PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

WARNING! Keep this leaflet as the 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 questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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
acts as a spasmolytic and relieves gastrointestinal motility disorders.
Indications
Symptomatic treatment of:

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

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
A doctor may consider using Debridat during pregnancy only if the potential benefits of treatment outweigh the risks to the mother and the unborn child.
Breastfeeding
The safety of Debridat during breastfeeding has not been established.
Fertility
There is no data available 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 their doctor before taking this medicine.
Debridat contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Debridat

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
MEDICINE INTENDED FOR USE IN ADULTS ONLY.
The usual dose is 1 tablet of 100 mg three times a day.
In exceptional cases, your doctor may increase the dose to 2 tablets of 100 mg three times a day.
Taking a higher than recommended dose of Debridat
If a higher than recommended dose of Debridat is taken, you should contact your doctor. The doctor will recommend appropriate symptomatic treatment.
Missing a dose of Debridat
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

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

states of drowsiness and (or) fainting*
rash

Frequency not known (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 a 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
By reporting adverse reactions, additional information on the safety of the medicine can 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 in use. This will 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.
The 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 ingredients: 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 with 15 tablets each).
For more detailed information, please contact the Marketing Authorisation Holder or 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:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
MEDICOFARMA S.A., ul. Sokołowska nr 9, lok. 19, 01-142 Warsaw
Marketing Authorisation number in Romania, country of export: 12582/2019/01
Parallel Import Licence number: 306/19