Ircolon forte

Package leaflet: Information for the user

Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are similar.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Ircolon Forte is and what it is used for

Ircolon Forte contains trimebutine maleate as the active substance. Trimebutine acts on the smooth muscles of the gastrointestinal tract, regulating gastrointestinal motility. It does not affect the central nervous system.
Ircolon Forte is used for symptomatic treatment of:

• gastrointestinal motility disorders, known as irritable bowel syndrome;
• pain associated with functional disorders of the gastrointestinal tract and biliary passages: diarrhoea, constipation, abdominal pain, intestinal spasms.

2. Important information before using Ircolon Forte

When not to use Ircolon Forte:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Ircolon Forte, please consult your doctor or pharmacist.
Children
Ircolon Forte is not recommended for use in children under 12 years of age.
Ircolon Forte and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform your doctor if the patient is taking any of the following medicines:

• zotepine (an antipsychotic medicine);
• d-tubocurarine (a muscle relaxant used in general anaesthesia);
• cisapride (a medicine used for gastrointestinal disorders);
• procainamide (a medicine used for heart rhythm disorders);
• calcium channel antagonists (medicines used for high blood pressure and heart diseases);
• captopril (a medicine used for high blood pressure);
• midazolam (a medicine used for sleep disorders).

Ircolon Forte with food and drink
The medicine should be taken before a meal, with a glass of water.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Currently, there are insufficient data to assess the potential for teratogenic or toxic effects of trimebutine during pregnancy.
The use of trimebutine during pregnancy should only be considered if the potential benefits of treatment outweigh the risks to the mother and the fetus.
Breastfeeding
The safety of using Ircolon Forte in breastfeeding women has not been established.
Driving and operating machinery
Ircolon Forte has no influence on the ability to drive or operate machinery.
Ircolon Forte contains monohydrated lactose (a sugar present in milk)
This medicine contains monohydrated lactose (one tablet contains 233 mg of monohydrated lactose). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. This medicine contains 0.233 g of lactose (0.1165 g glucose and 0.1165 g galactose) per tablet. This should be taken into account in patients with diabetes.
Ircolon Forte contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ircolon Forte

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults
Irritable bowel syndrome
Half a tablet (100 mg) three times daily (300 mg daily) before meals.
In exceptional cases, the doctor may increase the dose up to 600 mg daily.
In such cases, one tablet (200 mg) should be taken three times daily.
Functional gastrointestinal and biliary tract disorders

• Diarrhoea, constipation: one tablet (200 mg) once or twice daily (200 mg to 400 mg daily) before meals.
• Abdominal pain, intestinal spasms: half a tablet (100 mg) three times daily (300 mg daily) before meals. In exceptional cases, the doctor may increase the dose up to 600 mg daily. In such cases, one tablet (200 mg) should be taken three times daily.

Use in children
Children above 12 years of age
Trimebutine may be used in children above 12 years of age at a dose not exceeding 6 mg/kg
body weight daily.
Children below 12 years of age
Use of Ircolon Forte is not recommended in this age group (see section "Warnings and precautions").
Method and duration of administration
The tablet should be swallowed with a glass of water.
The tablet may be divided into equal doses.
Your doctor will advise you on how long to take the medicine.
Taking more Ircolon Forte than recommended
In case of overdose, symptomatic treatment should be administered.
Missing a dose of Ircolon Forte
Do not take a double dose to make up for a missed dose.
Stopping Ircolon Forte
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.
The following adverse reactions may occur during treatment with Ircolon Forte:
Common (in 1 to 10 out of 100 people):

• drowsiness, somnolence;
• feeling of fatigue;
• dizziness;
• sensation of heat or cold;
• headache;
• apathy;
• dryness of the mouth;
• taste disturbances;
• diarrhoea;
• indigestion;
• abdominal pain;
• numbness of the lips;
• nausea;
• vomiting;
• constipation;
• sensation of thirst.

Uncommon (in 1 to 10 out of 1,000 people):

• rash.

Rare (in 1 to 10 out of 10,000 people):

• irregular heartbeat;
• liver function disorders, including increased blood activity of liver enzymes AlAT and AspAT.

Very rare (less than 1 in 10,000 people, including isolated cases):

• anxiety;
• hearing impairment;
• hepatitis;
• skin reactions (itching, urticaria, erythema, blisters, nodules, exudation, rash);
• urinary retention;
• menstrual disorders;
• painful breast enlargement in women;
• breast enlargement in men (gynaecomastia);
• breast pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 helps to provide more information on the safety of the medicine.

5. How to store Ircolon Forte

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

6. Contents of the pack and other information

What Ircolon Forte contains

• The active substance is trimebutine maleate. One tablet contains 200 mg of trimebutine maleate.
• Other ingredients are: lactose monohydrate, sodium croscarmellose, hypromellose 6 cP, magnesium stearate, colloidal anhydrous silica, citric acid monohydrate.

What Ircolon Forte looks like and contents of the pack
Ircolon Forte is in the form of white or almost white, elongated, biconvex tablets,
with a break line on one side and possible acceptable discolorations.
The pack contains 60 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Poland