Gynepriston^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

OHFK, JSC (Russia)

ATC Code

G03XB01 (Mifepristone)

Active Substance

Mifepristone (Rec.INN WHO registered)

Dosage Form

Gynepriston®

Tablets 10 mg: 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow to light yellow with a greenish tint, round, flat-cylindrical, with a bevel on both sides.

Excipients: microcrystalline cellulose, sodium carboxymethyl starch, calcium stearate.

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

Clinical-Pharmacological Group

Antigestagenic drug. Postcoital oral contraceptive

Pharmacotherapeutic Group

Antigestagen

Pharmacological Action

Synthetic steroidal antigestagenic drug (blocks the action of progesterone at the receptor level), does not possess gestagenic activity. Antagonism with glucocorticoids is noted (due to competition at the level of receptor binding).

It increases the contractility of the myometrium by stimulating the release of interleukin-8 in choriodecidual cells and increasing the sensitivity of the myometrium to prostaglandins. Depending on the phase of the menstrual cycle, it inhibits ovulation, changes the endometrium, and prevents the implantation of a fertilized egg.

Pharmacokinetics

Absorption

After a single oral administration at a dose of 600 mg, C_max is achieved after 1.3 h and is 1.98 mg/l. The absolute bioavailability is 69%.

Distribution

Binding to plasma proteins (with albumin and acidic α₁-glycoprotein) is 98%.

Elimination

T_1/2 – 18 h. Elimination occurs in two phases: first, a slow elimination of the drug (the plasma concentration of mifepristone decreases by 2 times between 12-72 h), then a rapid elimination phase.

Indications

• Emergency postcoital contraception (after unprotected sexual intercourse or if the contraceptive method used cannot be considered reliable).

ICD codes

Dosage Regimen

Take one 10 mg tablet orally as a single dose.

Administer the tablet within 72 hours following unprotected sexual intercourse or a known or suspected contraceptive failure.

For optimal absorption, refrain from eating for 2 hours before and 2 hours after taking the tablet.

Gynepriston^® can be used during any phase of the menstrual cycle.

This regimen is for emergency postcoital contraception only and is not intended for routine use.

If vomiting occurs within two hours of administration, consult a physician as a repeat dose may be required.

Following administration, expect the next menstrual period at the expected time or within a few days; if a delay of more than 5-7 days occurs, rule out pregnancy.

This method does not terminate an established pregnancy.

Adverse Reactions

Digestive system: nausea, vomiting.

CNS: dizziness, headache.

Reproductive system: bloody discharge from the genital tract, menstrual cycle disorders.

Allergic reactions: urticaria.

Other: feeling of discomfort in the lower abdomen, weakness, hyperthermia.

Contraindications

• Adrenal insufficiency;
• Long-term use of glucocorticoids;
• Acute or chronic renal failure;
• Hepatic failure;
• Presence of severe extragenital pathology;
• History of hypersensitivity to mifepristone.

With caution, the drug should be prescribed for hemostasis disorders (including previous treatment with anticoagulants), chronic obstructive pulmonary diseases (including bronchial asthma), severe arterial hypertension, cardiac arrhythmias, chronic heart failure.

Use in Pregnancy and Lactation

Gynepriston^® is contraindicated for use during pregnancy.

Breastfeeding should be discontinued for 14 days after taking the drug.

Use in Hepatic Impairment

Contraindicated in hepatic failure.

Use in Renal Impairment

Contraindicated in acute or chronic renal failure.

Pediatric Use

No data.

Geriatric Use

No data.

Special Precautions

Gynepriston^® is not recommended for regular use as a routine permanent contraceptive.

The use of Gynepriston^® does not protect against sexually transmitted diseases and AIDS.

Effect on the ability to drive vehicles and mechanisms

Currently, there are no data indicating that the drug may affect the ability to drive a car and other mechanisms.

Overdose

Taking Gynepriston^® in doses up to 2 g does not cause adverse reactions.

Symptoms: in case of drug overdose, adrenal insufficiency may be observed.

Drug Interactions

The use of NSAIDs should be avoided.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life is 5 years. Do not use after the expiration date stated on the packaging.

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.