Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MEBEVERINE HYDROCHLORIDE
Abbott Healthcare Products Ltd
135 Milligram
Coated Tablets
2008-12-12
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 Read the complete document