Debridat

Leaflet attached to the packaging: patient information

Debridat, 100 mg, coated tablets

Trimebutini maleas

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

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on 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 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 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 agents. The medicine has an anti-spasmodic effect and alleviates gastrointestinal motility disorders.

Indications for use

Symptomatic treatment:

• of motility disorders and gastrointestinal complaints associated with functional gastrointestinal disorders;
• of pain associated with functional gastrointestinal disorders and biliary tract 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 to use Debridat, the patient should discuss it with their doctor or pharmacist.

Debridat and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Using Debridat at the same time as zotepine (a medicine used, among other things, in schizophrenia) may increase the anticholinergic effect.

Pregnancy and breastfeeding

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
The use of Debridat during pregnancy may 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 are no data on the effect of Debridat on fertility.

Debridat contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Debridat contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to use Debridat

This medicine 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.
THIS MEDICINE IS INTENDED FOR USE ONLY IN ADULTS.
Usually, 1 tablet of 100 mg is used 3 times a day.
In exceptional cases, the doctor may increase the dose to 2 tablets of 100 mg 3 times a day.

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

The patient should not use 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 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, erythema, pruritus, 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 any side effects not listed in this leaflet, they should inform their 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
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 to gather more information on the safety of the medicine.

5. How to store Debridat

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 is trimebutine maleate (Trimebutini maleas). One coated tablet contains 100 mg of trimebutine maleate.
• The other ingredients are: lactose monohydrate (see section 2 "Debridat contains lactose"), corn starch, hypromellose 6 mPa.s, sodium starch glycolate (see section 2 "Debridat contains sodium"), tartaric acid, silicon dioxide, magnesium stearate. The coating contains: hypromellose 15 mPa.s, lactose monohydrate (see section 2 "Debridat contains lactose"), Macrogol 4000, titanium dioxide.

What Debridat looks like and what the packaging contains

White coated tablets. The packaging contains 30 tablets (2 blisters of 15 each).

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 medicine, 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 update of the leaflet:

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-debridattabletki and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
http://www.urpl.gov.pl .