Cholebil (Capsules) Instructions for Use

Marketing Authorization Holder

Europlant Phytopharm, Sp. z o.o. (Poland)

ATC Code

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

Active Substance

Cynara (BAN)

Dosage Form

Cholebil

Capsules 400 mg

Dosage Form, Packaging, and Composition

Capsules are hard gelatin capsules No. 0, the upper part (cap) and the lower part (body) are matte, brown in color. The contents of the capsule are a powder ranging from yellowish-brown to brown in color with a characteristic odor.

Excipients: talc, magnesium stearate, colloidal silicon dioxide, corn starch, lactose monohydrate.

Capsule shell composition: gelatin, purified water, sodium lauryl sulfate, titanium dioxide E171, red iron oxide E172, black iron oxide E172, yellow iron oxide E172.

10 pcs. – blisters made of PVC/PVDC/aluminum foil (2) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with hepatoprotective and choleretic action

Pharmacotherapeutic Group

Choleretic agent of plant origin

Pharmacological Action

It has a choleretic and hepatoprotective effect, due to the content of a complex of biologically active substances from artichoke leaf extract – the phenolic compound cynarin in combination with phenolic acids (chlorogenic acid, etc.).

The drug stimulates the formation and outflow of bile, intestinal peristalsis, helps improve digestion processes and reduce the cholesterol content in the blood.

Indications

• As part of complex therapy for dyspeptic syndrome in chronic non-erosive gastritis, duodenitis;
• Steatosis;
• Chronic hepatitis of various etiologies with a mild course;
• Chronic non-calculous cholecystitis, biliary dyskinesia;
• Postcholecystectomy syndrome;
• Chronic pancreatitis;
• Chronic colitis.

ICD codes

Dosage Regimen

Take this medication orally.

Swallow the capsule whole with a sufficient amount of liquid.

Take the capsule with meals to improve tolerance and absorption.

The standard adult dose is 1 capsule taken 1 to 2 times per day.

Adhere to the twice-daily regimen if prescribed for more pronounced symptoms.

The typical course of treatment is 3 to 4 weeks.

Continue treatment for the full prescribed duration unless otherwise directed by a physician.

Do not exceed the recommended daily dose of 2 capsules (800 mg).

If no clinical improvement is observed after one week of use, consult a physician for re-evaluation.

Adverse Reactions

Allergic reactions, pain in the epigastric region, diarrhea, nausea, heartburn are possible.

Contraindications

• Hypersensitivity to the drug;
• Cholelithiasis;
• Obstruction of the biliary tract;
• Severe forms of hepatic insufficiency;
• Acute diseases of the liver, kidneys, biliary and urinary tracts;
• Pregnancy, lactation period;
• Children under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in severe forms of hepatic insufficiency; acute liver diseases.

Use in Renal Impairment

Contraindicated in acute kidney diseases.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

If no improvement in condition is observed after 7 days of taking the drug, a doctor should be consulted.

Due to the presence of lactose in the composition, it is not recommended for patients with lactose intolerance, lactase deficiency, or glucose-galactose malabsorption.

Effect on ability to drive vehicles or operate machinery

The drug does not affect psychophysical condition, does not cause drowsiness, and does not affect the ability to drive vehicles or operate machinery.

Overdose

Overdose may lead to an increase in the manifestation of the drug’s side effects. Treatment is symptomatic.

Drug Interactions

Concomitant use may weaken the effect of coumarin anticoagulants (phenprocoumon, warfarin), which requires dose adjustment and consultation with the attending physician.

Storage Conditions

Store the drug in a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years 6 months. Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.