Similar drugsTo uncover Dosage form: & nbspFilm coated tablets. Composition:Active substances: Estradiol 2 mg (estradiol hemihydrate 2,070 mg), norethisterone acetate 1 mg.Excipients:in the tablet core: silicon dioxide colloid, magnesium stearate, potato starch, povidone, talc, corn starch, lactose monohydrate;in a shell - Silicon dioxide colloid, titanium dioxide, tsv.ind. 77891, macrogol 6000, sepifilm 003 (hypromellose 3.9798 mg + Macrogol stearate 0.4422 mg). Description:White or almost white biconvex tablets, covered with a film membrane. Pharmacotherapeutic group:Anti-climacteric. Pharmacodynamics:Pausogest® is a combination of estrogen and progestogen and replenishes the lack of female sex hormones during the postmenopause. Pausogest® suppresses vegetative-vascular, psycho-emotional and other menopausal estrogen-dependent symptoms during the postmenopause, inhibits the development of hyperplastic endometrial processes, prevents the reduction of bone mass and the development of osteoporosis. Pharmacokinetics:Active substances are absorbed from the digestive tract (gastrointestinal tract).After taking estradiol TCmax (time to reach the maximum concentration) is 5-8 h, Cmax (maximum concentration) - 35 pg / ml (21-52 pg / ml). Linkage with proteins: albumin is 61%, globulins - 37%, 1-2% - remains unbound. T1 / 2 (half-life) - 12-14 hours.Metabolism occurs in the liver, with the formation of estrone, catechol estrogens, estrogen sulfates and glucuronides. It is excreted by the kidneys in the form of metabolites and partially unchanged, a small amount - through the intestine.After oral administration of norethisterone acetate is rapidly absorbed and converted into norethisterone. TCmax 0.5-1.5 h, Cmax - 3.9 ng / ml (1.4-6.8 ng / ml). Linkage with proteins: with albumin - 61%, globulins - 36%. T1 / 2 - 8-11 hours Metabolised in the liver with the formation of 5-alpha-dihydro-norethisterone and tetrahydro-norethisterone, which are excreted mainly by the kidneys in the form of sulfate and glucuronide conjugates. Indications:- Replacement hormone therapy (HRT) in postmenopausal women.- Prevention of postmenopausal osteoporosis.Use strictly according to the doctor's prescription! Contraindications:- Malignant breast tumors (or suspected of it), or their presence in the anamnesis.- An estrogen-dependent tumor (eg, endometrial carcinoma) or suspected of it.- Liver cancer (or suspected of it)- Acute / chronic liver disease or history of liver disease; liver failure.- Congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson and Rotor)- Idiopathic jaundice (including during the previous pregnancy)- Disorders of cerebral circulation (ischemic stroke, hemorrhagic stroke)- Bloody discharge (bleeding) from the vagina of unknown etiology.- Hypersensitivity to the drug components- Pregnancy or suspicion of pregnancy, lactation.- Kidney disease, kidney failure- Deep vein thrombosis of the lower extremities, thromboembolic disease orpresence of these diseases in the anamnesis. Carefully:Hysterectomy, hypertriglyceridemia, hypothyroidism, fluid retention, hypokalemia, diabetes mellitus, chronic cardiovascular diseases (including arterial hypertension), multiple sclerosis, liver and gall bladder disease with normal functional tests, leiomyoma, endometrial hyperplasia, dairy fibroadenoma glands, uterine myoma, mastopathy, ulcerative colitis. Pregnancy and lactation:During pregnancy and lactation, the drug is contraindicated. Dosing and Administration:One tablet per day for 28 days, continuously (the first tablet from the next package is taken the day after the end of the previous one). The duration of therapy with Pausogest® is determined by the attending physician depending on the clinical situation. Therapy should be started no earlier than one year after the onset of menopause. Side effects:- Menstrual-like bleeding, especially in the first months of therapy- Painful tension of mammary glands- Nausea, headache- Peripheral edema- Skin reactions (rash, itching, chloasma, erythema multiforme, erythema nodosum)- Visual disturbances- After 3 months. treatment possible abdominal pain, flatulence, the development of cholelithiasis; Arterial hypertension, thrombosis, thromboembolism, hemorrhage; dizziness, depression, insomnia, convulsions; hirsutism, alopecia; arthralgia, myalgia; increase or decrease in weight; change in sexual desire; candidiasis. Overdose:With proper use, an overdose of the drug is not possible.Symptoms: nausea, vomiting, uterine bleeding.There is no specific antidote.Treatment - symptomatic. Interaction:When combined with inducers of hepatic enzymes, the metabolism of estrogen increases and the effectiveness of the drug decreases. Barbiturates, antiepileptic medicines (carbamazepine, phenytoin), antibiotics (rifampicin, ampicillin), changing the microflora of the intestine, reduce the effective concentration. Also reduce the effectiveness of the drug funds for general anesthesia, narcotic analgesics, anxiolytics, certain antihypertensive drugs, ethanol.With a simultaneous appointment, you may need to adjust the dosage of hypoglycemic drugs. Special instructions:Before the start of therapy, it is necessary to collect individual and family history, conduct a thorough medical examination, paying special attention to blood pressure, the results of the examination of the mammary glands, abdominal organs, and gynecological examination data (to exclude endometrial hyperplasia). During taking the drug every 6 months. should be analyzed cytological smear of the cervix and breast examination. Regular monitoring of liver function, blood pressure (BP), urinalysis, blood lipids is necessary.Patients who received previous therapy with estrogens should be carefully examined to exclude possible hyperplasia of the endometrium.With prolonged use of the drug, the examination should be carried out at least once a year.In the first months of taking the drug, transient menstrual bleeding may occur. If these bleeds continue for a long time, it is necessary to perform diagnostic curettage or aspiration biopsy to exclude a possible malignant process of the endometrium.Therapy should be discontinued immediately if the following side effects occur:- signs of phlebitis (unusual pain or swelling of the veins on the legs) and / or deep vein thrombosis, including thromboembolic complications;- jaundice,- sudden impairment / visual impairment,- the appearance of a migraine-like headache,- marked increase in blood pressure,- the appearance of cerebrovascular disorders,- the appearance of stitching pains of unclear etiology during breathing or coughing, with pain and a feeling of restraint in the chest,- increased frequency of epileptic seizures, when liver tumors are detected.Treatment should also be discontinued, at least 6 weeks in advance.up to planned surgical intervention, with prolonged immobilization.If menstrual like bleeding lasts more than 3 months. or first appeared after several months of treatment, possibly diagnostic scraping, including for the exclusion of malignant neoplasms of the uterus.Long-term therapy for the prevention of osteoporosis should be performed in those women who have a high risk of bone fracture. Patients who receive antihypertensive therapy in combination with hormonal therapy should regularly monitor blood pressure.Patients with epilepsy, migraine, diabetes, bronchial asthma or cardiovascular diseases should be observed with particular care, since estrogens can worsen their course. Effect on the ability to drive transp. cf. and fur:Does not affect. Form release / dosage:Film-coated tablets. Packaging:28 tablets in a blister of PVC-foil and aluminum foil. 1 or 3 blisters in a cardboard box with the attached instruction for use. Storage conditions:At a temperature of 15-30 ° C.Keep out of the reach of children. Shelf life:3 years.Do not use after the expiration date printed on the package. Terms of leave from pharmacies:On prescription Registration number:П N013951 / 01 Date of registration:04.04.2008 Expiration Date:Unlimited The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary Manufacturer: & nbspGEDEON RICHTER, Ltd. Hungary Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary Information update date: & nbsp2016-12-15 Illustrated instructions × Illustrated instructions Instructions