Holestil Max

Package Leaflet: Information for the Patient

Cholestil Max, 200 mg, Tablets

(Hymecromone)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

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

Cholestil Max contains the active substance hymecromone, which is a coumarin derivative. It acts as a spasmolytic on the smooth muscle of the bile ducts and the sphincter of Oddi, increases bile secretion, and accelerates its elimination through the bile ducts. This action reduces bile stasis and related symptoms, as well as makes it difficult for cholesterol deposits and gallstones to form.

Indications:

• as an auxiliary in the symptomatic treatment of spastic conditions of the bile ducts, dyskinesia, dyspeptic disorders,
• post-operative conditions of the gallbladder and bile ducts, as well as in cases of decreased appetite, nausea, and constipation related to reduced bile secretion. If after 7 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Cholestil Max

When not to take Cholestil Max:

• if you are hypersensitive to hymecromone or any of the other ingredients of this medicine (listed in section 6);
• if you have bile duct obstruction;
• if you have severe liver and/or kidney failure;
• in patients with ulcerative colitis and Crohn's disease.

Warnings and precautions

Before starting to take Cholestil Max, discuss it with your doctor or pharmacist. In case of symptoms of liver and/or kidney failure, stop taking the medicine. Consult your doctor, even if the above warnings concern situations that occurred in the past.

Cholestil Max and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• Morphine weakens the effect of Cholestil Max.
• When taking Cholestil Max with metoclopramide, the effect of both medicines is weakened.

Cholestil Max with food and drink

Take the medicine half an hour before meals.

Cholestil Max in patients with kidney and/or liver function disorders

Do not use the medicine in patients with liver and/or kidney failure.

Cholestil Max in elderly patients

There is no need to change the dosage of the medicine in elderly patients.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There are no data on the safety of using the medicine during pregnancy. It is not recommended to use Cholestil Max in pregnant women. There are no data on the safety of using the medicine during breastfeeding. It is not recommended to use the medicine during breastfeeding.

Driving and using machines

There are no data on the effect on psychophysical abilities, ability to drive vehicles, and operate machinery.

Cholestil MAX contains sodium

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

3. How to take Cholestil Max

Take this medicine always exactly as described in the package leaflet for the patient or as advised by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. Adults: 200 to 400 mg (1 to 2 tablets) half an hour before meals, three times a day, for a week. Do not divide the tablets.

Taking a higher dose of Cholestil Max than recommended

There are no data on overdose. If you have taken a higher dose of the medicine than recommended, contact your doctor or pharmacist immediately.

Missing a dose of Cholestil Max

Take the missed dose immediately. Do not take a double dose to make up for the missed dose.

Stopping the use of Cholestil Max

In case of any further doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience allergic reactions, including rash, face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, or other serious side effects, stop taking Cholestil Max and contact your doctor or the Emergency Department of the nearest hospital immediately.Cholestil Max is generally well-tolerated. Side effects are listed according to their frequency: Rare (may affect up to 1 in 10,000 people): diarrhea, feeling of fullness or pressure in the abdominal cavity, hypersensitivity reactions, rash, or other skin allergic reactions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cholestil Max

Keep the medicine out of the sight and reach of children. Store in a temperature 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 given month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cholestil Max contains

The active substance of the medicine is hymecromone. The other ingredients are potato starch, gelatin, sodium lauryl sulfate, magnesium stearate.

What Cholestil Max looks like and contents of the pack

White or white with a yellowish tint, round, flat on both sides, tablets engraved with the letters "Ch" on one side. Cholestil Max 200 mg tablets are packaged in PVC/Aluminum blisters in a cardboard box. Each pack contains 30 or 50 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 Date of last revision of the leaflet: