Femoston conti pills, 28pcs

Composition

1 tablet contains:  

active ingredients:

estradiol 1 mg,

didrogesterone 5 mg;

excipients:

lactose monohydrate,

methylhydroxypropylcellulose,

corn starch,

colloidal anhydrous silicon dioxide,

magnesium stearate,

macrogol 400,

Titanium dioxide (E 171),

Iron oxide yellow and red (E 172),

Opadry orange (Y-8734).

Pharmacological action

Pharmacodynamics

Estradiol, which is part of the drug and is identical to endogenous estradiol, makes up for the lack of estrogens in the female body after menopause.

Estradiol provides an effective treatment for psychoemotional and vegetative climacteric symptoms: hot flashes, increased sweating, sleep disorders, increased nervous excitability, dizziness, headache, involutions of the skin and mucous membranes, especially the genitourinary system (dryness and irritation of the vaginal mucosa, soreness during sexual intercourse). Hormone replacement therapy (HRT) with Femoston 1/5 prevents bone loss in the postmenopausal period. Risk factors for postmenopausal osteoporosis include early onset of menopause, long-term use of corticosteroids in the recent past, and smoking.

Taking Femoston 1/5 changes the lipid profile: it reduces the level of total cholesterol, LDL and increases the level of HDL.

Didrogesterone is a progestogen that is effective when taken orally, which ensures the onset of the endometrial secretion phase. Didrogesterone reduces the risk of endometrial hyperplasia and/or carcinogenesis, which is increased under the influence of estrogen. Didrogesterone has no estrogenic, androgenic, anabolic or glucocorticoid activity.

To achieve the maximum preventive effect, HRT should be started immediately after the onset of menopause. The effect is manifested throughout the entire treatment period (information on the use of estrogens for more than 10 years is limited).

Pharmacokinetics

After oral use, micronized estradiol is easily absorbed. It is metabolized in the liver to estrone and estrone sulfate, which also undergoes hepatic biotransformation. Estrone and estradiol glucuronides are mainly excreted in the urine.

Didrogesterone is rapidly absorbed from the gastrointestinal tract after oral use. Completely metabolized, the main metabolite is 20-dihydrodirogesterone (DHD), which is present in the urine, mainly in the form of a glucuronic acid conjugate. T_1/2 — 5-7 hours, DGD-14-17 hours. Complete elimination occurs after 72 hours.

Indications

• hormone replacement therapy for disorders caused by estrogen deficiency in postmenopausal women (not earlier than 12 months after the last menstrual period);
• prevention of osteoporosis in postmenopausal women with a high risk of fractures with intolerance or contraindications to the use of other medications

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation. If pregnancy occurs during treatment with Femoston® conti therapy should be stopped immediately.

Contraindications

• pregnancy and breastfeeding;
• diagnosed or perceived breast cancer;
• diagnosed or suspected estrogen-dependent malignant tumors (eg, endometrial cancer);
• diagnosed or suspected progestagens. obesity tumors (e. g., meningioma);
• vaginal bleeding of unknown etiology;
• untreated endometrial hyperplasia;
• thrombosis (venous and arterial) and thromboembolism in the present or in history (including thrombosis, deep vein thrombosis; pulmonary embolism, myocardial infarction, ischemic or hemorrhagic cerebrovascular);
• multiple or severe factors for arterial or venous thrombosis associated with congenital or acquired predisposition, for instance, deficiency of protein C, protein S deficiency, deficiency of antithrombin III, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant), angina, prolonged immobilization, severe obesity (body mass index more than 30 kg/m 2), diseases of cerebral vessels or coronary arteries, transient ischemic attack, complicated by lesions of valvular apparatus of the heart, atrial fibrillation;
• acute or chronic liver disease at present or in history (up to normalization in liver function tests), including malignant tumors of the liver;
• porphyria,
• hypersensitivity to the components of the drug;
• galactose intolerance, lactase deficiency, malabsorption syndrome of glucose-galactose.

Femoston ® conti should be discontinued if contraindications are identified and/or if the following conditions occur: jaundice and/or impaired liver function; uncontrolled arterial hypertension; migraine-like headache that first appeared against the background of HRT medications.

Side effects

• Headache, migraine, dizziness,
• depression, nervousness;
• stomach pain, nausea, vomiting, flatulence;
• voltage/breast tenderness, “grease” spotting in postmenopausal metrorrhagia, profuse menstrualnopodobnoe bleeding, poor or lack menstrualnopodobnoe bleeding, acyclic bleeding, painful menstrualnopodobnoe bleeding, lower abdominal pain, a change in vaginal secretions, and vaginal candidiasis;
• back pain (lower back);
• allergic reactions such as hives, skin rash and itching;
• asthenic conditions (fatigue, malaise, fatigue), peripheral edema;
• increased body weight.

Interaction

The estrogenic effect of Femoston decreases when taken simultaneously with drugs that are inducers of microsomal liver enzymes: anticonvulsants(barbiturates, phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate), antimicrobials (rifampicin, rifabutin, nevirapine, efavirenz); with herbal preparations containing St. John’s wort (Hypericum perforatum).

The estrogenic effect of Femoston may be enhanced when taken concomitantly with drugs that inhibit microsomal liver enzymes (ritonavir, nelfinavir). Interactions of didrogesterone with other drugs are not known.

The patient should inform the doctor about the medications that she takes during HRT or took before prescribing Femoston.

How to take, course of use and dosage

For HRT and prevention of osteoporosis:  inside in a continuous mode,1 tablet per day (preferably at the same time of day), regardless of food intake. The duration of therapy is determined by the ratio of benefits and risks to a woman’s health and the degree of severity of estrogen deficiency.

Prevention of postmenopausal osteoporosis should be carried out taking into account the individual tolerability of the drug and possible effects on bone mass, which are dose-dependent.

Overdose

So far, no reports of overdose symptoms have been reported.

Symptoms: the side effects of the drug may increase.

Treatment: symptomatic, no specific antidote.

Description

Film-coated tablets of orange-pink color, round, biconvex, with the inscription “379” on one side of the tablet.

Special instructions

Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history, as well as conduct a general and gynecological examination in order to identify possible contraindications and conditions that require compliance with the necessary precautions. During treatment with Femoston®,1/5 of women are recommended to be examined periodically (the frequency and nature of studies are determined individually).

Breast examination and / or mammography are performed in accordance with accepted standards, taking into account clinical indications.

Femoston 1/5 is prescribed to postmenopausal women 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 a break in taking tablets.

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

Patients who receive HRT and have the following conditions (currently or in the past) should be closely monitored by a doctor: uterine leiomyoma, endometriosis, thrombosis or a history of thrombosis, hypertension, impaired renal function, diabetes mellitus with vascular complications, bronchial asthma, porphyria, hemoglobinopathy, cholelithiasis, epilepsy, otosclerosis, multiple sclerosis, a migraine or intense headache.

Generally recognized risk factors for thrombosis and thromboembolism associated with HRT include a history of thromboembolic complications, severe forms of obesity (body mass index greater than 30 kg/m2), and systemic lupus erythematosus. There is no general consensus on the role of varicose veins in the development of thromboembolism.

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

When considering HRT in patients with recurrent deep vein thrombosis or thromboembolism treated with anticoagulants, its benefits and risks should be carefully evaluated.

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, dyspnoea, visual impairment.

There are data showing a slight increase in the detection rate of breast cancer in women who received long-term (more than 10 years) hormone replacement therapy. Detection of breast cancer may be related to early diagnosis, the biological effects of HRT, or a combination of both. The likelihood of breast cancer diagnosis increases with the duration of treatment and returns to normal 5 years after HRT is discontinued.

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

Breakthrough uterine bleeding and not pronounced menstrual-like bleeding may occur in the first months of treatment with the drug. If, despite dose adjustment, such bleeding does not stop, the drug should be discontinued until the cause of the bleeding is determined. If the bleeding recurs after a period of amenorrhea or continues after discontinuation of treatment, its etiology should be established. This may require an endometrial biopsy.

Femoston 1/5 is not a contraceptive. Perimenopausal patients are recommended to use non-hormonal contraceptives.

The effect on the ability to drive a car and other mechanisms is unknown.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 30 °C (do not freeze)

Shelf life

1 year

Active ingredient

: Didrogesterone, Estradiol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For postmenopausal women, For menopausal women

Indications

Osteoporosis, Menopause