Trianol^® (Capsules) Instructions for Use

Marketing Authorization Holder

Lek d.d. (Slovenia)

Packaged By

PharmFirma Sotex, ZAO (Russia)

ATC Code

G04CX01 (African prune bark)

Active Substance

Pygeum africanum (BP British Pharmacopoeia)

Dosage Form

Trianol®

Capsules 25 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size No. 3, pale blue in color, opaque; the capsule contents are a granulate or compressed mass of brownish-yellow color.

Excipients: purified talc, magnesium oxide, magnesium stearate, colloidal silicon dioxide, lactose.

10 pcs. – blisters (3) – cardboard 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

A herbal preparation. It has an antiproliferative effect on fibroblasts stimulated by b-FGF (basic fibroblast growth factors). The drug does not affect the hormonal background of the male reproductive system.

Indications

Use this medication exclusively for the management of specific urinary symptoms.

• Administer for the relief of urinary symptoms associated with benign prostatic hyperplasia (BPH).
• Employ for symptoms such as nocturia, urinary frequency, and incomplete bladder emptying.

This treatment is intended for symptomatic control and does not reduce prostate size.

ICD codes

Dosage Regimen

Take the medication orally. The standard adult dose is 50 mg twice daily, which equates to two capsules per dose.

Administer one dose in the morning and one dose in the evening. Ingest the capsules before meals to ensure optimal absorption.

The initial treatment course typically lasts 6 to 8 weeks. A follow-up medical evaluation is necessary to assess therapeutic response. A repeat course may be initiated by a physician if clinically warranted.

Adverse Reactions

Adverse effects are generally infrequent and mild. Monitor for gastrointestinal disturbances, which are the most commonly reported.

From the digestive system: rarely, nausea, loss of appetite, constipation, or diarrhea may occur. Discontinuation of therapy should be considered if these effects persist or worsen.

Other: rarely, allergic reactions, including skin rash or pruritus, may manifest. Immediately discontinue use and seek medical attention if signs of a hypersensitivity reaction appear.

Contraindications

Do not administer this drug under any circumstances to patients with known hypersensitivity.

• Absolutely contraindicated in individuals with a known hypersensitivity to the active substance (Pygeum africanum), any of the excipients (including lactose), or other components of the formulation.
• Do not use in patients with a history of severe allergic reactions to plants of the Rosaceae family.

Verify patient allergy history prior to initiating treatment.

Special Precautions

It should be taken into account that treatment with Trianol^® does not replace surgical intervention if it is necessary.

Overdose

No specific cases of overdose have been documented in clinical experience. Given the pharmacological profile, symptoms would likely be an extension of the known adverse reactions, primarily gastrointestinal in nature.

In the event of suspected significant overdose, immediately discontinue the medication and institute supportive and symptomatic care. There is no known specific antidote. Gastric lavage may be considered if ingestion was recent.

Drug Interactions

Formal studies investigating drug-drug interactions have not been conducted. No clinically significant pharmacokinetic or pharmacodynamic interactions have been reported to date.

Exercise caution when co-administering with other medications metabolized by the liver due to the theoretical potential for interaction, although this has not been established. Monitor patients for any changes in therapeutic effect or adverse events when used concomitantly with other drugs.

Storage Conditions

The drug should be stored in a place protected from light at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Terms

The drug is dispensed by prescription.

Dispensing Status

Rx Only

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.