Bioprost^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Intelfarm CJS (Russia)

Manufactured By

Altpharm LLC (Russia)

Contact Information

INTELFARM CJSC (Russia)

ATC Code

G04CX (Other preparations for the treatment of benign prostatic hyperplasia)

Dosage Form

Bioprost®

Rectal suppositories 500 mg+100 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories of a greenish color, torpedo-shaped, waxy, brittle when broken, with a specific smell of thymol.

Suppository base witepsol grades H-15 and W-35 up to 2 g.

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

Clinical-Pharmacological Group

Herbal preparation, used for prostate gland diseases

Pharmacotherapeutic Group

Drugs used in urology; other drugs used in urology

Pharmacological Action

A combined preparation. It has anti-inflammatory, bacteriostatic, and analgesic action. It has a positive effect on the course of the pathological process in benign prostatic hyperplasia. It reduces pain in the prostate area and improves urination.

Pumpkin seed oil contains a large amount of unsaturated fatty acids, antioxidants, and trace elements.

Thymol has a pronounced antibacterial effect on microorganisms and is highly active against coccal flora.

The rectal route of drug administration in chronic prostatitis is preferable, considering that the active substances enter the bloodstream, bypassing the liver. Thus, a rapid onset of the therapeutic effect is ensured and the possibility of drug inactivation in the digestive tract and liver is excluded, which leads to the creation of a therapeutic concentration of active substances in the prostate secretion and tissue. Against the background of the drug application, the inflammatory reaction from the prostate tissue decreases.

Pharmacokinetics

Bioprost^® belongs to the group of multicomponent herbal preparations for which pharmacokinetic studies are not conducted.

Indications

• Chronic bacterial and abacterial prostatitis for reducing inflammation, pain in the prostate area, and improving urination.
• Benign prostatic hyperplasia for symptomatic therapy to alleviate urinary difficulties and other associated symptoms.

ICD codes

Dosage Regimen

Administer one suppository into the rectum one to two times daily for a duration of 14 days.

Adhere strictly to the prescribed frequency and treatment period. A repeated course of therapy may be prescribed by a physician if deemed necessary based on clinical evaluation.

Adverse Reactions

Adverse reactions are infrequent and primarily involve allergic reactions such as skin rash, itching, or localized irritation at the application site.

Discontinue use immediately and consult a healthcare professional if any signs of hypersensitivity or other undesirable effects manifest.

Contraindications

• Hypersensitivity to pumpkin seed oil, thymol, or any other component of the suppository base, including witepsol.
• Do not use in patients with a known history of allergic reactions to the product’s ingredients.

Overdose

No cases of overdose with this preparation have been reported to date. Given the nature of the rectal administration and the drug’s composition, the risk of systemic overdose is considered low.

In the event of suspected excessive use, symptomatic and supportive measures are recommended. There is no specific antidote.

Drug Interactions

No clinically significant drug interactions have been observed or reported with the concomitant use of this preparation and other medications.

The potential for enhancement or reduction of the pharmacological action of other drugs is considered negligible. Continue to inform your physician about all concomitant therapies.

Storage Conditions

The drug should be stored in a place protected from light, out of the reach of children, at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

Shelf Life

The shelf life is 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.