Cholelesan®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHOLELESAN® (Cholelesan)

Composition:

Active substances:

1 capsule contains:
extract of wild carrot fruits and marigold flowers, dry extract (7.75–13.4):1, obtained from wild carrot fruits (Daucus carota) and marigold flowers (Calendula officinalis), extracted with 70% ethanol, calculated as dry substance – 60 mg;
dry extract of sand everlasting flowers (Helichrysum arenarium florex) (40:1), extracted with 50% ethanol (v/v) – 50 mg;
curcumin C3 complex, derived from turmeric rhizomes (Curcuma longa rhizomes) (64–66):1, extracted with ethyl acetate – 20 mg;
turmeric oil (turmerone oil) – 5 mg;
peppermint oil – 7.5 mg.

Excipients:
magnesium aluminometasilicate (Aerosil® UFL2);
heavy magnesium carbonate;
talc;
lactose monohydrate (Tablettose – 80);
potato starch;
castor oil.

Capsule shell:
gelatin; titanium dioxide (E 171); yellow iron oxide (E 172).

Pharmaceutical form. Capsules.

Main physicochemical characteristics:
hard gelatin capsules, body and cap yellow in color. The capsule contents consist of granular powder and/or compacted mass ranging from yellow to yellow-orange with a greenish-brown tint, speckled, with a characteristic odor.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Agents used in the treatment of liver and biliary tract disorders. Agents used in biliary pathology.

ATC code: A05AX.

Pharmacological Properties

Pharmacodynamics.

Cholesan® is a multi-component agent of natural origin, whose pharmacological properties are determined by the combined action of a complex of biologically active substances contained in its composition.

The choleretic (bile-stimulating) effect of the medicinal product Cholesan® – stimulation of bile production – is due to the action of the following components: extract of wild carrot, extract of flowers of Anthriscus cerefolium, extract of Cuminum cyminum, oil of Curcuma longa, oil of Mentha piperita.

The cholekinetic action of the medicinal product Cholesan® – improved bile outflow through the biliary tract into the duodenum and prevention of bile stasis – is determined by the presence in its composition of extract of flowers of Anthriscus cerefolium, extract of Cuminum cyminum, and oil of Curcuma longa.

The cholospasmolytic effect of the medicinal product Cholesan® – relief of painful spasms of the biliary ducts – is due to the action of extract of wild carrot and oil of Mentha piperita.

The hepatoprotective action of the medicinal product Cholesan® – improvement of metabolic processes in the liver – is determined by the action of extract of wild carrot, extract of flowers of Anthriscus cerefolium, extract of Cuminum cyminum, oil of Curcuma longa, and oil of Mentha piperita.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Chronic non-calculous cholecystitis. Biliary tract dyskinesia. Chronic hepatitis (as part of complex therapy).

Contraindications.

Hypersensitivity to the components of the medicinal product, biliary tract obstruction, cholangitis, suppuration (empyema) of the gallbladder, cholelithiasis, acute inflammatory diseases of the liver and gallbladder, severe hepatic insufficiency, severe renal insufficiency, urinary tract obstruction, acute kidney diseases.

Interaction with other medicinal products and other types of interactions.

Interaction with other medicinal products and other types of interactions are unknown.

If it is necessary to use any other medicinal products concomitantly, a physician should be informed.

Special precautions for use.

Use with caution in patients with diseases that may lead to biliary tract obstruction or severe liver disorders. If diarrhea or abdominal pain occurs, treatment should be discontinued and medical advice should be sought.

Cholesan® contains lactose; therefore, it should be used with caution in patients with hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Cholesan® contains castor oil, which may cause gastrointestinal discomfort and diarrhea.

Use during pregnancy or breastfeeding. Cholesan® should be used during pregnancy or breastfeeding only if prescribed by a physician, when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction rate while driving or operating machinery. When using this medicinal product, adverse effects such as dizziness, drowsiness, headache, and sensation of heaviness in the head may occur. These effects should be taken into account when driving or operating machinery.

Method of administration and doses.

Oral use. Take 1–2 capsules three times a day. The medicinal product should be taken 30 minutes before meals, without chewing, swallowing with a small amount of water. Maximum daily dose – 6 capsules.

Dosage and duration of treatment are determined individually by a physician depending on the nature and course of the disease. Usually, the treatment course lasts 20 days. Repeated courses of treatment are possible after consultation with a physician.

Children. For children aged 6 years and older, use only as prescribed by a physician.

Overdose. No cases of overdose have been reported to date.

Symptoms: prolonged use at doses exceeding the recommended ones may lead to an increase in adverse reactions.

Treatment: discontinue the drug, symptomatic therapy; there is no specific antidote.

Side effects.

Gastrointestinal system: feeling of discomfort and bloating, intestinal rumbling, diarrhea, itching around the anus, nausea, belching.

Central nervous system: dizziness, drowsiness, headache, feeling of heaviness in the head.

Other side effects: sensation of warmth, facial flushing.

Shelf life. 3 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 blisters per pack.

Dispensing category. Over-the-counter.

Manufacturer. JSC "Kyivmedpreparat".

Manufacturer's address.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.