Prostatilen

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSTATILEN® (PROSTATILEN®)

Composition:

Active substance: prostathelen;

1 suppository contains 30 mg of prostathelen (0.03 g);

Excipients: dimethyl sulfoxide, polyethylene oxide 1500.

Dosage form. Rectal suppositories.

Main physicochemical properties: cream-colored or cream-colored with a grayish tint, bullet-shaped suppositories with a specific odor. Marbling is permissible.

Pharmacotherapeutic group. Agents used in benign prostatic hyperplasia. ATC code G04C X.

Pharmacological properties.

Pharmacodynamics.

Prostatielen exerts organotropic action on the prostate gland (prostate-protective effect). The drug reduces edema and leukocyte infiltration of the prostate gland, improves microcirculation and platelet-vascular hemostasis, and positively affects the functional activity of spermatozoa.

Prostatielen stimulates the activity of the humoral immune system and certain factors of the body's resistance. The drug modulates antibody production and enhances antimicrobial activity of neutrophils, and has anti-inflammatory action.

Prostatielen also affects the tone of the urinary bladder muscles, including the detrusor tone.

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Clinical characteristics.

Indications.

Prevention and treatment of chronic prostatitis, benign prostatic hyperplasia, and complications following prostate surgery. The medicinal product is indicated for sexual disorders, male infertility, and urinary voiding disturbances.

Contraindications.

Individual hypersensitivity to components of the medicinal product or to proteins of cattle.

Interaction with other medicinal products and other forms of interaction.

There is no data on interactions.

Special precautions.

Use with caution in patients with atherosclerosis and an increased risk of thromboembolism. When administering high doses of the drug for prolonged periods, blood coagulation time should be monitored.

Testing for clinical markers of prostate gland activity (prostate-specific antigen) is recommended.

After using suppositories, hands should be thoroughly washed.

The drug is intended for use in men only.

Use during pregnancy or breastfeeding.

This medicinal product is not intended for use in women.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Method of Administration and Dosage.

Before using the suppository, it is necessary to:

• tear off one suppository in the primary packaging along the perforation line of the blister pack;
• pull the edges of the film in opposite directions, tearing it apart, and remove the suppository from the primary packaging.

Insert the suppository deeply into the rectum. Administer 1 suppository 1–2 times daily (in the morning and evening) for 5–10 days.

The duration of treatment is determined by the physician depending on the nature and severity of the disease, the therapeutic effect achieved, and the type of therapy (monotherapy or combination treatment).

Children.

The drug is not intended for use in children.

Overdose.

Cases of overdose with prostatalene suppositories have not been reported.

When high doses of the drug are used (over 400 mg per day for a prolonged period), dyspeptic disorders, fatigue, general weakness, headache, creatinuria, increased creatine kinase activity, elevated cholesterol and triglyceride levels, decreased serum concentrations of thyroxine and triiodothyronine, and increased urinary excretion of estrogens and androgens may occur. There is no specific antidote. Treatment is symptomatic.

Adverse reactions.

Local site reactions, hypersensitivity reactions, including redness, swelling, itching.

Shelf life.

3 years.

Storage conditions.

Keep in a place inaccessible to children, at a temperature not exceeding 25 °C.

Packaging. 5 suppositories per blister; 1 or 2 blisters per carton.

Availability category.

Over-the-counter.

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's name and address of business location.

36 Severina Pototskogo Street, Kharkiv, Kharkiv region, 61115, Ukraine.