Herbion^® Urtica (Capsules) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

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

Active Substances

Urticae radix (DAB German Pharmacopoeia)

Sitosterol (BP British Pharmacopoeia)

Dosage Form

Herbion® Urtica

Capsules 300 mg+10 mg: 40 pcs.

Dosage Form, Packaging, and Composition

Capsules green color; contents of capsules – powder light-brown color with visible particles of darker color.

Auxiliary substances : lactose monohydrate, talc, magnesium stearate, colloidal silicon dioxide.

Composition of shell titanium dioxide, dyes (E110, E104, E124, E131), methylhydroxybenzoate, propylhydroxybenzoate, gelatin.

10 pcs. – blister pack contour (4) – packs cardboard.

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

Indications

• Herbion^® Urtica is indicated for the symptomatic treatment of functional urinary disorders associated with Stage I-II benign prostatic hyperplasia (BPH), also known as prostate gland enlargement.
• It is used to alleviate symptoms such as nocturia (frequent urination at night), urinary frequency, urgency, and difficulty in urination (dysuria).
• The preparation helps to improve the quality of life by reducing the obstructive and irritative symptoms caused by BPH.

It is important to note that this treatment is for symptomatic relief and does not reduce the size of the enlarged prostate. A proper medical diagnosis by a physician is essential before initiating therapy to rule out prostate cancer and other serious conditions.

Contraindications

• Hypersensitivity to the active substances (nettle root extract, β-Sitosterol) or to any of the excipients listed in the composition, including dyes (E110, E104, E124, E131) and parabens (methylhydroxybenzoate, propylhydroxybenzoate).
• Patients with severe renal or hepatic impairment should not use this product due to the lack of safety data in these populations.
• Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, as the product contains lactose monohydrate.
• This product is not intended for use in women, children, or adolescents under 18 years of age.
• It is contraindicated in patients with established diagnosis of prostate cancer or other malignant neoplasms of the genitourinary system.

Self-diagnosis and treatment without consulting a physician is strongly discouraged, as symptoms of BPH can mimic those of more serious conditions like prostate cancer.

Dosage Regimen

The recommended dosage for adults (men over 18 years of age) is one capsule taken three times daily.

The capsules should be swallowed whole with a sufficient amount of liquid (e.g., a glass of water), preferably during or after meals to improve gastrointestinal tolerance.

Consistency in administration is key for optimal therapeutic effect; therefore, the doses should be taken at regular intervals throughout the day.

The duration of treatment should be determined by a physician based on the patient’s response and symptom severity. Long-term use may be necessary for sustained symptom control. If symptoms worsen or do not improve after a reasonable period (e.g., 4-6 weeks), the patient must reconsult their physician for re-evaluation.

Do not exceed the recommended dose. For patients with mild to moderate renal or hepatic impairment, use with caution and under strict medical supervision.

Adverse Reactions

Like all medicines, Herbion^® Urtica can cause adverse reactions, although not everybody gets them. Adverse reactions are generally mild and transient.

Gastrointestinal disorders are the most commonly reported. These may include mild nausea, epigastric discomfort, abdominal pain, dyspepsia, flatulence, or diarrhea. Taking the capsules with food can often mitigate these effects.

Uncommonly, allergic skin reactions such as rash, pruritus (itching), urticaria (hives), or erythema may occur due to hypersensitivity to the active ingredients or excipients.

In rare instances, a slight increase in liver enzymes has been observed, which is typically reversible upon discontinuation of the product.

If any adverse reaction becomes severe or if you notice any side effect not listed in this instruction, please inform your doctor or pharmacist. This is especially important for any signs of a serious allergic reaction, such as swelling of the face, lips, tongue, or throat, or difficulty breathing, which require immediate medical attention.

Drug Interactions

Formal interaction studies with other medicines have not been conducted. However, due to the pharmacological activity of the components, potential interactions should be considered.

Theoretically, nettle root extract may possess diuretic properties. Concurrent use with other diuretic agents (e.g., furosemide, hydrochlorothiazide) may lead to an additive effect, potentially increasing the risk of dehydration or electrolyte imbalances (such as hypokalemia). Patients should be monitored for signs of excessive diuresis.

β-Sitosterol, a plant sterol, may interfere with the intestinal absorption of fat-soluble vitamins (A, D, E, K). Patients on long-term therapy or those taking supplements for vitamin deficiency should be monitored.

There is a potential for interaction with hormonal therapies, including medications for prostate cancer (e.g., anti-androgens), due to the possible mild anti-androgenic and sex hormone-binding globulin (SHBG)-modulating effects attributed to nettle root. The clinical significance of this is not fully established, but concomitant use should be under medical supervision.

As a general precaution, patients should inform their physician or pharmacist about all the medicines they are taking, including prescription, over-the-counter, and herbal products, before starting treatment with Herbion^® Urtica.

Overdose

There are no reported cases of overdose with Herbion^® Urtica capsules. Given the pharmacological profile and composition, significant acute toxicity is unlikely.

In the event of suspected overdose, where a large number of capsules have been ingested, symptoms would likely be an exaggeration of the known adverse effects, primarily severe gastrointestinal upset (nausea, vomiting, diarrhea, abdominal pain).

There is no specific antidote. Treatment should be symptomatic and supportive. It is recommended to discontinue the medication immediately and consult a physician or contact a poison control center.

Gastric lavage or administration of activated charcoal may be considered if the overdose is recent. The patient should be kept well-hydrated. Hospitalization is generally not required unless symptoms are severe or the patient has a pre-existing complicating condition.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.