Holestil

Package Leaflet: Information for the Patient

Cholestil, 400 mg, Tablets

(Hymecromonum)

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 or pharmacist.
• 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 those not listed in this leaflet, tell your doctor or pharmacist. 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

Cholestil contains the active substance hymecromon, 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 excretion through the bile ducts. This action reduces bile stasis and related symptoms, as well as prevents the formation of cholesterol deposits and gallstones.

Indications:

• 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 hypersensitive to hymecromon 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 or pharmacist. 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, as well as any medicines you plan to take.

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

Cholestil with food and drink

Take the medicine half an hour before meals.

Cholestil in patients with kidney and/or liver function 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. There is no data on the safety of using the medicine during pregnancy. It is not recommended to use Cholestil in pregnant women. There is no data on the safety of using the medicine during breastfeeding. It is not recommended to use the medicine during breastfeeding. Cholestil does not affect fertility.

Driving and using machines

Cholestil does not impair psychophysical abilities, the ability to drive vehicles, or operate machinery.

Cholestil contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, 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: 400 mg (1 tablet) half an hour before meals, three times a day, for two weeks. Do not divide the tablets.

Overdose of Cholestil

There is no data on overdose. If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

Missed dose of Cholestil

Take the missed dose as soon as possible. Do not take a double dose to make up for the missed dose.

Stopping Cholestil treatment

If you have any further questions about 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. 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 and contact your doctor or the Emergency Department of the nearest hospital immediately.Cholestil 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, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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. There are no special precautions for storage. Do not use this medicine after the expiry date stated on the packaging. The expiry date (EXP) 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 contains

The active substance is hymecromon. 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.

• both sides of the tablets are smooth.

Cholestil 400 mg tablets are packaged in PVC/Aluminum blisters, in a cardboard box. The 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. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Date of last revision of the leaflet: