LESPEFRIL

INSTRUCTION
for medical use of medicinal product

LESPEFRIL
(LESPEFRIL)

Composition:

active ingredient: 100 ml of solution is obtained from 70.8 g of shoots of Lespedeza bicolor (Cormus Lespedeza bicolor Turcz.);

excipients: 95% ethanol, anise oil, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: solution of light brown with an orange tint to reddish-brown color with a specific odor. A slight sediment is permissible.

Pharmacotherapeutic group. Agents used in urology.

ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

A complex of biologically active substances contained in the medicinal product Lespefril promotes increased renal filtration, reduces azotemia, accelerates excretion of nitrogenous waste with urine, increases diuresis, enhances sodium excretion and, to a lesser extent, potassium excretion.

Clinical characteristics.

Indications.

The drug is indicated in adults as a hypoazotemic and diuretic agent for symptomatic therapy in chronic renal insufficiency.

Contraindications.

Increased individual sensitivity to the components of the drug; pregnancy, breastfeeding; liver diseases, alcoholism, epilepsy, craniocerebral trauma, brain disorders; age under 18 years.

If you have any of the listed conditions, you should consult a doctor before taking the medicinal product.

Special precautions.

When using the drug, follow the physician's recommendations.

Interaction with other medicinal products and other forms of interaction.

Due to the ethanol content, the medicinal product should not be prescribed to patients receiving drugs that suppress the central nervous system, insulin, antidiabetic agents (metformin, sulphonamides), or drugs for the treatment of alcoholism (e.g., disulfiram).

When co-administering other medicinal products, it should be borne in mind that ethanol may alter or enhance their effects.

Special precautions.

If hyponatremia develops, it should be corrected by administration of medicinal products containing sodium ions.

The medicinal product contains not less than 40% ethanol. In a single maximum dose, the ethanol content is not less than 4.7 g; in a maximum daily dose – not less than 18.8 g.

Use during pregnancy or breastfeeding.

Lеспефрил is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Due to the presence of ethanol in the product, psychomotor reactions may be reduced; this should be taken into account when driving vehicles or operating machinery.

Method of administration and dosage.

Lеспефрил should be taken orally, 5–15 ml (1 teaspoon – 1 tablespoon) 3–4 times daily. Dilution of the preparation with water before intake is allowed. Treatment duration is 3–4 weeks.

Repeating the treatment course is possible only after 2–3 weeks and only following consultation with a physician.

Children.

The medicinal product should not be used for treatment of children (under 18 years of age).

Overdose.

Symptoms are related to the presence of ethanol in the product.

In case of overdose, adverse effects may be intensified.

Treatment is symptomatic.

Adverse reactions.

May include allergic reactions. Rarely, the product may cause hyponatremia.

Shelf life.

3 years.

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

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

100 ml in a bottle or jar; 1 bottle or jar per carton.

Prescription status.

Over-the-counter.

Manufacturer.

LLC "Lubnipharm".

Manufacturer's name and address of place of business.

Ukraine, 37500, Poltava region, Lubny, Barvinkova St., 16.

Applicant.

LLC "Sumyfitofarmatsiya".

Address of the applicant.

Ukraine, 40035, Sumy, Zalivna Street, 11.