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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mebecon 135 mg Coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains Mebeverine hydrochloride 135 mg.
Excipients: Contains lactose monohydrate 97 mg and sucrose 79 mg.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated Tablet.
White, circular, sugar coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of irritable bowel syndrome (particularly gastrointestinal spasm).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 10 years:
One tablet three times a day preferably 20 minutes before meals.
After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.
Children and Infants:
Not Recommended.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to mebeverine.
Hypersensitivity to any component of the product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prior to treating patients with mebeverine, care should be taken to exclude organic disease of the bowel, particularly
malignancy.
Since Mebecon coated tablets contain lactose, people with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Mebecon coated tablets contain sucrose and should not be used by patients with rare hereditary problems of fructose
intolerence, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/04/2012_
_CRN 2093798_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None.
4.6 FERTILITY, PREGNANCY AND LACTATIO
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