DEBRIDAT TABLET 100 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TRIMEBUTINE MALEATE

Available from:

PFIZER PRIVATE LIMITED

ATC code:

A03AA05

Dosage:

100 mg

Pharmaceutical form:

TABLET

Composition:

TRIMEBUTINE MALEATE 100 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

FARMEA

Authorization status:

ACTIVE

Authorization date:

1989-05-22

Patient Information leaflet

 
D É B R I D A T  
(Trimebutine maleate) 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Trimebutine maleate: 100 mg per tablet.  

Excipient: lactose, pregelatinized corn starch,
hypromellose, sodium carboxymethylcellulose, tartric acid, 
anhydrous colloidal silica, magnesium stearate, macrogol 4000,
coloring agent: titanium dioxide, purified 
water q.s. 1 film-coated tablet. 

PHARMACEUTICAL FORM 
Film-coated tablets (white): pack of 30 

PHARMACOLOGICAL PROPERTIES 
PHARMACODYNAMIC PROPERTIESMuscolotropic antispasmodic
(A: gastrointestinal tract and metabolism) 

Gastrointestinal motility modifier. Peripheral enkephalinergic
agonist. 

Trimebutine stimulates intestinal motility (triggering phase-III
waves propagated by the migrating motor 
complex) and inhibits it in the event of prior stimulation. 

PHARMACOKINETIC PROPERTIES 
Peak blood levels obtained after 1 to 2 hours. 

Rapid elimination, mainly in the urine: on average 70%
in 24 hours. 

PRECLINICAL SAFETY DATA 
Studies in animals have not revealed any teratogenic effect.  

THERAPEUTIC INDICATIONS 
GASTROENTEROLOGY: 
Polymorphous symptoms of the gastro-intestinal tract, grouped
under the irritable bowel syndrome entity or 
functional digestive disorders, in particular abdominal pain and
cramps, spasms, flatulence, diarrhoea 
and/or constipation. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Follow the doctor’s Prescription. 

For reference: Adults : 1 or 2 tablets 3 times a day 

CONTRAINDICATIONS – DRUG INTERACTIONS 
None  

SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
The administration of this product does not dispense with the
need for the specific treatment of other anal 
diseases. Treatment must be short-term. If the symptoms are not
relieved rapidly, a proctological 
examination must be carried out and the treatment reviewed. 

FERTILITY, PREGNANCY AND LACTATION 
_PREGNANCY: _
Studi

Summary of Product characteristics

D É B R I D A T
(Trimebutine maleate)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimebutine maleate: 100 mg per tablet.
Excipient: lactose monohydrate, pre-gelatinized corn starch,
hypromellose, sodium starch
glycollate, tartaric acid, anhydrous colloidal silica, magnesium
stearate, macrogol 4000,
coloring agent: titanium dioxide, purified water q.s. 1 film-coated
tablet.
PHARMACEUTICAL FORM
Film-coated tablets (white).
THERAPEUTIC INDICATIONS
GASTROENTEROLOGY:
Polymorphous symptoms of the gastro-intestinal tract, grouped under
the irritable bowel
syndrome entity or functional digestive disorders, in particular
abdominal pain and cramps,
spasms, flatulence, diarrhea and/or constipation.
POSOLOGY AND METHOD OF ADMINISTRATION
Follow the doctor’s prescription.
For reference: Adults: 1 or 2 tablets 3 times a day.
CONTRAINDICATIONS – DRUG INTERACTIONS
None.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None.
FERTILITY, PREGNANCY AND LACTATION
_PREGNANCY:_
Studies in animals have not revealed any teratogenic effect. There are
no adequate and well
controlled studies of trimebutine in pregnant women. There was no
evidence of teratogenicity
or other adverse developmental effects when trimebutine was
administered to pregnant rats
and rabbits. Trimebutine should be used during pregnancy only if the
potential benefit to the
patient outweighs the risk to the patient and fetus.
_LACTATION:_
Safety for use in lactation has not been established.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The effect of trimebutine on the ability to drive or use machinery has
not been systematically
evaluated.
UNDESIRABLE EFFECTS
The following Adverse Drug Reactions (ADRs) have been reported in
patients receiving
trimebutine.
OVERDOSE
In the event of overdose, symptomatic treatment should be implemented.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Gastrointestinal motility modifier. Peripheral enkephalinergic
agonist.
Trimebutine stimulates intestinal motility (triggering phase-III waves
propagated by the
migrating motor complex) and in