Package leaflet: Information for the user

Tribux Bio
100 mg, tablets
Trimebutine maleate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Contents of the leaflet

What Tribux Bio is and what it is used for
What you need to know before taking Tribux Bio
How to take Tribux Bio
Possible side effects
How to store Tribux Bio
Contents of the pack and other information

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

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

Digestive disturbances manifested by: a feeling of fullness, bloating, nausea, and abdominal pain.
Functional gastrointestinal disorders caused by stress (diarrhea, constipation, abdominal pain).

Tribux Bio is intended for short-term treatment. If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.

2. Important information before using Tribux Bio

When not to use Tribux Bio

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.

Children and adolescents
Use of Tribux Bio is not recommended in children under 12 years of age.
Consult a doctor before using Tribux Bio in children and adolescents over 12 years of age – see section 3, "Use in children and adolescents".

Tribux Bio and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
In particular, inform about the following medicines:

zotepine (a medicine used to treat schizophrenia),
d-tubocurarine (a muscle relaxant used in general anaesthesia),
cisapride (a medicine used for gastrointestinal disorders),
procainamide (a medicine used for heart rhythm disorders),
calcium channel blockers (medicines used for high blood pressure and heart diseases),
captopril (a medicine used for high blood pressure),
reserpine (a medicine used for high blood pressure),
midazolam (a medicine used for 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Tribux Bio is contraindicated during pregnancy.

Breastfeeding
Tribux Bio may be used by breastfeeding women only if clearly necessary.

Driving and operating machinery
When used according to the recommended dosage, Tribux Bio does not affect the ability to drive or operate machinery, nor does it impair psycho-physical performance.

Tribux Bio contains lactose (a sugar found in milk).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Tribux Bio

This medicine should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally.
Dosage
Adults
1 tablet 2 or 3 times daily before meals
Use in children and adolescents
Children and adolescents over 12 years of age
The decision on using Tribux Bio in this age group should be made by a doctor.
The daily dose must not exceed 6 mg per kilogram of the child's body weight.
Children under 12 years
Tribux Bio is not recommended for use in children under 12 years of age.
Duration of treatment
Tribux Bio should not be taken for longer than 3 days without consulting a doctor.
Method of administration
The tablet should be swallowed whole with a glass of water.
Overdose of Tribux Bio
In case of taking more than the recommended dose, consult a doctor or pharmacist immediately.
Missed dose of Tribux Bio
Do not take a double dose to make up for a missed dose.
If a dose is missed, take the next dose at the usual time.
Stopping Tribux Bio
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with Tribux Bio:
Common (in 1 to 10 out of 100 people):

drowsiness, somnolence,
feeling of fatigue,
apathy,
dizziness,
headache,
sensation of heat or cold,
dry mouth,
numbness of the lips,
taste disturbances,
diarrhoea,
indigestion,
abdominal pain,
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 blood activity of liver enzymes AlAT and AspAT.

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

anxiety,
hearing impairment,
hepatitis,
skin reactions (itching, urticaria, erythema, blisters, nodules, exudation, erythema),
urinary retention,
menstrual disorders,
painful breast enlargement in women,
breast enlargement in men (gynaecomastia),
breast pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for Monitoring of Adverse Drug Reactions 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
E-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tribux Bio

Keep the medicine out of the sight and reach of children.
Store in the original packaging, at a temperature not exceeding 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures 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: monohydrate lactose, microcrystalline cellulose, povidone, crospovidone and magnesium stearate. What Tribux Bio looks like and contents of the pack White or almost white, round, biconvex tablets. The tablets are packed in blisters made of PVC/PVDC-Aluminum or PVC/PE/PVDC-Aluminum, placed in a cardboard box. The pack contains 10 tablets.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]