Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
LOPERAMIDE HYDROCHLORIDE
McNeil Healthcare (Ireland) Ltd
0.2mg/5ml MG/5ml
2009-07-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imodium 1mg/5ml Oral Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of oral solution contains 1mg loperamide hydrochloride. Excipients: Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Alcohol 3 PHARMACEUTICAL FORM Oral solution. A clear, red, slightly viscous fruit-flavoured oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults As an adjunct in the management of acute diarrhoea, together with appropriate fluid and electrolyte replacement. In the symptomatic control of diarrhoea associated with chronic inflammatory bowel disease, eg., Crohn’s disease and ulcerative colitis, as an adjunct to specific measures such as corticosteroids and sulphasalazine. Use in these conditions should be under specialist supervision. In the adjunctive short-term, control of post-surgical diarrhoea, including ileostomy. Children For the occasional use in the control of intractable diarrhoea under specialist supervision. Since persistent diarrhoea can be an indicator of potentially serious conditions, the underlying cause must always be investigated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of Administration Oral use. a. As an adjunct in the management of acute diarrhoea _Adults and children 9-12 years_ 2 to 4mg (10 to 20ml) is the usual initial dose, followed by 2mg (10ml) three times daily. The maximum daily dose should not exceed 10mg. _Children 4-8 years_ A total maximum daily dose of 4mg (20ml) in divided doses. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/02/2012_ _CRN 2100711_ _page number: 1_ _Children under 4 years_ Not recommended. _Use in Elderly_ No dose adjustment is required for the eld Izlasiet visu dokumentu