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Chophytol (Tablets, Solution) Instructions for Use

ATC Code

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

Active Substance

Cynara

Clinical-Pharmacological Group

Herbal preparation with choleretic and diuretic effect

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of diseases of the biliary tract; other agents for the treatment of diseases of the biliary tract

Pharmacological Action

The drug is of plant origin. The pharmacological effect of the drug is due to the complex of biologically active substances contained in the leaves of the field artichoke.Cynarin in combination with phenolic acids has a choleretic and hepatoprotective effect.Ascorbic acid, carotene, vitamins B1 and B2, and inulin contained in artichoke help to normalize metabolic processes.

It also has a diuretic effect and enhances the excretion of urea.

Pharmacokinetics

The action of Chophytol is the combined action of its components, so conducting kinetic observations is not possible; all components together cannot be traced using markers or bioassays. For the same reason, it is also impossible to detect the drug’s metabolites.

Indications

As part of complex therapy

  • biliary dyskinesia of the hypokinetic type;
  • chronic noncalculous cholecystitis;
  • chronic hepatitis;
  • liver cirrhosis;
  • chronic nephritis;
  • chronic renal failure.

ICD codes

ICD-10 code Indication
B18.1 Chronic viral hepatitis B without delta-agent
B18.2 Chronic viral hepatitis C
K73 Chronic hepatitis, not elsewhere classified
K74 Fibrosis and cirrhosis of liver
K81.1 Chronic cholecystitis
K82.8 Other specified diseases of gallbladder and cystic duct (including dyskinesia)
N03 Chronic nephritic syndrome
N11 Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N18 Chronic kidney disease
ICD-11 code Indication
1E51.0Z Chronic hepatitis B, unspecified
1E51.1 Chronic viral hepatitis C
DB93 Fibrosis or cirrhosis of liver
DB97.2 Chronic hepatitis, not elsewhere classified
DC12.1 Chronic cholecystitis
DC1Z Diseases of gallbladder and biliary tract, unspecified
DD94 Functional disorder of the gallbladder
GB40 Nephritic syndrome
GB55.Z Chronic tubulo-interstitial nephritis, unspecified
GB61.Z Chronic kidney disease, unspecified stage
GB40 Nephritic syndrome
XT8W Chronic course

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Adults are prescribed 2-3 tablets or 2.5-5 ml of oral solution 3 times/day before meals. The course of treatment is 2-3 weeks.

Children over 6 years are prescribed 1-2 tablets 3 times/day before meals. The oral solution, depending on age, is prescribed at a dose ranging from 1/4 to 1/2 of the dose used in adults. The course of treatment is 2-3 weeks.

The need for repeated courses of therapy is determined by the doctor individually.

Solution

The dose is set individually, depending on the indications and the dosage form used.

Adverse Reactions

From the digestive system, the development of diarrhea is possible with long-term use of the drug in high doses.

Other allergic reactions.

Contraindications

  • cholelithiasis;
  • obstruction of the biliary tract;
  • acute diseases of the liver, kidneys, biliary and urinary tracts;
  • children under 6 years of age (for tablets);
  • hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of Chophytol during pregnancy and lactation (breastfeeding) is possible only under medical supervision.

Use in Hepatic Impairment

Contraindicated in obstruction of the biliary tract, cholelithiasis, acute diseases of the liver and biliary tract.

Use in Renal Impairment

Contraindicated in acute kidney diseases.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

1 teaspoon of solution contains 0.13 g of ethyl alcohol.

Overdose

Symptoms possible intensification of manifestations of adverse reactions.

Drug Interactions

Drug interactions of Chophytol have not been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life of tablets is 3 years; oral solution is 4 years.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Laboratoires Mayoly-Spindler (France)

Contact Information

MAYOLI PHARMA LLC (Russia)

Dosage Forms

Bottle OTC Icon Chophytol Coated tablets, 200 mg: 60 or 180 pcs.
Oral solution 20 g/100 ml: 120 ml bottle

Dosage Form, Packaging, and Composition

Coated tablets brown, round, biconvex.

1 tab.
Dry aqueous extract of fresh field artichoke leaves 200 mg

Excipients: magnesium trisilicate – 12 mg, corn starch – 22 mg, talc – 3 mg, magnesium stearate – 3 mg.

Shell composition shellac – 1.152 mg, rosin – 1.152 mg, talc – 16.3 mg, gelatin – 0.384 mg, sucrose – 86.146 mg, calcium carbonate – 2.2 mg, disperse dye (sucrose, yellow, black and brown iron oxides (E172), methylparahydroxybenzoate (E218), ethylparahydroxybenzoate (E214)) – 2.58 mg, carnauba wax – 0.082 mg, polysorbate 80 – 0.004 mg.

12 pcs. – blisters (5) – cardboard packs.
30 pcs. – blisters (2) – cardboard packs.
30 pcs. – blisters (6) – cardboard packs.
60 pcs. – polypropylene tubes (1) – cardboard packs.
180 pcs. – polypropylene tubes (1) – cardboard packs.

Oral solution dark brown, opaque, with a slight yellowish sediment; a slight sediment may be present during storage.

100 ml
Thick aqueous extract of fresh field artichoke leaves 20 g

Excipients: ethanol – 2.8 g, orange flavor – 2.8 g, glycerol – 0.18 g, methylparahydroxybenzoate – 0.092 g, propylparahydroxybenzoate – 0.046 g, purified water – up to 100 ml.

120 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Laboratoires Rosa-Phytopharma (France)

Dosage Form

Bottle Rx Icon Chophytol Solution for intravenous and intramuscular injection 100 mg/5 ml: amp. 5 or 12 pcs.

Dosage Form, Packaging, and Composition

Solution for IV and IM administration transparent, from colorless to dark yellow.

1 ml 1 amp.
Purified extract of juice from fresh field artichoke leaves 20 mg 100 mg

Excipients: purified water.

5 ml – glass ampoules (5) – cardboard packs.
5 ml – glass ampoules (12) – cardboard packs.

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