Tadenan^® (Capsules) Instructions for Use

Marketing Authorization Holder

Fournier Laboratories S.A. (France)

ATC Code

G04CX01 (African prune bark)

Active Substance

Pygeum africanum (BP British Pharmacopoeia)

Dosage Form

Tadenan®

Capsules 50 mg: 10, 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules soft gelatin, opaque, size No. 4, oval, consisting of two longitudinal halves of white/light green color; the capsule contents are an oily brown liquid.

Excipients: peanut oil (150 mg).

Shell composition gelatin, glycerol, titanium dioxide, sodium copper chlorophyllin.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
30 pcs. – blisters (1) – cardboard packs.
30 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 the treatment of prostate adenoma

Pharmacological Action

A herbal preparation for the treatment of benign prostatic hyperplasia. Reduces the proliferation of prostate cells.

It has an anti-inflammatory and anti-edematous effect. The action is determined by the antiproliferative effect on fibroblasts stimulated by b-FGF (basic fibroblast growth factor).

It eliminates and reduces functional urination disorders – dysuria, nocturia, pollakiuria in prostate diseases.

It reduces the inflammatory reaction in prostate tissues and helps to enhance its secretory activity; reduces the amount of residual tissue after surgery.

Pharmacokinetics

Data on the pharmacokinetics of Tadenan^® are not available.

Indications

• Treatment of moderate functional disorders of the urinary system in benign prostatic hyperplasia (adenoma) (frequent urination during the day and night, weak stream, intermittent urination, sensation of incomplete bladder emptying, imperative urges and urination);
• Condition after adenomectomy and prostatectomy.

ICD codes

Dosage Regimen

Administer the drug orally.

Take 50 mg (1 capsule)twice daily, in the morning and evening.

Alternatively, take 100 mg (2 capsules) as a single daily dose.

Take capsules preferably before meals.

The total daily dose is 100 mg.

The standard treatment course is 6 weeks.

This course can be extended to 8 weeks based on clinical assessment.

If symptoms recur, a repeat treatment course is permissible.

Adverse Reactions

From the digestive system: rarely – constipation, nausea, decreased appetite, constipation, diarrhea.

From the reproductive system: very rarely – gynecomastia, testicular pain.

Allergic reactions rarely – urticaria.

Contraindications

• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

Tadenan^® is not intended for women.

Special Precautions

In benign prostatic hyperplasia, regular monitoring of the prostate condition is necessary, including periodic digital rectal examination to exclude prostate cancer.

Tadenan^® therapy does not replace surgical intervention if it is necessary.

Since the drug contains peanut oil, there is a risk of hypersensitivity reactions.

Overdose

Currently, there are no data on overdose of Tadenan^®.

Drug Interactions

Currently, there are no data on the drug interactions of Tadenan^®.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.