Package leaflet: Information for the patient

Cholestil, 400 mg, tablets
(Hymecromonum)
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Cholestil is and what it is used for
Important information before taking Cholestil
How to take Cholestil
Possible side effects
How to store Cholestil
Contents of the pack and other information

1. What Cholestil is and what it is used for

Cholestil contains the active substance hymecromone, a derivative of coumarin. It exerts a spasmolytic effect on the smooth musculature of the biliary tract and the sphincter of Oddi, increases bile secretion, and accelerates bile excretion through the biliary ducts. This action reduces bile stasis and associated symptoms, and hinders the formation of cholesterol deposits and gallstones.

Indications:

As an adjunct in symptomatic treatment of biliary spasm, dyskinesia, and dyspeptic disorders;
Functional biliary tract disorders in patients with uncomplicated gallstones;
Conditions following surgery of the gallbladder and biliary tract, as well as in cases of loss of appetite, nausea, and constipation associated with reduced bile secretion.

2. Important information before using Cholestil

When not to take Cholestil

if the patient is hypersensitive to hymecromone or any of the other ingredients of this medicine (listed in section 6),
if the patient has biliary obstruction,
if the patient has severe hepatic and/or renal insufficiency,
in patients with ulcerative colitis or Crohn's disease.

Warnings and precautions
Before starting treatment with Cholestil, discuss it with your doctor or pharmacist.
If symptoms of liver and/or kidney insufficiency occur, discontinue taking the medicine.
Consult your doctor, even if the above warnings refer to conditions that occurred in the past.

Cholestil with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.

Morphine reduces the effect of Cholestil.
When Cholestil is used concomitantly with metoclopramide, the effect of both medicines is reduced.

Cholestil with food and drink
The medicine should be taken half an hour before meals.

Cholestil in patients with impaired kidney and/or liver function
Cholestil should not be used in patients with hepatic and/or renal insufficiency.

Cholestil in elderly patients
There is no need to adjust the dosage in elderly patients.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
There are no data on the safety of Cholestil during pregnancy. The use of Cholestil is not recommended in pregnant women.
There are no data on the safety of Cholestil during breastfeeding. The use of Cholestil is not recommended during breastfeeding.
Cholestil does not affect fertility.

Driving and operating machinery
Cholestil does not impair psycho-physical performance, the ability to drive vehicles or operate machinery.

Cholestil contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium in the maximum daily dose, meaning the medicine is considered "sodium-free".

3. How to take Cholestil

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Adults: 400 mg (1 tablet) half an hour before a meal, three times daily for two weeks.
Do not split the tablets.
Taking more Cholestil than recommended
There is no data available regarding overdose of this medicine.
If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.
Missing a dose of Cholestil
Take the missed dose as soon as possible.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Cholestil
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and/or
throat, which may cause difficulty in breathing or swallowing, or other serious adverse reactions occur,
treatment with Cholestil must be discontinued and immediate contact must be made with a doctor or
the nearest hospital Emergency Department.
Cholestil is generally well tolerated.
Adverse reactions are listed below according to their frequency of occurrence:
Rare (may occur in 1 to 10 people in 10,000): diarrhoea, feeling of fullness or pressure in the abdominal cavity, hypersensitivity reactions, rash or other skin allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Cholestil

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date (EXP) refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cholestil contains
The active substance is hymecromone.
The other ingredients are potato starch, gelatin, sodium lauryl sulfate, magnesium stearate.

What Cholestil looks like and contents of the pack
Cholestil is a white or almost white, oval, biconvex tablet without engraving on either side.

Both sides of the tablets are smooth.

Cholestil tablets, 400 mg, are packed in PVC/Aluminum blisters in a cardboard box.
The pack contains 30 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice