Trikolon forte

Package leaflet: information for the patient

Trikolon Forte, 200 mg, coated tablets
Trimebutine maleate
Please read this 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, 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 the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

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

Trikolon Forte 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, diarrhoea, or constipation.

2. Important information before using Trikolon Forte

When not to use Trikolon Forte

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

Warnings and precautions
Before taking Trikolon Forte, consult your doctor, pharmacist, or nurse.
Children
Use in children under 12 years of age is not recommended.
Trikolon Forte and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor if the patient is taking zotepine (an antipsychotic medicine).
Trikolon Forte 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 child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There are insufficient studies confirming the safety of trimebutine use 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 be considered only if necessary.
Breastfeeding
The safety of trimebutine use in breastfeeding women has not been established.
Fertility
There is no data regarding the effect of trimebutine on fertility.
Driving and operating machinery
Trikolon Forte has no effect or has a negligible effect on the ability to drive and operate machinery.
This medicine contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Trikolon Forte

This medicine should always be used as directed by the physician. In case of doubts, consult a
doctor or pharmacist.
The medicine is taken orally. The recommended dose is 100 mg (half a tablet) three times daily, before meals.
When clinically justified, the dose may be increased up to 600 mg per day in divided doses.
The tablet should be swallowed whole with a glass of water.
The score line on the tablet allows for dividing the tablet into equal doses.
Use in children and adolescents
The medicine may be used in adolescents above 12 years of age at a dose not exceeding 6 mg/kg body
weight per day.
Use of a higher than recommended dose of Trikolon Forte
In case of overdose, contact a physician who will recommend appropriate symptomatic treatment.
Missed dose of Trikolon Forte
Do not take a double dose to make up for a missed dose.
If you have any further questions concerning use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Not common (occur in no more than 1 in 100 people):

• rash.

Frequency not known (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 this 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
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 helps to provide more information on the safety of the medicine.

5. How to store Trikolon Forte

Keep this 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 container. 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 Forte contains

• The active substance is trimebutine (in the form of trimebutine maleate). One coated tablet contains 200 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 the coating contains: monohydrate lactose, hypromellose 2910 (15 mPa·s), titanium dioxide (E 171), macrogol 4000.

What Trikolon Forte looks like and contents of the pack
Trikolon Forte is a white, oval, biconvex coated tablet measuring 14x8 mm, with a break line on both sides.
One pack contains 30 or 60 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]