Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
MEBEVERINE HYDROCHLORIDE
Abbott Healthcare Products Ltd
135 Milligram
Tablets
1983-02-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colofac 135 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mebeverine Hydrochloride 135 mg. Excipients: also includes Lactose monohydrate 97.0 mg per tablet and Sucrose 79.0 mg per tablet. 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 For use 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. 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. Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/02/2011_ _CRN 2096067_ _page number: 1_ 4.6 FERTILITY, PREGNANCY AND LACTATION Although studies in animals have not shown any teratogenic effect which can be definitely attributed to mebeverine, the safety of Colofac in human pregnancy has not been established. On basic principles therefore, its use is Leggi il documento completo