ARTICHOKE-ASTRAPHARM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARTICHOKE-ASTRAFARM

Composition:

Active substance: cynara scolymus;

One capsule contains 100 mg of dry extract of cultivated artichoke (Cynara scolymus) (extractant: ethanol 60%), with a content of hydroxycinnamic acids of not less than 2.5%, calculated on dry substance;

Excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, calcium stearate;

Capsule shell composition: gelatin, titanium dioxide (E 171), indigocarmine (E 132), quinoline yellow (E 104).

Dosage form. Capsules.

Main physicochemical properties: hard gelatin capsules No. 1, cylindrical in shape with hemispherical ends; body – white, cap – green.

The capsule content is a mixture of powders ranging from light brown to brown in color, with a characteristic odor, in the form of powder, granulated mass, or a column partially or completely formed.

Pharmacotherapeutic group.

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

Pharmacological properties.

Pharmacodynamics.

Artichoke-Astrafarm is a plant-derived agent containing artichoke leaf extract.

The pharmacological effects are due to a complex of biologically active substances present in field artichoke leaves (Cynara scolymus). The product exerts choleretic, hepatoprotective, and diuretic actions and also reduces blood urea levels. Inulin and other constituents of artichoke improve metabolic processes in the body.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug or to other plants of the Asteraceae (Compositae) family. Biliary or urinary tract obstruction, cholelithiasis, acute hepatitis, severe hepatic insufficiency, acute kidney diseases.

Interaction with other medicinal products and other forms of interactions.

If taking any other medicinal products, a doctor must be consulted regarding the possibility of using the drug.

The drug may weaken|weaken,weakening| the effect of coumarin-type anticoagulants| (phenprocoumon|, warfarin|), which requires dose adjustment of the latter. When used simultaneously|concomitantly| with |hypotensive| and |hypocholesterolemic| agents, an enhancement of the hypotensive |and

and |hypocholesterolemic| effects is possible.

Special precautions.

The drug should be used with caution in diseases that may lead to biliary tract obstruction and in severe liver diseases.

Patients must inform their physician about any previous reaction to drugs of this group.

With prolonged use of the drug, blood levels of nitrogen-containing substances and cholesterol decrease.

The need for repeated treatment courses is determined individually by the physician.

If disease symptoms do not disappear, constantly recur, or if diarrhea or abdominal pain occurs, treatment with the drug should be discontinued and medical advice should be sought.

During treatment, alcohol consumption should be avoided.

Before first taking the drug, consult a physician. Do not use the drug beyond the established duration without medical consultation.

Use during pregnancy or breastfeeding.

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

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

Ability to influence the reaction rate when driving vehicles or operating machinery.

No effect.

Method of administration and dosage.

|Administration|For adults and children aged|Administration|6 years and older, 15–30 minutes before meals|meals|.

The dose and duration of treatment are determined individually by a physician depending on the nature and severity of the disease.

Adults and children aged 12 years and older: 2–3 capsules three times daily.

Children aged 6 to 12 years: 1 capsule three times daily.

The usual duration of treatment is 2–3 weeks. Repeated courses of treatment are possible after consultation with a physician.

Children.

The drug is contraindicated in children under 6 years of age.

Overdose.

There is no available information regarding cases of overdose. Overdose may enhance adverse effects.

Treatment. Discontinue the drug, gastric lavage. Symptomatic therapy. There is no specific antidote.

Adverse reactions.

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, it is essential to 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 °C.

Keep out of reach of children.

Packaging.

10 capsules per blister; 3 or 6 blisters per box.

Prescription status.

Over-the-counter.

Manufacturer.

LLC "ASTRAFARM".

Manufacturer's address and location of its business activities.

6 Kyivska Street, m. Vyshneve, Kyiv-Sviatoshyn district, Kyiv region, 08132, Ukraine.

INSTRUCTION

for medical use of medicinal product

ARTICHOKE-ASTRAFARM

Composition:

Active ingredient: Cynara scolymus;

1 capsule contains 100 mg of dry extract of cultivated artichoke (Cynara scolymus) (extraction agent ethanol 60%), with hydroxycinnamic acid content not less than 2.5%, calculated on dry substance;

Excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, calcium stearate;

Capsule shell composition: gelatin, titanium dioxide (E 171), indigocarmine (E 132), quinoline yellow (E 104).

Dosage form. Capsules.

Main physicochemical properties: hard gelatin capsules No. 1, cylindrical in shape with hemispherical ends; body – white, cap – green.

Capsule contents – a mixture of powders ranging from light brown to brown with a characteristic odor, in the form of powder or granulated mass, or a partially or completely formed column.

Pharmotherapeutic group.

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

Pharmacological properties.

Pharmacodynamics.

Artichoke-AstraFarm is a plant-derived agent containing artichoke leaf extract.

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

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug or to other plants of the Asteraceae (Compositae) family. Biliary or urinary tract obstruction, cholelithiasis, acute hepatitis, severe hepatic insufficiency, acute kidney diseases.

Interaction with other medicinal products and other types of interactions.

When taking any other medicinal products, it is essential to consult a physician regarding the possibility of using this drug.

The drug may reduce the effect of coumarin-type anticoagulants (phenprocoumon, warfarin), which requires dose adjustment of the latter. Concurrent use of the drug with hypotensive and hypocholesterolemic agents may enhance hypotensive and hypocholesterolemic effects.

Special precautions.

The drug should be used with caution in diseases that may lead to biliary tract obstruction and in severe liver diseases.

Patients must inform the physician about any previous reactions to drugs of this group.

With prolonged use of the drug, blood levels of nitrogen-containing substances and cholesterol decrease.

The need for repeated treatment courses is determined individually by the physician.

If disease symptoms do not disappear or persistently recur, or if diarrhea or abdominal pain occurs, treatment with the drug should be discontinued and medical advice sought.

During treatment, alcohol consumption should be avoided.

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

Use during pregnancy or breastfeeding.

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

If use is necessary, breastfeeding should be discontinued.

Ability to affect driving performance and operating machinery.

No effect.

Method of administration and dosage.

For oral use in adults and children aged 6 years and older, 15–30 minutes before meals.

Dosage and duration of use are determined individually by the physician depending on the nature and severity of the disease.

Adults and children aged 12 years and older – 2–3 capsules three times daily.

Children aged 6 to 12 years – 1 capsule three times daily.

Typical treatment duration is 2–3 weeks. Repeat treatment courses are possible only after consultation with a physician.

Children.

The drug is contraindicated in children under 6 years of age.

Overdose.

Information regarding overdose cases is unavailable. Adverse effects may be intensified.

Treatment. Discontinue the drug, gastric lavage. Symptomatic therapy. No specific antidote available.

Adverse reactions.

With prolonged use of the drug in high doses, diarrhea, upper abdominal pain, nausea and heartburn, as well as allergic reactions may occur.

In case of any unusual reactions, it is essential to 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 °C.

Keep out of reach of children.

Packaging.

10 capsules per blister; 3 or 6 blisters per box.

Prescription status.

Over-the-counter.

Manufacturer.

LLC "ASTRAFARM".

Manufacturer's address and location of its business activities.

6 Kyivska Street, m. Vyshneve, Kyiv-Sviatoshyn district, Kyiv region, 08132, Ukraine.