Herbion^® Urological drops (Drops) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Dosage Form

Herbion® Urological drops

Oral drops: 30 ml bottle with dropper.

Dosage Form, Packaging, and Composition

Drops for oral administration in the form of a dark brown solution with the smell of extracts of medicinal plants; during storage the formation of sediment is possible.

Auxiliary substances : ethanol 75 vol.%.

30 ml – dark glass bottles (1) in a set with a dropper – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation, used for kidney and urinary tract diseases

Pharmacotherapeutic Group

Antimicrobial agent of plant origin

Indications

• Herbion^® Urological drops are indicated for use in inflammatory diseases of the lower urinary tract and kidneys as part of complex therapy.
• The preparation is used for cystitis (inflammation of the bladder), urethritis (inflammation of the urethra), and for the symptomatic relief of uncomplicated urinary tract infections.
• It is also employed as an adjuvant therapy for urolithiasis (kidney stones) to facilitate the excretion of urinary gravel and to provide a mild diuretic effect.

The therapeutic effect is due to the combined action of the plant extracts, which possess antimicrobial, anti-inflammatory, antispasmodic, and diuretic properties, helping to flush out the urinary system and reduce irritation.

Contraindications

• Hypersensitivity to any of the active or auxiliary substances of the preparation, including a known allergy to plants of the Apiaceae family (such as parsley, celery, carrots) or any other component.
• Severe renal impairment (e.g., glomerulonephritis, renal failure) where the fluid and electrolyte balance must be strictly monitored, as the diuretic effect may be detrimental.
• Severe hepatic impairment due to the ethanol content, which may exacerbate liver dysfunction.
• Edema associated with cardiac or renal decompensation, as the increased urine output could place additional strain on the compromised cardiovascular or renal system.
• Pregnancy and breastfeeding are contraindications due to the lack of sufficient safety data and the presence of ethanol and active compounds that may pass into breast milk or affect the fetus.
• The preparation is not recommended for children and adolescents under 18 years of age due to insufficient data on safety and efficacy in this population group and its ethanol content.

Dosage Regimen

The dosage of Herbion^® Urological drops must be determined by a physician based on the patient’s condition and response to therapy. The following is a general guideline for adults.

The usual dose is 20-30 drops taken orally three times a day. The drops should be taken with a sufficient amount of water (approximately 100-150 ml). It is recommended to take the drops before meals.

To ensure accurate dosing, use the dropper provided with the bottle. The duration of treatment is determined by the physician. For acute conditions, treatment typically lasts for 2-4 weeks. Do not exceed the recommended daily dose without medical supervision.

Due to the ethanol content, the preparation should be used with caution in patients with a history of alcoholism, epilepsy, or liver disease. Patients should be advised that the drops may cause drowsiness and should exercise caution when driving or operating machinery.

Adverse Reactions

Like all medicines, Herbion^® Urological drops can cause adverse reactions, although not everybody gets them.

Gastrointestinal disorders such as nausea, epigastric discomfort, or diarrhea may occur infrequently. Allergic reactions are possible, including skin rash, pruritus (itching), urticaria (hives), and in very rare cases, more severe reactions like angioedema.

Due to the diuretic effect of the preparation, increased frequency of urination is expected and is not considered an adverse reaction. However, if dysuria (painful urination) or hematuria (blood in the urine) occurs, treatment should be discontinued, and a doctor should be consulted immediately.

If any of the adverse reactions become serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Drug Interactions

Before taking Herbion^® Urological drops, inform your doctor about all the medicines you are currently taking, including prescription, over-the-counter, and herbal products.

The diuretic effect of this preparation may potentiate the action of other diuretic agents, potentially leading to excessive fluid and electrolyte loss (e.g., hypokalemia). Concurrent use with anti-diabetic medications (insulin, sulfonylureas) may require adjustment of the antidiabetic dose, as certain components might influence blood glucose levels.

Due to the ethanol content (75 vol.%), interactions with drugs that can cause a disulfiram-like reaction (e.g., metronidazole, certain cephalosporins) are possible, leading to symptoms such as flushing, nausea, vomiting, and tachycardia. Ethanol may also enhance the sedative effects of central nervous system depressants (e.g., benzodiazepines, barbiturates, some antidepressants).

The preparation may also interact with lithium, as increased urine output can reduce lithium clearance and increase the risk of lithium toxicity. Close monitoring of serum lithium levels is recommended. Consult your physician for any potential interactions.

Overdose

In case of overdose, symptoms related to the effects of the active ingredients and the ethanol content are to be expected.

Symptoms may include severe nausea, vomiting, diarrhea, abdominal pain, dizziness, vertigo, and signs of excessive diuresis leading to dehydration and electrolyte imbalances (e.g., weakness, muscle cramps). Symptoms of ethanol intoxication, such as CNS depression, ataxia, slurred speech, and in severe cases, respiratory depression, may also occur.

There is no specific antidote. Treatment should be symptomatic and supportive. Gastric lavage or administration of activated charcoal may be considered if ingestion was recent. Maintain fluid and electrolyte balance. In cases of severe ethanol intoxication, medical monitoring and supportive care, including respiratory support if necessary, are essential. If you suspect an overdose, contact a poison control center or seek immediate medical attention.

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.