Tribux

Leaflet attached to the packaging: information for the user

Tribux

100 mg, tablets

Trimebutine maleate

Please read carefully the contents of the leaflet 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 or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tribux and what is it used for

Tribux contains 100 mg of trimebutine per tablet. Trimebutine acts on the smooth muscles of the digestive tract, regulating its function (motility) and does not affect the central nervous system.

Indications

Tribux is used to treat:

• motility disorders of the digestive tract, known as irritable bowel syndrome,
• functional disorders of the digestive tract: diarrhea, constipation, abdominal pain, intestinal spasms.

2. Important information before using Tribux

When not to use Tribux

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

Warnings and precautions

Before starting to use Tribux, the patient should discuss it with their doctor or pharmacist.

Children and adolescents

Tribux is not recommended for children under 12 years of age, as the available form of the medicine (tablets) does not allow for adequate dose adjustment.

Tribux and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as those they plan to take. In particular, the patient should inform their doctor if they are taking any of the following medicines:

• zotepine (an antipsychotic medicine),
• d-tubocurarine (a muscle relaxant used in general anesthesia),
• cisapride (a medicine used for stomach disorders),
• procainamide (a medicine used for heart rhythm disorders),
• calcium channel blockers (medicines used for high blood pressure and heart disease),
• captopril (a medicine used for high blood pressure),
• reserpine (a medicine used for high blood pressure),
• midazolam (a medicine used for sleep disorders).

Tribux with food and drink

The medicine should be taken before a meal, with a glass of boiled water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
There is not enough data on the use of trimebutine in pregnancy, so it is not recommended to use Tribux in the first trimester of pregnancy. The medicine may be used in the second and third trimesters of pregnancy only if necessary.
Breastfeeding
Tribux may be used by breastfeeding women only if necessary.

Driving and using machines

Tribux used as directed does not affect the ability to drive vehicles and use machines, and does not reduce psychophysical fitness.
Tribux contains lactose monohydrate.If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use Tribux

Tribux should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

Adults
1 tablet 3 times a daybefore a meal.
In exceptional cases, the doctor may increase the dose to 6 tablets a day
in divided doses.

Use in children and adolescents

Children over 12 years of age
Tribux can be used in children at a dose not exceeding 6 mg/kg body weight per day.
Children under 12 years of age
Tribux is not recommended for this age group (see section "Important information before using Tribux").

Method of administration

Tablets should be swallowed whole, with a glass of boiled water.

Taking a higher dose of Tribux than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor, pharmacist, or go to the nearest hospital.

Missing a dose of Tribux

The patient should not take a double dose to make up for a missed dose.
In case of missing a dose, the patient should take the next dose at the scheduled time.

Stopping Tribux

In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur when using Tribux:

Common (in 1 to 10 out of 100 people):

• drowsiness, lethargy,
• feeling of fatigue,
• dizziness,
• feeling of heat or cold,
• headache,
• apathy,
• dry mouth,
• taste disorders,
• diarrhea,
• indigestion,
• abdominal pain,
• numbness of the mouth,
• nausea,
• vomiting,
• constipation,
• feeling of thirst.

Uncommon (in 1 to 10 out of 1,000 people):

• rash.

Rare (in 1 to 10 out of 10,000 people):

• irregular heartbeat,
• liver function disorders, including increased activity of liver enzymes AlAT and AspAT in the blood.

Very rare (less than 1 in 10,000 people, including single cases):

• anxiety,
• hearing loss,
• hepatitis,
• skin changes (itching, hives, redness, blisters, nodules, exudate, erythema),
• urinary retention,
• menstrual disorders,
• painful breast enlargement in women,
• breast enlargement in men (gynecomastia),
• breast pain.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their 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: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tribux

Store in a place out of sight and reach of children.
Store at a temperature below 25°C.
Store in the original packaging to protect from moisture.
Do not use after the expiration date stated on the box and blister pack. The expiration date is the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist what to do with medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tribux contains

• The active substance of the medicine is 100 mg of trimebutine maleate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K30, crospovidone (type A), magnesium stearate.

What Tribux looks like and what the packaging contains

Round, biconvex, smooth tablets, white to creamy in color, without spots and cracks, with a diameter of 8.0 mm ± 0.2 mm.
Tablets are packaged in PVC/PVDC/Aluminum blisters placed in a cardboard box.
The packaging contains 20, 30, 60, 90, 100, or 120 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

Date of last update of the leaflet: