Uronefron®

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

Composition:

Active ingredients: 1 tablet contains 188 mg of dry extract from 9 plants: onion peel (Allium cepa), birch leaves (Betula alba), couch grass rhizome (Agropyron repens), curly parsley root (Petroselinum sativum), fenugreek seeds (Trigonella foenum-graecum), common goldenrod herb (Solidago virgaurea), field horsetail stems (Equisetum arvense), common knotweed herb (Polygonum aviculare), and medicinal lovage root (Levisticum officinale);

Excipients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon dioxide;

Coating: Opadry 200 Green 200F210013 (polyvinyl alcohol, talc, macrogol, titanium dioxide (E 171), quinoline yellow (E 104), indigo carmine (E 132), methacrylic acid copolymer type C, sodium hydrogencarbonate, yellow azorubine FCF (E 110)).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets with a film coating, dark green in colour.

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. Silicates also enhance the excretion of uric acid in cases of urate deposition in the kidneys. The medicinal product prevents crystallization of mineral components in the urinary tract and favorably influences 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 and the formation of new ones. The action of Uronefro on the tubular and glomerular systems of the kidneys results in reduced protein excretion in proteinuria.

Allium cepa (bulb scales) contains 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 effects.

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

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

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

Euphorbia hirta (herb of common milkweed) contains flavonoids: kaempferol, quercetin, and their glycosides—astragalin, rutin. Its main actions are diuretic, antibacterial, and anti-inflammatory.

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

Polygonum aviculare (herb of common knotweed) contains flavonoids, phenolic acids, carotene, ascorbic acid, and tannins. Its main actions are diuretic and hemostatic.

Levisticum officinale (medicinal lovage). The aerial parts and roots of lovage contain essential oil (in fresh roots—0.1–0.2%, in dried roots—0.6–1.0%), sugars, organic acids, minerals, resins, and starch. The essential oil includes terpineol, cineole, acetic, isovaleric, and benzoic acids. Its main actions are diuretic and anti-inflammatory.

The 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 antimicrobial efficacy of the preparation.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

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

• acute and chronic cystitis;
• acute and chronic pyelonephritis;
• chronic urethritis;
• chronic prostatitis.

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

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 failure, cardiac failure).
• Conditions associated with increased blood coagulation.
• Obstruction of urinary tracts.
• 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, and anticoagulants; and may prolong the action of pentobarbital, paracetamol, and aminopyrine.

The drug may reduce the 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 mellitus due to the possible hypoglycemic effect of fenugreek seeds.

If pain, urinary difficulties, presence of blood in urine, worsening of symptoms, or elevated body temperature occur, immediate medical advice must be sought.

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

This medicinal product should not be used if edema caused by cardiac or renal insufficiency is present.

The medicinal product contains the colouring agent "Yellow Sunset FCF" (E 110), which may cause allergic reactions. This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. it is practically sodium-free.

If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicinal product, as it contains lactose monohydrate.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction speed when driving or operating machinery.

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

Dosage and Administration.

For use in adults.

Take orally after meals, 1 tablet 3–4 times daily.

The treatment course lasts from 2 to 6 weeks.

The duration of treatment should be determined by a physician. 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, an increase in the manifestations of adverse reactions is possible.

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, bloating.

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.

No special storage conditions required.

Keep out of reach of children.

Packaging.

10 tablets in a blister. 3 or 6 blisters per carton.

Availability. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address.

74, Kyrylivska St., Kyiv, 04080, Ukraine.