PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Debridat
7.87 mg/g, granules for oral suspension
Trimebutine
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

Keep this leaflet, you may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else 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.

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 package 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 has an antispasmodic effect and helps relieve gastrointestinal motility disorders.
Debridat is indicated for:

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

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, pharmacist, or
nurse. If the patient has diabetes, the sucrose content of the medicine should be taken into account:
0.6 g/ml, i.e. approximately 0.20 g per dose unit (example: one dose unit corresponding to 15 kg body weight contains 3 g of sucrose).
Debridat contains natural orange flavour and orange yellow dye, which may cause allergic reactions.
Debridat with other medicines
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 may enhance anticholinergic effects.
Pregnancy, breastfeeding and fertility
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 taking this medicine.
Pregnancy
Pregnant women may use this medicine only on medical advice. The use of Debridat during pregnancy will be considered by the doctor only if the potential benefits of treatment outweigh the risks to the mother and the child.
Breastfeeding
The safety of Debridat in breastfeeding women has not been established.
Fertility
There is no data available on the effect of Debridat on fertility.
Debridat contains sucrose and orange yellow dye
Debridat contains sugar: sucrose at 0.6 g/ml. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Debridat contains orange yellow dye. The medicine may cause allergic reactions.

3. How to use Debridat

Before administering the medicine, an oral suspension must be prepared.
Preparation of the oral suspension

Fill the bottle with still mineral water or cooled boiled water up to the white mark indicated on the bottle.
Close the bottle and shake it until a homogeneous mixture is obtained. The suspension is then ready for use. Shake the bottle well before each use.
After using Debridat, the measuring spoon for the suspension should be thoroughly rinsed.

Dosage
This medicine should always be used as directed by the physician or pharmacist. In case of doubt,
consult your physician or pharmacist.
Use in adult patients

The usual dose is 15 ml of suspension - 3 times daily.
In exceptional cases, the physician may decide to increase the dose to 30 ml of suspension - 3 times daily.

Use in children and adolescents
The usual dose is 1 ml/kg body weight per day, divided into 2–3 doses (maximum dose in children and adolescents with body weight above 45 kg is 45 ml per day).

Administration method
The suspension may be taken directly (using the provided measuring spoon) or mixed with another liquid. It is recommended to pour the measured amount into a bottle with food, onto a spoon, or into a glass and immediately give it to the child to drink.
In infants, it may be added to a bottle containing water or milk.

Use of a higher than recommended dose of Debridat
If a higher than recommended dose of Debridat is taken, contact your physician.
The physician will recommend appropriate symptomatic treatment.

Missed dose of Debridat
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

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

pre-syncopal states and/or syncope*
rash
Frequency unknown (cannot be estimated from available data)
hypersensitivity
contact dermatitis, dermatitis, erythema, pruritus, and urticaria
severe skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruptions, and exfoliative dermatitis

* Adverse reactions observed mainly after intravenous administration of the medicine
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 enables continuous monitoring of the medicine's safety and helps collect more information on its safe use.

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 in the original packaging.
The suspension must not be stored for longer than 4 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Debridat contains

The active substance is trimebutine (Trimebutinum). 1 ml of suspension contains: 4.8 mg of trimebutine.
Other ingredients are: sucrose, sunset yellow (E 110), natural orange flavour, polysorbate 80.

What Debridat looks like and contents of the pack
A 250 ml amber glass bottle (Type III) with an aluminum cap with a tamper-evident ring and a polypropylene measuring cup graduated at 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml, packed in a cardboard box.
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 Sud d’Orgemont
49007 Angers
France
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
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
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Marketing authorisation number in Romania, country of export: 12584/2019/01
Parallel import licence number: 219/19