Palprostes (Capsules) Instructions for Use

Marketing Authorization Holder

TAD PHARMA GmbH (Germany)

Manufactured By

Swiss Caps AG (Switzerland)

Labeled By

SWISS CAPS, AG (Germany)

ATC Code

G04CX02 (Serenoa repens fruits)

Active Substance

Serenoa repens (BP British Pharmacopoeia)

Dosage Form

Palprostes

Capsules 320 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

15 pcs. – blisters (2) – carton packs.
15 pcs. – blisters (4) – carton packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Herbal remedy for the treatment of prostate adenoma

Pharmacological Action

Saw palmetto fruit extract reduces edema and obstruction in the periglandular, proper stromal, and glandular tissues of the prostate gland.

It increases the activity of the enzyme 3α-hydroxysteroid oxidoreductase (3α-HSOR), involved in the metabolism of dihydrotestosterone (DHT), and the enzyme creatine kinase in the prostate tissue.

An increase in the content of myristic and lauric acids, contained in the Palprostes preparation, can be observed in the prostate tissue.

In vitro experiments have demonstrated suppression of 5α-reductase activity under the influence of these acids.

Pharmacokinetics

Studies of pharmacokinetic properties have not been conducted because saw palmetto fruit extract is a multicomponent mixture, and studying its pharmacokinetics is not feasible.

Indications

• benign prostatic hyperplasia (stage I and II);
• As part of complex therapy for chronic prostatitis to eliminate dysuric symptoms (urination disorder, nocturnal pollakiuria, pain syndrome, etc.).

ICD codes

Dosage Regimen

Orally, daily, preferably at the same time, after meals, 1 capsule once a day. The capsules should be swallowed whole, without chewing, with a small amount of liquid.

The drug Palprostes is recommended to be taken long-term. The duration of the treatment course is at least 3 months. The optimal regimen and repeated courses of treatment are determined and prescribed by the doctor individually in each case based on the patient’s diagnostic examination.

Adverse Reactions

From the digestive system gastrointestinal disorders (nausea, vomiting, abdominal pain, diarrhea).

From the cardiovascular system arterial hypotension, fainting.

From the nervous system impaired coordination of movements.

Other allergic reactions.

Contraindications

• Children under 18 years of age (lack of clinical studies on the use of the drug in children);
• Hereditary fructose intolerance;
• Hypersensitivity to any of the components of the drug.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Before prescribing the saw palmetto fruit preparation, it is necessary to ensure that the disease is benign.

Patients taking the drug Palprostes for a long time should undergo regular medical check-ups. If the patient’s condition worsens while taking the drug, and symptoms such as arterial hypotension, impaired coordination of movements, fainting, traces of blood in the urine, or acute urinary retention appear, it is necessary to discontinue the drug and consult a doctor.

Effect on the ability to drive vehicles and mechanisms

When using the drug Palprostes, one should exercise particular caution when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

An increase in the severity of side effects from the gastrointestinal tract organs is possible.

Treatment symptomatic.

Drug Interactions

No data on interaction with other medicinal products.

Storage Conditions

At a temperature not exceeding 30°C (86°F). Keep out of reach of children.

Shelf Life

The shelf life is 3 years.

Dispensing Status

Without a prescription.

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.