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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Coated tablets, 200 mg: 60 or 180 pcs.
Oral solution 20 g/100 ml: 120 ml bottle
Marketing Authorization Holder
Laboratoires Mayoly-Spindler (France)
Contact Information
MAYOLI PHARMA LLC (Russia)
Dosage Forms
| 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.
Solution for intravenous and intramuscular injection 100 mg/5 ml: amp. 5 or 12 pcs.
Marketing Authorization Holder
Laboratoires Rosa-Phytopharma (France)
Dosage Form
| 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.
