Permixon^® (Capsules) Instructions for Use

Marketing Authorization Holder

Pierre Fabre Medicament (France)

Manufactured By

Pierre Fabre Medicament Production (France)

ATC Code

G04CX02 (Serenoa repens fruits)

Active Substance

Serenoa repens (BP British Pharmacopoeia)

Dosage Form

Permixon®

Capsules 160 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules of light green color, size No. 1; the capsule contents are a paste-like substance of a greenish color, possibly a crumbling waxy mass with lumps of a greenish-yellow color, with a characteristic odor.

Excipients: macrogol 10000 – 290 mg.

Capsule shell composition: yellow iron oxide (E172) – 0.38 mg, indigotine (E132) – 0.02 mg, titanium dioxide – 3.08 mg, gelatin – up to 77 mg.

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

Clinical-Pharmacological Group

Herbal preparation used for functional urinary disorders associated with benign prostatic hyperplasia

Pharmacotherapeutic Group

Herbal remedy for benign prostatic hyperplasia

Pharmacological Action

Extract of Serenoa repens fruits. 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 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, 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 (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 one capsule of Permixon^® 160 mg twice daily, in the morning and evening.

Administer the capsules with meals to minimize potential gastrointestinal adverse reactions such as gastralgia.

The standard duration of treatment is determined by the physician based on symptomatic response and clinical findings; long-term therapy may be required for sustained effect.

Undergo a diagnostic examination before initiation to confirm benign prostatic hyperplasia and exclude prostate malignancy.

Attend regular medical examinations during prolonged use to monitor therapeutic efficacy and prostate status.

Discontinue use and consult a physician immediately if symptoms worsen or if acute urinary retention, hematuria, dizziness, or fainting occurs.

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

Used only for the treatment of adult men; 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 during the use of 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 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 2°C (36°F) to 30°C (86°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.