Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE
Merck Sharp and Dohme Limited
ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE
20/12.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Innozide 20 mg/12.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg enalapril maleate and 12.5 mg hydrochlorothiazide. Excipients: Contains 141.00 mg lactose monohydrate. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Tablet. Round, fluted, yellow tablets with MSD 718 on one side and scored on the other The scoreline allows breaking for ease of swallowing only. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of hypertension where a further reduction in blood pressure is required following the use of 20 mg enalapril. Management of hypertension in patients who have been stabilised on the individual components. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The dosage of ‘Innozide’ should be determined primarily by the experience with the enalapril maleate component. The maximum recommended daily dose is two tablets. _Adults_ _Essential hypertension_ The dosage is one tablet, taken once daily. If necessary, the dosage may be increased by a small increment of either constituent. _Dosage in renal insufficiency_ Thiazides may not be appropriate diuretics for use in patients with renal impairment and are ineffective at creatinine clearance values of 30 ml/min or below (i.e. moderate or severe renal insufficiency). In patients with creatinine clearance of >30 and <80 ml/min, ‘Innozide’ should be used only after titration of the individual components. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/02/2012_ _CRN 2103806_ _page number: 1_ _Use in the elderly_ In clinical studies the efficacy and tolerability of enalapril maleate and hydrochlo Aqra d-dokument sħiħ