Tribux forte

Package Leaflet: Information for the User

Tribux Forte

200 mg, tablets

Trimebutine maleate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of Contents of the Leaflet:

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

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

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

Indications

Tribux Forte is used to treat:

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

Tribux Forte is used for symptomatic treatment.

2. Important information before taking Tribux Forte

When not to take Tribux Forte

• if you are allergic to trimebutine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Tribux Forte, consult your doctor or pharmacist.

Children

Tribux Forte is not recommended for children under 12 years of age.

Other medicines and Tribux Forte

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor if you 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 Forte with food and drink

Take the medicine before a meal, with a glass of water.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Pregnancy: There is not enough data on the use of trimebutine during pregnancy. Therefore, Tribux Forte should not be taken during the first three months of pregnancy. The medicine may be used from the fourth month of pregnancy only if necessary. Breastfeeding: Tribux Forte may be used by breastfeeding women only if necessary.

Driving and using machines

Tribux Forte, when taken as directed, does not affect the ability to drive or operate machinery, and does not impair psychophysical performance. Tribux Forte contains lactose monohydrate(a sugar found in milk). If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Tribux Forte

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

Adults
Irritable bowel syndrome
half a tablet(100 mg) 3 times a day(300 mg per day) before meals
In exceptional cases, your doctor may increase the dose to 600 mg per day.
Then take one tablet(200 mg) 3 times a day.
Functional disorders of the gastrointestinal tract and bile ducts

• diarrhea, constipation one tablet(200 mg) 1 or 2 times a day(200 mg to 400 mg per day) before meals
• abdominal pain, intestinal spasms half a tablet(100 mg) 3 times a day(300 mg per day) before meals In exceptional cases, your doctor may increase the dose to 600 mg per day. Then take one tablet(200 mg) 3 times a day.

Use in children

Children over 12 years old
Trimebutine can be used in children over 12 years old in a dose not exceeding 6 mg/kg
body weight per day.
Children under 12 years old
Tribux Forte is not recommended for this age group (see section "Warnings and precautions").

Method and duration of administration

• Swallow the tablet with a glass of water.
• The tablet can be divided into equal doses.
• Your doctor will advise you how long to take the medicine.

Overdose

If you take more than the recommended dose, consult your doctor or pharmacist immediately.

Missed dose

Do not take a double dose to make up for a missed dose.
If you forget to take a dose, take the next dose at the usual time.

Stopping treatment

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur when taking Tribux Forte:

Common (in 1 to 10 users):

• drowsiness, drowsiness,
• 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 users in 1,000):

• rash.

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

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

Very rare (less than 1 in 10,000 users, 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Reporting side effects will help gather 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 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 pack and other information

What Tribux Forte contains

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

What Tribux Forte looks like and contents of the pack

White or almost white tablets, oblong, biconvex, with a score line on one side.
The tablets are packaged in PVC/PE/PVDC-Aluminum blisters, placed in a cardboard box.
The pack contains 10, 20, 30, 60, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
For more detailed information, please contact the local representative of the marketing authorization holder:
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505

Date of last revision of the leaflet: