Artichoke extract-zdorovya

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

Composition:

Active ingredient: cynara scolymus;

One capsule contains artichoke dry extract (Extractum Cynarae siccum) (7.5:1) (extraction solvent – purified water), equivalent to 100 mg or 300 mg of dry substance;

Excipients: lactose monohydrate, colloidal anhydrous silicon dioxide, calcium stearate, crospovidone; the capsule shell contains: titanium dioxide (E 171), sunset yellow FCF (E 110), gelatin (100 mg dosage) or titanium dioxide (E 171), erythrosine (E 127), quinoline yellow (E 104), indigocarmine (E 132), gelatin (300 mg dosage).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules with an orange cap and body (100 mg dosage) or with a green cap and yellow body (300 mg dosage). The capsule contents are a fine granular powder ranging from light brown with a greyish tint to dark brown with a greyish tint. The presence of white inclusions, powder, and powder aggregates is permissible.

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

Pharmacological properties.

Pharmacodynamics. A plant-derived 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 activity is expressed to a lesser extent. 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. Reduces the sensation of stomach fullness or distension and relieves spasms.

Promotes the elimination from the body of urea, creatinine, and also toxins (including nitro compounds, alkaloids, and salts of heavy metals).

Clinical characteristics.

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

Contraindications. Hypersensitivity to components of the drug or to 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, it is mandatory to consult a physician regarding the possibility of using the drug.

The drug may weaken the effect of coumarin-type anticoagulants (phenprocoumon, warfarin), requiring dose adjustment of these agents. 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 reactions to medications of this group.

Prior to first use of the drug, consult a physician. Do not use the drug beyond the recommended duration without medical consultation.

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 persistently, or if diarrhea or abdominal pain occurs, discontinue treatment and consult a physician.

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

The drug contains lactose; therefore, if the patient has been diagnosed with intolerance to certain sugars, consult a physician before taking this medication.

The dye "Sunset Yellow FCF" (E 110) may cause allergic reactions.

Use during pregnancy or breastfeeding. The drug may be used during pregnancy only under medical supervision when the expected benefit to the mother outweighs the potential risk to the fetus. If use of the drug is necessary, breastfeeding should be discontinued.

Ability to influence reaction rate while driving or operating machinery. Does not affect.

Method of administration and dosage.

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

|Administration| Take 15–30 minutes before meals. For adults and children aged 12 years and older – 200–300 mg three times daily.

For children aged 6 to 12 years – 100 mg three times daily.

The treatment course lasts 2–4 weeks. Treatment may be repeated after a 1–2 month break, following consultation with a physician.

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

Overdose. Cases of overdose have not been reported. Overdose may enhance adverse effects of the drug.

Treatment: Discontinue 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. 3 years (100 mg dosage), 2 years (300 mg dosage).

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

Keep out of reach of children.

Packaging. Capsules 100 mg № 10×2, № 10×6 in blisters in a box or 300 mg № 10×3, № 10×6 in blisters in a box.

Availability category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY «CORPORATION «ZDOROVYA».

LIMITED LIABILITY COMPANY «FARMEKS GROUP».

Manufacturer's address and location of business activity. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka street, building 22.

(LIMITED LIABILITY COMPANY «CORPORATION «ZDOROVYA»)

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka street, building 100.

(LIMITED LIABILITY COMPANY «FARMEKS GROUP»)