Iboten
IBOTEN
COMPOSITION:
Trimebutine maleate ........................... 100 mg
Excipients q.s ..................................... 1 tablet
(Lactose monohydrate, wheat starch, tartaric acid, povidone K30, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate).
DOSAGE FORM: Tablet.
PRESENTATIONS: Box of 2 blisters x 10 tablets. Box of 10 blisters x 10 tablets.
PHARMACODYNAMICS:
Trimebutine is a spamolytic agent which acts on muscles, regulates digestive motility, and is a peripheral enkephalinergic agonist. Trimebutine acts to regulate digestive tract motility; it may stimulate gastrointestinal motility and also may inhibit such motility in case of previously stimulated.
PHARMACOKINETICS:
Iboten is well absorbed following oral administration; peak blood concentration was attained within 1 - 2 hours after oral administration. Iboten is rapidly excreted and mainly via urine with an average rate of 70% after 24 hours.
INDICATIONS:
For the treatment of:
Painful symptoms associated with functional disorders of digestive tract and biliary tract.
Irritable bowel syndrome, functional digestive disorders, abdominal pain and cramps, abdominal distension, diarrhea or constipation.
Postoperative paralytic ileus, decrease in pyloric or colonic spasm during endoscopic time.
CONTRAINDICATIONS:
Hypersensitivity to trimebutine and any of the excipients.
Children aged less than 12 years.
PRECAUTIONS:
Pregnancy and lactation: Trimebutine can be used for breast-feeding mothers. Trimebutine should be used with cautions in pregnant women.
Drivers and machinery users: Cautions should be taken when driving and using machines.
INTERACTIONS:
Trimebutine may affect the absorption and enhance the adverse effects of tubocurarine.
ADVERSE EFFECTS:
Adverse effects rarely occur at the recommended dose; they include dry mouth, foul taste, nausea, diarrhea, constipation, drowsiness, fatigue, dizziness, headache.
The very rarely reported adverse effects are rash, anxiety, urinary retention, tinnitus, ...
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: No documents have been reported.
DOSAGE & ADMINISTRATION:
Take the drug before meals.
Adults and children over 12 years: oral dose of 1 or 2 tablets x 3 times daily, maximum of 6 tablets/day.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.