Trikolon

Leaflet attached to the packaging: patient information

Trikolon, 100 mg, coated tablets

Trimebutine maleate

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Trikolon and what is it used for
• 2. Important information before using Trikolon
• 3. How to use Trikolon
• 4. Possible side effects
• 5. How to store Trikolon
• 6. Contents of the packaging and other information

1. What is Trikolon and what is it used for

Trikolon 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 is used for symptomatic treatment of:

• motor disorders of the gastrointestinal tract and intestinal complaints in the course of irritable bowel syndrome;
• functional disorders of the gastrointestinal tract - 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, you should discuss it with your doctor, pharmacist, or nurse.

Children

The use of Trikolon is not recommended in children under 12 years of age.

Trikolon and other medicines

You should tell your doctor or pharmacist about all medicines that you are taking or have recently taken, as well as any medicines that you plan to take. In particular, you should inform your doctor if you are taking zotepine (an antipsychotic medicine).

Trikolon 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, you should consult your doctor or pharmacist before using this medicine. Pregnancy There are no sufficient studies to confirm the safety of trimebutine during pregnancy. For this reason, trimebutine is not recommended during the first trimester of pregnancy. It is not expected to have a harmful effect on the mother or child, but the use of trimebutine during the second or third trimester should only be considered 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 has no influence or negligible influence on the ability to drive and use machines.

The medicine contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to use Trikolon

This medicine should always be used exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist. The medicine is taken orally. The recommended dose is 100 mg, 3 times a day, before meals. In justified cases, the dose can be increased to 600 mg per day in divided doses. The tablet should be swallowed whole, with a glass of water.

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.

Using a higher dose of Trikolon than recommended

In case of using a higher dose of the medicine than recommended, you should contact your doctor, who will prescribe the appropriate treatment.

Missing a dose of Trikolon

You should not take a double dose to make up for a missed dose. If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trikolon can cause side effects, although not everybody gets them.

Uncommon (occurring in less than 1 in 100 people):

• rash.

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

• hypersensitivity,
• contact dermatitis, skin inflammation, erythema, 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 any side effects not listed in this leaflet, you should inform 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 the medicine.

5. How to store Trikolon

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Store 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 month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Trikolon contains

• The active substance of the medicine is trimebutine (in the form of trimebutine maleate). One coated tablet contains 100 mg of trimebutine.
• The other ingredients (excipients) are: lactose monohydrate, sodium carboxymethylcellulose (Type A), corn 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 looks like and what the packaging contains

Trikolon, 100 mg, is a white, round, biconvex coated tablet with a diameter of 8 mm. One packaging of the medicine contains 30 or 100 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

Medicine information

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

Date of the last update of the leaflet: