Femoston pills 1/10mg №28

Indications

- hormone replacement therapy for disorders caused by natural menopause, or menopause resulting from surgery;

- prevention of postmenopausal osteoporosis.

Dosage and administration

Femoston^® 1/10 take 1 tab. / Day (preferably at the same time of day) without a break, regardless of the meal.

In the first 14 days of the 28-day cycle, take 1 pill daily. white (from half of the package with an arrow labeled with the number "1") containing 1 mg of estradiol, and in the remaining 14 days daily 1 tab. gray (from half of the package with an arrow marked “2”) containing 1 mg of estradiol and 10 mg of didrogesterone.

Femoston^® 2/10 take 1 tab. / Day (preferably at the same time of day) without a break, regardless of the meal.

In the first 14 days of the 28-day cycle, take 1 pill daily. pink (from half of the package with an arrow marked “1”) containing 2 mg of estradiol, and in the remaining 14 days - daily 1 tab. light yellow (from half of the package with an arrow labeled "2") containing 2 mg of estradiol and 10 mg of didrogesterone.

Patients whose menstruation has not stopped are recommended to begin treatment on the first day of the menstrual cycle. Patients with an irregular menstrual cycle, it is advisable to begin treatment after 10-14 days of progestogen monotherapy ("chemical curettage").

Patients whose last menstruation was observed more than 1 year ago can start treatment at any time.

Adverse effects

From the reproductive system: possible pain of the mammary glands, breakthrough bleeding, pain in the pelvic region; 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.

Gastrointestinal: nausea, flatulence, abdominal pain; sometimes cholecystitis; rarely (0.01-0.1%) - abnormal 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.

Cardiovascular: sometimes - venous thromboembolism; very rarely - myocardial infarction.

Hemic and lymphatic: very rarely (<0.01%) - hemolytic anemia.

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

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

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

Contraindications

- established or suspected pregnancy;

- lactation period (breastfeeding);

- diagnosed or suspected breast cancer, a history of breast cancer;

- diagnosed or suspected estrogen-dependent malignant neoplasms;

- untreated endometrial hyperplasia;

- vaginal bleeding of unknown etiology;

- previous idiopathic or confirmed vein thromboembolism (deep vein thrombosis, pulmonary vascular thromboembolism);

- 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);

- porphyria;

- hypersensitivity to the drug.

with caution and under the supervision of a physician, use in patients receiving HRT and having the following 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 glands in the patient's mother), arterial hypertension, benign liver tumor, diabetes mellitus, cholelithiasis, epilepsy, migraine or intense headache, endometrial hyperplasia in history, systemic lupus erythematosus, bronchial ac TMA, renal failure, otosclerosis.

Use during pregnancy and lactation

Femoston^® contraindicated for use during pregnancy and lactation.

Application for violations of the liver

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

Application for violations of kidney function

Caution should be taken when renal failure.

Use in children

Not applicable.

Special notes

Before the appointment or renewal of HRT, it is necessary to collect a full medical and family history, conduct a general and gynecological examination in order to identify possible contraindications and conditions requiring compliance with precautionary measures. During treatment with drug Femoston ^® It is recommended to periodically conduct a survey (the frequency and nature of research is 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 more than 30 kg / m²) and systemic lupus erythematosus. Concerning the role of varicose veins in the development of thromboembolism there is no generally accepted opinion.

The risk of thrombosis of deep veins of the lower extremities may temporarily increase with prolonged immobilization, extensive injuries or surgical interventions. In cases where prolonged immobilization is necessary after surgical interventions, the possibility of a temporary cessation of HRT 4-6 weeks before surgery should be considered.

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

If thrombosis develops after the onset of HRT, femoston^® should cancel.

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, impaired vision.

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

There are data from studies showing a slight increase in the detection rate of 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 discontinuation of HRT.

Patients who have previously received HRT using only estrogen drugs should be carefully examined before starting treatment with femoston.^® in order to identify possible endometrial hyperstimulation.

Breakthrough uterine bleeding and mild menstrual bleeding may occur in the first months of drug treatment.If, despite the dose adjustment, such bleeding does not stop, the drug should be stopped 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. This may require an endometrial biopsy.

Drug Femoston^® not a contraceptive. Patients in perimenopause are recommended to use non-hormonal contraceptives.

The patient should inform the doctor about the drugs she is currently taking or has taken before the appointment of Femoston.^®.

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

Influence on ability to drive motor transport and control mechanisms

Femoston^® does not affect the ability to drive motor vehicles and control mechanisms.

Overdose

Symptoms: nausea, vomiting, drowsiness, dizziness.

Treatment: symptomatic therapy.

Drug interaction

The simultaneous use of drugs that are inducers of liver microsomal enzymes (including barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine) may weaken the estrogenic effect of the drug Femoston^®.

Ritonavir and nelfinavir, although known as inhibitors of microsomal metabolism, can play the role of inducers while being taken with steroid hormones.

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

The interaction of didrogesterone, which is part of the drug Femoston^®, with other drugs is not known.

Terms and conditions of storage

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