Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
METOCLOPRAMIDE HYDROCHLORIDE
Rowa Pharmaceuticals Limited
10 Milligram
Tablets
1986-04-23
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metocyl 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Metoclopramide 10 mg (as hydrochloride). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, convex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (A) Metocyl is indicated in the treatment of disorders of the gastrointestinal tract associated with delayed gastric emptying. (B) Metocyl is indicated in the treatment of nausea and vomiting, including that associated with the administration of some cytostatic drugs and radiotherapy. (C) Metocyl is also indicated for diagnostic procedures, e.g. barium studies and duodenal intubation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral. Recommended Dosage Schedule: The maximum daily dose, especially for children and young adults should not exceed 0.5 mg/kg body weight. FOR INDICATIONS (A) AND (B) ABOVE: Adults 20 years and over 10 mg three times daily. For patients of less than 60kg see below. Elderly patients: As for adults. To avoid adverse reactions adhere strictly to dosage recommendations and where prolonged therapy is considered necessary, patients should be regularly reviewed. Young Adults 15 – 19 years 60kg and over: 5 – 10 mg three times daily commencing with the lower dose. 30-59kg:5mg three times daily. Children (under 15 years) Tablets should not be used in children under the age of 15 years. A syrup formulation should be used to facilitate more accurate dosing. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/12/2006_ _CRN 2031332_ _page number: 1_ FOR INDICATIONS (C) ABOVE: A single dose of Metocyl may be Läs hela dokumentet