Debridat

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Debridat

7.87 mg/g, granules for oral suspension

Trimebutinum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep the leaflet so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Debridat and what is it used for
• 2. Important information before using Debridat
• 3. How to use Debridat
• 4. Possible side effects
• 5. How to store Debridat
• 6. Contents of the packaging and other information

1. What is Debridat and what is it used for

Debridat belongs to a class of medicines called musculotropic, anti-spasmodic medicines.
The medicine has an anti-spasmodic effect and alleviates disturbances in bowel function.
Debridat is indicated for use:

• to alleviate pain associated with functional disorders of the gastrointestinal tract and bile ducts;
• to correct motility disorders and intestinal symptoms associated with functional disorders of the gastrointestinal tract.

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 to use Debridat, you should discuss it with your doctor, pharmacist, or nurse. If the patient has diabetes, they should take into account the sugar content of the medicine: 0.6 g/ml, which is approximately 0.20 g per dosage unit (e.g., one dosage unit corresponding to 15 kg of body weight contains 3 g of sugar).
Debridat contains a natural orange flavor and orange yellow, which may cause allergic reactions.

Debridat and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking Debridat with zotepine may increase the anticholinergic effect.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Women who are pregnant may use the medicine only on the advice of a doctor. The doctor will consider using Debridat during pregnancy only if the potential benefits of treatment outweigh the risks to the mother and child.
Breastfeeding
The safety of using Debridat in breastfeeding women has not been established.
Fertility
There is no data on the effect of Debridat on fertility.

Debridat contains sugar and orange yellow

Debridat contains sugar: sucrose in an amount of 0.6 g/ml. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Debridat contains orange yellow. The medicine may cause allergic reactions.

3. How to use Debridat

Before using the medicine, you should prepare an oral suspension.

Preparing the oral suspension

• 1. Fill the bottle with non-carbonated mineral water or cooled boiled water to the white line marked on the bottle.
• 2. Close the bottle and shake it until a uniform mixture is obtained. The suspension is ready for use. You should shake the bottle before each use.
• 3. After using Debridat, you should carefully rinse the measuring cup.

Dosage

This medicine should always be used as directed by a doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.

Use in adults

• The dose is usually 15 ml of suspension - 3 times a day.
• In exceptional cases, the doctor may decide to increase the dose to 30 ml of suspension - 3 times a day.

Use in children and adolescents

Usually, a dose of 1 ml/kg of body weight per day is used, divided into 2-3 doses (the maximum dose for children and adolescents with a body weight over 45 kg is 45 ml per day).

Method of administration

The suspension can be taken directly (using the measuring cup provided) or mixed with another liquid. It is recommended to pour the contents of the measuring cup into a bottle with food, onto a spoon, or into a glass and immediately give the medicine to the child to drink.
In infants, it can be added to a bottle with water or milk.

Using a higher dose of Debridat than recommended

In case of using a higher dose of Debridat than recommended, you should contact a doctor.
The doctor will recommend appropriate symptomatic treatment.

Missing a dose of Debridat

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Debridat can cause side effects, although not everybody gets them.
Uncommon:may affect up to 1 in 100 people

• pre-syncopal and (or) syncopal episodes*
• rash Frequency not known(cannot be estimated from the available data)
• hypersensitivity
• contact dermatitis, skin inflammation, erythema, pruritus, and urticaria
• severe skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, toxic epidermal necrolysis, and exfoliative dermatitis

*Side effects mainly observed after intravenous administration of the medicine

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects, you can help provide more information on the safety of this medicine.

5. How to store Debridat

The medicine should be stored 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 month stated.
Store in a temperature below 25°C in the original packaging.
The suspension should not be stored for more than 4 weeks.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Debridat contains

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

What Debridat looks like and what the packaging contains

Bottle made of brown glass (type III), with a capacity of 250 ml, with an aluminum cap with a guarantee ring and a measuring cup made of PP with a scale of 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the 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 by:

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 authorization number in Romania, the country of export: 12584/2019/01
Parallel import authorization number: 219/19

Date of approval of the leaflet: 14.05.2024

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