Femoston pills 1/5mg №28

film coated tablets
1 pill contains estradiol 1 mg, didrogesterona 5 mg;
other ingredients: lactose monohydrate, methylhydroxypropylcellulose, corn starch, anhydrous colloidal silicon dioxide, Magnesium stearate, macrogol 400, titanium dioxide (E171), ferric oxide yellow and red (E172), Opadry orange (Y-8734).
28 pcs. in a blister, 1 blister in a carton box.

FEMOSTON 1/5 - monophasic drug for hormonal replacement therapy with low-dose content as an estrogen component - estradiol, as a gestagen component - didrogesterone.

Indications and usage

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

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;
- 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);
- untreated endometrial hyperplasia;
- porphyria;
- hypersensitivity to the drug.
Carefully and under the supervision of a physician to use in patients receiving HRT and having the following conditions (now or in history): uterine leiomyoma, endometriosis, thrombosis and their risk factors in history, with the presence of risk factors for estrogen-dependent tumors (for example, breast cancer in mothers of the patient), arterial hypertension, benign liver tumor, diabetes mellitus, cholelithiasis, epilepsy, migraine or intense headache, history of endometrial hyperplasia, systemic lupus erythematosus, bronchial asthma, kidney disease Single failure, otosclerosis.

appoint inside on 1 tab. / day (preferably at the same time of day), without a break.

Adverse reactions

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 - 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 (less than 0.01%) - hemolytic anemia.
Dermatologic: sometimes - rash, itching; very rarely - chloasma, melasma, polymorphic erythema, erythema nodosum, hemorrhagic purpura.
Allergic reactions: sometimes - urticaria; in some cases, 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 (less than 0.01%) - exacerbation of porphyria.

Pregnancy and breastfeeding

Femoston is contraindicated for use during pregnancy and lactation.

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 the drug, Femoston is recommended to periodically conduct an examination (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.
Femoston 1/5 prescribed to women in postmenopausal at least 1 year.
When switching from another estrogen-progestin drug for hormone replacement therapy, Femoston 1/5 should be started at the end of the estrogen-progestogenic phase without interruption in taking the tablets.
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.
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 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, impaired vision.
There are data from studies 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 discontinuation of HRT.
Patients who have previously received HRT using only estrogenic 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.
The drug Femoston is not a contraceptive. Patients in perimenopause are recommended to use non-hormonal contraceptives.
The patient should inform the doctor about the medications that she is currently taking or has taken before the appointment of the drug 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 vehicles and control mechanisms.

Overdosage

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

Drug Interactions

The simultaneous use of drugs that are inducers of liver microsomal enzymes (including barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine) can weaken the estrogenic effect of the drug Femoston.
Ritonavir and nelfinavir, although known as microsomal metabolism initiators, 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.

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