Package leaflet: Information for the user

Tribux Forte
200 mg, tablets
Trimebutini maleas
Please read the entire leaflet before use, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
If any adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.

Table of contents:

What Tribux Forte is and what it is used for
Important information before taking Tribux Forte
How to take Tribux Forte
Possible side effects
How to store Tribux Forte
Contents of the pack and other information

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

Tribux Forte contains 200 mg of trimebutine per tablet. Trimebutine acts on the smooth muscles of the gastrointestinal tract, regulating gastrointestinal motility. It does not affect the central nervous system.
Indications
Tribux Forte is used in the treatment of:

Gastrointestinal motility disorders, known as irritable bowel syndrome,
Functional disorders of the gastrointestinal tract and biliary passages: diarrhoea, constipation, abdominal pain, intestinal spasms.

Tribux Forte is used for symptomatic treatment.

2. Important information before using Tribux Forte

When not to use Tribux Forte

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 treatment with Tribux Forte, consult a doctor or pharmacist.
Children
Tribux Forte is not recommended for children under 12 years of age.
Other medicines and Tribux Forte
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to use.
In particular, inform your doctor if the patient is taking any of the following medicines:

zotepine (an antipsychotic medicine),
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 antagonists (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 Forte with food and drink
The medicine should be taken before a meal, with a glass of water.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Pregnancy
There is insufficient data on the use of trimebutine during pregnancy. Therefore, Tribux Forte is not recommended until the end of the third month of pregnancy. The medicine may be used from the fourth month of pregnancy only if clearly necessary.
Breastfeeding
Tribux Forte may be used by breastfeeding women only if clearly necessary.
Driving and operating machinery
Tribux Forte, when used according to the recommended dosage, does not affect the ability to drive or operate machinery and does not impair psycho-physical performance.
Tribux Forte contains monohydrate 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 Forte

This medicine should always be used as directed by the physician. In case of doubts, consult
a physician or pharmacist.
Dosage
Adults
Irritable bowel syndrome
Half a tablet (100 mg) three times daily (300 mg daily) before meals.
In exceptional cases, the physician may increase the dose to 600 mg daily.
In such cases, one tablet (200 mg) should be taken three times daily.
Functional disorders of the gastrointestinal tract and biliary tract

Diarrhoea, constipation: one tablet (200 mg) once or twice daily (200 mg to 400 mg daily) before meals
Abdominal pain, intestinal spasms: half a tablet (100 mg) three times daily (300 mg daily) before meals. In exceptional cases, the physician may increase the dose to 600 mg daily. In such cases, one tablet (200 mg) should be taken three times daily.

Use in children
Children above 12 years of age
Trimbutine may be used in children above 12 years of age at a dose not exceeding 6 mg/kg
body weight per day.
Children under 12 years of age
Use of Tribux Forte is not recommended in this age group (see section "Warnings and precautions").
Method and duration of administration

The tablet should be swallowed with a glass of water.
The tablet may be divided into equal doses.
The physician will advise how long the medicine should be taken.

Overdose of Tribux Forte
In case of overdose, seek immediate advice from a physician or pharmacist.
Missed dose of Tribux Forte
Do not take a double dose to make up for a missed dose.
If a dose is missed, the next dose should be taken at the usual time.
Discontinuation of Tribux Forte
In case of any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with Tribux Forte:

Common (affects 1 to 10 users in 100):

drowsiness, somnolence,
feeling of fatigue,
dizziness,
sensation of heat or cold,
headache,
apathy,
dry mouth,
taste disturbances,
diarrhoea,
indigestion,
abdominal pain,
numbness of the lips,
nausea,
vomiting,
constipation,
feeling of thirst.

Uncommon (affects 1 to 10 users in 1,000):

rash.

Rare (affects 1 to 10 users in 10,000):

irregular heartbeat,
liver function disorders, including increased blood levels of liver enzymes AlAT and AspAT.

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

anxiety,
hearing impairment,
hepatitis,
skin reactions (itching, urticaria, erythema, blisters, nodules, exudation, rash),
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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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]
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tribux Forte

Keep the medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
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. This will help protect the environment.

6. Contents of the package and other information

What Tribux Forte contains

The active substance is 200 mg of trimebutine maleate.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, povidone, crospovidone, magnesium stearate.

What Tribux Forte looks like and contents of the pack
White or almost white tablets, elongated, biconvex, with a score line on one side to facilitate
dividing.
The tablets are packed in blisters made of PVC/PE/PVDC-Aluminium, placed in a
cardboard box.
The pack contains 10, 20, 30, 60 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
For further information, please contact the local representative of the Marketing Authorisation Holder:
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505