Package leaflet: Information for the patient

Trikolon, 100 mg, film-coated tablets
Trimebutini maleas
Please read the entire leaflet carefully before using 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, pharmacist, or nurse.
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 identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What Trikolon is and what it is used for

Trikolon contains trimebutine maleate as the active substance. Trimebutine acts on the smooth muscles of the gastrointestinal tract, regulating gastrointestinal motility (peristalsis). The effect of the drug depends on the functional state of the gastrointestinal tract, and the regulation of peristalsis involves the entire gastrointestinal tract. Trimebutine does not affect the central nervous system.

Trikolon is used for symptomatic treatment of:

gastrointestinal motility disorders and intestinal symptoms in irritable bowel syndrome;
functional gastrointestinal disorders – including dyspepsia (indigestion), abdominal pain, intestinal spasms, diarrhea, or constipation.

2. Important information before using Trikolon

When not to use Trikolon

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

Warnings and precautions
Before starting to use Trikolon, please discuss this with your doctor, pharmacist, or nurse.
Children
Use in children under 12 years of age is not recommended.
Trikolon and other medicines
Tell 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.
In particular, inform your doctor if the patient is taking zotepine (an antipsychotic medicine).
Trikolon with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There are insufficient studies to confirm the safety of trimebutine during pregnancy. For this reason, trimebutine is not recommended during the first trimester of pregnancy. Harmful effects on the mother or child are not expected; however, the use of trimebutine during the second or third trimester should only be considered if necessary.
Breastfeeding
The safety of trimebutine use in breastfeeding women has not been established.
Fertility
There is no data available regarding the effect of trimebutine on fertility.
Driving and operating machinery
Trikolon has no effect or has a negligible effect on the ability to drive and operate machinery.
Lactose content
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Trikolon

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Trikolon is taken orally. The recommended dose is 100 mg three times daily, before meals.
In justified cases, the dose may be increased up to 600 mg daily in divided doses.
The tablet should be swallowed whole with a glass of water.
Use in children and adolescents
This medicine may be used in adolescents above 12 years of age at a dose not exceeding 6 mg/kg body weight daily.
Taking more Trikolon than recommended
If more Trikolon is taken than recommended, contact your doctor, who will advise appropriate symptomatic treatment.
Missing a dose of Trikolon
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning 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.
Not common (occur in not more than 1 in 100 people):

Rash.

Frequency unknown (cannot be estimated from 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 this leaflet, inform your 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
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of this medicine to be collected.

5. How to store Trikolon

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Trikolon contains

The active substance is trimebutine (in the form of trimebutine maleate). One coated tablet contains 100 mg of trimebutine.
The other ingredients (excipients) are: monohydrate lactose, sodium carboxymethyl starch (Type A), pregelatinized corn starch, hypromellose 2910 (6 mPa·s), tartaric acid, colloidal anhydrous silica, magnesium stearate, and a coating containing: monohydrate lactose, hypromellose 2910 (15 mPa·s), titanium dioxide (E 171), polyethylene glycol 4000.

What Trikolon looks like and contents of the pack
Trikolon 100 mg is a white, round, biconvex coated tablet with a diameter of 8 mm.
One pack contains 30 or 100 coated tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]