Artichoke

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARTICHOKE (ARTICHOKE)

Composition:

Active ingredient: Cynara scolymus;

1 ml of oral solution contains artichoke extract, dry (Extractum Cynarae siccum)
(7.5 : 1) (extraction solvent – purified water), equivalent to 100 mg of dry artichoke extract;

Excipients: glycerol, ethanol 96%, methylparaben (E 218), propylparaben (E 216), sorbitol (E 420), sodium saccharin, purified water.

Medicinal form. Oral solution.

Main physico-chemical properties: a solution ranging in color from brown to dark brown with a characteristic odor. A greenish tint, opalescence, and sediment formation during storage are permissible.

Pharmacotherapeutic group. Agents used in liver and biliary tract disorders. Agents used in biliary pathology. ATC code A05AX.

Pharmacological properties.

A herbal preparation containing artichoke extract. Exerts choleretic, hepatoprotective, and diuretic effects.

The pharmacological effect is due to a complex of biologically active substances contained in the preparation: cynarin, chlorogenic acid, ascorbic acid, carotene, B-group vitamins, and inulin. The main active ingredient, cynarin, predominantly produces a choloretic effect, while the cholekinetic effect is less pronounced. Ascorbic acid, carotene, B-group vitamins, and inulin improve metabolic processes.

The preparation stimulates bile secretion, reduces blood cholesterol levels, promotes hepatocyte regeneration, and exerts diuretic and hypolipidemic effects. It reduces the sensation of stomach fullness or distension and relieves spasms.

It facilitates the excretion from the body of urea, creatinine, and also toxins (including nitro compounds, alkaloids, heavy metal salts).

Clinical characteristics.

Indications. Biliary dyskinesia of the hypotonic-hypokinetic type, chronic non-calculous cholecystitis, chronic hepatitis of various etiologies, chronic renal failure, chronic intoxications (by hepatotoxic substances, nitro compounds, alkaloids, heavy metal salts), dyspeptic disorders (epigastric heaviness, meteorism, nausea, belching).

Contraindications. Hypersensitivity to the components of the drug / other plants of the Asteraceae (Compositae) family, obstruction of biliary or urinary tracts, suppuration (empyema) of the gallbladder, cholelithiasis, acute hepatitis, severe hepatic insufficiency, acute kidney diseases.

Interaction with other medicinal products and other forms of interaction.

If the patient is taking any other medicinal products, consultation with a physician regarding the possibility of using the drug is mandatory! The drug may reduce the effect of coumarin-type anticoagulants (phenprocoumon, warfarin), requiring dose adjustment of the latter. Concomitant use of the drug with hypoazotemic and hypocholesterolemic agents may enhance their hypoazotemic and hypocholesterolemic effects.

Special precautions for use.

Before first use of the medicine, consult a physician!

Do not use the medicine for longer than the recommended duration without consulting a physician!

It is essential to inform the physician about any previous reaction to medicines of this group.

Use with caution in diseases that may lead to biliary tract obstruction and in severe liver disorders. If disease symptoms do not resolve or recur persistently, or if diarrhea or abdominal pain develops, treatment with the medicine should be discontinued and medical advice sought.

During treatment, abstain from alcohol consumption. Prolonged use of the medicine reduces blood levels of nitrogen-containing substances and cholesterol.

The medicine contains sorbitol (E 420). If the patient has intolerance to certain sugars, consult a physician before taking this medicine.

The medicine contains methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions (possibly delayed).

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

Use during pregnancy or breastfeeding. Use during pregnancy is possible only on a physician's prescription and only when the expected benefit to the mother outweighs the potential risk to the fetus.

If use of the medicine is necessary, breastfeeding should be discontinued.

Effect on ability to drive or operate machinery. No effect.

Method of Administration and Dosage.

The physician determines the dose and duration of treatment individually, depending on the severity of the disease!

Before use, the preparation should be shaken and the required amount of solution diluted in 2 tablespoons (30 mL) of water.

Take 15–30 minutes before meals.

For adults and children aged 12 years and older: 2–3 mL three times daily.

For children aged 6 to 12 years: 1 mL three times daily.

The treatment course lasts 2–4 weeks. Treatment may be repeated after an interval of 1–2 months, as agreed with the physician.

Children. To be used in children aged 6 years and older.

Overdose. Cases of overdose have not been reported. Overdose may result in an intensification of the drug's adverse reactions.

Treatment: Discontinuation of the drug, gastric lavage, symptomatic therapy. There is no specific antidote.

Adverse reactions.

With prolonged use of the drug at high doses, diarrhea, upper abdominal pain, nausea, and heartburn, as well as allergic reactions may occur. If any unusual reactions occur, it is essential to consult a physician regarding further use of the drug.

Shelf life. 2 years.

Shelf life after opening the bottle – 28 days when stored at a temperature not exceeding 25 °C.

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

Keep out of reach of children.

Packaging. 100 ml of the drug in polymer bottles closed with caps. Each bottle with a dosing device is placed in a cardboard box.

Availability category. Over-the-counter.

Manufacturer. Limited Liability Company "Kharkiv Pharmaceutical Enterprise "Zdorov'ya Narodu"".

Manufacturer's location and address of business activity.

41, Kulikovska Street, Kharkiv, Kharkiv Region, 61002, Ukraine.

Bulk production by the company LLC "Pharmaceutical Company "Zdorov'ya", Ukraine.