Universal reference book for medicines
Product name: GENALE ® (ZHENALE)

Active substance: mifepristone

Type: Anti-gestagenic drug

Manufacturer: ИЗВАРИНО ФАРМА (Russia)
Composition, form of production and packaging
Tablets of
light yellow with a greenish shade of color, round, biconcave.

1 tab.

mifepristone 10 mg

Excipients: lactose monohydrate - 123.4 mg, potato starch - 22 mg, povidone K25 - 6 mg, sodium carboxymethyl starch - 5 mg, magnesium stearate - 1.6 mg.

1 PC.
- packings of cellular contour (1) - packs cardboard.
1 PC.
- packings cellular planimetric (2) - packs cardboard.
1 PC.
- cans of orange glass (1) - packs of cardboard.
2 pcs.
- cans of orange glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

Synthetic steroidal anti-progestagenic drug.
It blocks the action of progesterone at the level of receptors, does not possess gestagenic activity. Antagonism with GCS was noted due to competition at the level of communication with receptors.
Depending on the phase of the menstrual cycle, it increases the contractility of the myometrium, stimulating the release of interleukin-8 in choroid-epidural cells, increasing the sensitivity of the myometrium to the prostaglandins.
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

Suction and distribution

After a single intake of C max is achieved after 1.3 hours. Absolute bioavailability is 69%.
In blood plasma, mifepristone binds 98% to proteins: albumin and acidic 1-glycoprotein.
Excretion

After the distribution phase, the excretion first occurs slowly, the concentration decreases 2 times between 12-72 hours, then more rapidly.
T 1/2 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 their unsuccessful application (including error in the use of the calendar method, unsuccessful interruption of sexual intercourse, rupture or slipping of the condom).

DOSING MODE

It should be taken 1 tab.
inside 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.
SIDE EFFECT

From the genital system: bloody discharge from the genital tract, discomfort and pain in the lower abdomen, exacerbation of inflammatory diseases of the uterus and appendages.

From the digestive system: nausea, vomiting, diarrhea.

From the side of the central nervous system: headache, dizziness.

Other: weakness, hyperthermia, urticaria.

CONTRAINDICATIONS

acute or chronic renal and / or hepatic insufficiency;

- long-term therapy with glucocorticosteroid agents;

- porphyria;

- Anemia;

- violations of hemostasis (including the previous treatment with anticoagulants);

- presence of severe extragenital pathology;

- adrenal insufficiency;

- Pregnancy;

- lactation period;

- a history of hypersensitivity to mifepristone and / or ancillary components.

PREGNANCY AND LACTATION

The drug should not be used during pregnancy.
Breastfeeding should be discontinued for 14 days after taking the drug.
APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in acute or chronic renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in acute or chronic hepatic insufficiency.

APPLICATION IN ELDERLY PATIENTS

Not applicable.

SPECIAL INSTRUCTIONS

The drug does not protect against sexually transmitted diseases and AIDS.

It is not recommended to use the drug as a planned, permanent contraception after each sexual intercourse, as well as 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 abortion, so before its further use, a highly sensitive pregnancy test should be conducted to ensure 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 exclude the risk to the health of the unborn child.
Impact on the ability to drive vehicles and manage mechanisms

The effect of the drug on the ability to drive and work with machinery has not been noted.

OVERDOSE

In cases of drug overdose, adrenal insufficiency may occur.

DRUG INTERACTION

It should avoid the use of NSAIDs within 8-12 days after taking the drug.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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