Lespefril (Solution) Instructions for Use

Marketing Authorization Holder

Vifitech, CJSC (Russia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Lespedeza bicolor (Grouping name)

Dosage Form

Lespefril

Oral solution: bottle 100 ml

Dosage Form, Packaging, and Composition

100 ml – bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug reducing azotemia, with a diuretic effect

Pharmacotherapeutic Group

Drugs used in urology; other drugs used in urology

Pharmacological Action

It promotes an increase in renal filtration, reduces azotemia, increases the excretion of nitrogenous wastes with urine, increases diuresis and the excretion of sodium ions and, to a lesser extent, potassium ions.

Indications

• Chronic renal failure (symptomatic therapy).

ICD codes

Dosage Regimen

Administer the solution orally.

Measure the dose using a standard teaspoon or tablespoon.

The standard single dose is 5-15 ml, equivalent to one teaspoon to one tablespoon.

Take the dose 3-4 times per day, at regular intervals.

For administration, dilute the measured dose in a small amount of water before use.

The standard treatment course is 3-4 weeks.

Do not initiate a repeated course independently.

A repeated course of treatment is permissible only after a 2-3 week interval and following consultation with a physician.

Adhere strictly to the prescribed dosage and duration of therapy.

Adverse Reactions

Allergic reactions are possible. In rare cases – hyponatremia.

If any of the side effects mentioned in the instructions worsen, or you notice any other side effects not listed in the instructions, inform your doctor.

Contraindications

• Pregnancy, breastfeeding period;
• Liver diseases;
• Alcoholism;
• Epilepsy;
• Traumatic brain injuries;
• Brain diseases;
• Age under 18 years;
• Increased individual sensitivity to the drug components.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in liver diseases.

Use in Renal Impairment

Used in the symptomatic therapy of chronic renal failure.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

If hyponatremia develops, it should be compensated by the administration of drugs containing sodium ions.

The drug contains at least 40% ethanol. The ethanol content in the maximum single dose of the drug is at least 4.7 g, in the maximum daily dose – at least 18.8 g.

Effect on the ability to drive vehicles and operate machinery

During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Overdose may lead to an increase in side effects.

Treatment is symptomatic.

Drug Interactions

Due to the ethanol content in the drug, the simultaneous use of disulfiram, sedative drugs, non-selective MAO inhibitors, insulin, metformin, and sulfonamide is contraindicated.

When prescribing several drugs simultaneously, the presence of ethanol in the drug must be taken into account, as it may change or enhance the effect of other drugs.

Storage Conditions

Store in a light-protected place at a temperature between 15°C and 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

Available without a prescription.

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.