Zhenale^® (Tablets) Instructions for Use

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Contact Information

IZVARINO PHARMA LLC (Russia)

ATC Code

G03XB01 (Mifepristone)

Active Substance

Mifepristone (Rec.INN)

Dosage Form

Zhenale®

Tablets 10 mg: 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow with a greenish tint, round, biconvex.

Excipients: lactose monohydrate – 123.4 mg, potato starch – 22 mg, povidone K25 – 6 mg, sodium starch glycolate, type A – 5 mg, magnesium stearate – 1.6 mg.

1 pc. – blister packs (1) – cardboard boxes.
1 pc. – blister packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Antigestagenic drug. Postcoital oral contraceptive

Pharmacotherapeutic Group

Sex hormones and modulators of the genital system; other sex hormones and modulators of the genital system; progesterone receptor modulators

Pharmacological Action

Synthetic steroidal antigestagenic drug. It blocks the action of progesterone at the receptor level and has no gestagenic activity. Antagonism with glucocorticoids has been noted due to competition at the level of receptor binding.

Depending on the phase of the menstrual cycle, it increases the contractility of the myometrium by stimulating the release of interleukin-8 in choriodecidual cells, increasing the sensitivity of the myometrium to prostaglandins. As a result of the drug’s action, desquamation of the decidual membrane and expulsion of the ovum occur. It inhibits ovulation, changes the endometrium, and prevents the implantation of a fertilized egg.

Pharmacokinetics

Absorption and Distribution

After a single oral administration, C_max is reached after 1.3 hours. The absolute bioavailability is 69%. In blood plasma, Mifepristone is 98% bound to proteins: albumin and acidic α1-glycoprotein.

Elimination

After the distribution phase, elimination initially occurs slowly, with the concentration halving between 12-72 hours, then more rapidly. T_1/2 is 18 hours.

Indications

• Emergency (postcoital) contraception within 72 hours after sexual intercourse without prior use of contraceptive means or methods, as well as in case of their unsuccessful application (including error in using the calendar method, coitus interruptus failure, condom breakage or slippage).

ICD codes

Dosage Regimen

Take one 10 mg tablet orally as a single dose for emergency contraception.

Administer the tablet within 72 hours (3 days) following unprotected sexual intercourse or contraceptive failure.

Ingest the tablet either 2 hours before or 2 hours after a meal to ensure optimal absorption.

This regimen is effective regardless of the menstrual cycle phase.

Do not use this product for routine, permanent contraception.

After use, employ a barrier method of contraception for any subsequent sexual intercourse until the next menstrual period begins.

This drug is not intended to terminate an established pregnancy.

Adverse Reactions

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

Digestive system: nausea, vomiting, diarrhea.

CNS: headache, dizziness.

Other: weakness, hyperthermia, urticaria.

Contraindications

• Acute or chronic renal and/or hepatic failure;
• Long-term therapy with glucocorticoid agents;
• Porphyria;
• Anemia;
• Hemostasis disorders (including previous treatment with anticoagulants);
• Presence of severe extragenital pathology;
• Adrenal insufficiency;
• Pregnancy;
• Lactation period;
• History of hypersensitivity to mifepristone and/or excipients.

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

Contraindicated in acute or chronic hepatic failure.

Use in Renal Impairment

Contraindicated in acute or chronic renal failure.

Geriatric Use

Not used.

Special Precautions

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

It is not recommended to use the drug as a routine, permanent contraceptive after each sexual act, or monthly.

After use as a postcoital contraceptive and until the end of the current menstrual cycle, subsequent sexual intercourse without the use of contraceptive means is not recommended. For further sexual acts, a barrier method of contraception should be used.

The 10 mg dose of the drug is insufficient to cause an abortion, so before its further use, a highly sensitive pregnancy test should be performed to ensure that this drug is used only in the absence of pregnancy. In case of pregnancy occurring despite the use of the drug, its termination by medication or surgery is recommended. If the patient decides to continue the pregnancy, it is impossible to completely exclude the risk to the health of the unborn child.

Effect on the ability to drive vehicles and machinery

No effect of the drug on the ability to drive a car and work with machinery has been noted.

Overdose

In cases of drug overdose, adrenal insufficiency may be observed.

Drug Interactions

The use of NSAIDs should be avoided for 8-12 days after taking the drug.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.