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MIOPROPAN S
Trimebutine Maleate - Simethicone 
Film-coated Tablets 
Prescription Medicine 
Description
Mode of Action
Indications
Dosage and Administration
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdosage
How Supplied
 
 Description:
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 ........
1,280 mg
 Mode of Action:
Spasmolytic agent. Digestive motility modulator. Antiflatulent. ATC Code: A03AA05
 Indications:
•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.
 Contraindications:
Hypersensitivity to the drug or any component of this medicine. First trimester of pregnancy. Nursing mothers. Intestinal perforation or obstruction regardless of its cause.
 Warnings:
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.
 Precautions:
There is not sufficient data to recommend use of this product for periods longer than 1 month.
 Drug Interactions:
Trimebutine: 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.
 Overdosage:
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.





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