Keep out of reach of children.
Read the directions carefully before use.
For prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Trimebutine maleate ................................. 100 mg
Excipients q.s …………………………………… 1 tablet
Tablet.
Product description: A round, white to off-white tablet, engraved with a triangle on one side, a circle on the other side, undamaged edges.
Box of 2 blisters x 10 tablets.
Box of 10 blisters x 10 tablets.
Pharmacotherapeutic group: Agent regulating lower gastrointestinal motility. ATC code: A03AA05.
Clinical data have confirmed the regulating effects of trimebutine maleate on the lower gastrointestinal tract. This data is based on intestinal electromyographic recordings or by stool transit time determinations in patients with postoperative paralytic ileus or patients suffering from irritable bowel syndrome (lBS).
In addition, these regulating effects were also confirmed by sigmoid motor activity in patients with hypo- or hypersigmoid activity
Metabolic studies in rats, dogs, and men showed the C14-trimebutine maleate or its free base is rapidly absorbed after oral administration. Peak plasma concentrations of radioactivity were observed within one hour in men and rats and within 2 to 4 hours in dogs.
Plasma radioactivity in man indicated a kinetic model with central and peripheral compartments and a mean distribution half-life of 0.66 hours.
Tissue distribution studies showed high concentrations of the radiolabelled drug in the stomach and the intestinal walls of rats and in the major organs of metabolism and excretion in mice.
Placental transfer without teratogenic effect was observed in the rat. Protein-binding was less than 5% in vivo (rat plasma) and in vitro (bovine serum albumin).
Urine was the main route of elimination in all species while a small percentage (5 to 12%) of radioactivity was detected in the faeces. The plasma half-life of trimebutine was short, but the elimination half-life of radioactivity was approximately 10 to 12 hours in men and rats. In the rat, an entero-hepatic circulation was also demonstrated.
Extensive metabolism of the parent compound was indicated since less than 2.4% of the urinary radioactivity was found as an unchanged drug in all species. The livers of rats and dogs appeared to be the major site of hydrolysis of the ester and also capable of a "first pass" metabolism.
The main urinary metabolites in all species were 2-amino (I) or 2-methylamino (II) or 2-dimethylamino-2-phenylbutan-1-ol (III). These three metabolites plus mono-N-desmethyl trimebutine (IV) were also shown in plasma; the major component was III in rats and dogs and IV in men. Sulphate and/or glucuronic acid conjugation was also shown to play an important role in metabolism.
Trimebutine should be used with caution in drivers and machine users.
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 in pregnant women is not recommended.
Animal studies have shown that trimebutine maleate increases the duration of d-tubocurarine-induced curarisation. No other drug interactions have been observed during clinical trials or otherwise reported.
In clinical studies, adverse effects of mild to moderate nature occurred in 7% of the patients treated with trimebutine maleate. 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:
Gastrointestinal disorders: Dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea, and constipation were reported in a total of 3.1% of the patient population.
CNS: Drowsiness, fatigue, dizziness, hot/cold sensations, and headaches were reported in 3.3%.
Allergic reactions: Rash in 0.4% of the patients.
Miscellaneous effects: Menstrual problems, painful enlargement of breast, anxiety, urine retention, and slight deafness were also infrequently reported.
Please inform your doctor of all undesirable effects upon drug administration.
For management of a suspected drug overdose, contact your regional poison control center immediately.
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.
Store in dry places, not exceeding 30°C, protect from light.
Children: Not recommended for use in children under 12 years of age.
Excipients
Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease. If you have wheat allergy (different from coeliac disease) you should not take this medicine.
Lactose monohydrate: Patients with problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Trimebutine is indicated:
For the treatment and relief of symptoms associated with the irritable bowel syndrome (spastic colon).
In postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.
Trimebutine is contraindicated in patients with known hypersensitivity to trimebutine or any of the excipients of this medicine.
No other contraindications have been identified at this time.
The adult recommended dose is up to 600 mg daily in divided doses.
It may be administered as two 100 mg tablets three times daily before meals.
Or as directed by the physician.
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