Uriflorin^® (Tablets) Instructions for Use

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Uvae ursi folium (DAB German Pharmacopoeia)

Dosage Form

Uriflorin®

Tablets 300 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets from light green to dark green in color, with white and brown specks, flat-cylindrical in shape, with a bevel and a score line.

Excipients: lactose monohydrate (milk sugar) – 127 mg, potato starch (MCC-200) – 70 mg, povidone (medium molecular weight medical polyvinylpyrrolidone) – 25 mg, colloidal silicon dioxide (aerosil) – 3 mg, calcium stearate monohydrate (calcium stearate 1-hydrate) – 5 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
30 pcs. – dark glass jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with diuretic, antimicrobial, and anti-inflammatory action

Pharmacotherapeutic Group

Herbal diuretic agent

Pharmacological Action

It is a herbal product. The complex of biologically active substances of bearberry leaves has a diuretic, anti-inflammatory, and antimicrobial effect.

Hydroquinone is released from the phenolic glycosides of bearberry – arbutin and methylarbutin – under the action of the enzyme arbutase.

Excreted in the urine, hydroquinone enhances diuresis and exerts an antimicrobial effect. The anti-inflammatory properties of bearberry are due to the high content of tannins.

Indications

• Use as part of complex therapy for inflammatory diseases of the urinary bladder and urinary tract.
• Employ for conditions such as cystitis and urethritis.
• Utilize for its diuretic, antimicrobial, and anti-inflammatory properties to alleviate symptoms associated with these urological conditions.

ICD codes

Dosage Regimen

Administer orally as a prepared decoction using 10 g of raw material per 200 ml of water.

Take 1/3 to 1/2 cup of the decoction three to five times daily.

Adhere strictly to the prescribed frequency and duration of administration to ensure therapeutic efficacy and minimize the risk of adverse effects.

Adverse Reactions

Monitor for gastrointestinal disturbances such as nausea, vomiting, and diarrhea.

Observe for potential allergic reactions, including skin rash and pruritus.

Note that dark green coloration of urine is a harmless and expected effect due to the composition of the herbal extract and does not require discontinuation of therapy.

Drug Interactions

Avoid concurrent use with medications or substances that acidify urine, as this can reduce the antimicrobial efficacy of the preparation.

Exercise caution when administering with other diuretic agents due to the potential for additive effects on urine output and electrolyte balance.

Consult a healthcare professional before combining with any other prescription or over-the-counter medications.

Contraindications

• Do not use in patients with known hypersensitivity to bearberry (Uvae ursi folium) or any of the excipients in the formulation.
• Contraindicated in cases of acute renal failure and acute glomerulonephritis due to the risk of exacerbating renal irritation and impairment.
• Administration is strictly prohibited during pregnancy and in children under the age of 12 years.

Overdose

Symptoms of overdose may include severe nausea, vomiting, tinnitus, and shortness of breath.

In case of suspected overdose, discontinue use immediately and initiate symptomatic and supportive treatment.

Seek immediate medical attention or contact a poison control center for management advice, as there is no specific antidote.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy. During breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the infant.

Use in Renal Impairment

Use is contraindicated in acute renal failure.

Pediatric Use

Use is contraindicated in children under 12 years of age.

Special Precautions

When taking large doses of bearberry preparations or during their long-term use, an exacerbation of inflammatory kidney diseases may be observed due to prolonged irritation of the renal tubules.

Bearberry preparations should not be used simultaneously with agents that acidify urine.

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

Over-the-Counter

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.