Prostopine (Suppositories) Instructions for Use

Marketing Authorization Holder

Binnopharm JSC (Russia)

Contact Information

ALIUM JSC (Russia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Dosage Form

Prostopine

Rectal suppositories: 10 or 15 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories of a torpedo-like shape, from greenish-yellow to greenish-brown in color with dark inclusions, with a characteristic odor.

Excipients: beeswax – 0.06 g, anhydrous lanolin – 0.12 g, cocoa butter – 1.91 g.

5 pcs. – contour cell packs (2) – cardboard boxes.
5 pcs. – contour cell packs (3) – cardboard boxes.

Clinical-Pharmacological Group

A drug with anti-inflammatory and wound-healing action for use in urology and proctology

Pharmacotherapeutic Group

Remedy for chronic prostatitis

Pharmacological Action

A combined drug that has anti-inflammatory and wound-healing effects.

Indications

Use as part of a complex therapy for the management of the following conditions.

• Chronic prostatitis.
• Hemorrhoids.
• Anal fissures.

ICD codes

Dosage Regimen

Administer one suppository rectally once daily, preferably at bedtime.

Ensure prior bowel evacuation, either naturally or via a cleansing enema, before insertion.

The standard treatment course lasts from 15 to 30 days.

A repeat course may be considered after an interval of 2 to 3 months, subject to medical consultation and approval.

Adverse Reactions

The primary risk associated with use is the development of allergic reactions.

These reactions are a potential side effect, particularly in individuals with known sensitivities.

Discontinue use immediately and seek medical attention if any signs of hypersensitivity, such as skin rash, itching, or swelling, occur.

Contraindications

Do not use under the following conditions.

• Known hypersensitivity or allergy to any bee product, including propolis, bee bread, royal jelly, pollen, honey, beeswax, or lanolin.
• Patients in childhood.
• During pregnancy.
• Throughout the lactation period.

Drug Interactions

Formal studies on drug interactions have not been conducted.

Concurrent use with other rectally administered medicinal products is not recommended.

Inform your physician about all medications you are taking, including prescription, over-the-counter, and herbal products.

Overdose

Cases of overdose have not been reported to date.

In the event of suspected excessive use, symptomatic and supportive measures are recommended.

Discontinue the drug and consult a healthcare professional if any adverse effects are experienced due to unintended overuse.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation.

Pediatric Use

The use of the drug is contraindicated in childhood.

Storage Conditions

The drug should be stored out of the reach of children at a temperature between 2°C (35.6°F) and 8°C (46.4°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is available without a 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.