Active substanceMifepristoneMifepristone Similar drugsTo uncover Agesta pills inwards Promomed Rus, Open Company Russia Gynepristone® pills inwards Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSC Gynestril® pills inwards NIZHFARM, JSC Russia Genale® pills inwards IZVARINO PHARMA, LLC Russia Miropristone® pills inwards NIZHFARM, JSC Russia Mifegin pills inwards Exceleljin France Mifyprex pills inwards MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia Mifepristone pills inwards China Resource Zizhu Pharmaceutical Co., Ltd China Mifepristone pills inwards IZVARINO PHARMA, LLC Russia Mythophianus pills inwards Shanghai New Hualian Pharmaceutical Co., Ltd. China Pencroft® pills inwards FARMSINTEZ, PAO Russia Dosage form: & nbspPills. Composition:Active substance: Mifepristone - 200 mg Excipients: corn starch - 264 mg, lactose (milk sugar) - 80 mg, microcrystalline cellulose - 36 mg, calcium stearate, 1-water-6 mg, silicon dioxide colloid (grade A-300 aerosil) - 14 mg. Description:Tablets are flat-cylindrical light yellow with a greenish shade of color with a risk. Pharmacotherapeutic group:Antigestagen. ATX: & nbspG.03.X.B.01 Mifepristone Pharmacodynamics:Pencroft® is a synthetic steroid anti-gestagenic agent (blocks the action of progesterone at the receptor level),gestational activity does not possess. Antagonism with glucocorticosteroids was noted (due to competition at the receptor level). Increases the contractility and sensitivity of the myometrium to prostaglandins. As a result of the action of the drug desquamation of the decidual membrane occurs and the expulsion of the fetal egg. Pharmacokinetics:After a single dose of 600 mg, the maximum concentration of -1.98 mg / l is achieved after 1.5 hours. Absolute bioavailability is 69%.In the blood plasma mifepristone on 98% is associated with proteins: albumin and acid alpha-1-glycoprotein.After the distribution phase, excretion first occurs slowly, the concentration decreases 2 times between 12-72 hours, then more rapidly. The half-life is 18 hours. Indications:- Medication interruption of uterine pregnancy at early stages (up to 42 days amenorrhea).- Preparation for childbirth and induction of labor in term of full term pregnancy. Contraindications:Hypersensitivity to mifepristone, adrenal insufficiency, long-term use of glucocorticosteroids, acute or chronic renal and / or hepatic insufficiency, anemia,porphyria, uterine myoma, presence of a scar on the uterus, hemostasis disorders (including the previous treatment with anticoagulants), inflammatory diseases of the genital organs, and the presence of severe extragenital pathology.Do not use smoking women older than 35 years without first consulting a therapist.With drug abortion: suspicion of ectopic pregnancy; pregnancy, not confirmed by clinical studies; pregnancy exceeding 42 days of amenorrhea; a pregnancy that occurs when intrauterine contraception is used, or after the abolition of hormonal contraception.When preparing for childbirth and induction of labor: severe preeclampsia, preeclampsia, eclampsia, preterm or premature pregnancy, placenta previa, mismatch in femoral head and pelvis size, abnormal fetal position, spotting from the genital tract of unclear etiology. Carefully:Caution is prescribed for chronic obstructive pulmonary diseases (including bronchial asthma), severe arterial hypertension, heart rhythm disorders and heart failure. Pregnancy and lactation:Breastfeeding should be discontinued for a period of 14 days after taking Pencroftone®. Dosing and Administration:The drug should be used in medical institutions that have appropriately trained medical personnel and the necessary equipment.For medical termination of early pregnancy.600 mg of Pencroftone ® (3 tablets of 200 mg) are taken orally once in the presence of a doctor. The patient should be under the supervision of medical personnel, at least within 2 hours after application.After 36-48 hours after taking Pencroftone®, the patient should undergo ultrasound (ultrasound). After 8-14 days, the clinical examination and ultrasound are repeated, and the level of beta-chorionic hormone is determined to confirm that the miscarriage has occurred. In the absence of effect of the drug on day 14 (incomplete abortion or ongoing pregnancy) is carried out, followed by vacuum aspiration of aspirate histological examination.To prepare and induction of labor in term of full term pregnancy: once 200 mg of Pencroftone ® (1 tablet) in the presence of a doctor.After 24 hours, a second dose of 200 mg.After 48-72 hours assesses the state of the birth canal, and, if necessary, prostaglandins or appointed oxytocin. Side effects:Menstrual disorders, amenorrhea, metrorrhagia, lohiometra, uterine subinvoljutcija, discomfort and pain in the abdomen; exacerbation of inflammatory processes of the uterus, appendages, urinary tract; weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia, chills, urticaria. Overdose:The intake of mifepristone in doses up to 2 g does not cause undesirable reactions. In cases of drug overdose, symptoms of adrenal insufficiency may appear. Interaction:It is necessary to avoid the simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs), as well as the administration of NSAIDs within 8-12 days after the administration of mifepristone. Special instructions:Patients should be informed that, in the absence of effect by 10-14 days from the use of the drug (incomplete abortion or continuing pregnancy), pregnancy should be discontinued in another way because of the high risk of formation, congenital malformations in the fetus.The use of the drug requires the prevention of rhesus-alloimmunization and other general activities associated with abortion.Patients with artificial heart valves or infective endocarditis with mifepristone should be given prophylactic antibiotic treatment.The drug does not protect against sexually transmitted diseases and AIDS, and is not recommended as a planned continuous contraception. Effect on the ability to drive transp. cf. and fur:Information on the possible negative impact of the drug on the performance of potentially hazardous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.) is not available. Form release / dosage:Tablets 200 mg. Packaging:3 tablets in a jar of light-protective glass or a polymer can; or in a planar cell package. Each jar or contour mesh box is placed in a cardboard box together with instructions for medical use. Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C.Keep out of the reach of children. Shelf life:3 years. Do not use after expiry date. Terms of leave from pharmacies:For hospitals Registration number:LS-001474 Date of registration:24.06.2009 / 11.09.2012 Expiration Date:Unlimited The owner of the registration certificate:FARMSINTEZ, PAO FARMSINTEZ, PAO Russia Manufacturer: & nbspFARMSINTEZ, JSC Russia Information update date: & nbsp2016-09-19 Illustrated instructions × Illustrated instructions Instructions