Debridat

Package Leaflet: Information for the Patient

Debridat, 7.87 mg/g, Granules for Oral Suspension

Trimebutinum

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 package and other information

1. What is Debridat and what is it used for

Debridat belongs to a class of medications called musculotropic, antispasmodic agents. The medication has an antispasmodic effect and alleviates gastrointestinal motility disorders.
Debridat is indicated for use:

• to alleviate pain associated with functional disorders of the gastrointestinal tract and bile ducts;
• to correct motility disorders and gastrointestinal 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 medication (listed in section 6).

Warnings and precautions

Before starting to use Debridat, the patient should discuss it with their doctor, pharmacist, or nurse.
If the patient has diabetes, they should take into account the sugar content of the medication:
0.6 g/ml, which is approximately 0.20 g per dose unit (e.g., a dose 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 medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they 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 medication.
Pregnancy
Women who are pregnant may use the medication only on the advice of a doctor. 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 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

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 consult their doctor before taking the medication.

3. How to use Debridat

Before using the medication, an oral suspension should be prepared.

Preparing the oral suspension

• 1. The contents of the bottle should be filled 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. The bottle should be shaken before each use.
• 3. After using Debridat, the measuring cup should be rinsed carefully.

Dosage

This medication should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their 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 in 2-3 divided 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 attached measuring cup) 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 medication 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, the patient should contact their doctor. The doctor will recommend appropriate symptomatic treatment.

Missing a dose of Debridat

A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medications, Debridat can cause side effects, although not everybody gets them.
Uncommon:may occur in less than 1 in 100 people

• pre-syncopal and (or) syncopal states*
• rash

Frequency not known(cannot be estimated from the available data)

• hypersensitivity
• contact dermatitis, skin inflammation, redness, itching, and urticaria
• severe skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, toxic epidermal necrolysis, and exfoliative dermatitis

*

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Debridat

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiry date stated on the packaging after "Expiry Date (EXP)". The expiry date refers to the last day of the specified month.
After reconstitution, store at a temperature below 25°C. Do not store in the refrigerator or freeze.
The suspension should not be stored for more than 4 weeks.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the package and other information

What Debridat contains

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

What Debridat looks like and what the package contains

A 250 ml bottle made of orange glass with a white line, closed with a metal cap, containing 152.5 g of granules (1.2 g of trimebutine) for the preparation of an oral suspension. The package contains a polypropylene measuring cup for measuring the suspension.

Marketing authorization holder and manufacturer:

Marketing authorization holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
FARMEA
10 rue Bouché Thomas
ZAC d’Orgemont
ANGERS, 49000,
France
To obtain more detailed information about this medication, the patient should contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o., phone: 22 335 61 00

Date of last revision of the leaflet: 08/2022