Uronefron®

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

Composition:

Active substances: 100 g of gel contains 12 g of thick herbal extract with preservative (1-3):1 (calculated as 65% dry residue), derived from a mixture of herbal raw materials: onion husk (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), preservative ethylparahydroxybenzoate (E 214); extraction solvent – ethanol 45%;

Excipients: ethylparahydroxybenzoate (E 214), sage oil (Salvia oil), peppermint oil (Mentha oil), mountain pine oil (Oil pinus mugo), orange oil (Oil citrus sinensis), hypromellose, vanillin, purified water.

Pharmaceutical form. Gel.

Main physico-chemical properties: soft mass of yellowish-brown to greenish-brown color with a characteristic aromatic odor. Dark specks may be present.

Pharmacotherapeutic group. Agents promoting dissolution of urinary calculi.

ATC code G04BC.

Pharmacological Properties

Pharmacodynamics

Uronеphron® 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 the excretion of uric acid in cases of urate deposits in the kidneys. The medicinal product prevents crystallization of mineral components in the urinary tract and favorably influences the maintenance of the balance between colloids and crystalloids in urine. Saponins reduce surface tension, form protective colloids, and emulsify pathogenic components of urine, thus preventing the formation of sand and kidney stones. It promotes the flushing out of sand and small concrements and prevents the growth of existing concrements or the formation of new ones.

Onion bulb husks 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. They exert an anti-inflammatory effect.

Couch grass (Agropyron repens). The rhizome contains polysaccharides, sugars, alcohols, glycosides, vitamins, essential and fatty oils, and organic acids. The main effects are diuretic and regulation of metabolism.

Birch leaves contain essential oils, saponins, tannins, resins, ascorbic acid, and nicotinic acid. The main effects are diuretic, choleretic, spasmolytic, and anti-inflammatory.

Fenugreek seeds contain trigonelline, nicotinic acid, rutin, steroidal saponins and phytosterins, flavonoids, and essential oils. The main effects are anti-inflammatory, general strengthening, and wound healing.

Parsley root contains apiol, myristicin, and flavonoids. The main effects are diuretic, anti-inflammatory, and litholytic.

Goldenrod herb contains flavonoids: kaempferol, quercetin, and their glycosides – astragalin, rutin. The main effects are diuretic, antibacterial, and anti-inflammatory.

Field horsetail (Equisetum arvense) contains flavonoids: derivatives of apigenin, luteolin, kaempferol, and quercetin; it also contains phenolic carboxylic acids, tannins, and saponins. The main effects are diuretic, anti-inflammatory, litholytic, and detoxifying.

Bird's knotweed herb (Polygonum aviculare) contains flavonoids, phenolic acids, carotene, ascorbic acid, and tannins. The main effects are diuretic and hemostatic.

Love root (Levisticum officinale). 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. The main effects are diuretic and anti-inflammatory.

The components contained in the herbal medicinal product Uronеphron® exhibit complex activity, manifested in anti-inflammatory effects and relief of urinary tract spasms, diuretic and vasodilatory effects, and also contribute to the antimicrobial efficacy of the preparation.

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 concrements.

Contraindications.

• Hypersensitivity to any component of the medicinal product or to plants of the genus Asteraceae (Compositae) (common goldenrod), Apiaceae (Umbelliferae), anethole (lovage root), or 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 considered.

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

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

Special precautions for use.

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 during urination, blood appears in the urine, symptoms worsen, or body temperature rises, 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 occurs.

The product contains ethyl parahydroxybenzoate (E 214), which may cause allergic reactions (possibly delayed).

The herbal extract contains a small amount of ethanol (less than 100 mg per dose).

Use during pregnancy or breastfeeding.

Animal experimental studies have not shown any teratogenic effects of Uronefron® on the fetus. There is no clinical experience with use in pregnant women. Therefore, as a safety precaution, the use of this medicinal product should be avoided during pregnancy and breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery.

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

Dosage and Administration.

For oral use in adults.

Take after meals 3–4 times daily, dissolving 1 teaspoon (5 g) of gel in 100 ml (1/2 glass) of warm boiled water.

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

Children.

There is no experience with the use of the medicinal product in children and adolescents 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 rashes, urticaria, itching, allergic rhinitis, facial swelling.

Nervous system: dizziness.

Gastrointestinal tract: nausea, vomiting, diarrhea, abdominal distension.

Skin and subcutaneous tissue: increased sensitivity to ultraviolet radiation (photosensitization).

Urinary system: renal colic.

Shelf life. 3 years.

Do not use the drug 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 g in a tube. 1 tube per carton.

Availability. Over-the-counter.

Manufacturer: JSC "Farmak".

Manufacturer's address.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.