Trikolon Forte

Package Leaflet: Information for the Patient

Trikolon Forte, 200 mg, Coated 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

Trikolon Forte contains trimebutine maleate as the active substance. Trimebutine acts on the smooth muscles of the gastrointestinal tract, regulating its function (peristalsis). The action of the medicine depends on the functional state of the gastrointestinal tract, and the regulation of peristalsis covers the entire gastrointestinal tract. Trimebutine does not affect the central nervous system. Trikolon Forte is used for symptomatic treatment of:

• motor disorders of the gastrointestinal tract and intestinal symptoms in irritable bowel syndrome;
• functional disorders of the gastrointestinal tract - including dyspepsia (indigestion), abdominal pain, intestinal spasms, diarrhea, or constipation.

2. Important information before taking Trikolon Forte

When not to take Trikolon Forte

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

Warnings and precautions

Before taking Trikolon Forte, discuss it with your doctor, pharmacist, or nurse.

Children

It is not recommended to use in children under 12 years of age.

Trikolon Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take. In particular, inform your doctor if you are taking zotepine (an antipsychotic medicine).

Trikolon Forte with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy There are no sufficient studies to confirm the safety of trimebutine during pregnancy. Therefore, trimebutine is not recommended during the first trimester of pregnancy. It is not expected to have a harmful effect on the mother or the child, however, the use of trimebutine during the second or third trimester should be considered only if necessary. Breastfeeding The safety of trimebutine in breastfeeding women has not been established. Fertility There are no data on the effect of trimebutine on fertility.

Driving and using machines

Trikolon Forte has no or negligible influence on the ability to drive and use machines.

The medicine contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking the medicine.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.

3. How to take Trikolon Forte

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. The medicine should be taken orally. The recommended dose is 100 mg (half a tablet), 3 times a day, before meals. In justified cases, the dose can be increased to 600 mg per day in divided doses. Swallow the tablet whole with a glass of water. The dividing line on the tablet allows you to divide the medicine into equal doses.

Use in children and adolescents

The medicine can be used in adolescents over 12 years of age in a dose not exceeding 6 mg/kg body weight per day.

Overdose of Trikolon Forte

In case of overdose, contact your doctor, who will recommend appropriate symptomatic treatment.

Missed dose of Trikolon Forte

Do not take a double dose to make up for a forgotten dose. 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 (affects less than 1 in 100 people):

• rash.

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

• hypersensitivity,
• contact dermatitis, skin inflammation, redness, itching, 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 those 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, Tel.: +48 22 49 21 301, Fax: +48 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 Trikolon Forte

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 light and moisture. Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month stated. 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 Trikolon Forte contains

• The active substance is trimebutine (as trimebutine maleate). One coated tablet contains 200 mg of trimebutine.
• The other ingredients (excipients) are: lactose monohydrate, sodium carboxymethylcellulose (Type A), maize starch, hypromellose 2910 (6 mPa·s), tartaric acid, colloidal anhydrous silica, magnesium stearate, and the coating contains: lactose monohydrate, hypromellose 2910 (15 mPa·s), titanium dioxide (E 171), and macrogol 4000.

What Trikolon Forte looks like and contents of the pack

Trikolon Forte is a white, oval, biconvex coated tablet with a size of 14x8 mm, with a dividing line on both sides. One pack contains 30 or 60 coated tablets in PVC/PVDC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A., 51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: 22 742 00 22, e-mail: [email protected]

Date of last revision of the leaflet: