Ircolon

Package Leaflet: Information for the User

IRCOLON, 100 mg, tablets

Trimebutine maleate

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. 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Ircolon and what is it used for

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

• motor disorders and intestinal disorders associated with functional gastrointestinal disorders,
• pain associated with functional gastrointestinal and biliary disorders.

2. Important information before taking Ircolon

When not to take Ircolon:

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

Warnings and precautions

Before taking Ircolon, discuss it with your doctor or pharmacist.

Ircolon and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
Especially, tell your doctor if you are taking a medicine containing zotepine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are currently no sufficient data to assess the risk of trimebutine administered during pregnancy on the occurrence of congenital anomalies or toxic effects on the fetus.
As a precautionary measure, it is not recommended to administer Ircolon during the first trimester of pregnancy. It is not expected to have a harmful effect on the mother or child, however, only if necessary, the doctor will consider the use of Ircolon during the second or third trimester of pregnancy.
Breastfeeding
The safety of Ircolon in breastfeeding women has not been established.
Fertility
There are no data on the effect of Ircolon on fertility.

Driving and using machines

Ircolon has no effect on the ability to drive and use machines.

Ircolon contains lactose monohydrate

The medicine contains lactose monohydrate (one tablet contains 116.5 mg of lactose monohydrate). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. This medicine contains 0.0116 g of lactose (0.0058 g of glucose and 0.0058 g of galactose) in one 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, which means the medicine is considered "sodium-free".

3. How to take Ircolon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
This medicine is for use in adults only.
Usually, take 1 tablet 3 times a day.
In exceptional cases, the doctor may decide to increase the dose to 6 tablets.

Overdose of Ircolon

In case of overdose, symptomatic treatment should be applied.

Missed dose of Ircolon

Do not take a double dose to make up for a forgotten dose.

Stopping Ircolon treatment

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects:occurring in 1 to 10 per 1000 patients

• pre-syncopal and (or) syncopal states
• rash

Frequency not known (cannot be estimated from the available data)

• hypersensitivity
• contact dermatitis, skin inflammation, erythema, pruritus, and urticaria
• severe skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, toxic epidermal necrolysis, and exfoliative dermatitis

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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, you can help provide more information on the safety of this medicine.

5. How to store Ircolon

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original package 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 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 Ircolon contains

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

What Ircolon looks like and contents of the pack

Ircolon is a white to light cream-colored, round, biconvex tablet, with a nominal diameter of 9 mm, with possible acceptable color variations, without damage.
The pack contains 20, 30, 60, or 100 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Polska (Poland)
Phone: (24) 357 44 44
Fax: (24) 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: