Artihol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARTIHOL (Artihol)

Composition:

Active substance: dry artichoke extract;

One tablet contains dry artichoke extract 200 mg or 400 mg;

Excipients: magnesium oxide heavy, colloidal anhydrous silicon dioxide, maize starch, talc, magnesium stearate;

Coating: film-coating mixture Opadry 200 Brown: polyvinyl alcohol, talc, titanium dioxide (E 171), polyethylene glycol, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), methacrylate copolymer (type C), sodium bicarbonate.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets, film-coated with a light brown coating.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Agents used in the treatment of liver and biliary tract disorders. Agents used in biliary pathology. ATC code A05AX.

Pharmacological properties.

Pharmacodynamics.

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

Pharmacokinetics.

The action of the medicinal product Artihol results from the combined effect of its components; therefore, kinetic studies are not feasible, as all components together cannot be traced using markers or biological assays. For the same reason, it is impossible to identify the metabolites of the medicinal product.

Clinical characteristics.

Indications.

Chronic hepatitis, liver cirrhosis, chronic acalculous cholecystitis, biliary dyskinesia of the hypokinetic type, chronic nephritis, chronic renal insufficiency.

Contraindications.

Hypersensitivity to the components of the medicinal product, to plants of the family Asteraceae (Compositae); 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.

Unknown.

Special precautions for use.

Use with caution in diseases that may lead to biliary tract obstruction and in severe liver diseases. If diarrhea or abdominal pain occurs, treatment should be discontinued and a doctor should be consulted.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the medicinal product should be used only as prescribed by a physician, if the expected benefit for the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction speed when driving or operating machinery.

The medicinal product does not affect reaction speed when driving or operating machinery.

Dosage and Administration.

For oral use in adults and children aged 6 years and older. Administer before meals.

For adults and children aged 12 years and older: 200–400 mg three times daily.

For children aged 6–12 years: 200 mg three times daily.

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. Repeat courses of treatment are possible after consultation with a physician.

Children. To be used in children aged 6 years and older, as prescribed by a physician.

Overdose.

May result in an intensification of adverse effects.

Adverse Reactions.

With prolonged use of the drug in high doses, diarrhea, as well as abdominal cramps, gastric disturbances, nausea, and heartburn may occur.

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

Shelf Life. 3 years.

Storage Conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

200 mg tablets: 10 tablets in a blister; 3 blisters per pack.

400 mg tablets: 10 tablets in a blister; 4 blisters per pack.

Prescription Status. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's Address and Location of Business Activity.

38 Kopilivska Street, Kyiv, Ukraine, 04073.

Web-site: www.vitamin.com.ua.

INSTRUCTION

for Medical Use of the Medicinal Product

ARTIHOL

(Artihol)

Composition:

Active ingredient: dry extract of artichoke;

1 tablet contains dry extract of artichoke 200 mg or 400 mg;

Excipients: magnesium oxide heavy, colloidal anhydrous silicon dioxide, corn starch, talc, magnesium stearate;

Coating: film-coating mixture Opadry 200 Brown: polyvinyl alcohol, talc, titanium dioxide (E 171), polyethylene glycol, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), methacrylate copolymer (type C), sodium bicarbonate.

Pharmaceutical Form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets with a light brown film coating.

Pharmacotherapeutic Group. Agents affecting the digestive system and metabolism. Agents used in the treatment of liver and biliary tract disorders. Agents used in biliary pathology. ATC code A05AX.

Pharmacological Properties.

Pharmacodynamics.

Pharmacological properties are determined by the action of a complex of biologically active substances contained in the leaves of field artichoke. The drug exerts choleretic, hepatoprotective, and diuretic effects, and also reduces blood urea levels. Inulin and other components of artichoke improve metabolic processes in the body.

Pharmacokinetics.

The effect of the medicinal product Artihol is a combined effect of its components; therefore, kinetic studies are not feasible, as all components together cannot be traced using markers or bioassays. For the same reason, metabolites of the medicinal product cannot be identified.

Clinical Characteristics.

Indications.

Chronic hepatitis, liver cirrhosis, chronic non-calculous cholecystitis, hypokinetic biliary dyskinesia, chronic nephritis, chronic renal failure.

Contraindications.

Hypersensitivity to the components of the medicinal product or to plants of the Asteraceae (Compositae) family; biliary tract obstruction, cholangitis, gallbladder empyema, gallstone disease or other biliary tract disorders, acute liver diseases, severe hepatic insufficiency; urinary tract obstruction, acute kidney diseases.

Interaction with Other Medicinal Products and Other Types of Interactions.

Not known.

Special Precautions.

Use with caution in diseases that may lead to biliary tract obstruction and in severe liver diseases. If diarrhea or abdominal pain occurs, discontinue treatment and consult a physician.

Use during Pregnancy or Breastfeeding.

During pregnancy or breastfeeding, the medicinal product should be used only as prescribed by a physician, if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to Affect Reaction Rate When Operating Vehicles or Machinery.

The medicinal product does not affect reaction rate when driving vehicles or operating machinery.

Method of Administration and Dosage.

For oral use in adults and children over 6 years of age. Take before meals.

Adults and children over 12 years: 200–400 mg three times daily.

Children 6–12 years: 200 mg three times daily.

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

Children. For use in children aged 6 years and older only as directed by a physician.

Overdose.

May result in an intensification of adverse effects.

Adverse Reactions.

With prolonged use of the drug in high doses, diarrhea, abdominal cramps, gastric disturbances, nausea, and heartburn may occur.

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

Shelf Life. 3 years.

Storage Conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

200 mg tablets: 10 tablets in a blister; 3 blisters per pack.

400 mg tablets: 10 tablets in a blister; 4 blisters per pack.

Prescription Status. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's Address and Location of Business Activity.

38 Kopilivska Street, Kyiv, Ukraine, 04073.

Web-site: www.vitamin.com.ua.