Prostatex (Suppositories) Instructions for Use

Marketing Authorization Holder

Geropharm, LLC (Russia)

Manufactured By

Altpharm LLC (Russia)

Packaging and Quality Control Release

Altpharm LLC (Russia)

Quality Control Release

Geropharm LLC (Russia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Prostate extract (Grouping name)

Dosage Form

Prostatex

Rectal suppositories 10 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from white to white with a yellowish or grayish-brown tint, torpedo-shaped, of uniform consistency; the appearance of a white coating on the surface of the suppository and the presence of an air rod or funnel-shaped depression on the longitudinal section are allowed.

Excipients: hard fat.

5 pcs. – contour cell packs (1) – cardboard boxes.
5 pcs. – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Drug of animal origin used for prostate diseases

Pharmacotherapeutic Group

Drugs used in urology; other drugs used in urology

Pharmacological Action

A drug of animal origin. It has an organotropic effect on the prostate gland.

It reduces the degree of edema and leukocyte infiltration of the prostate gland, normalizes the secretory function of epithelial cells, increases the number of lecithin grains in the secretion of acini, and stimulates the muscle tone of the bladder.

It reduces thrombus formation, has antiplatelet activity, and prevents the development of thrombosis in the venules of the prostate gland. It normalizes the parameters of the prostate gland and ejaculate.

Pharmacokinetics

As a peptide substance, it is broken down by cellular proteases into amino acids. It does not have a cumulative effect.

Indications

Chronic prostatitis; benign prostatic hyperplasia; conditions before and after surgical interventions on the prostate gland.

ICD codes

Dosage Regimen

Use rectally in adult men only.

Administer one 50 mg suppository twice daily.

Insert the suppository deeply into the rectum after bowel evacuation.

Adhere to a treatment course of 15 to 30 days.

Repeat the course if necessary, as directed by a physician.

For chronic prostatitis, use as part of a comprehensive treatment plan.

For benign prostatic hyperplasia, use for symptomatic relief.

For perioperative care, use as prescribed before and after prostate surgery.

Perform standard monitoring for benign prostatic hyperplasia during therapy.

Discontinue use immediately and consult a physician if signs of an allergic reaction appear.

Adverse Reactions

Allergic reactions very rarely – urticaria.

Contraindications

Hypersensitivity to the active substance; age under 18 years.

Use in Pregnancy and Lactation

Not applicable.

Pediatric Use

Contraindicated for use under the age of 18 years.

Special Precautions

Before starting treatment for chronic prostatitis and, if necessary, during treatment, it is recommended to perform an analysis of the prostate secretion.

During the use of the drug for the treatment of benign prostatic hyperplasia, standard monitoring of this disease should be regularly performed. Before starting treatment, it is necessary to ensure that the pathology is benign.

Drug Interactions

Compatible with antibacterial drugs used to treat prostatitis.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.