Holestil

Package Leaflet: Information for the Patient

Cholestil, 200 mg, Tablets

Hymecromone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Cholestil and what is it used for

Hymecromone is a coumarin derivative. It has a spasmolytic effect on the smooth muscle of the bile ducts and the Oddi sphincter, increases bile secretion, and accelerates its elimination through the bile ducts. This action reduces bile stasis and related symptoms, as well as prevents the formation of cholesterol deposits and gallstones.

• as an auxiliary treatment for symptomatic treatment of spastic conditions of the bile ducts, dyskinesia, dyspeptic disorders,
• functional disorders of the bile ducts in patients with uncomplicated cholelithiasis,
• 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.

2. Important information before taking Cholestil

When not to take Cholestil:

• if you are allergic 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 taking Cholestil, discuss it with your doctor, pharmacist, or nurse. If you experience symptoms of liver and/or kidney failure, stop taking the medicine. Consult your doctor, even if the above warnings refer to past situations.

Cholestil and other medicines

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

• Morphine reduces the effect of hymecromone.
• When taking hymecromone with metoclopramide, the effect of both medicines is reduced.

Taking Cholestil with food and drink

Take the medicine half an hour before meals.

Cholestil in patients with kidney and/or liver disorders

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

Cholestil in elderly patients

There is no need to change the dosage 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 for advice before taking this medicine. There is no data on the safety of using the medicine during pregnancy. Administration of hymecromone to pregnant women is only justified when the benefit to the mother outweighs the potential risk to the fetus. There is 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

The medicine does not affect psychophysical abilities, the ability to drive vehicles, and operate machinery.

Cholestil 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Adults: 200 to 400 mg (1 to 2 tablets) half an hour before meals, three times a day, for two weeks. Do not divide the tablets. If you feel that the effect of Cholestil is too strong or too weak, ask your doctor.

Taking more Cholestil than prescribed

There is no data on overdose. If you have taken more than the prescribed 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 the missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cholestil can cause side effects, although not everybody gets them. Cholestil is generally well-tolerated. Diarrhea, feeling of fullness or pressure in the abdominal cavity, hypersensitivity reactions may occur. If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including any 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, 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

Keep the medicine out of the sight and reach of children. Store in the original package. Store at a temperature below 25°C. Do not use this medicine after the expiry date stated on the package after EXP. The expiry date refers to the last day of the month stated. 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 contains

The active substance is hymecromone. One tablet contains 200 mg of hymecromone. The other ingredients are: potato starch, gelatin (type A), sodium lauryl sulfate, magnesium stearate.

What Cholestil looks like and contents of the pack

White or white with a yellowish tint, round, flat on both sides, tablets engraved with "Ch" on one side. The tablets are packaged in PVC/Al blisters or a polyethylene container in a cardboard box with a patient leaflet. The pack contains 50 tablets.

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: