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P  - Caution when used during pregnancy

L  - Caution when used during lactation 

Molecule Info

ATC Classification
A03AA05 - trimebutine; Belongs to the class of synthetic anticholinergics, esters with tertiary amino group. Used in the treatment of functional bowel disorders.
Gastroenterology: Polymorphous symptoms of the gastrointestinal tract, grouped under the irritable bowel syndrome entity or functional digestive disorders, in particular abdominal pain and cramps; spasms, flatulence, diarrhoea and/or constipation.
Dosage & Administration

The adult recommended dose is up to 600 mg daily in divided doses. It is administered as one 200 mg tablet three times daily before meals. 

Film-Coated Tablet: Adults: 1-2 tablets 3 times daily.
Oral Suspension: Adults: 15-30 mL 3 times daily. Usual Doses: Children >5 years: 10 mL 3 times daily ie, 5 mL/5 kg body weight/day; 1-5 years: 5 mL 3 times daily; 6 months to 1 year: 5 mL twice daily; <6 months: 2.5 mL 2-3 times daily.


In the event of overdose, symptomatic treatment should be instigated.

No evidence of overdosage has been reported to date. However, if overdosage should occur following oral administration of Trimebutine maleate, gastric lavage is recommended. Treatment should be made according to the symptoms observed.


Trimebutine maleate is contraindicated in patients with known hypersensitivity to trimebutine maleate or any of the excipients.

Warning & Precautions

Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy in laboratory animals by both oral and parenteral routes, the use of Trimebutine maleate in pregnant women is not recommended. 

Children: Not recommended for use in children under 12 years of age.

Oral Suspension: In the event of diabetes, take into account the sucrose content (5 mL contains sucrose 3 g).
The administration of Debridat oral suspension 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.
Effects on the Ability to Drive or Operate Machinery: The effect of trimebutine on the ability to drive or use machinery has not been systemically evaluated.

Caution for usage

Oral Suspension: Instructions for Use: Fill the bottle to the mark with nonsparkling water. Shake vigorously until thoroughly mixed. Shake the bottle each time before use. The reconstituted oral suspension cannot be stored at room temperature (between 15°C and 25°C, do not refrigerate or freeze) for >4 weeks after reconstitution.

Adverse Drug Reactions

In clinical studies, adverse effects of mild to moderate nature occurred in 7% of the patients treated with Trimebutine maleate (MODULON®). No single side effect occurred in more than 1.8% of the patients and some of these might have been related to the patient’s condition rather than the medication. The commonly reported adverse effects are as follows: a) Gastrointestinal: Dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea and constipation were reported in total of 3.1% of the patient population; b) CNS: Drowsiness, fatigue, dizziness, hot/cold sensations and headaches were reported in 3.3%; c) Allergic reactions: Rash in 0.4% of the patients; and d) Miscellaneous effects: Menstrual problems, painful enlargement of breast, anxiety, urine retention and slight deafness were also infrequently reported.

Drug Interactions

Animal studies have shown that trimebutine maleate increases the duration of d-tubocurarine-induced curarization. No other drug interactions have been observed during clinical trials or otherwise reported.

Use in Pregnancy & Lactation

Use in pregnancy: Studies in animals have not revealed any teratogenic effect.
No sufficiently relevant data are currently available to be able to assess a potential malformative or fetotoxic effect of trimebutine when it is administered during pregnancy.
Consequently, as a precautionary measure, it is preferable not to use trimebutine during the 1st trimester of pregnancy. In the absence of any expected harmful effect for either mother or child, the use of trimebutine during the 2nd or 3rd trimesters of pregnancy should only be considered if it is necessary.
Use in lactation: Breastfeeding is possible during treatment with trimebutine.

Store below 25°C.
Trimebutine maleate is a musculotropic antispasmodic (A: Gastrointestinal tract and metabolism).
Pharmacodynamics: Film-Coated Tablet: Through its action on the enkephalinergic system of the gut. Trimebutine is a regulator of digestive motility. Acting as an enkephalinergic agonist on excitatory and inhibitory receptors, it exerts a stimulating action on hypokinetic and a spasmolytic effect on hyperkinetic digestive muscle. Trimebutine restores a physiologic motility in functional digestive diseases related to mobility disorders.
Oral Suspension: 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.
Pharmacokinetics: Oral Suspension: Peak blood levels obtained after 1-2 hrs. Rapid elimination, mainly in the urine: On average 70% in 24 hrs.

Brand/Product Info

Total Products : 2  
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
TIMOTOR Square Pharmaceuticals Ltd. Trimebutine Maleate 100mg Tablet 5x10's: 251.50 MRP
Trimotil Incepta Pharmaceuticals Limited Trimebutine Maleate INN 100 mg Film Coated Tablet 10x5's:MRP 250 Tk

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