HOFITOL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT XOPLITOL

Composition:

Active substance: aqueous extract of field artichoke leaves (Cynara scolymus);

100 ml of solution contain 20 g of concentrated aqueous extract of field artichoke leaves (Cynara scolymus) 10-20:1;

Excipients: ethanol 96%, orange peel tincture, glycerin, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: dark brown opaque solution with a slight yellowish sediment.

Pharmacotherapeutic group. Agents used in liver and biliary tract disorders. Other agents used in biliary pathology.

ATC code A05A X.

Pharmacological Properties.

Pharmacodynamics.

The pharmacological properties are determined by the action of the complex of biologically active substances contained in the leaves of field artichoke. It exerts choleretic, hepatoprotective, and diuretic effects, and also reduces the level of urea in the blood. Inulin and other constituents of artichoke improve metabolic processes in the body.

Pharmacokinetics.

The action of Hofitol is the combined effect of its components; therefore, kinetic studies are not feasible, as all components together cannot be traced using markers or biodetection methods. For the same reason, it is impossible to identify the metabolites of the drug.

Clinical characteristics.

Indications.

Improvement of cholagogue and diuretic functions in liver, biliary tract, and kidney disorders, such as liver cirrhosis, chronic non-calculous cholecystitis, hypokinetic-type biliary dyskinesia, chronic nephritis, and chronic renal insufficiency.

Contraindications.

Hypersensitivity to the components of the medicinal product, particularly to methyl parahydroxybenzoate or propyl parahydroxybenzoate, or to plants of the Asteraceae (Compositae) family; hepatitis, biliary tract obstruction, cholangitis, suppuration (empyema) of the gallbladder, cholelithiasis or other biliary tract diseases, acute liver diseases, severe hepatic insufficiency; urinary tract obstruction, acute kidney diseases.

Interaction with other medicinal products and other types of interactions.

Combinations that should be considered (due to the presence of ethanol (0.20 g per teaspoon) in the medicinal product):

• medicinal products that may cause an antabuse-like reaction (sensation of warmth, flushing, nausea, tachycardia) when used concomitantly with ethanol;
• medicinal products that depress central nervous system function.

Special precautions for use.

Since the medicinal product contains ethanol, consumption of any alcoholic beverages should be avoided.

Use with caution in diseases that may lead to biliary tract obstruction and in severe liver disorders. If diarrhea or abdominal pain occurs, treatment should be discontinued and medical advice should be sought.

This medicinal product contains 5.1 % v/v ethanol (alcohol), i.e. 200 mg/dose, equivalent to 5.1 ml of beer or 2.1 ml of wine per dose.

Harmful for patients suffering from alcoholism. Caution is advised when used during pregnancy and breastfeeding, in children, and in patients with liver disorders or epilepsy.

One teaspoon of the solution contains 0.20 g of ethanol.

Contains glycerol, methylparahydroxybenzoate (E 218), and propylparahydroxybenzoate (E 216).

Use during pregnancy or breastfeeding.

This medicinal product should be used during pregnancy or breastfeeding only if clearly needed and prescribed by a physician, when the expected benefit to the woman outweighs the potential risk to the fetus or infant.

Ability to influence reaction speed when driving or operating machinery.

May affect the ability to drive and operate machinery, as the product contains ethanol.

Method of administration and dosage.

For oral use. The solution should be shaken before use and diluted with water.

Adults are prescribed 1 teaspoon (5 ml of solution) 3 times daily before meals.

For children aged 12 years and older: ½–1 teaspoon of solution should be diluted in 1 tablespoon of water and taken 3 times daily, 20 minutes before meals.

The duration of treatment is determined individually by a physician, depending on the nature and course of the disease. Usually, the treatment course lasts 2–3 weeks. Repeated courses of treatment are possible only after consultation with a physician.

Children.

The medication can be used in children aged 12 years and older, as prescribed by a doctor. For children under 12 years of age, Hofitol tablets coated with film are recommended.

Overdose.

May result in an intensification of adverse effects.

Side effects.

If the drug is used for a prolonged period at high doses, diarrhea, abdominal cramps, gastric disturbances, nausea, and heartburn may occur.

Allergic reactions are possible, including urticaria, skin rashes, hyperemia, and itching.

Shelf life. 4 years.

Storage conditions. Store at a temperature not exceeding 25°C, in a place inaccessible to children.

Packaging.

120 ml of solution in a bottle. 1 bottle in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

Laboratoires Mayoly Spindler.

Manufacturer's address and place of business.

6, Avenue de l’Europe, 78400 Chatou, France.