Vitaprost forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITAPROST FORTE

Composition:

Active ingredient:

1 suppository contains 0.008 g of lyophilized aqueous extract of bovine prostate gland obtained by extraction, calculated as peptides, not less than 0.008 g;
Excipients: glycine, polysorbate 80, pumpkin seed oil, hard fat.

Pharmaceutical form. Rectal suppositories.

Main physicochemical characteristics: suppositories ranging in color from light yellow with a greenish tint to green with a yellowish tint.

Pharmacotherapeutic group. Agents used in urology. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product is used for the treatment of prostate gland disorders. The extract of bovine prostate gland contained in the suppositories exerts organotropic action on the prostate gland (prostate-protective effect), exerts anti-inflammatory action by reducing edema and leukocyte infiltration of the gland, improves microcirculation and platelet-vascular hemostasis, and positively influences the functional activity of spermatozoa. It stimulates the activity of the humoral immune system and certain factors of the body's resistance, and affects the tone of the urinary bladder muscles, including the detrusor tone.

Pharmacokinetics.

The components of the medicinal product are effectively absorbed from the rectum. The extract of bovine prostate gland is cleaved by cellular proteases into amino acids and does not accumulate. The extract of bovine prostate gland and its metabolites are excreted in urine.

Clinical characteristics.

Indications.

• Chronic prostatitis;
• conditions before and after surgical interventions on the prostate gland;
• benign prostatic hyperplasia, age-related functional disorders of the prostate and associated urinary disorders;
• interoceptive copulative dysfunction.

Contraindications.

Hypersensitivity to the components of the drug, particularly to bovine proteins.

Interaction with other medicinal products and other types of interactions.

Drug interaction with the medicinal product VITAPROST FORTE has not been studied.

Special precautions for use.

Use with caution in patients with atherosclerosis and increased risk of thromboembolism. When high doses of the medicinal product are used for prolonged periods, blood coagulation time should be monitored. It is recommended to perform clinical tests assessing prostate gland activity (prostate-specific antigen) during treatment with this medicinal product. After administration of suppositories, hands should be thoroughly washed.

Use during pregnancy or breastfeeding.

The medicinal product is not intended for use in women.

Ability to affect reaction speed when driving or operating machinery. Data are lacking.

Dosage and Administration.

Remove the suppository from its packaging and insert deeply into the rectum.

Apply 1 suppository 1–2 times daily (in the morning and evening) for 5–10 days. The duration of treatment is determined by the nature and severity of the disease, the therapeutic effect achieved, and the type of therapy (monotherapy or combination treatment). If necessary, the course may be repeated after 1–6 months.

Children. Do not use in children.

Overdose.

Symptoms. There have been no reports of overdose with suppositories containing bull prostate extract. When high doses of the drug are used (over 400 mg daily for a prolonged period), possible symptoms include dyspeptic disorders, fatigue, general weakness, headache, creatinuria, increased creatine kinase activity, elevated levels of cholesterol and triglycerides, decreased serum concentrations of thyroxine and triiodothyronine, and increased urinary excretion of estrogens and androgens.
Treatment. There is no specific antidote. Treatment is symptomatic.

Side effects.

Allergic reactions: itching, skin hyperemia, skin rashes;

changes at the site of administration: burning sensation.

Reporting of suspected side effects

Reporting suspected side effects after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy to the State Expert Center of the Ministry of Health of Ukraine via the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions. Store in the original packaging to protect from light at a temperature of 2 to 8 °C. Keep out of reach and sight of children.

Packaging. 5 suppositories in a contour cell pack. 2 contour cell packs in a cardboard box.

Supply category. Over-the-counter.

Manufacturer. LLC "FZ "BIOPHARMA", Ukraine.

Manufacturer's address and location of business activity.

37, Kyivska Street, Bila Tserkva, Kyiv region, 09100, Ukraine.