Artichoke extract-zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARTICHOKE EXTRACT-ZDOROVYE (ARTICHOKE EXTRACT-ZDOROVYE)

Composition:

Active substance: cynara scolymus;

1 ml of the preparation contains 100 mg of artichoke dry extract equivalent to artichoke extract (7.5:1) (extraction agent – purified water);

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

Pharmaceutical form. Oral solution.

Main physico-chemical properties: brown to dark brown solution with a specific odor. A greenish tint, opalescence, and sediment formation may occur during storage.

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

ATC code A05AX.

Pharmacological properties.

Pharmacodynamics.

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 of the preparation—cynarin—exerts primarily choleretic action. 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 promotes the excretion from the body of urea, creatinine, and also toxins (including nitro compounds, alkaloids, salts of heavy metals).

Clinical characteristics.

Indications.

Biliary dyskinesia with hypotonic-hypokinetic type, chronic non-calculous cholecystitis, chronic hepatitis of various etiologies, chronic renal insufficiency, chronic intoxications (hepatotoxic substances, nitro compounds, alkaloids, salts of heavy metals), dyspeptic disorders (epigastric fullness, meteorism, nausea, belching).

Contraindications.

Hypersensitivity to 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 types of interactions.

If the patient is taking any other medications, it is mandatory to consult a physician regarding the possibility of using this medicinal product! The medicinal product may weaken the effect of coumarin-type anticoagulants (phenprocoumon, warfarin), requiring dose adjustment of the latter. Concurrent use of the drug with hypoazotemic and hypocholesterolemic agents may enhance hypoazotemic and hypocholesterolemic effects.

Special precautions for use.

Patients must inform their doctor about any previous reaction to the use of drugs of this group. Consult a physician before first taking the medication! Do not use the drug beyond the recommended duration without medical advice!

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

During treatment, alcohol consumption should be avoided. With prolonged use of the drug, blood levels of nitrogen-containing substances and cholesterol may decrease.

The drug contains sorbitol; therefore, if the patient has known sugar intolerance, consult a physician before taking this medicinal product.

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

Methylparaben (E 218) and propylparaben (E 216) may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

The use of this drug during pregnancy is possible only if prescribed by a physician and only when the expected benefit to the pregnant woman outweighs the potential risk to the fetus.

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

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of administration and dosage.

Dose and duration of use should be determined individually by a physician depending on the severity of the disease!

|Administration|

Before use, the preparation should be shaken and 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. The treatment may be repeated after a break of 1–2 months, with prior agreement with a physician.

Children. The preparation may be used in children aged 6 years and older.

Overdose.

Cases of overdose have not been reported. Overdose may lead to an increase in the drug's adverse effects.

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

Side effects.

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

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging. 100 ml in a bottle with a dosing device, in a box.

Availability. Over-the-counter (without prescription).

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and place of business. 22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.