CHOLESTIL MAX

Package leaflet: Information for the user

Cholestil Max, 200 mg, tablets
(Hymecromonum)
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet:

1. What Cholestil Max is and what it is used for
2. Important information before taking Cholestil Max
3. How to take Cholestil Max
4. Possible side effects
5. How to store Cholestil Max
6. Contents of the pack and other information

1. What Cholestil Max is and what it is used for

Cholestil Max contains the active substance hymecromone, a derivative of coumarin. It exerts a spasmolytic effect on the smooth muscle of the bile ducts and the sphincter of Oddi, increases bile secretion, and accelerates bile excretion through the bile 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 spastic conditions of the biliary tract, dyskinesias, and dyspeptic disorders;
• States following surgery of the gallbladder and biliary tract, as well as lack of appetite, nausea, and constipation associated with reduced bile secretion. If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

2. Important information before using Cholestil Max

When not to take Cholestil Max:

• if the patient is hypersensitive to hymecromone or any of the other components 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 Cholestil Max, discuss this 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 Max and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.

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

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

Cholestil Max in patients with renal and/or hepatic impairment
The medicine should not be used in patients with liver and/or kidney insufficiency.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are no data on the safety of using this medicine during pregnancy. The use of Cholestil Max is not recommended in pregnant women.
There are no data on the safety of using this medicine during breastfeeding. The use of this medicine is not recommended during breastfeeding.

Driving and operating machinery
There are no data regarding the influence on psychophysical performance, ability to drive mechanical vehicles, or operate machinery.

Cholestil Max contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Cholestil Max

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults: 200 to 400 mg (1 to 2 tablets) half an hour before meals, three times daily for one week.
Do not divide the tablets.
Taking more Cholestil Max than recommended
There is no available data regarding overdose with this medicine.
If you take more than the recommended dose, consult a doctor or pharmacist immediately.
If you forget to take Cholestil Max
Take the missed dose as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
Stopping Cholestil Max
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 everybody gets 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 if other serious adverse reactions occur,
treatment with Cholestil Max must be discontinued and immediate contact must be made with a
doctor or the nearest hospital Emergency Department.
Cholestil Max is generally well tolerated.
Adverse reactions are listed below according to their frequency of occurrence:
Rare (may occur in up to 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 for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Cholestil Max

Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

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

What Cholestil Max looks like and contents of the pack
White or slightly yellowish white, round, biconvex tablets, engraved on one side with the letters "Ch".
Cholestil Max 200 mg tablets are packed in PVC/Aluminium blisters in a cardboard box.
Each 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.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów