receive HRT.

Depending on the duration of estrogen monotherapy and the dose of estrogen, the increase in risk in epidemiological studies ranged from 5 to 55 additional cases for every 1000 women aged 50 to 65 years.

Administration of an additional progestogen for at least 12 days during the cycle may prevent this risk from increasing.

In the MWS study, the use of combined (continuous or cyclic) HRT for 5 years did not lead to an increased risk of developing endometrial cancer (hazard ratio 1.0 (0.8-1.2)).

ovarian cancer

The use of estrogen-only HRT or combined estrogen and progestogen HRT was associated with a slight increase in the risk of diagnosed ovarian cancer. Data from a meta-analysis of 52 epidemiological studies indicate an increased risk of developing ovarian cancer in women currently using HRT compared with women who have never used HRT (hazard ratio 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years who took HRT for 5 years, this resulted in approximately one additional case per 2000 patients. In women aged 50 to 54 who have not taken HRT, approximately two out of 2,000 women are diagnosed with ovarian cancer within 5 years.

Risk of venous thromboembolism

HRT is associated with a 1.3-3-fold increase in the relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis of the lower limb or pulmonary embolism. The development of such a phenomenon is more likely during the first year of receiving HRT (see section "Precautions for medical use").

The results of the WHI studies are presented:

ResearchWHI- Additional risk of VTE after 5 years of therapy;

c Study in women with a history of hysterectomy.

risk of coronary heart disease

The risk of coronary heart disease is slightly higher in women receiving combined estrogen-progestogen HRT at the age of 60 (see section "Precautions for medical use").

Ischemic stroke risk

Or estrogen-only therapy is associated with a 1.5-fold increase in the relative risk of ischemic stroke. The risk of hemorrhagic stroke does not increase with HRT

The relative risk does not depend on age or time of menopause. However, due to the fact that the initial risk of stroke is highly dependent on age, the overall risk of stroke in women receiving HRT will increase with age (see section "Precautions for medical use").

Aggregate Study DataWHI- Additional risk of ischemic strokedfor 5 years of hormone replacement therapy;

d There was no difference between ischemic and hemorrhagic stroke.

Other adverse reactions associated with estrogen treatment/progestogens(includingestradiol / dydrogesterone):

Benign, malignant and unspecified neoplasms: estrogen-dependent tumors both benign and malignant, for example, endometrial cancer, ovarian cancer. Enlargement of the meningioma.

Blood and lymphatic system disorders: hemolytic anemia.

Immune system disorders: systemic lupus erythematosus.

Nervous system disorders: possible dementia, chorea, relapse of epilepsy.

Metabolic and nutritional disorders: hypertriglyceridemia.

On the part of the organ of vision: curvature of the cornea, intolerance to contact lenses.

Vascular disorders: arterial thromboembolism.

Gastrointestinal disorders: pancreatitis (in women with previous hypertriglyceridemia).

Skin and subcutaneous tissue disorders: erythema multiforme, erythema nodosum, chloasma or melasma, which may persist after discontinuation of the drug.

Musculoskeletal and connective tissue disorders: cramps in the calf muscles.

Renal and urinary disorders: Urinary incontinence.

Violations of the genital organs and mammary gland: cystic-fibrous mastopathy, erosion of the cervix.

Congenital, familial and genetic disorders: deterioration in porphyria.

Influences on the results of laboratory and instrumental studies: an increase in the total level of thyroid hormones.

Contraindications

Diagnosed or suspected breast cancer, history of breast cancer. Diagnosed or suspected estrogen-dependent malignant neoplasms (for example, endometrial cancer). Diagnosed or suspected progestogen-dependent malignancies (eg, meningioma). Vaginal bleeding of unknown etiology. Untreated endometrial hyperplasia. Current or past thromboembolic disease (eg, deep vein thrombosis, pulmonary embolism). Diagnosed thrombophilic disorders (eg, deficiency of protein C, protein S, or antithrombin). Arterial thromboembolism at present or in history (for example, angina pectoris or myocardial infarction). Acute liver disease or a history of liver disease in which liver function tests have not returned to normal. Porfiry. Known hypersensitivity to active substances or other components of the drug.

Precautions for medical use

Hormone replacement therapy (HRT) is prescribed in cases where postmenopausal symptoms negatively affect a woman's quality of life. It is necessary to conduct a thorough assessment of the risks and benefits, at least annually, HRT is continued until the expected benefits far outweigh the possible risks. The available information on the risks associated with HRT in the treatment of premature menopause is limited. However, due to the low level of absolute risk in younger women, the benefit / risk ratio in these women may be in favor of HRT, compared with older women.

Medical examination / observation

Before starting or resuming HRT, the patient's medical history and family history should be examined. In this case, a physical examination (including the pelvic organs and mammary glands) should be performed and contraindications and special precautions for medical use should be taken into account. In the course of treatment, it is recommended to conduct periodic examinations of the patient, the frequency and volume of which must be selected for each patient individually. Women should be encouraged to report any breast changes they observe to their doctor or nurse (see the Breast Cancer section). In accordance with current screening practice, examinations, including mammography, should be performed, adjusted according to individual clinical indications.

Conditions requiring medical supervision

If any of the following conditions are present, past and/or worsened during pregnancy or previous hormonal therapy, patients should be under close medical supervision.

It must be borne in mind that these diseases may recur or worsen during treatment with Femoston® 1/5 Conti, in particular:

Leiomyoma of the uterus (uterine fibroadenoma) or endometriosis; risk factors for thromboembolism (see section "Venous thromboembolism") -, the presence of risk factors for the occurrence of estrogen-dependent tumors (for example, the presence of relatives of the 1st degree of kinship suffering from breast cancer); arterial hypertension; liver disease (eg, liver adenoma); diabetes mellitus with or without vascular damage; cholelithiasis; migraine or severe headaches; systemic lupus erythematosus; history of endometrial hyperplasia (see section "Hyperplasia of the endometrium") -, epilepsy; bronchial asthma; otosclerosis; meningioma.

Reasons for immediate discontinuation of therapy

Therapy should be discontinued if a contraindication is identified, as well as in the following situations:

The appearance of jaundice or impaired liver function; a significant increase in blood pressure; a new attack of migraine-like headache; pregnancy.

Hyperplasia and endometrial cancer

In women with an intact uterus, the risk of developing endometrial hyperplasia and cancer increases with the use of estrogens alone for a long time. The risk of developing endometrial cancer with estrogen monotherapy is 2 to 12 times higher than in women not receiving hormonal treatment. The increase in risk depends on the duration of treatment and the dose of estrogen (see section "Side Effects"). After discontinuation of estrogen monotherapy for HRT, the risk may remain elevated for at least 10 years. Administration of additional progestogen in cycles of at least 12 days for a 28-day cycle, or continuous estrogen therapy in combination with progestogen in women who have not undergone a hysterectomy, may prevent the additional risk associated with estrogen monotherapy for HRT. In the first months of treatment with the drug, breakthrough bleeding and / or spotting from the vagina may occur. If breakthrough bleeding and / or spotting from the vagina appear some time after the start of therapy with Femoston® 1/5 Conti or continue after stopping treatment, their cause should be investigated, for which an endometrial biopsy may be required to exclude a malignant neoplasm of the endometrium .

Mammary cancer

Overall, evidence suggests an increased risk of breast cancer in women taking combined estrogen and pregestagen replacement therapy, and possibly estrogens alone. The risk depends on the duration of taking HRT.

Combination therapy with estrogen and progestogen

The results of a randomized placebo-controlled WHI study and epidemiological studies have shown an increased risk of developing breast cancer in women taking combined estrogen and progestogen HRT, which becomes apparent approximately 3 years after the start of treatment (see section "Side Effects").

Estrogen monotherapy

In the WHI study, there was no increase in the risk of developing breast cancer in women with a previous hysterectomy who received estrogen-only HRT. The results of observational studies, for the most part, have shown a slight increase in the risk of breast cancer, which is much lower than in women taking combination therapy with estrogen and progestogen (see section "Side Effects").

The increased risk becomes apparent within a few years of HRT, but after discontinuation of therapy, it returns to baseline within a few (maximum five) years.

With HRT, especially with combined treatment with estrogen-progestogen, the density of the mammographic image increases, which may have a negative impact on the radiological diagnosis of breast cancer.

ovarian cancer

Ovarian cancer is much less common than breast cancer.

Epidemiological data from an extensive meta-analysis have shown a slightly increased risk in women using estrogen monotherapy or estrogen in combination with progestogen as HRT, which manifests itself within 5 years of use and decreases over time after discontinuation of use. Some other studies, including the WHI, suggest that the use of combined HRT preparations may be associated with the same or slightly lower risk (see section "Side Effects").

Venous thromboembolism

HRT is associated with a 1.3-3-fold increase in the risk of developing venous thromboembolism (VTE), that is, deep vein thrombosis and pulmonary embolism. The likelihood of such a complication is higher in the first year of treatment than in subsequent years (see section "Side effects"). Patients with known thrombophilic conditions have an increased risk of VTE, and HRT may increase this risk. Therefore, HRT is contraindicated in this group of patients (see section "Contraindications"). Commonly recognized risk factors for VTE are: estrogen use, older age, major surgery, prolonged immobilization, severe obesity (BMI over 30 kg/m2), pregnancy and the postpartum period, systemic lupus erythematosus, and cancer. Currently, there is no consensus on the role of varicose veins in the development of VTE.

As with all patients in the postoperative period, special attention should be paid to the implementation of measures to prevent VTE after surgery. If a long period of immobilization is expected after a planned operation, it is recommended to cancel HRT 4-6 weeks before surgery. As with all patients in the postoperative period, special attention should be paid to the implementation of measures to prevent VTE after surgery. The resumption of treatment is possible only after a complete restoration of motor activity.

Women who do not have a history of VTE, but who have had venous thromboembolism in their next of kin at a young age, may be offered screening (screening does not detect all clotting disorders). If a thrombosis disorder is identified that explains cases of thrombosis in family members or in the case of a “severe” disorder (for example, antithrombin, protein S, protein C deficiency or a combined defect), HRT is contraindicated. Before prescribing HRT, women already receiving anticoagulant treatment should be given a comprehensive assessment of the possible risks of hormone therapy. If VTE develops after the start of therapy, the drug should be discontinued. The patient should be aware that at the first possible symptoms of VTE (painful swelling of the lower extremities, sudden chest pain, shortness of breath), she should immediately contact her doctor.

Ischemic heart disease (CHD)

In randomized clinical trials, there is no evidence that HRT (only estrogens or in combination with progestogens) protects against the development of myocardial infarction in women with or without coronary artery disease.

Combination therapy with estrogen and progestogen

The relative risk of coronary artery disease during treatment with combined drugs for HRT increases slightly. Since the initial absolute risk of developing coronary artery disease is significantly dependent on age, the number of additional cases of coronary artery disease in women receiving combined HRT is very low in the group of healthy women close to the onset of menopause, and increases with age.

Estrogen monotherapy

Based on data from randomized controlled trials, there was no increase in the risk of developing coronary artery disease in women with a previous hysterectomy who received estrogen replacement therapy alone.

Ischemic stroke

The risk of ischemic stroke in combination therapy with estrogen and progestogen or estrogen monotherapy increases by 1.5 times. The relative risk does not change with age or time of menopause. However, due to the fact that the initial risk of stroke is highly dependent on age, the overall risk of stroke in women receiving HRT will increase with age (see section "Side Effects").

Other states

Estrogens can cause fluid retention and, therefore, patients with impaired cardiac and renal function should be closely monitored. Women with a history of hypertriglyceridemia should be closely monitored in the future while taking HRT (estrogens or estrogen-progestogens), since in very rare cases a significant increase in the concentration of triglycerides in the blood plasma in such women has been reported, which led to the development of pancreatitis. Estrogens increase the concentration of thyroxine-binding globulin, which leads to an increase in the total concentration of circulating thyroid hormones, determined by the content of protein-bound iodine, the concentration of thyroxine (T4) (determined by column chromatography or radioimmunoassay), or triiodothyronine (determined by radioimmunoassay) . The level of absorption of triiodothyronine (T3) decreases, indicating an increase in the concentration of thyroxine-binding globulin (TSG). The concentrations of free thyroxine (T4) and triiodothyronine (T3) remain unchanged. The concentrations of other serum binding proteins may increase, incl. corticoid-binding globulin (CBG), sex hormone-binding globulin (SHBG), which leads to an increase in the concentration of circulating corticosteroids and sex hormones, respectively. The concentrations of free or biologically active hormones do not change. The concentration of other plasma proteins (angiotensinogen / renin substrate, alpha 1-antitrypsin, ceruloplasmin) may also increase. HRT does not improve cognitive function. There is limited evidence of a possible increased risk of developing dementia in women over the age of 65 who started continuous combined HRT or estrogen monotherapy. Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Femoston® 1/5 Conti. The drug Femoston® 1/5 Conti does not have a contraceptive effect.

Overdose

Estradiol and dydrogesterone are substances with low toxicity. In case of overdose, symptoms such as nausea, vomiting, breast tenderness, drowsiness, dizziness, abdominal pain, lethargy/fatigue, withdrawal bleeding may occur. It is unlikely that overdose will require any specific symptomatic treatment.

The above information also applies to overdose in children.

Interaction with other drugs

No drug interaction studies have been conducted.

The effectiveness of estrogenprogestogensmay be violated

Metabolism of estrogens and progestogens may be increased by the concomitant use of substances known to induce drug metabolism isoenzymes, in particular cytochrome P450 isoenzymes, such as antiepileptics (eg, phenobarbital, phenytoin, carbamazepine) and anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz). Although ritonavir and nelfinavir are known to be potent inhibitors, when used concomitantly with steroid hormones, they exhibit stimulatory properties on estrogen and progestogen metabolism. Herbal preparations containing St. John's wort (Hypericum perforatum) may also stimulate the metabolism of estrogens and progestogens. Clinically, increased metabolism of estrogens and progestogens can lead to a decrease in the effectiveness of action and changes in the nature of uterine bleeding.

Use during pregnancy and during breastfeeding

Taking the drug Femoston® 1/5 conti is not indicated during pregnancy.

If pregnancy occurs during treatment with Femoston® 1/5 conti, therapy should be stopped immediately.

The results of most of the epidemiological studies conducted to date relating to accidental exposure of the fetus to combined compositions of estrogens and progestogens indicate the absence of teratogenic and fetotoxic effects. Available data on the use of estradiol/dydrogesterone in pregnant women is limited.

Taking the drug Femoston® 1/5 conti is not indicated during breastfeeding.

Influence on the ability to drive vehicles and mechanisms

Femoston® 1/5 conti has no or no significant effect on the ability to drive vehicles and mechanisms.

Registration certificate holder

Abbott Healthcare Product B.V.

S.D. van Houtenlaan 36,

NL -1381 SP Veesp, the Netherlands.

Manufacturer

Abbott Biologicals B.V.

Veerweg 12,

8121 AA Olst, The Netherlands

Claims for the quality of the medicinal product should be sent to:

Representative office of Abbott Laboratories S.A. (Swiss Confederation), Republic of Belarus, 220073 Minsk, 1st Zagorodny lane, 20, office 1503, tel./fax: +375 17 256 7920, e-mail: .

You can also report an adverse drug event or quality complaint to Abbott by calling +380 44 498 6080 (24 hours a day).

Instructions for use

Active ingredients

Release form

Pills

Compound

1 tablet contains: Active substance: estradiol hemihydrate 1.03 mg, which corresponds to the content of estradiol 1 mg, dydrogesterone 5 mg. , magnesium stearate - 0.7 mg. iron oxide red (E172) - 0.024 mg) - 4 mg .;

Pharmacological effect

Estradiol, which is part of the drug Femoston; 1/5 conti, identical to human endogenous estradiol, which is the most active estrogen. Estradiol compensates for the estrogen deficiency in the female body after menopause and provides effective treatment of psycho-emotional, vegetative and urogenital menopausal symptoms.; Hormone replacement therapy (HRT) with Femoston; 1/5 conti prevents bone loss in the postmenopausal period.; Taking the drug Femoston; 1/5 conti leads to a change in the lipid profile in the direction of lowering the level of total cholesterol and LDL and increasing HDL.; Dydrogesterone is a progestogen that is effective when taken orally. It does not have estrogenic, androgenic, anabolic or glucocorticoid activity.; When conducting HRT, the inclusion of dydrogesterone provides a complete secretory transformation of the endometrium, thereby reducing the risk of developing hyperplasia and / or endometrial cancer increased by estrogens.

Pharmacokinetics

After oral administration, micronized estradiol is readily absorbed. Metabolized in the liver to estrone and estrone sulfate, which also undergoes hepatic biotransformation. Glucuronides of estrone and estradiol are excreted mainly in the urine.; Dydrogesterone after oral administration is rapidly absorbed from the gastrointestinal tract. It is metabolized completely, the main metabolite is 20-dihydrodydrogesterone (DHD), which is present in the urine, mainly in the form of a glucuronic acid conjugate. T1 / 2 - 5–7 h, DGD - 14–17 h. Complete elimination occurs after 72 hours.

Indications

Hormone replacement therapy for disorders caused by estrogen deficiency in postmenopausal women; - prevention of postmenopausal osteoporosis in women at high risk of fractures with intolerance or contraindications to the use of other drugs.

Contraindications

Established or suspected pregnancy; - lactation period; - diagnosed or suspected breast cancer, history of breast cancer; - diagnosed or suspected progestogen-dependent neoplasms; - diagnosed or suspected estrogen-dependent malignant neoplasms, including endometrial cancer, incl. in history; - bleeding from the vagina of unknown etiology; - thromboembolic diseases at present or in history (for example, myocardial infarction, deep vein thrombosis, pulmonary embolism); - violation of cerebral circulation; - acute or chronic liver disease at present or in history (before normalization of laboratory parameters of liver function); - untreated endometrial hyperplasia; - porphyria; - galactose intolerance, lactase deficiency, glucose / galactose malabsorption syndrome; - hypersensitivity to the components of the drug.; With caution, HRT in postmenopausal women is prescribed if they have been diagnosed at present or in history: - uterine leiomyoma, endometriosis; - the presence of risk factors for the occurrence of estrogen-dependent tumors (for example, I degree of heredity of breast cancer); - liver adenoma; - cholelithiasis; - migraine or severe headache; - renal failure; - bronchial asthma; - a history of endometrial hyperplasia; - epilepsy; - otosclerosis; - multiple sclerosis; - hemoglobinopathies; - risk factors for the development of thromboembolic conditions, incl. angina pectoris, prolonged immobilization, severe forms of obesity (body mass index over 30 kg/m2); - arterial hypertension; - diabetes mellitus, both in the presence of vascular complications, and in cases of their absence; - systemic lupus erythematosus.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and during breastfeeding.; If pregnancy occurs during treatment with Femoston; 1/5 conti, therapy should be stopped immediately.

Dosage and administration

For the purpose of HRT and the prevention of osteoporosis, the drug is taken orally in a continuous mode, 1 tablet / day (preferably at the same time of day) regardless of food intake. ; Prevention of postmenopausal osteoporosis should be carried out taking into account the individual tolerability of the drug and the possible effect on bone mass, which are dose-dependent.

Side effects

From the nervous system: often - headache, migraine; infrequently - dizziness; Very rarely - chorea , abdominal pain, flatulence; infrequently - cholecystitis; rarely - impaired liver function, sometimes in combination with asthenia, malaise and abdominal pain, jaundice (cholestatic); very rarely - vomiting.; From the reproductive system and mammary glands: often - tension / soreness of the mammary glands, metrorrhagia in the first months of treatment, spotting from the vagina, pain in the lower abdomen; infrequently - a change in the cervical epithelium during cervical erosion, a change in cervical secretion, dysmenorrhea, an increase in the size of leiomyoma, vaginal candidiasis; rarely - an increase in the mammary glands, premenstrual-like syndrome; Hereditary disorders: very rarely - clinical manifestations of previously undiagnosed porphyria.; From the hematopoietic system: very rarely - hemolytic anemia.; From the musculoskeletal system: often - cramps in the muscles of the lower extremities; infrequently - pain in the back (lower back).; From the immune system: infrequently - allergic reactions such as urticaria, skin rash and itching; very rarely - angioedema, hypersensitivity reactions.; Dermatological reactions: very rarely - chloasma and / or melasma, which may persist after discontinuation of the drug, erythema multiforme, erythema nodosum, vascular purpura.; On the part of the body as a whole: often - asthenia, increase or decrease in body weight; infrequently - peripheral edema.; Other: rarely - intolerance to contact lenses, an increase in the curvature of the cornea.

Overdose

Estradiol and dydrogesterone are substances with low toxicity. No cases of overdose have been reported.; Symptoms: theoretically, in case of an overdose, symptoms such as nausea, vomiting, drowsiness, dizziness may occur.; Treatment: symptomatic therapy.

Interaction with other drugs

The estrogenic effect of the drug Femoston; 1/5 conti decreases when taken simultaneously with drugs-inducers of microsomal liver enzymes: anticonvulsants (barbiturates, carbamazepine, phenytoin, oxcarbazepine, topiramate, felbamate), antimicrobial drugs (rifampicin, rifabutin, nevirapine, efavirenz); with herbal preparations containing St. John's wort (Hypericum perforatum).; It is possible to increase the estrogenic effect of Femoston; 1/5 conti while taking with drugs that are inhibitors of microsomal liver enzymes (ritonavir, nelfinavir).; Interaction of dydrogesterone with other drugs is not known.

special instructions

The drug is prescribed to postmenopausal women only in the presence of symptoms that adversely affect the quality of life: "hot flashes", increased sweating, sleep disturbance, increased nervous irritability, dizziness, headache, involution of the skin and mucous membranes, especially the mucous membranes of the genitourinary system (dryness and irritation of the vaginal mucosa, soreness during intercourse). Therapy should be continued as long as the benefit of taking the drug outweighs the risk of side effects, while it is necessary to strive for the appointment of the minimum therapeutically effective dose of the drug. You should strive to achieve the shortest duration of treatment. The experience of using the drug in women over 65 years of age is limited.; Medical examination; Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history and conduct a general and gynecological examination of the patient in order to identify possible contraindications and conditions requiring precautions. During treatment with Femoston; 1/5 conti is recommended to conduct periodic examinations, the frequency and nature of which is determined individually, but not less than 1 time per year, based on the collected anamnesis, clinical and laboratory parameters. It is advisable to conduct a study of the mammary glands, incl. mammography. Women should be informed about those possible changes in the mammary glands that need to be reported to the attending physician.; The use of estrogens may affect the results of the following laboratory tests: determination of glucose tolerance, examination of the functions of the thyroid gland and liver.; Endometrial hyperplasia; For the purpose of timely diagnosis, it is advisable conducting ultrasound screening, if necessary, conducting a histological (cytological) study. If such bleeding occurs some time after the start of therapy or continues after discontinuation of treatment, their cause should be determined. It is possible to conduct an endometrial biopsy to exclude a malignant neoplasm.; Venous thromboembolism; In the presence of thromboembolism in the patient's history (including family history), as well as with a history of habitual miscarriage in anamnesis, it is necessary to conduct a study of hemostasis. Until the completion of a thorough assessment of the factors of the possible development of thromboembolism or the initiation of anticoagulant therapy, HRT is not used. ;The risk of developing deep vein thrombosis of the lower extremities may temporarily increase with prolonged immobilization, extensive trauma or surgery. If long-term immobilization is necessary after surgical interventions, HRT should be discontinued for 4-6 weeks. before surgery, the resumption of the drug is possible after the complete restoration of the woman's motor activity. If thrombosis develops after initiation of therapy, HRT should be discontinued. and ovarian cancer; In women who have been receiving HRT for a long time, the frequency of diagnosing breast cancer increases, which returns to baseline within 5 years after stopping therapy.; Against the background of HRT, an increase in the density of breast tissue during mammography may be observed, which can make it difficult to diagnose breast cancer.; An increase in the risk of ovarian cancer when using estrogen-progestin drugs for HRT has not been proven.; Other conditions; Estrogens can cause fluid retention, which can adversely affect the condition of patients with impaired cardiac and renal function.; In women with triglyceridemia against the background of HRT, in very rare cases, there may be a significant increase in the concentration of triglycerides in the blood plasma, which contributes to the development of pancreatitis. usually do not change). Serum levels of other binding proteins (corticoid-binding globulin, sex hormone-binding globulin) may also be elevated, leading to 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 substrate, -l-antitrypsin, ceruloplasmin). 1/5 conti should be discontinued if contraindications are identified and / or if the following conditions occur: - jaundice and / or abnormal liver function; - a significant increase in blood pressure; - the appearance of a migraine-like attack against the background of HRT; - in case of recurrence or aggravation of the severity of the diseases or conditions listed above. ;Drug Femoston; 1/5 conti is not a contraceptive.; The patient should inform the doctor about the medications that she takes during HRT or took before prescribing Femoston; 1/5 conti.; Influence on the ability to drive vehicles and control mechanisms; Femoston; 1/5 conti does not affect the ability to drive vehicles and mechanisms.

Menopause is an integral part of the life of every representative of the beautiful half of humanity. These are natural processes of age-related changes in the hormonal background in the female body, which occur against the background of a decrease in the functionality of the ovaries and the production of sex hormones. In most cases, the menopausal period is characterized by a deterioration in general well-being, the appearance of attacks of a rush of blood, a violation of the psycho-emotional state and the performance of the endocrine and cardiovascular systems, as well as many other unpleasant symptoms. To improve well-being and prevent the development of pathology, hormonal drugs are prescribed. One of the most effective hormone-containing drugs is Femoston 1/5 Conti in postmenopausal women.

A decrease in the production of sex hormones in the female body has a huge impact on the functioning and condition of almost all organs and systems. The skin begins to lose its former elasticity, which is accompanied by the appearance of deep wrinkles. Starting from the period of premenopause, the performance of the cardiovascular system is disrupted, which manifests itself in the spasmodic nature of blood pressure. Formed chronic fatigue and weakness throughout the body. The level of sexual activity also decreases against the background of characteristic changes in the vaginal area, namely:

1. the appearance of itching and burning;
2. decreased production of cervical mucus;
3. the appearance of dryness on the mucous surfaces of the intimate zone, which causes pain during intercourse with a partner.

All of the above symptoms of menopause are just a part of the whole range of menopausal symptoms that can cause discomfort to mature ladies. The main reason for these manifestations lies in the irreversible process of the age-related development of the woman's body, aimed at the onset of the senile period.

It is impossible to prevent the onset of menopause, but it is quite possible to maintain the level of hormonal levels in a woman's body over a certain period of time.

This slows down the aging process and prevents the development of serious pathological changes.

The use of hormone replacement therapy will help women with pronounced menopausal symptoms to survive this period at a more relaxed and satisfactory level, while maintaining excellent health. The first assistant for women is the drug Femoston for menopause, which contains in its composition the main components in the form estradiol, which is an active sex hormonal substance. AND dydrogesterone, belonging to the group of steroids that are actively involved in important vital processes of the female body. The pharmacological action of these substances is supported by additional components.

When is the use of Femoston prescribed?

The use of this drug with a combined spectrum of action is prescribed for a sharp decrease in the level of estrogens in the menopausal period. It is recommended to take this drug no earlier than six months after the last menstruation.

Femoston helps to get rid of the manifestation of common menopausal symptoms and normalize the general well-being in women entering the postmenopausal period.

Among other things, the drug Femoston is necessary for preventive measures against the development of osteoporosis.

In this case, this medication is prescribed even without the manifestation of an acute clinical picture of the climacteric syndrome, if there are any contraindications for therapy with special drugs to eliminate this pathology.

Release form

This drug is produced in the form of tablets with a content of various dosages, which is selected according to the individual characteristics of each woman. These tablets may have the following dosage:

• 1/5 Conti;
• 1/10 Conti;
• 2/10 Conti.

Where the values ​​1 and 2, which are in the numerator, are indicators of the amount of estradiol in one tablet, expressed in milligrams. Accordingly, the values ​​of 5 and 10, which are in the denominator, indicate the level of dydrogexterone content.

As additional substances in the composition of this medication are:

• colloidal silicon dioxide;
• corn starch;
• magnesium stearates;
• lactose monohydrate and other excipients.

The tablet drug Femoston is available in 28 tablets in one blister, on which the days of admission are marked.

One package of the drug is designed for a two-week course.

The mechanism of action of Femoston

The component of estradiol, which is part of Femoston, has a similar effect on the female body as the sex hormone estrogen, which is produced naturally in the ovaries. Therefore, the mechanism of action of the hormone-containing agent is aimed at replenishing the deficient level of estrogen in the female body in the postmenopausal period, associated with a decrease in the functionality and hormone-secreting performance of the ovaries.

This helps to reduce the intensity of flushing attacks and the occurrence of sudden heat, eliminate increased levels of anxiety and hyperhidrosis. As well as the normalization of sleep, the elimination of pain in the head area and the stop of excessive atrophic processes in the area of ​​the urinary tract and genital organs. Moreover, Femoston helps to increase the level of elasticity and toning of muscle fibers in the vaginal and genitourinary system.

The action of the second main active component of this drug, dydrogesterone, is to ensure the normal structure of the mucous surface of the functional layer of the endometrium and to prevent the development of endometriosis, that is, its excessive growth. And also helps to slow down the process of reducing the level of calcium in bone tissues. Accordingly, it prevents the development of chronic fractures and dislocations, as well as such a serious pathology as osteoporosis.

Regular intake of this drug will help normalize the level of hormones in the body of a woman who has entered the menopause and at a relatively young age, up to 40 years.

Normalization of estrogen levels will contribute to:

1. Eliminate the feeling of dryness in the vaginal area, especially during moments of intimacy with a partner.
2. Prevention of the development of pathologies such as atherosclerosis.
3. Decrease in the level of sweating.
4. Mood boost.

Drinking Femoston is recommended not only during the postmenopausal period, but also when surgical menopause or early menopause. It is very important that this medicine helps to normalize the cholesterol level of the circulatory system. And also the agent takes part in the regulation of the quantitative content of lipoproteins in the blood plasma.

Application and doses

Femoston is prescribed for daily oral administration, one tablet at the same time of day. When the first package of the drug is completed, it is necessary, without stopping taking the drug, to proceed to the next one.

In the event that, due to the circumstances, one pill was missed, but no more than 9-10 hours have passed from the prescribed time of taking, then we drink the pill as quickly as possible. Well, if 11 or more hours have already passed, then the next pill should be taken the next day at the set time, in no case should the dosage be doubled.

If you abruptly completely refuse to continue taking the drug, this may cause the discovery of uterine hemorrhage.

Before prescribing Femoston for use, specialists usually refer a woman to blood tests to determine the level of estrogen. If the estrogen level is markedly reduced, then treatment with this drug can be started.

The course duration of treatment with this drug must be determined only by a qualified specialist, taking into account all the individual characteristics of each woman.

Responses of the body and contraindications for use

Femoston, regardless of the type of dosage, is absolutely contraindicated for all young mothers who are breastfeeding and pregnant. Even in the case when a woman, being in adulthood, takes this drug to normalize her general well-being and suddenly the conception and further development of the fetus occurs, the drug should be stopped at an immediate pace. The subsequent course of pregnancy should be discussed with a specialist and a mutual decision made.

Before starting hormone replacement therapy with the use of Femoston, it is necessary to carefully examine the condition of the woman's genital system and her mammary glands. Obvious contraindications to the use of this medication are:

1. dysfunctional state of the renal system of organs;
2. insufficiency of the cardiovascular system;
3. pathological changes in the chronic nature of the course in the liver;
4. development of neoplasms in the uterus, mammary glands and ovaries.

Moreover, if even a small seal is detected in the mammary gland during Femoston therapy, it is urgent to consult a specialist.

In the case when, before the onset of menopausal changes, a woman has undergone the development of such pathologies as:

• tumor in the breast area;
• hypertension and diabetes;
• obesity;
• sclerosis and bronchial asthma;
• thromboembolism, etc.

then it is necessary to undergo an appropriate examination every 6-8 weeks to prevent the development of exacerbation of past pathologies.

Among the side effects from taking this drug are noted:

1. The appearance of swelling.
2. Violation of the functionality of the gastrointestinal tract.
3. Dizziness and the development of migraines.
4. Soreness in the mammary glands and the development of compaction in them.
5. A set of extra pounds.

If Femoston is poorly tolerated, or there are obvious contraindications to its use, then experts suggest replacing it with no less effective herbal preparations that are part of homeopathic anti-climacteric remedies, among which Remens and Estrovel are the most effective.

Femoston 1/5 Conti is a fairly commonly used drug in the treatment of menopausal symptoms. But every woman has the right to decide whether she needs hormone replacement therapy or not. It is important not to forget that, in accordance with the existing clinical picture and the development of menopausal symptoms, the treatment should be appropriate.

Useful video on this topic:

pharmachologic effect

Femoston (Femoston)
Femoston 1/5 (Femoston 1/5)

Composition and form of release
FEMOSTON 1/10 coated tablets

Two kinds.
Tablets white, round, biconvex, embossed "S" over the "dlt" on one side, "379" - on the other side (14 pieces in a blister).
1 tablet contains estradiol 1 mg;
other ingredients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate
Sheath composition: Opadry OY-1-7000 white.

Tablets are gray, round, biconvex, embossed "S" above the "dlt" on one side, "379" on the other side; white tablet core (14 pieces in a blister).
1 tablet contains estradiol 1 mg, dydrogesterone 10 mg;

Shell composition: Opadry OY-8243 grey.

FEMOSTON 2/10 coated tablets

Two kinds.
Pink, round, biconvex tablets, embossed with "S" above "dlt" on one side and "379" on the other side; white tablet core (14 pieces in a blister).
1 tablet contains estradiol 2 mg;
other ingredients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate.
Shell composition: Opadry OY-6957 pink.

Tablets are light yellow, round, biconvex, embossed with "S" above the "dlt" icon on one side and "379" on the other side; white tablet core (14 pieces in a blister).
1 tablet contains estradiol 2 mg, dydrogesterone 10 mg;
Other Ingredients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate.
Shell composition: Opadry OY-02B22764 yellow.
28 pcs. in a calendar package, 1, 3 or 10 blisters in a carton box.

FEMOSTON 1/5

film-coated tablets

1 tablet contains estradiol 1 mg, dydrogesterone 5 mg;
other ingredients: lactose monohydrate, methylhydroxypropyl cellulose, corn starch, colloidal anhydrous silica, magnesium stearate, macrogol 400, titanium dioxide (E171), iron oxide yellow and red (E172), Opadry orange (Y-8734).
28 pcs. in a blister, 1 blister in a cardboard box.

Registration numbers

FEMOSTON 1/10, FEMOSTON 2/10 - P No. 011361/01, 12/28/04
FEMOSTON 1/5 - P No. 014320/01-2002, 26.08.02

pharmachologic effect

FEMOSTON 1/10, FEMOSTON 2/10 are combined biphasic preparations for hormone replacement therapy containing micronized 17-b-estradiol as an estrogen component and dydrogesterone as a progestogen component. Both components are chemically and biologically identical to the endogenous female sex hormones produced in the ovaries (estradiol and progesterone).
Estradiol compensates for the estrogen deficiency in the female body after menopause and provides effective relief of psycho-emotional and autonomic menopausal symptoms, such as hot flashes, increased sweating, sleep disturbances, increased nervous irritability, dizziness, headache, involution of the skin and mucous membranes, especially the genitourinary system (dryness and irritation of the vaginal mucosa, pain during intercourse).
Hormone replacement therapy (HRT) with Femoston prevents bone loss in the postmenopausal period caused by estrogen deficiency.
Taking the drug Femoston leads to a change in the lipid profile in the direction of lowering the level of total cholesterol and LDL and increasing HDL.
Dydrogesterone is an orally effective progestogen that fully ensures the onset of the secretion phase in the endometrium, thereby reducing the risk of endometrial hyperplasia and / or carcinogenesis (increased by the use of estrogens). Dydrogesterone does not have estrogenic, androgenic, anabolic or glucocorticoid activity.

FEMOSTON 1/5 is a monophasic drug for hormone replacement therapy with a low-dose content of estradiol as an estrogen component, and dydrogesterone as a progestogen component.

Indications

Hormone replacement therapy for disorders caused by natural menopause or menopause resulting from surgery;
- Prevention of osteoporosis in postmenopausal women.

Contraindications

Established or suspected pregnancy;
- lactation period (breastfeeding);
- diagnosed or suspected breast cancer; history of breast cancer;
- diagnosed or suspected estrogen-dependent malignant neoplasms;
- vaginal bleeding of unknown etiology;
- previous idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism);
- active or recently transferred arterial thromboembolism;
- acute liver disease, as well as a history of liver disease (before normalization of laboratory parameters of liver function);
- untreated endometrial hyperplasia;
- porphyria;
- Hypersensitivity to the components of the drug.
Use with caution and under the supervision of a physician in patients receiving HRT and having the following conditions (currently or in history): uterine leiomyoma, endometriosis, thrombosis and their risk factors in history, in the presence of risk factors for estrogen-dependent tumors (for example, breast cancer gland in the patient's mother), arterial hypertension, benign liver tumor, diabetes mellitus, cholelithiasis, epilepsy, migraine or intense headache, a history of endometrial hyperplasia, systemic lupus erythematosus, bronchial asthma, renal failure, otosclerosis.

Dosage and administration
FEMOSTON 1/10

In the first 14 days of a 28-day cycle, take 1 tab daily. white (from half of the package with an arrow marked with the number "1") containing 1 mg of estradiol, and for the remaining 14 days - daily 1 tab. gray color (from half of the package with an arrow marked with the number "2") containing 1 mg of estradiol and 10 mg of dydrogesterone.

FEMOSTON 2/10

Take 1 tablet per day (preferably at the same time of day) without interruption.
In the first 14 days of a 28-day cycle, take 1 tab daily. pink (from half of the package with an arrow marked with the number "1") containing 2 mg of estradiol, and for the remaining 14 days - daily 1 tab. light yellow color (from half of the package with an arrow marked with the number "2") containing 2 mg of estradiol and 10 mg of dydrogesterone.
For patients who have not stopped menstruating, it is recommended to start treatment on the first day of the menstrual cycle. For patients with irregular menstrual cycles, it is advisable to start treatment after 10-14 days of progestogen monotherapy ("chemical curettage").
Patients who last menstruated more than 1 year ago can start treatment at any time.
When taking the drug every month, a regular menstrual-like reaction is observed.

FEMOSTON 1/5

Assign inside 1 tab. / day (preferably at the same time of day), without interruption.

Side effect

From the reproductive system: possible soreness of the mammary glands, breakthrough bleeding, pain in the pelvic area; sometimes - changes in cervical erosion, changes in secretion, dysmenorrhea; rarely - an increase in the mammary glands, premenstrual-like syndrome; in some cases - a change in libido.
From the digestive system: nausea, flatulence, abdominal pain are possible; sometimes - cholecystitis; rarely (0.01-0.1%) - impaired liver function, in some cases accompanied by asthenia, malaise, jaundice or abdominal pain; very rarely - vomiting.
From the side of the central nervous system: headache, migraine (1-10%); sometimes (0.1-1%) - dizziness, nervousness, depression; very rarely - chorea.
From the side of the cardiovascular system: sometimes - venous thromboembolism; very rarely - myocardial infarction.
From the hemopoietic system: very rarely (less than 0.01%) - hemolytic anemia.
Dermatological reactions: sometimes - rash, itching; very rarely - chloasma, melasma, erythema multiforme, erythema nodosum, hemorrhagic purpura.
Allergic reactions: sometimes - urticaria; in some cases - angioedema.
Others: change in body weight; sometimes - vaginal candidiasis, breast carcinoma, an increase in the size of the leiomyoma; rarely - peripheral edema, intolerance to contact lenses, an increase in the curvature of the cornea; in some cases (less than 0.01%) - exacerbation of porphyria.

Pregnancy and lactation

Femoston is contraindicated for use during pregnancy and lactation.

special instructions

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, it is recommended to periodically conduct an examination (the frequency and nature of the studies are determined individually). In addition, it is advisable to conduct a study of the mammary glands (including mammography) in accordance with accepted standards, taking into account clinical indications.
Femoston 1/5 is prescribed for women who have been postmenopausal for at least 1 year.
When switching from another estrogen-progestogen drug for HRT, Femoston 1/5 should be started at the end of the estrogen-progestogen phase without interruption in taking the tablets.
After consultation with the doctor, the patient should stop taking the drug if jaundice or deterioration in liver function occurs, a pronounced rise in blood pressure, a migraine-like attack for the first time, pregnancy, or any contraindication is manifested.
Risk factors for thrombosis and thromboembolism while taking HRT are a history of thromboembolic complications, severe obesity (body mass index over 30 kg/m2) and systemic lupus erythematosus. There is no generally accepted opinion about 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, extensive trauma or surgery. In cases where prolonged immobilization is necessary after surgery, consideration should be given to temporarily stopping HRT 4-6 weeks before surgery.
When considering HRT in patients with recurrent deep vein thrombosis or thromboembolism receiving anticoagulant treatment, the benefits and risks of HRT should be carefully assessed.
If thrombosis develops after the start of HRT, Femoston should be discontinued.
The patient should be informed about the need to consult a doctor in case of the following symptoms: painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, blurred vision.
There is research data showing a slight increase in the likelihood of developing breast cancer in women who received HRT for a long time (more than 10 years). The probability of diagnosing breast cancer increases with the duration of treatment and returns to normal 5 years after the cessation of HRT.
Patients who previously received HRT using only estrogenic drugs should be especially carefully examined before starting treatment with Femoston in order to identify possible endometrial hyperstimulation.
Breakthrough uterine bleeding and mild menstrual-like bleeding may occur in the first months of drug treatment. 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 established. This may require an endometrial biopsy.
The drug Femoston is not a contraceptive. Patients in perimenopause are advised to use non-hormonal contraceptives.
The patient should inform the doctor about the medications that she is currently taking or took before prescribing Femoston.
The use of estrogens may affect the results of the following laboratory tests: glucose tolerance, thyroid and liver function tests.
Influence on the ability to drive vehicles and control mechanisms
Femoston does not affect the ability to drive vehicles and control mechanisms.