Cholelesan capsules blister No. 30

Instructions for use Cholelesan capsules blister No. 30

Composition

active ingredients:

1 capsule contains: wild carrot fruit and marigold flower extract thick, (7.75-13.4):1, obtained from wild carrot fruit (Daucus carota) and marigold flower (Calendula officinalis), extractant ethanol 70%, calculated on dry matter – 60 mg; sand flower extract dry (Helichrysum arenarium florex), (40:1), extractant ethanol 50% (v/v) – 50 mg; curcumin C3 complex obtained from turmeric long roots (Curcuma longa rhizomes), (64-66):1, extractant ethyl acetate – 20 mg; turmeric long oil (turmerone oil) – 5 mg; peppermint oil – 7.5 mg;

excipients: magnesium aluminometasilicate (neucilin UFL2); heavy magnesium carbonate; talc; lactose monohydrate (tabletose – 80), potato starch, castor oil;

capsule shell: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172).

Dosage form

Main physicochemical properties: hard gelatin capsules, yellow body and cap. Capsule contents – granular powder and/or compacted mass from yellow to yellow-orange with a greenish-brown tint, with inclusions and a specific odor.

Pharmacotherapeutic group

Drugs affecting the digestive system and metabolism. Drugs used to treat liver and biliary tract diseases. Drugs used in biliary pathology. ATC code A05A X.

Pharmacological properties

Pharmacodynamics

Cholelesan® is a multi-component product of natural origin, the pharmacological properties of which are due to the combined effect of a complex of biologically active substances that make up the drug.

The choleretic (cholesterologenic) effect of the drug Cholelesan® - stimulation of bile formation - is due to the action of the following components of the drug: wild carrot extract, marigold flower extract, sandwort extract, turmeric oil, peppermint oil.

The cholekinetic effect of the drug Cholelesan® - improving the outflow of bile through the biliary tract into the duodenum and preventing bile stasis - is due to the presence of marigold flower extract, sandwort extract, and turmeric oil in its composition.

The cholespasmolytic effect of the drug Cholelesan® – the elimination of painful spasms of the bile ducts – is due to the action of wild carrot extract and peppermint oil.

The hepatoprotective effect of the drug Cholelesan® - improvement of metabolic processes in the liver - is due to the action of wild carrot extract, marigold flower extract, sand thistle extract, turmeric oil, and peppermint oil.

Pharmacokinetics

Not studied.

Indication

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

Contraindication

Hypersensitivity to the components of the drug, biliary tract obstruction, cholangitis, suppuration (empyema) of the gallbladder, cholelithiasis, acute inflammatory diseases of the liver and gallbladder, severe liver failure, severe renal failure, urinary tract obstruction, acute kidney disease.

Interaction with other medicinal products and other types of interactions

Interactions with other drugs and other types of interactions are unknown.

Application features

Use with caution in diseases that may lead to biliary obstruction and in severe liver disease. If diarrhea or abdominal pain occurs, treatment should be discontinued and a doctor should be consulted.

Cholelesan® contains lactose, so the drug should be used with caution in patients with hereditary galactose intolerance, lactase deficiency or glucose/galactose malabsorption syndrome.

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug does not affect the reaction speed when driving or working with other mechanisms.

Use during pregnancy or breastfeeding

During pregnancy or breastfeeding, the drug is used only as prescribed by a doctor, if the expected benefit to the woman outweighs the potential risk to the fetus or child.

Method of administration and doses

Use internally. 1-2 capsules 3 times a day. The drug is taken 30 minutes before meals, without chewing, with a small amount of water. The maximum daily dose is 6 capsules.

The dosage and duration of the course of treatment is determined by the doctor individually, depending on the nature and course of the disease. Usually the course of treatment is 20 days. Repeated courses of treatment are possible after consultation with the doctor.

Children

Used in children over 6 years of age as prescribed by a doctor.

Overdose

No cases of overdose have been registered so far.

Symptoms: with prolonged use in doses exceeding the recommended ones, increased adverse reactions are possible.

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

Adverse reactions

On the part of the digestive system: feeling of discomfort and bloating, rumbling in the intestines, diarrhea, itching in the anus, nausea, belching.

From the side of the central nervous system: dizziness, drowsiness, headache, feeling of heaviness in the head.

Other side effects: feeling hot, facial redness.

Expiration date

3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ºС.

Keep out of reach of children.

Packaging

10 capsules in a blister; 3 blisters in a pack.

Vacation category

Without a prescription.

Producer

PJSC "Kyivmedpreparat".

Location of the manufacturer and its business address

Ukraine, 01032, Kyiv, Saksaganskoho St., 139.