Debridat
Ask a doctor about a prescription for Debridat
How to use 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 .
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterFarmea
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to DebridatDosage form: Tablets, 200 mgActive substance: trimebutineManufacturer: Zakłady Farmaceutyczne POLPHARMA S.A.Prescription requiredDosage form: Tablets, 100 mgActive substance: trimebutineManufacturer: Zakłady Farmaceutyczne POLPHARMA S.A.Prescription requiredDosage form: Tablets, 100 mgActive substance: trimebutine
Alternatives to Debridat in other countries
The best alternatives with the same active ingredient and therapeutic effect.
Alternative to Debridat in Ukraine
Alternative to Debridat in Spain
Online doctors for Debridat
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for Debridat – subject to medical assessment and local rules.
Get updates and exclusive offers
Be the first to know about new services, marketplace updates, and subscriber-only promos.
