Trimebutine Maleate is indicated for

• the treatment and relief of symptoms associated with Irritable Bowel Syndrome (IBS).
• It is also used in postoperative paralytic ileus to accelerate the return of intestinal transit following abdominal surgery.

Trimebutine Maleate is a noncompetitive spasmolytic agent with moderate affinity for opiate receptors and marked anti-serotonin activity, particularly at mu receptors. It regulates spontaneous intestinal activity and improves synchronization between electrical spikes and muscular contractions in the colon and ileum. It does not affect normal gastrointestinal motility but helps normalize abnormal intestinal function.

Children over 12 years and Adults: 1 or 2 tablets, 3 times/day before meals.

No clinically significant drug interactions have been reported in clinical trials or post-marketing experience.

Trimebutine Maleate is contraindicated in patients with known hypersensitivity to the drug or any of its excipients.

Trimebutine Maleate is generally well tolerated. Reported adverse effects include dry mouth, unpleasant taste, diarrhea, dyspepsia, epigastric pain, nausea, constipation, drowsiness, fatigue, dizziness, hot and cold sensations, and headache.

Although animal studies have not shown teratogenic effects, the use of Trimebutine Maleate during pregnancy is not recommended. It is unknown whether the drug passes into breast milk. It should be used during breastfeeding only if the potential benefit outweighs the risk to the infant.

Use with caution in elderly patients, during pregnancy, and during lactation.

No cases of overdose have been reported. If overdose occurs, gastric lavage is recommended after oral ingestion, and treatment should be symptomatic and supportive.

Antispasmodic agent

Store in a cool, dry place away from light and moisture.