Debridat

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Debridat

100 mg, coated tablets

Trimebutini maleas

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

• The leaflet should be kept so that it can be read 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. 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 taking Debridat
• 3. How to take 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 acts as an anti-spasmodic and alleviates disturbances in bowel function.

Indications for use

Symptomatic treatment:

• of motor and intestinal disorders associated with functional disorders of the gastrointestinal tract,
• of pain associated with functional disorders of the gastrointestinal tract and bile ducts.

2. Important information before taking Debridat

When not to take 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 take Debridat, the patient should discuss it with their doctor or pharmacist.

Debridat and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. Taking 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 taking this medicine.
Pregnancy
The doctor may 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 lactose monohydrate

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

Debridat contains sodium

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

3. How to take Debridat

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
THE MEDICINE IS INTENDED FOR USE ONLY IN ADULTS.
Usually, 1 tablet of 100 mg is taken 3 times a day.
In exceptional cases, the doctor may increase the dose to 2 tablets of 100 mg 3 times a day.

Taking a higher dose of Debridat than recommended

In case of taking 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 taken 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 side effects: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.

*Side effects mainly observed after intravenous administration of the medicine.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. 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, more information can be gathered 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.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste containers. 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). 1 coated tablet contains 100 mg of trimebutine maleate.
• The other ingredients are: lactose monohydrate, corn starch, hypromellose 6 mPa.s, sodium carboxymethyl starch (type A), tartaric acid, colloidal anhydrous silica, magnesium stearate. The coating contains: hypromellose 15 mPa.s, lactose monohydrate, macrogol 4000, titanium dioxide (E 171).

What Debridat looks like and what the packaging contains

White coated tablets. The packaging contains 30 tablets (2 blisters of 15 each).
To obtain more detailed information, the patient 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 Bouche Thomas – ZAC d’Orgemont
49000 Angers
France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 12582/2019/01

Parallel import authorization number: 203/12 Date of approval of the leaflet: 07.04.2022

[Information about the trademark]