Novoprost (Suppositories) Instructions for Use

Marketing Authorization Holder

Novoprost, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Prostate extract (Grouping name)

Dosage Form

Novoprost

Rectal suppositories 10 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

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

Excipients: hard fat (Witepsol brand H15, Suppocire brand NA15) – 0.6 g, hard fat (Witepsol brand W35, Suppocire brand NAS50) – sufficient quantity to obtain a suppository weighing 1.25 g.

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

Clinical-Pharmacological Group

Drug used for diseases of the prostate gland

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 venule thrombosis in 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

This medication is for adult men only. Use rectally. The standard dose is one 10 mg suppository administered twice daily.

Insert the suppository deeply into the rectum after bowel evacuation. Follow a consistent schedule, typically in the morning and evening.

The standard treatment course is 10 days. A second course may be administered if clinically indicated, following a consultation with a physician.

For pre-operative and post-operative preparation for prostate surgery, use one suppository twice daily for 3-5 days before the scheduled intervention and for 10-14 days after surgery, as directed.

Before initiating treatment for benign prostatic hyperplasia, confirm the benign nature of the condition. Perform standard monitoring for this disease regularly during therapy.

Before and during treatment for chronic prostatitis, analyze prostate secretion as recommended by a physician.

Discontinue use and seek medical advice if severe local irritation or signs of an allergic reaction occur.

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 18 years of age.

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.