Prostamol^® UNO (Capsules) Instructions for Use

Marketing Authorization Holder

Berlin-Pharma CJS (Russia)

Manufactured By

R.P. Scherer, GmbH & Co. KG (Germany)

ATC Code

G04CX02 (Serenoa repens fruits)

Active Substance

Serenoa repens (BP British Pharmacopoeia)

Dosage Form

Prostamol® UNO

Capsules 320 mg: 15, 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules soft gelatin, oval, with a light-protective two-tone red-black shell; the contents of the capsules are a greenish-brown liquid with a characteristic odor.

Excipients: succinylated gelatin, glycerol, purified water, titanium dioxide, iron oxide black, ponceau 4R.

15 pcs. – blisters (1) – cardboard packs.
15 pcs. – blisters (2) – cardboard packs.
15 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation, used for prostate gland diseases

Pharmacotherapeutic Group

Drugs used in urology; drugs for the treatment of benign prostatic hyperplasia; other drugs for the treatment of benign prostatic hyperplasia;

Pharmacological Action

Extract of the plant Serenoa repens. A non-competitive inhibitor of type 1 5-alpha-reductase. It disrupts the conversion of testosterone to dihydrotestosterone, which stimulates the proliferation of prostate cells. It has antiandrogenic properties that are selectively manifested at the level of the prostate gland.

It does not cause changes in the hormonal balance in the blood, does not affect the hypothalamic-pituitary system. It also has an anti-inflammatory effect, reducing the synthesis of prostaglandins by inhibiting the activity of phospholipase A-2 and the release of arachidonic acid.

It reduces capillary permeability and vascular stasis, reduces swelling and the inflammatory process in the prostate, eliminates compression of the bladder neck and urethra, improving urodynamic parameters. It has antiestrogenic activity.

It helps to reduce the intensity of symptoms of benign prostatic hyperplasia and reduce its size. It does not reduce potency in men, does not affect the level of PSA in the blood plasma.

Pharmacokinetics

Due to the complex composition of the Serenoa repens extract, all components cannot be traced using markers in pharmacokinetic studies.

Indications

Benign prostatic hyperplasia (stage I and II). Elimination of dysuric symptoms (urination disorder, nocturnal pollakiuria, pain syndrome, etc.) as part of the complex therapy of chronic prostatitis.

ICD codes

Dosage Regimen

Take orally with a sufficient amount of water.

Administer one capsule (320 mg)once daily.

Take the capsule during or after a meal to minimize potential gastrointestinal discomfort.

The duration of treatment is determined individually based on diagnostic findings and clinical response.

Continue therapy for several months as symptoms of benign prostatic hyperplasia regress slowly.

Adhere to the prescribed course; do not interrupt treatment without consulting a physician.

For chronic prostatitis, use as part of a comprehensive therapeutic regimen.

Regular medical supervision is required to assess efficacy and the need for repeated courses.

Adverse Reactions

Possible allergic reactions.

Rarely nausea, heartburn, vomiting, diarrhea, gastralgia (when taken on an empty stomach).

Contraindications

Hypersensitivity to saw palmetto; children and adolescents under 18 years of age.

With caution in patients with gastrointestinal diseases.

Use in Pregnancy and Lactation

Not applicable.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

It is used only for the treatment of adult men; it is not used in women and children.

Before starting a course of treatment, it is necessary to make sure that the pathology is benign. Patients taking saw palmetto preparations for a long time should undergo regular medical examination.

Patients with a large volume of residual urine and/or significantly reduced urine flow should be regularly monitored for the detection of obstructive uropathy.

If the patient’s condition worsens while using the product and symptoms such as arterial hypotension, impaired coordination of movements, dizziness, fainting, traces of blood in the urine, or acute urinary retention appear, it is necessary to stop taking the product and consult a doctor.

Drug Interactions

No antagonism of the saw palmetto extract and drugs from the groups most commonly used in the treatment of dysuria caused by benign prostatic hyperplasia has been identified: antibiotics, uroantiseptics and anti-inflammatory agents.

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.