Femoston 1 tablet 1 + 10mg, No. 28

HRT disorders caused by natural menopause, or menopause resulting from surgery.

Prevention of postmenopausal osteoporosis.

Preparations containing dydrogesterone / estradil in fixed combinations are taken orally according to special schemes, depending on the indications and the dosage form used.

Film-coated tablets Active substance: estradiol hemihydrate dydrogesterone

Established or suspected pregnancy; lactation period (breastfeeding); diagnosed or suspected breast cancer, history of breast cancer; diagnosed or suspected estrogen-dependent malignant neoplasms; untreated endometrial hyperplasia; vaginal bleeding of unknown etiology; previous idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism); active or recent arterial thromboembolism; acute liver disease, as well as a history of liver disease (before the normalization of laboratory parameters of liver function); porphyria; hypersensitivity to the components of the combination.

pharmachologic effect

Combined drug for HRT containing 17?-estradiol as an estrogenic component and dydrogesterone as a gestagenic component. Both components are analogs of female sex hormones (estradiol and progesterone).

Estradiol replenishes the estrogen deficiency in the female body after menopause and provides effective relief of psychoemotional and vegetative climacteric symptoms, such as hot flashes, increased sweating, sleep disturbances, increased nervous irritability, dizziness, headache, involution of the skin and mucous membranes (especially urinary and irritation of the vaginal mucosa, soreness during intercourse).

HRT with a combination of dydrogesterone / estradiol prevents postmenopausal bone loss caused by estrogen deficiency.

Taking a combination of dydrogesterone / estradiol leads to a change in the lipid profile towards a decrease in total cholesterol and LDL cholesterol levels and an increase in HDL cholesterol.

Dydrogesterone is an effective progestogen when taken orally, which completely ensures the onset of the secretion phase in the endometrium, thereby reducing the risk of endometrial hyperplasia and / or carcinogenesis (increased with the use of estrogens). Dydrogesterone has no estrogenic, androgenic, anabolic, or glucocorticoid activity.

Indications of the active substances of the drug FemostonЃ

HRT disorders caused by natural menopause, or menopause resulting from surgery.

Prevention of postmenopausal osteoporosis.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen. Preparations containing dydrogesterone / estradil in fixed combinations are taken orally according to special schemes, depending on the indications and the dosage form used.

N obochnoe action

From the reproductive system: soreness of the mammary glands, breakthrough bleeding, pain in the pelvic region are possible; sometimes - changes in cervical erosion, changes in secretion, dysmenorrhea; rarely - an increase in the mammary glands, premenstrual syndrome; in some cases (0.1-1%) - a change in libido.

From the digestive system: nausea, flatulence, abdominal pain are possible; sometimes - cholecystitis; rarely (0.01-0.1%) - liver dysfunction, 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 hematopoietic system: very rarely (<0.01%) - hemolytic anemia.

Dermatological reactions: sometimes - rash, itching; very rarely - chloasma, melasma, erythema multiforme, erythema nodosum, hemorrhagic purpura.

Allergic reactions: sometimes - urticaria; very rarely - angioedema.

Others: change in body weight; sometimes - vaginal candidiasis, breast carcinoma, an increase in the size of the leiomyoma; rarely - peripheral edema, contact lens intolerance, an increase in the curvature of the cornea; in some cases (<0.01%) - exacerbation of porphyria.

Contraindications for use

Established or suspected pregnancy; lactation period (breastfeeding); diagnosed or suspected breast cancer, history of breast cancer; diagnosed or suspected estrogen-dependent malignant neoplasms; untreated endometrial hyperplasia; vaginal bleeding of unknown etiology; previous idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism); active or recent arterial thromboembolism; acute liver disease, as well as a history of liver disease (before the normalization of laboratory parameters of liver function); porphyria; hypersensitivity to the components of the combination.

Carefully

Diseases and 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 in the patient's mother), arterial hypertension, benign liver tumor, sugar diabetes, cholelithiasis, epilepsy, migraine or intense headache, history of endometrial hyperplasia, systemic lupus erythematosus, bronchial asthma, renal failure, otosclerosis.

Application during pregnancy and lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Application for violations of liver function

Contraindicated in acute liver disease, as well as a history of liver disease (before the normalization of laboratory parameters of liver function).

Application for impaired renal function

The drug should be taken with caution in case of renal failure.

Application in children

Not applicable.

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 precautionary measures.

During treatment with a combination of dydrogesterone / estradiol, 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.

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, major trauma, or surgery. In cases where prolonged immobilization is necessary after surgery, consideration should be given to temporarily discontinuing HRT 4-6 weeks before surgery.

When deciding on HRT in patients with recurrent deep vein thrombosis or thromboembolism receiving treatment with anticoagulants, it is necessary to carefully assess the benefits and risks of HRT.

If thrombosis develops after starting HRT, then therapy should be canceled.

The patient should be informed about the need to consult a doctor if the following symptoms appear: painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, visual impairment.

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

There is research data showing a slight increase in the incidence 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 discontinuation of HRT.

Patients who have previously received HRT using only estrogenic drugs should be especially carefully examined before starting the use of a combination of dydrogesterone / estradiol in order to identify possible endometrial hyperstimulation.

Breakthrough uterine bleeding and mild menstrual bleeding may occur in the first months of treatment. If, despite dose adjustment, such bleeding does not stop, treatment should be canceled until the cause of the bleeding is established. If bleeding recurs after a period of amenorrhea or continues after discontinuation of treatment, its etiology should be established.

The combination dydrogesterone / estradiol is not used as a contraceptive.

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

Drug interactions

The simultaneous use of drugs that are inducers of microsomal liver enzymes (including barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine) can weaken the estrogenic effect of the dydrogesterone / estradiol combination.

Ritonavir and nelfinavir, although known to be inhibitors of microsomal metabolism, can act as inducers when taken concomitantly with steroid hormones.

Herbal preparations containing St. John's wort can stimulate the exchange of estrogen and progestogen.