Tribux Bio

Package Leaflet: Information for the User

Tribux Bio

100 mg, tablets

Trimebutine maleate

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Tribux Bio and what is it used for

Tribux Bio contains 100 mg of trimebutine per tablet. Trimebutine acts directly on the
smooth muscles of the digestive tract and regulates the motility of the digestive tract. It does not
affect the central nervous system.

Indications for the use of Tribux Bio

• Digestive disorders characterized by: feeling of fullness, bloating, nausea, and abdominal pain.
• Functional disorders of the digestive system caused by stress (diarrhea, constipation, abdominal pain). Tribux Bio is intended for short-term treatment. If there is no improvement or the patient feels worse after 3 days, they should consult their doctor.

2. Important information before taking Tribux Bio

When not to take Tribux Bio

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

Children and adolescents

Tribux Bio is not recommended for children under 12 years of age.
Before taking Tribux Bio in children and adolescents over 12 years of age, the doctor should be consulted – see section 3, "Use in children and adolescents".

Tribux Bio and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, the following medicines should be mentioned:

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

Tribux Bio with food and drink

Tribux Bio should be taken before meals, with a glass of water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Tribux Bio is contraindicated during pregnancy.
Breastfeeding
Tribux Bio may be used by breastfeeding women only if necessary.

Driving and using machines

Tribux Bio, when taken as directed, does not affect the ability to drive or operate machinery and does not impair psychophysical performance.
Tribux Bio contains lactose(a sugar found in milk).
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Tribux Bio

This medicine should always be taken exactly as described in the patient leaflet or as directed by
the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted.
The medicine should be taken orally.

Dosage

Adults
1 tablet 2 or 3 times a daybefore meals

Use in children and adolescents

Children and adolescents over 12 years of age
The use of Tribux Bio in this age group should be decided by the doctor.
The daily dose should not exceed 6 mg per kilogram of the child's body weight.
Children under 12 years of age
Tribux Bio is not recommended for children under 12 years of age.

Duration of treatment

Tribux Bio should not be taken for more than 3 days without consulting a doctor.

Method of administration

The tablet should be swallowed whole, with a glass of water.

Taking a higher dose of Tribux Bio than recommended

In case of taking a higher dose of the medicine than recommended, the doctor or pharmacist should be consulted immediately.

Missing a dose of Tribux Bio

A double dose should not be taken to make up for a missed dose.
If a dose is missed, the next dose should be taken at the usual time.

Stopping treatment with Tribux Bio

If there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

The following side effects may occur when taking Tribux Bio:

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

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

Uncommon (in 1 to 10 out of 1000 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 doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: ndl@urpl.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 Bio

The medicine should be stored out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Tribux Bio contains

• The active substance is 100 mg of trimebutine maleate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, crospovidone, and magnesium stearate.

What Tribux Bio looks like and what the pack contains

White or almost white tablets, round, biconvex.
The tablets are packaged in PVC/PVDC-Aluminum or PVC/PE/PVDC-Aluminum blisters placed in a cardboard box.
The pack contains 10 tablets.

Marketing authorization holder and manufacturer

Biofarm Sp. z o. o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
biofarm@biofarm.pl

Date of last revision of the leaflet: