Composition, form of production and packaging
The tablets covered with a film membrane of two kinds.
The tablets covered with a film shell of white color, round, biconcave, with engraving "379" on one side and "S" above the badge "? Black" on - on the other; on a break - white, rough (14 pieces in a blister).
1 tab.
Estradiol 1 mg
Excipients: lactose monohydrate - 119.1 mg, hypromellose - 2.8 mg, corn starch - 15 mg, silicon dioxide colloid - 1.4 mg, magnesium stearate - 0.7 mg.
Sheath composition: Opadri Y-1-7000 white (hypromellose - 2.5 mg, titanium dioxide (E171) - 1.25 mg, macrogol 400 - 0.25 mg) - 4 mg.
The tablets covered with a film membrane of gray color, round, biconcave, with an engraving "379" on one side and "S" above a badge "? Black" - on another; on a break - white, rough (14 pieces in a blister).
1 tab.
Estradiol 1 mg
dydrogesterone 10 mg
Excipients: lactose monohydrate - 110.2 mg, hypromellose - 2.8 mg, corn starch - 13.9 mg, silicon dioxide colloid - 1.4 mg, magnesium stearate - 0.7 mg.
Sheath composition: Opadri II 85F27664 gray (polyvinyl alcohol 1.6 mg, titanium dioxide (E171) 0.928 mg macrogol 3350 0.808 mg, talc 0.592 mg iron (II) black oxide (E172) 0.072 mg) 4 mg .
28 pcs. - blisters (1) - packs of cardboard.
28 pcs. - blisters (3) - packs of cardboard.
28 pcs. - blisters (10) - packs of cardboard.
Tablets, coated with a shell , are of two kinds.
The tablets covered with a cover of pink color, round, biconcave, with an embossed "S" above the badge "? Black" on one side and "379" - on the other side; the core of the tablet is white (14 pcs in the blister).
1 tab.
Estradiol 2 mg
Excipients: lactose monohydrate, hypromellose, corn starch, silicon dioxide colloid, magnesium stearate.
Composition of the shell: Opadri OY-6957 pink.
The tablets covered with a cover of light yellow color, round, biconcave, with an embossed "S" above the badge "? Black" on one side and "379" - on the other side;the core of the tablet is white (14 pcs in the blister).
1 tab.
Estradiol 2 mg
dydrogesterone 10 mg
Excipients: lactose monohydrate, hypromellose, corn starch, silicon dioxide colloid, magnesium stearate.
Composition of the shell: Opadri OY-02B22764 yellow.
28 pcs. - blisters (1) - packs of cardboard.
28 pcs. - blisters (3) - packs of cardboard.
28 pcs. - blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Combined two-phase preparation for hormonal replacement therapy, containing as an estrogen component micronized 17? -estradiol and as a progestogen component of dydrogesterone. Both components are analogues of female sex hormones (estradiol and progesterone).
Estradiol replenishes the estrogen deficiency in the female body after the onset of menopause and provides effective relief of psychoemotional and vegetative climacteric symptoms such as hot flashes, increased sweating, sleep disorders, increased nervous excitability, dizziness, headache, involution of the skin and mucous membranes, especially the genitourinary system and irritation of the vaginal mucosa, soreness in sexual intercourse).
Hormone replacement therapy (HRT) with Femoston В® prevents the loss of bone mass in the postmenopausal period caused by estrogen deficiency.
Reception of the drug Femoston В® 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 decreasing the risk of developing endometrial hyperplasia and / or carcinogenesis (increasing with the use of estrogens). Dydrogesterone does not possess estrogenic, androgenic, anabolic or glucocorticoid activity.
PHARMACOKINETICS
Estradiol
Suction
After taking the drug inside, micronized estradiol is easily absorbed.
Metabolism and excretion
Estradiol is metabolized in the liver with the formation of estrone and estrone sulfate. Estrone sulfate is subjected to intrahepatic metabolism.
Glucuronides of estrone and estradiol are excreted mainly in urine.
Dydrogesterone
Suction
In the human body, dydrogesterone is rapidly absorbed from the digestive tract.
Metabolism
Metabolized completely. The main metabolite of dydrogesterone is 20-dihydrodidrogesterone, which is present in the urine mainly in the form of glucuronic acid conjugate.
Excretion
Complete elimination of dydrogesterone occurs after 72 hours.
INDICATIONS
- hormone replacement therapy due to natural menopause, or menopause, resulting from surgery;
- prevention of postmenopausal osteoporosis.
DOSING MODE
Femoston В® 1/10 take 1 tablet / day (preferably at the same time of day) without interruption, regardless of food intake.
In the first 14 days of the 28-day cycle, 1 tablet is taken daily. white (from the half of the package with the arrow marked with the number "1") containing 1 mg of estradiol, and for the remaining 14 days - 1 tablet daily. gray (from the half of the package with an arrow marked with the number "2") containing 1 mg of estradiol and 10 mg of dydrogesterone.
Femoston В® 2/10 take 1 tablet / day (preferably at the same time of day) without interruption, regardless of food intake.
In the first 14 days of the 28-day cycle, 1 tablet is taken daily. pink (from the half of the package with an arrow marked with the number "1") containing 2 mg of estradiol, and for the remaining 14 days - 1 tablet every day. light yellow color (from the half of the package with an arrow marked with the number "2") containing 2 mg of estradiol and 10 mg of dydrogesterone.
Patients who have not stopped menstruating, are recommended to begin treatment on the first day of the menstrual cycle. Patients with irregular menstrual cycles are advisable to start treatment after 10-14 days of monotherapy with progestogen ("chemical curettage").
Patients who have had their last menstrual period more than 1 year ago can start treatment at any time.
SIDE EFFECT
On the part of the reproductive system: possible soreness of the mammary glands, breakthrough bleeding, pain in the pelvic region; sometimes - changes in cervical erosion, changes in secretion, dysmenorrhea; rarely - breast enlargement, premenstrual-like syndrome; in some cases (0.1-1%) - a change in libido.
From the digestive system: nausea, flatulence, abdominal pain; sometimes - cholecystitis; rarely (0.01-0.1%) - a violation of the liver, 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 - trochaic.
From the cardiovascular system: sometimes - venous thromboembolism; very rarely - myocardial infarction.
From the hemopoietic system: very rarely (<0.01%) - hemolytic anemia.
Dermatological reactions: sometimes - a rash, itching; very rarely - chloasma, melasma, erythema multiforme, erythema nodosum, hemorrhagic purpura.
Allergic reactions: sometimes - hives; very rarely - angioedema.
Other: change in body weight; sometimes - vaginal candidiasis, breast carcinoma, increase in the size of the leiomyoma; rarely - peripheral edema, intolerance to contact lenses, increased curvature of the cornea; in some cases (<0.01%) - exacerbation of porphyria.
CONTRAINDICATIONS
- established or suspected pregnancy;
- the period of lactation (breastfeeding);
- diagnosed or suspected breast cancer, history of breast cancer;
- diagnosed or suspected estrogen-dependent malignant neoplasms;
- untreated endometrial hyperplasia;
- vaginal bleeding of unclear etiology;
- previous idiopathic or confirmed thromboembolism of veins (deep vein thrombosis, pulmonary thromboembolism);
- active or recently transferred arterial thromboembolism;
- Acute liver disease, as well as liver disease in the history (before the normalization of laboratory indicators of liver function);
- porphyria;
- Hypersensitivity to the components of the drug.
With caution and under the supervision of a doctor, use in patients receiving HRT and having the following diseases and conditions (currently or in history): uterine leiomyoma, endometriosis, thromboses and risk factors in history, with risk factors for estrogen-dependent tumors (for example, breast cancer in the patient's mother), arterial hypertension, benign liver tumor, diabetes mellitus, cholelithiasis, epilepsy, migraine or severe headache, history of endometrial hyperplasia, systemic lupus erythematosus, A bronchial asthma, a renal insufficiency, an otosclerosis.
PREGNANCY AND LACTATION
Femoston В® is contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution should take the drug for kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in acute liver diseases, as well as liver diseases in the history (before the normalization of laboratory indicators of liver function).
APPLICATION FOR CHILDREN
Not applicable.
SPECIAL INSTRUCTIONS
Before the appointment or resumption of HRT, it is necessary to collect a complete medical and family history, conduct a general and gynecological examination to identify possible contraindications and conditions requiring compliance with precautionary measures. During treatment with the drug Femoston В® is recommended to periodically conduct a survey (the frequency and nature of the studies determined individually). In addition, it is advisable to carry out a study of the mammary glands (including mammograms) in accordance with accepted norms, taking into account clinical indications.
The risk factors for thrombosis and thromboembolism with HRT are thromboembolic complications in history, severe forms of obesity (body mass index more than 30 kg / m 2 ) and systemic lupus erythematosus. Regarding the role of varicose veins in the development of thromboembolism, there is no generally accepted opinion.
The risk of developing deep vein thrombosis in the lower extremities may temporarily increase with prolonged immobilization, extensive injuries or surgical interventions. In cases where prolonged immobilization is necessary after surgical interventions, consideration should be given to the temporary discontinuation of HRT 4 to 6 weeks before surgery.
When deciding HRT in patients with recurrent deep vein thrombosis or thromboembolism treated with anticoagulants, the use and risk of HRT must be carefully evaluated.
If thrombosis develops after the onset of HRT, the drug Femoston В® should be discontinued.
The patient should be informed of the need to consult a doctor if the following symptoms appear: painful swelling of the lower limbs, sudden loss of consciousness, dyspnea, impaired vision.
After consultation with the doctor, the patient should stop taking the medication if there is jaundice or worsening liver function, pronounced lifting of blood pressure, first detected migraine-like attack, pregnancy, manifestation of any contraindication.
There are data from studies showing a slight increase in the incidence 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 the termination of HRT.
Patients who previously received HRT using only estrogen preparations should be carefully examined before starting treatment with the drug Femoston В® in order to identify possible hyperstimulation of the endometrium.
Breakthrough uterine bleeding and mildly expressed menstrual bleeding can occur during the first months of treatment with the drug. If, in spite of dose adjustment, such bleeding does not stop, the drug should be discontinued until the cause of bleeding is established. If bleeding recurs after a period of amenorrhea or continues after withdrawal of treatment, its etiology should be established. This may require an endometrial biopsy.
Femoston В® is not a contraceptive. Patients in the perimenopause are recommended to use non-hormonal contraceptives.
The patient should inform the physician about the medicinal preparations that she is currently taking or taking before the appointment of the drug Femoston В® .
The use of estrogens can affect the results of the following laboratory tests: the determination of glucose tolerance, the study of the functions of the thyroid and liver.
Impact on the ability to drive vehicles and manage mechanisms
Femoston В® does not affect the ability to drive vehicles and control mechanisms.
OVERDOSE
Symptoms: nausea, vomiting, drowsiness, dizziness.
Treatment: symptomatic therapy.
DRUG INTERACTION
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 drug Femoston В® .
Ritonavir and nelfinavir, although known as inhibitors of microsomal metabolism, can play the role of inducers with simultaneous administration with steroid hormones.
Herbal preparations containing St. John's wort can stimulate the exchange of estrogens and progestogens.
The interaction of dydrogesterone, which is part of the drug Femoston В® , with other drugs is not known.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, at a temperature of no higher than 30 В° C. Shelf life - 3 years.
