Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
DEBRIDAT, 100 mg, coated tablets
Trimebutine maleate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Debridat is and what it is used for

Debridat belongs to a class of medicines known as musculotropic spasmolytics.
The medicine exerts antispasmodic action and relieves intestinal motility disorders.
Indications
Symptomatic treatment of:

intestinal motility disorders and gastrointestinal symptoms associated with functional gastrointestinal disorders;
pain associated with functional disorders of the gastrointestinal tract and biliary system.

2. Important information before using Debridat

When not to use Debridat

if the patient is allergic to the active substance (trimebutine) or to any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
Before starting treatment with Debridat, discuss this with your doctor or pharmacist.
Debridat and other medicines
You must tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Concomitant use of Debridat with zotepine (a medicine used, among others, in schizophrenia) may enhance anticholinergic effects.
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 her doctor or pharmacist before using this medicine.
Pregnancy
The use of Debridat during pregnancy should be considered by the physician only if the potential benefits of treatment outweigh the risks to the mother and the fetus.
Breastfeeding
The safety of Debridat in women who are breastfeeding has not been established.
Fertility
There is no data regarding the effect of Debridat on fertility.
Debridat contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Debridat contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Debridat

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
MEDICINE INTENDED FOR USE IN ADULTS ONLY.
The usual dose is 1 tablet of 100 mg taken 3 times daily.
In exceptional cases, your doctor may increase the dose to 2 tablets of 100 mg 3 times
daily.
Taking more Debridat than recommended
If you take more Debridat than prescribed, contact your doctor. The doctor will advise appropriate symptomatic treatment.
If you forget to take Debridat
Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Uncommon adverse reactions: may occur in less than 1 in 100 people

pre-syncopal and (or) syncopal states*
rash

Frequency unknown (cannot be estimated from the available data)

hypersensitivity
contact dermatitis, dermatitis, erythema, pruritus, and urticaria
severe skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruptions, exfoliative dermatitis

* Adverse reactions observed mainly after intravenous administration of the medicine
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows more information on the safety of the medicine to be collected.

5. How to store Debridat

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must 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 Debridat contains

The active substance is trimebutine maleate (Trimebutini maleas). One coated tablet contains 100 mg of trimebutine maleate.
Other ingredients are: monohydrate lactose (see section 2 "Debridat contains monohydrate lactose"), maize starch gelatinized, hypromellose 6 mPa.s, sodium carboxymethyl starch (type A) (see section 2 "Debridat contains sodium"), tartaric acid, colloidal anhydrous silica, magnesium stearate.
Coating composition: Opadry White OY-LS-28900: hypromellose 15 mPa.s, monohydrate lactose (see section 2 "Debridat contains monohydrate lactose"), macrogol 4000, titanium dioxide (E 171).

What Debridat looks like and contents of the pack
White coated tablets. The pack contains 30 tablets (2 blisters of 15 tablets each).
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Farmea,
10 rue Bouché Thomas, ZAC d’Orgemont, 49000 Angers
France
Parallel importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Cieszyn
Czech Republic
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Euceryn Manufacturing Plant COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Marketing authorisation number in Romania, country of export: 12582/2019/01
Parallel import authorisation number: 401/22