Expiration date: 04/2025

Release form and composition: 

Tablets from pale yellow to light yellow color with a greenish tinge, Valium, with a facet.

1 tablet contains mifepristone 50 mg

Excipients: lactose, microcrystalline cellulose, povidone, potato starch, sodium carboxymethyl starch, magnesium stearate.

Pharmachologic effect:

A synthetic steroid drug antigestagens. Blocks the action of progesterone at the receptor level. Gestagenic activity is not. There antagonism with GCS (due to competition on the level of communication with the receptors).

A key role in the pathogenesis of uterine leiomyoma play sex hormones, especially progesterone. The blockade of progesterone receptors may contribute to both the inhibition of tumor growth and reduction of fibroids and uterine size.

Pharmacokinetics:

Suction

After taking the drug inside the Cmax is achieved in 1.3 hours. The absolute bioavailability is 69%.

Distribution

Binding to plasma proteins is 98% (albumin and sour apha1-glycoprotein).

breeding

Excretion is carried out in two phases: first, a slow elimination of the drug for 12-72 h (Mifepristone concentration in blood plasma decreases by 2 times), followed by rapid elimination phase. T1 / 2 - 18 hours.

Testimony:

- Uterine leiomyoma (up to 12 weeks gestation).

Dosage and administration:

The drug is administered orally in a single dose of 50 mg (1 tab.) 1 times / day. The course of treatment - 3 months.

Side effects:

From the digestive system: nausea, vomiting, diarrhea.

CNS: dizziness, headache.

From the reproductive system: menstrual disorders, amenorrhea.

Allergic reactions: urticaria.

Other: fatigue, pyrexia, pain and discomfort in the lower abdomen.

Contraindications:

• pregnancy
  
• Lactation (breastfeeding)
  
• Adrenal insufficiency and long-term GCS therapy
  
• Acute or chronic renal failure
  
• Acute or chronic liver failure
  
• porphyria
  
• anemia
  
• Hemostasis disorders (including previous treatment with anticoagulants)
  
• Pelvic inflammatory disease
  
• Severe extragenital pathology
  
• The location of the submucosal fibroids
  
• The value of uterine leiomyoma in excess of 12 weeks of pregnancy
  
• Ovarian tumors
  
• Endometrial hyperplasia
  
• Hypersensitivity to mifepristone.
  

With care use in patients with COPD (including bronchial asthma), severe hypertension, arrhythmia, congestive heart failure.

Pregnancy and lactation:

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Special instructions:

Patients with prosthetic heart valves or with infective endocarditis of Gynestril administration should conduct preventive antibiotic therapy.

Overdose:

When taken at doses up to 2 g of the drug does not cause undesirable reactions.

Symptoms: adrenal insufficiency may occur.

Treatment: symptomatic therapy if necessary.

Drug Interactions:

joint application with NSAIDs should be avoided.

When concomitantly with corticosteroids Gynestril administration last dose should be increased, because possible reduction of their effects.

Conditions and terms:

List A. The preparation should be stored in a dry, dark, place inaccessible to children at temperature not above 30 ° C. Shelf life - 3 years. Do not use after the expiration date printed on the package.