| MIOPROPAN S|
|Trimebutine Maleate - Simethicone |
|Film-coated Tablets |
|Prescription Medicine |
|Trimebutine maleate .........................||200 mg|
|Simethicone .................................||120 mg|
|Inactive ingredients:(Tricalcium phosphate, microcrystalline cellulose, crospovidone, povidone, silicon dioxide, polyvinyl alcohol /titanium dioxide/|
|polyethylene glycol/talc, sodium stearyl|
fumarate, antifoam, lactose) q.s. to ........
|Spasmolytic agent. Digestive motility modulator. Antiflatulent.
ATC Code: A03AA05|
•Post-prandial pain in irritable colon syndrome.
•Post-surgical recovery of intestinal functions (post-surgical ileus).
•Abdominal pain caused by functional disorders in the intestine (Aerophagia, meteorism, abdominal distention, flatulence)
•Non-ulcerative dyspepsia (previous negative gastric endoscopy).
| Dosage and Administration:|
|1 coated tablet three times daily, before meals.
Treatment lasts 2 to 4 weeks.
It is not to be used for long-term maintenance treatment.|
|Hypersensitivity to the drug or any component of this medicine.
First trimester of pregnancy. Nursing mothers.
Intestinal perforation or obstruction regardless of its cause.
|The symptomatic response to the treatment with MIOPROPAN S does not exclude the existence of a specific organic process that causes
alterations in the digestive tube motility, such as acute or chronic intestinal infections, parasitosis, diverticulosis, neoplasia, etc.
Do not exceed the recommended dose.
Do not use after the expiration date.
Since this medicine contains lactose, it is contraindicated in congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency.|
|There is not sufficient data to recommend use of this product for periods longer than 1 month.|
| Drug Interactions:|
Cisapride: the efficacy of cisapride decreases when coadministered with trimebutine.
Procainamide: coadministration exacerbates the antivagal effects on cardiac conduction.
Zotepine: its anticholinergic effects are exacerbated with a risk of undesirable effects: delirium, agitation, insomnia, gastrointestinal discomfort.
Studies in animals have revealed that the effects of curarizing agents are increased when coadministered with trimebutine.|
| Adverse Reactions:|
|Skin: there have been rare reports of allergic reactions, hot-cold sensations.
CNS: there have been occasional reports of weakness and dizziness.
Gastrointestinal: constipation or diarrhea, dry mouth, nausea, vomiting.|
There have been no reports. In the event of accidental overdosage patient may experience: drowsiness, faintness, diarrhea and nausea.
Treatment should be symptomatic. If less than one hour has transpired since intake, induce vomiting or perform gastric lavage.
In the event of accidental overdosage, seek medical advice or immediately contact the following Poison Control Centers:
Hospital de Pediatría Ricardo Gutiérrez: (011) 4962-6666/1177
Hospital A. Posadas: (011)4654-6648/4658-7777
Store in a dry place at 15° to 30°C
Keep this and all drugs out of the children’s reach
Pharmaceutical product authorized by the Ministry of Health
Certificate Number: 54,886.
Regulatory Affairs Manager: Rogelio José Calleja. Pharmacist
| How Supplied:|
|MIOPROPAN S: Packaged in boxes containing 30 and 60 coated tablets.