Prostaherb^® N (Tablets) Instructions for Use

Marketing Authorization Holder

Cesra Arzneimittel, GmbH & Co. KG (Germany)

ATC Code

G04CX (Other preparations for the treatment of benign prostatic hyperplasia)

Active Substance

Urticae radix (DAB German Pharmacopoeia)

Dosage Form

Prostaherb® N

Coated tablets, 230 mg: 60, 120, or 200 pcs.

Dosage Form, Packaging, and Composition

Coated tablets brown in color, round, biconvex; on the fracture – a brown core and a two-layer shell (inner layer – white, outer – brown).

* Excipients : lactose – 69 mg.

Excipients : microcrystalline cellulose – 28 mg, povidone – 6 mg, crospovidone – 4 mg, talc – 3.3 mg, colloidal silicon dioxide – 2.4 mg, magnesium stearate – 1.3 mg.

Shell composition methacrylic acid copolymer (type A) – 1.62 mg, dibutyl phthalate – 0.16 mg, magnesium carbonate – 8.61 mg, talc – 36.65 mg, gum arabic – 6.47 mg, titanium dioxide (E171) – 13.26 mg, glucose syrup (calculated as dry substance) – 3.4 mg, macrogol 6000 – 6.79 mg, povidone – 0.97 mg, calcium carbonate (E 170) – 19.4 mg, sucrose – 124.32 mg, opalux AS 26520 – 2.38 mg, capol 600 Pharma – 0.5 mg.

20 pcs. – blisters (3) – cardboard packs.
20 pcs. – blisters (6) – cardboard packs.
20 pcs. – blisters (10) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Benign prostatic hyperplasia treatment agent of plant origin

Pharmacological Action

Normalizes diuresis in benign prostatic enlargement: promotes an increase in volume and maximum urine flow, and a decrease in the amount of residual urine, reduces dysuria, nocturia, and pain sensations.

Does not affect the volume of the enlarged prostate.

Indications

• Complex therapy of urinary disorders in benign prostatic hyperplasia, including stage I and II adenoma.

ICD codes

Dosage Regimen

Take the tablets orally.

Administer one coated tablet three times daily.

Swallow the tablet whole; do not chew it.

Take with a small amount of water.

Continue treatment for a duration of two to six months.

Adhere to the prescribed schedule for the full therapeutic course.

Do not discontinue use without consulting a physician.

Adverse Reactions

In rare cases, mild reactions from the digestive system (nausea, heartburn, feeling of fullness, diarrhea, flatulence), allergic reactions (itching, skin rash, including urticaria) are possible, which disappear after discontinuation of the drug.

Contraindications

• Chronic heart failure;
• Chronic renal failure;
• Increased individual sensitivity.

Use in Pregnancy and Lactation

The drug is used only in men.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Special Precautions

If blood appears in the urine or acute urinary retention occurs, you should consult your doctor.

Instructions for patients with diabetes: 1 tablet contains 0.2 g of carbohydrates, which corresponds to 0.02 XE.

Effect on the ability to drive vehicles and mechanisms

There are no data on the effect of the drug on the ability to participate in road traffic or operate machinery.

Overdose

No cases of overdose have been observed.

Drug Interactions

Not identified.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F). Keep out of the reach of children.

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

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.