Ircolon Forte

Package Leaflet: Information for the User

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

• motility disorders of the digestive tract, known as irritable bowel syndrome;
• pain associated with functional disorders of the digestive tract and bile ducts: diarrhea, constipation, abdominal pain, intestinal spasms.

2. Important information before taking Ircolon Forte

When not to take Ircolon Forte:

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

Warnings and precautions

Before starting treatment with Ircolon Forte, the doctor or pharmacist should be consulted.

Children

Ircolon Forte should not be used in children under 12 years of age.

Ircolon Forte and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any planned to be taken.
In particular, the doctor should be informed if the patient is taking any of the following medicines:

• zotepine (an antipsychotic medicine);
• d-tubocurarine (a muscle relaxant used in general anesthesia);
• cisapride (a medicine used for stomach disorders);
• procainamide (a medicine used for heart rhythm disorders);
• calcium channel blockers (medicines used for high blood pressure and heart disease);
• 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 or breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
There are currently no sufficient data to assess the impact of trimebutine administered during pregnancy on the occurrence of congenital defects or toxic effects on the fetus.
The use of trimebutine during pregnancy can be considered only if the potential benefits of treatment outweigh the risks to the mother and fetus.
Breastfeeding
The safety of using Ircolon Forte in breastfeeding women has not been established.

Driving and using machines

Ircolon Forte does not affect the ability to drive or operate machines.
Ircolon Forte contains lactose monohydrate(a sugar found in milk)
The medicine contains lactose monohydrate (one tablet contains 233 mg of lactose monohydrate). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. This medicine contains 0.233 g of lactose (0.1165 g of glucose and 0.1165 g of 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, which means the medicine is considered "sodium-free".

3. How to take Ircolon Forte

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.

Adults

Irritable bowel syndrome
half a tablet (100 mg) 3 times a day (300 mg per day) before meals.
In exceptional cases, the doctor may increase the dose to 600 mg per day.
This is taken as one tablet (200 mg) 3 times a day.
Functional disorders of the digestive tract and bile ducts

• diarrhea, constipation: one tablet (200 mg) 1 or 2 times a day (200 mg to 400 mg per day) before meals.
• abdominal pain, intestinal spasms: half a tablet (100 mg) 3 times a day (300 mg per day) before meals. In exceptional cases, the doctor may increase the dose to 600 mg per day. This is taken as one tablet (200 mg) 3 times a day.

Use in children

Children over 12 years of age
Trimebutine can be used in children over 12 years of age at a dose not exceeding 6 mg/kg body weight per day.
Children under 12 years of age
The use of Ircolon Forte is not recommended in this age group (see "Warnings and precautions").

Method and duration of administration

The tablet should be swallowed with a glass of water.
The tablet can be divided into equal doses.

The doctor will recommend how long to take the medicine.

Taking more than the recommended dose of Ircolon Forte

In case of overdose, symptomatic treatment should be applied.

Missing a dose of Ircolon Forte

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Ircolon Forte

In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Ircolon Forte can cause side effects, although not everybody gets them.

The following side effects may occur when taking Ircolon Forte:

Frequent (in 1 to 10 out of 100 people):

• drowsiness, drowsiness;
• feeling of fatigue;
• dizziness;
• feeling of heat or cold;
• headaches;
• apathy;
• dry mouth;
• taste disorders;
• diarrhea;
• indigestion;
• abdominal pain;
• numbness of the mouth;
• nausea;
• vomiting;
• constipation;
• feeling 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 activity of liver enzymes AlAT and AspAT in the blood.

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

• anxiety;
• hearing loss;
• hepatitis;
• skin changes (itching, hives, redness, blisters, nodules, exudate, erythema);
• urinary retention;
• menstrual disorders;
• painful breast enlargement in women;
• breast enlargement in men (gynecomastia);
• breast pain.

Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed, or the 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
Phone: 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, more information can be collected on the safety of the medicine.

5. How to store Ircolon Forte

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the box and blister after: "EXP". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Ircolon Forte contains

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

What Ircolon Forte looks like and contents of the pack

Ircolon Forte is a white or almost white, oblong, biconvex tablet with a dividing line on one side, with possible acceptable color variations.
The pack contains 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Poland (Poland)
ks

Date of last revision of the leaflet: