Uronefron®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT URONEPHRON® (URONEPHRON)

Composition:

Active ingredients: 5 ml of syrup contains 0.6 g of dry extract (calculated as 65% dry residue) from a mixture of: onion peel (Allium Cepa L.), couch grass rhizome (Rhizoma Agropyri), birch leaf (Betulae folium), fenugreek seed (Foenugraeci semen), parsley root (Radix Petroselini), goldenrod herb (Solidaginis herba), field horsetail herb (Equiseti herba), birdweed herb (Polygoni avicularis herba), lovage root (Radix Levistici) (1-3):1; extraction solvent – ethanol 45%;

Excipients: potassium sorbate, xanthan gum, sorbitol (E 420), purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: a liquid ranging from light brown to dark brown in color, with a yellowish or greenish tint, having a characteristic aromatic odor. Formation of fine dispersed particles may occur during storage.

Pharmacotherapeutic group. Agents promoting dissolution of urinary calculi.

ATC code G04BC.

Pharmacological Properties.

Pharmacodynamics.

Uronefro® is a combined herbal medicinal product. It exerts anti-inflammatory, diuretic, spasmolytic, and antimicrobial effects. The diuretic action is due to flavone derivatives, inositol, saponins, and silicates. The latter also enhance excretion of uric acid in the case of urate deposits in the kidneys. The medicinal product prevents crystallization of mineral components in the urinary tract and favorably influences the maintenance of balance between colloids and crystalloids in urine. Saponins reduce surface tension, form protective colloids, and emulsify pathogenic components of urine, thus preventing formation of sand and kidney stones. It promotes flushing out of sand and small concrements and prevents enlargement of existing concrements or formation of new ones. The action of Uronefro on the tubular and glomerular systems of the kidneys leads to reduced protein excretion in proteinuria.

Allii cepae squamae (onion bulb scales) contain essential oil (up to 0.15%), vitamin C, riboflavin, thiamine, carotenoids, phytic, citric, and malic acids, sugars (glucose, fructose, sucrose), flavonoids, and compounds of potassium, iron, manganese, zinc, and cobalt. It exerts anti-inflammatory action.

Betulae folium (birch leaves) contain essential oils, saponins, tannins, resins, ascorbic acid, and nicotinic acid. Its main actions are diuretic, cholagogue, spasmolytic, and anti-inflammatory.

Agropyri rhizoma (creeping couch grass rhizome) contains polysaccharides, sugars, alcohols, glycosides, vitamins, essential and fatty oils, and organic acids. Its main actions are diuretic and regulation of metabolism.

Petroselini radix (parsley root) contains apiol, myristicin, and flavonoids. Its main actions are diuretic, anti-inflammatory, and litholytic.

Trigonella foenum-graecum (fenugreek seeds) contain trigonelline, nicotinic acid, rutin, steroidal saponins and phytosterols, flavonoids, and essential oils. Its main actions are anti-inflammatory, general strengthening, and wound healing.

Solidaginis herba (goldenrod herb) contains flavonoids: kaempferol, quercetin, and their glycosides—astragalin, rutin. Its main actions are diuretic, antibacterial, and anti-inflammatory.

Equiseti herba (field horsetail herb) contains flavonoids: derivatives of apigenin, luteolin, kaempferol, and quercetin; it also contains phenolcarboxylic acids, tannins, and saponins. Its main actions are diuretic, anti-inflammatory, litholytic, and detoxifying.

Polygoni avicularis herba (birdweed herb) contains flavonoids, phenolic acids, carotene, ascorbic acid, and tannins. Its main actions are diuretic and hemostatic.

Levisticum (lovage). The aerial parts and roots of lovage contain essential oil (0.1–0.2% in fresh roots, 0.6–1% in dried roots), sugars, organic acids, minerals, resins, and starch. The essential oil contains terpineol, cineole, acetic, isovaleric, and benzoic acids. Its main actions are diuretic and anti-inflammatory.

Components of the herbal medicinal product Uronefro® exhibit complex activity, manifested as anti-inflammatory effects and relief of urinary tract spasms, diuretic and vasodilatory effects, and also contribute to the effectiveness of the drug's antimicrobial action.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

In complex therapy of infectious and inflammatory diseases of the urinary system:

• Acute and chronic cystitis;
• Acute and chronic pyelonephritis;
• Chronic urethritis;
• Chronic prostatitis.

Treatment and prevention of urolithiasis, including after surgical removal of urinary calculi.

Contraindications.

• Hypersensitivity to any component of the medicinal product or to plants of the genus Asteraceae (Compositae) (common goldenrod), Apiaceae (Umbelliferae), or anethole (lovage root), birch pollen (birch leaves).
• Conditions where reduced fluid intake is recommended (e.g., renal insufficiency, cardiac insufficiency).
• Conditions associated with increased blood coagulation.
• Obstruction of urinary tract.
• Acute nephritis, nephroses, phosphate lithiasis.

Interaction with other medicinal products and other types of interactions.

Due to the diuretic effect of the drug, the possibility of accelerated excretion of other concurrently administered medicinal products should be taken into account.

The drug may enhance the effects of hypoglycemic agents, nonsteroidal anti-inflammatory drugs, lithium salts, monoamine oxidase inhibitors, anticoagulants; and may prolong the action of pentobarbital, paracetamol, aminopyrine.

The drug may reduce absorption of medicinal products in the small intestine, particularly beta-carotene, alpha-tocopherol, as well as cholesterol.

Special precautions.

When using this medicinal product, blood glucose monitoring is necessary in patients with diabetes due to the possible hypoglycemic effect of fenugreek.

If pain occurs, complications with urination, blood in the urine, worsening of symptoms, or an increase in body temperature, immediate medical advice must be sought.

During treatment with this medicinal product, it is recommended to drink plenty of fluids.

The drug should not be used if edema caused by cardiac or renal insufficiency is present.

If a patient has known sensitivities to certain sugars, a doctor should be consulted before taking this medicinal product, as it contains sorbitol.

This medicinal product contains a small amount of ethanol – less than 100 mg/dose.

This medicinal product contains less than 1 mmol (39 mg)/dose of potassium, i.e., it is practically potassium-free.

Use during pregnancy or breastfeeding.

In experimental animal studies, no teratogenic effects of Uronefron® on the fetus were observed. There is no experience with use in pregnant women. Therefore, as a precaution, use of the drug should be avoided during pregnancy and breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

If dizziness occurs during treatment with this drug, driving or operating machinery should be avoided.

Dosage and Administration.

For oral use in adults. Take after meals, 1 measuring spoon (5 ml) of syrup 3–4 times daily, with a small amount of water (100 ml).

The duration of treatment is determined by the physician. Usually, the treatment course lasts from 2 to 6 weeks. If necessary, the course of treatment may be repeated.

Children.

There is no experience with the use of the drug in children (under 18 years of age); therefore, it should not be prescribed to patients in this age group.

Overdose.

In case of overdose, adverse reactions may be intensified.

Treatment is symptomatic.

Side effects.

Immune system:

Allergic reactions, including rash, urticaria, itching, allergic rhinitis, facial swelling.

Nervous system:

Dizziness.

Gastrointestinal tract:

Nausea, vomiting, diarrhea, bloating.

Skin and subcutaneous tissue:

Increased sensitivity to ultraviolet radiation (photosensitization).

Urinary system:

Renal colic.

Shelf life. 4 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

100 ml in a bottle. 1 bottle with a dosing spoon in a carton.

Availability category. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's address.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.