Prostatoff (Capsules) Instructions for Use

ATC Code

G04CX02 (Serenoa repens fruits)

Active Substance

Serenoa repens (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Herbal preparation, used for prostate gland diseases

Pharmacotherapeutic Group

Benign prostatic hyperplasia treatment agent of plant origin

Pharmacological Action

Extract of the fruits of the Serenoa repens plant. 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 and does not affect the hypothalamic-pituitary system. It also has an anti-inflammatory effect by reducing the synthesis of prostaglandins through inhibition of phospholipase A-2 activity 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 and does not affect the level of PSA in the blood plasma.

Pharmacokinetics

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

Indications

Benign prostatic hyperplasia (stages 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 one capsule orallytwice daily, in the morning and in the evening.

Administer the capsules with a sufficient amount of water during a meal to reduce the potential for gastrointestinal adverse reactions.

The standard treatment duration is three months.

Continue the course of therapy for the full prescribed duration, even if symptom improvement occurs earlier.

The need for a subsequent treatment course must be determined by a physician based on a follow-up diagnostic examination and clinical assessment.

Do not exceed the recommended daily dose of two capsules.

For patients with gastrointestinal diseases, administer the capsules with particular caution and always with food.

If a dose is missed, take it as soon as remembered unless it is almost time for the next scheduled dose. Do not take a double dose to make up for a forgotten one.

Adverse Reactions

Possible allergic reactions.

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

Contraindications

Hypersensitivity to Serenoa repens; 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 ensure that the pathology is benign. Patients taking Serenoa repens 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 has been identified between the Serenoa repens extract and drugs from the groups most commonly used in the treatment of dysuria caused by benign prostatic hyperplasia: antibiotics, uroantiseptics, and anti-inflammatory agents.

Storage Conditions

Store at 15°C (59°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.