Pencroftonum^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pentcroft Pharma, CJS (Russia)

Manufactured By

Pharmsintez PJSC (Russia)

Or

Biokhimik, JSC (Russia)

Contact Information

PHARMSINTEZ CJSC (Russia)

ATC Code

G03XB01 (Mifepristone)

Active Substance

Mifepristone (Rec.INN WHO registered)

Dosage Form

Pencroftonum®

200 mg tablets: 3 pcs.

Dosage Form, Packaging, and Composition

Excipients: lactose, corn starch, microcrystalline cellulose, calcium stearate, aerosil.

3 pcs. – polymer jars (1) – cardboard packs.
3 pcs. – dark glass jars (1) – cardboard packs.
3 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Antigestagenic drug for termination of early uterine pregnancy, for preparation and induction of labor

Pharmacotherapeutic Group

Antigestagen

Pharmacological Action

Antiprogesterone drug. The action of Pencroftonum^® is due to the blocking of progesterone activity at the receptor level.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract and reaches C_max values in blood plasma. The degree of binding to plasma proteins is high. T_1/2 is about 18 h.

Indications

• Medical termination of uterine pregnancy at early stages (up to 42 days of amenorrhea), confirmed by a pregnancy test;
• Preparation for childbirth and induction of labor in full-term pregnancy.

ICD codes

Dosage Regimen

The drug is prescribed orally at a dose of 600 mg (3 tablets of 200 mg) in a single dose in the presence of a doctor.

After taking the drug, the patient should be under the supervision of medical personnel for at least 2 hours.

A clinical examination with ultrasound and determination of the β-hCG level in the blood is performed after 8-14 days. In the absence of the drug’s effect on the 14th day (incomplete abortion or ongoing pregnancy), the patient should undergo vacuum aspiration followed by histological examination of the aspirate.

The drug can only be used in an institution that has highly qualified, certified, trained medical personnel and the necessary resuscitation equipment.

Adverse Reactions

Procedure-related: possible heavy bleeding, which may require immediate surgical intervention (curettage); sometimes – pain in the lower abdomen; inflammatory processes of the uterus and appendages.

Pencroftonum^®-related: rarely – discomfort in the lower abdomen, weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia.

Contraindications

• Suspected ectopic pregnancy;
• Pregnancy exceeding 42 days of amenorrhea;
• Chronic adrenal insufficiency;
• Long-term corticosteroid therapy;
• Anemia;
• Hemorrhagic disorders;
• Treatment with anticoagulants;
• Inflammatory diseases of the vagina;
• Pregnancy that occurred while using intrauterine contraception or after discontinuation of hormonal contraception;
• Presence of a uterine scar;
• Uterine fibroids;
• Smoking women over 35 years of age;
• Hypersensitivity to mifepristone.

Use in Pregnancy and Lactation

Patients should be informed that in case of ineffectiveness of this method (ongoing pregnancy), the pregnancy should be terminated by another method, because the drug may affect the fetus.

If it is necessary to use Pencroftonum^® during lactation, breastfeeding should be discontinued for 14 days after taking the drug.

The use of the drug requires compliance with all preparation related to abortion. Precautions should be taken when taking synthetic prostaglandins.

Use in Hepatic Impairment

It is not recommended to prescribe Pencroftonum^® to patients with hepatic insufficiency.

Use in Renal Impairment

It is not recommended to prescribe Pencroftonum^® to patients with renal insufficiency.

Special Precautions

The drug should be used with particular caution in patients of the following high-risk groups: with bronchial asthma, COPD, cardiovascular diseases or predisposition to them.

It is not recommended to prescribe Pencroftonum^® to patients with renal and hepatic insufficiency.

Overdose

In case of an overdose of Pencroftonum^®, acute adrenal insufficiency may develop.

Drug Interactions

Concomitant use of Pencroftonum^® with NSAIDs (including acetylsalicylic acid) should be avoided, as they may affect the effectiveness of the drug.

Storage Conditions

List A. The drug should be stored in a dry, light-protected place, out of reach of children, at a temperature from 18°C (64.4°F) to 22°C (71.6°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is supplied only to obstetric-gynecological medical institutions belonging to the state healthcare system, municipal and private institutions that have licenses for this type of activity.

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.