Debridat

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

Debridat, 100 mg, coated tablets

Trimebutini maleas

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

• You should keep this 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 acts as an anti-spasmodic and alleviates disorders of bowel function.

Indications for use

Symptomatic treatment:

• of motor disorders and intestinal complaints 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 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 or pharmacist.

Debridat and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take. Using Debridat at the same time as zotepine (a medicine used, among other things, in schizophrenia) may cause an increase in anticholinergic activity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of Debridat during pregnancy may be considered by your doctor only if the potential benefits of treatment outweigh the risk 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 you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.
Debridat contains sodiumThe medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Debridat

This medicine should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
THE 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, you should contact your doctor. The doctor will recommend appropriate symptomatic treatment.

Missing a dose of Debridat

You 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 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, itching, 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, 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, you can help 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. The expiry date refers to the last day of the specified month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste containers. 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 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 monohydrate"), corn starch, hypromellose 6 mPa.s, sodium carboxymethylcellulose (type A) (see section 2 "Debridat contains sodium"), tartaric acid, colloidal anhydrous silica, magnesium stearate. The coating contains: hypromellose 15 mPa.s, lactose monohydrate (see section 2 "Debridat contains 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, 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 d’Orgemont, 49000 Angers, France

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
MEDICOFARMA S.A., ul. Sokołowska nr 9, lok. 19, 01-142 Warsaw
Romanian marketing authorization number, the country of export:12582/2019/01
Parallel import authorization number:306/19
Date of approval of the leaflet: 01.03.2022
[Information about the trademark]