Cynarix forte

INSTRUCTIONS for medical use of the medicinal product Cynarix forte (Cynarix forte)

Composition:

Active ingredient: 1 coated tablet contains dry artichoke leaf extract (Cynara scolymus L., folium) (4–6:1) (extractant: water) – 600 mg;

Excipients: maltodextrin, colloidal anhydrous silicon dioxide, talc, low-substituted hydroxypropylcellulose, magnesium stearate;

coating: acacia (gum arabic), sucrose, talc, titanium dioxide (E 171), Eudragit E12.5 (dry substance solution of curcumin 12.5% (E 100) in a mixture of 60% isopropyl alcohol and 40% acetone), methylcellulose, calcium carbonate (E 170), povidone, colloidal anhydrous silicon dioxide, glycerol 85%, montan glycol wax.

Pharmaceutical form. Coated tablets.

Main physico-chemical properties: biconvex, elongated, glossy, smooth, white coated tablets.

Pharmacotherapeutic group. Agents used in biliary pathology. ATC code A05A X

Pharmacological properties.

Pharmacodynamics.

Pharmacological properties are determined by the action of a complex of biologically active substances contained in the leaves of field artichoke, namely: caffeoylquinic acids (CQA), flavonoids (e.g., luteolin), and sesquiterpene lactones. CQA enhance bile secretion. The hypolipidemic effect is attributed to luteolin, which inhibits cholesterol biosynthesis. Bitter sesquiterpene lactones (e.g., cynaropicrin) stimulate gastric acid secretion. In vitro, CQA have demonstrated protective properties towards hepatocytes.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the medicinal product and to plants of the Asteraceae family (compositae); biliary tract obstruction, cholangitis, gallbladder suppuration (empyema), cholelithiasis or other biliary tract diseases, acute liver diseases, severe hepatic insufficiency; urinary tract obstruction, acute kidney diseases.

Special safety precautions.

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 medical advice sought.

The medicinal product contains sucrose. Therefore, patients with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not use this medicinal product.

Interaction with other medicinal products and other forms of interaction.

No reports of interactions between "Cinarix Forte" and other medicinal products have been received.

Special precautions.

Use during pregnancy or breastfeeding.

Due to insufficient data, use during pregnancy and breastfeeding is not recommended.

Ability to affect reaction speed when driving or operating machinery.

"Cinarix Forte" does not affect the ability to drive or operate machinery.

Dosage and Administration.

Dosage

Adults and children aged 12 years and older:

1 coated tablet twice daily.

Administration method

The medication should be taken during meals, with sufficient amount of water (e.g., 1 glass).

The treatment duration 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 only after consultation with a physician.

Children.

Not recommended for children under 12 years of age due to insufficient data on use.

Overdose.

May lead to an intensification of adverse effects.

Side effects.

Possible moderate diarrhea with abdominal cramps, as well as epigastric disturbances such as nausea or heartburn, and allergic reactions including urticaria, skin rashes, hyperemia, and itching. If adverse reactions occur, consult a physician.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C. Keep in the original packaging to protect from light.

Packaging.

15 tablets per blister pack, 30 tablets (15×2) or 90 tablets (15×6) per cardboard box.

Supply classification.

Over-the-counter.

Manufacturer.

Pharmazeutische Fabrik Montavit GmbH

Manufacturer's location and address of its business site.

Salzbergstraße 96, 6067 Absam, Austria