Package leaflet: Information for the user

IRCOLON, 100 mg, tablets
Trimebutini maleas
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Ircolon is and what it is used for
Important information before taking Ircolon
How to take Ircolon
Possible side effects
How to store Ircolon
Contents of the pack and other information

1. What Ircolon is and what it is used for

Ircolon contains trimebutine maleate as the active substance.
Ircolon is used for symptomatic treatment of:

gastrointestinal motility disorders and intestinal discomfort associated with functional gastrointestinal disorders,
pain associated with functional disorders of the gastrointestinal tract and biliary pathways.

2. Important information before using Ircolon

When not to use Ircolon:

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, consult your doctor or pharmacist.
Ircolon and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Especially inform your doctor if the patient is taking a medicine containing zotepine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or 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 effect of trimethylbutine administered during pregnancy on the occurrence of congenital malformations or fetal toxicity.
For this reason, as a precautionary measure, Ircolon is not recommended during the first trimester of pregnancy. No harmful effects on the mother or child are expected; however, only if necessary, the doctor may consider using Ircolon during the second or third trimester of pregnancy.
Breastfeeding
The safety of Ircolon in women who are breastfeeding has not been established.
Fertility
There are no data regarding the effect of Ircolon on fertility.
Driving and operating machinery
Ircolon has no influence on the ability to drive or operate machinery.
Ircolon contains lactose monohydrate
This medicine contains lactose monohydrate (one tablet contains 116.5 mg of lactose monohydrate). 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 0.0116 g of lactose (0.0058 g glucose and 0.0058 g galactose) per tablet. This should be taken into account in patients with diabetes.
Ircolon contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Ircolon

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
This medicine is intended for use in adults only.
The usual dose is 1 tablet three times daily.
In exceptional cases, your doctor may decide to increase the dose up to 6 tablets.
Taking more Ircolon medicine than recommended
In case of overdose, symptomatic treatment should be applied.
Missing a dose of Ircolon
Do not take a double dose to make up for a missed dose.
Stopping Ircolon medicine
If you have any further doubts regarding 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 everybody will get them.

Uncommon adverse reactions: occurring in 1 to 10 out of 1000 patients

pre-syncope and (or) syncope
rash

Frequency unknown (cannot be estimated from the available data)

hypersensitivity
contact dermatitis, dermatitis, erythema, pruritus, and urticaria
severe skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruptions, exfoliative dermatitis

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the package leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
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

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 mentioned month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ircolon contains

The active substance is trimebutine maleate. One tablet contains 100 mg of trimebutine maleate.
The other ingredients are: monohydrate lactose, hypromellose, sodium croscarmellose, monohydrate citric acid, magnesium stearate, colloidal silicon dioxide, anhydrous.

What Ircolon looks like and contents of the pack
Ircolon is in the form of white to light cream-colored tablets, round, biconvex,
with a nominal diameter of 9 mm, possibly with acceptable discolorations, without damage.
The pack contains 20, 30, 60 or 100 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: (24) 357 44 44
Fax: (24) 357 45 45
e-mail: [email protected]