Instruction for use: Zhenale

Active substance Mifepristone

ATX code G03XB01 Mifepristone

Pharmacological groups

Estrogens, gestagens; Their homologues and antagonists

Nosological classification (ICD-10)

Z30 Monitoring contraceptive use

Local Contraception, Contraception oral, Local contraception, Episodic prevention of pregnancy, Hormonal Contraception, Contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Contraceptive intrauterine, Contraception in women with androgenization phenomena, Installation and removal of the intrauterine device, Prevention of pregnancy (contraception)

Z30.0 General advice and advice on contraception

Safe sex, Intrauterine device contraception, Contraception, Contraceptive intrauterine, Oral contraception, Oral contraception during lactation and with estrogen contraindications, Postcoital contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Emergency Contraception, Episodic prevention of pregnancy, Contraception in adolescents, Prevention of pregnancy (contraception)

Composition and form of release

Tablets 1 table.

active substance:

Mifepristone 10 mg

Auxiliary substances: lactose monohydrate - 123.4 mg; Potato starch - 22 mg; Povidone K25 - 6 mg; Carboxymethyl starch sodium (primogel) - 5 mg; Magnesium stearate 1.6 mg

In the package of contour cells 1 pc .; In a pack of cardboard 1 or 2 packs or in a jar 1 or 2 pcs .; In a pack of cardboard 1 can.

pharmachologic effect

The pharmacological action is contraceptive, anti-gestagenic.

Pharmacodynamics

Mifepristone is a synthetic steroid anti-gestagenic agent (blocks the action of progesterone at the level of receptors), does not possess gestagenic activity. Antagonism with GCS (glucocorticosteroids) was noted (due to competition at the level of communication with receptors).

Depending on the phase of the menstrual cycle, it causes an increase in the contractility of the myometrium, stimulating the release of interleukin-8 in choroidectid cells, increasing the sensitivity of the myometrium to PG. As a result of the action of the drug desquamation of the decidual membrane occurs and excretion of the fetal egg. It causes inhibition of ovulation, changes in the endometrium and prevents the implantation of a fertilized egg.

Pharmacokinetics

After a single oral intake, Cmax is achieved after 1.3 hours. Absolute bioavailability is 69%. In blood plasma, mifepristone binds 98% to proteins: albumin and acid α1-glycoprotein.

After the distribution phase, the excretion first occurs slowly, the concentration decreases 2 times between 12-72 hours, then more rapidly. T1 / 2 is 18 hours.

Indications

Emergency (postcoital) contraception within 72 hours after sexual intercourse without previous use of contraceptives or methods, and also in case of unsuccessful use (including an error with the use of the calendar method, unsuccessful interruption of sexual intercourse, rupture or slipping of the condom).

Contraindications

The presence in the anamnesis of hypersensitivity to mifepristone and / or accessory components;

Adrenal insufficiency;

Acute or chronic renal and / or liver failure;

Long-term therapy with glucocorticosteroid agents;

Porphyria;

anemia;

Violations of hemostasis (including the previous treatment with anticoagulants);

Presence of severe extragenital pathology;

pregnancy;

Lactation period.

pregnancy and lactation

The drug should not be used during pregnancy. Breastfeeding should be discontinued for 14 days after taking the drug.

Side effects

Bloody discharge from the genital tract, discomfort and pain in the lower abdomen; Exacerbation of inflammatory diseases of the uterus and appendages; Weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia, urticaria.

Interaction

It should avoid the use of NSAIDs (non-steroidal anti-inflammatory drugs) for 8-12 days after taking the drug.

Dosing and Administration

Inside. According to 1 table. For 2 hours before or 2 hours after ingestion (within the next 72 hours after unprotected sexual intercourse), regardless of the phase of the menstrual cycle.

Overdose

Symptoms: in cases of drug overdose, adrenal insufficiency may occur.

Precautionary measures

The drug does not protect against sexually transmitted diseases and AIDS; It is not recommended to use the drug as a planned, constant contraception after each sexual intercourse, and also monthly.

After applying as postcoital contraception and until the end of the current menstrual cycle, subsequent sexual acts are not recommended without the use of contraceptives. With further sexual intercourse, a barrier method of contraception should be used.

The dose of 10 mg is not enough to cause an abortion, so before its further use, a highly sensitive pregnancy test should be carried out, ensuring that the drug is used only in the absence of pregnancy. In the case of pregnancy, despite the use of the drug, it is recommended that it be interrupted by a medical or surgical method. If the patient decides to keep the pregnancy, it is impossible to completely eliminate the risk to the health of the unborn child.

Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. The effect of the drug on the ability to drive a car and work with mechanisms is not noted.

Terms of leave from pharmacies

On prescription.

storage Conditions

In dry, the 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 the expiry date printed on the package.