Kavechol (Granules) Instructions for Use

Marketing Authorization Holder

Vifitech, CJSC (Russia)

ATC Code

A05AX (Other drugs for the treatment of biliary tract diseases)

Dosage Form

Kavechol

Granules for oral solution 0.789 g: 1.5 g sachets, 10, 15, 20, 25, or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for the preparation of an oral solution brown in color, with a characteristic odor.

* containing total nitrogen in terms of dry substance 1.35%.

Excipients: potato starch – 0.711 g.

1.5 g – sachets (10) – cardboard packs.
1.5 g – sachets (15) – cardboard packs.
1.5 g – sachets (20) – cardboard packs.
1.5 g – sachets (25) – cardboard packs.
1.5 g – sachets (30) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with choleretic and spasmolytic action

Pharmacotherapeutic Group

Choleretic agent of plant origin

Pharmacological Action

Kavechol has a pronounced choleretic effect, stimulating the bile-forming and bile-excreting function of the liver, and activates the synthesis of bile acids.

It possesses antioxidant and membrane-stabilizing properties, exhibits a moderate spasmolytic effect.

In experimental acute toxic hepatitis, it has a hepatoprotective effect, normalizing the increased activity of ALT and AST enzymes, normalizes bilirubin levels, total cholesterol, levels of alpha- and gamma-globulins, stimulates the detoxification function of the liver, and restores the morphofunctional structure of hepatocytes.

Clinical use of Kavechol contributes to the normalization of the function of the gallbladder and biliary tract, relief of pain syndrome, reduction of nausea, flatulence, and normalization of stool.

Pharmacokinetics

The drug contains dry kava extract (cocoa bean husk extract) as an active component, which is a complex of biologically active substances, making pharmacokinetic studies not feasible.

Indications

As a choleretic agent for

• Biliary dyskinesia and gallbladder hypomotility;
• Chronic non-calculous cholecystitis;
• Postcholecystectomy syndrome.

ICD codes

Dosage Regimen

Administer orally.

Dissolve the contents of one sachet in 100 ml (approximately 1/2 glass) of warm boiled water immediately before use.

Take the prepared solution 30 minutes before a meal.

The standard frequency of administration is one sachet per dose.

Adhere to a treatment course of 4 weeks.

Do not exceed the maximum single dose of 3 g, equivalent to two sachets.

Do not exceed the maximum daily dose of 6 g, equivalent to four sachets.

For repeated courses, maintain an interval of 2-3 months between treatments.

Initiate a repeat course only on the recommendation of a physician.

Adverse Reactions

Allergic reactions are possible.

Contraindications

• Hypersensitivity to the drug components;
• Cholelithiasis;
• Age under 18 years.

With caution in patients with diabetes mellitus and individuals on a low-carbohydrate diet.

Use in Pregnancy and Lactation

Not recommended for use during pregnancy and breastfeeding due to the lack of specific studies.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Patients with diabetes mellitus should take into account that one sachet of the drug contains about 0.7 g of carbohydrates (0.06 XE).

Effect on the ability to drive vehicles and operate machinery

The use of the drug does not affect the performance of potentially hazardous activities requiring special concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms).

Overdose

Overdose is unlikely. In case of overdose, an increase in dose-dependent side effects is possible.

Treatment is symptomatic.

Drug Interactions

Not studied.

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-counter.

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.