Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
LISINOPRIL DIHYDRATE
Ergha Healthcare Ltd
LISINOPRIL DIHYDRATE
20 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-01-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ByZestra 20 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 20mg of lisinopril (as dihydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. White, oval tablets, marked ‘LSN20’ on one face and with a scoreline on the other. The scoreline is to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Arterial hypertension It may be used alone or concomitantly with other classes of antihypertensive agents, e.g. thiazide diuretics. o Treatment of heart failure as additive therapy to non-potassium-sparing diuretics and where appropriate, digitalis. o Treatment of acute myocardial infarction, in haemodynamically stable patients (systolic blood pressure >100 mm Hg) without significant renal dysfunction (serum creatinine <177 micromol/l [2.0 mg/dl] and proteinuria <500 mg/24 hours.) Lisinopril should be given in addition to usual standard therapy in MI (thrombolytics, acetylsalicylic acid and ß blocking agents), especially together with nitrates. o Renal Complications of Diabetes Mellitus Treatment of renal disease in hypertensive patients with type 2 daibetes mellitus and incipient nephropathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Precautionary note:_ Excessive first dose hypotension may occur in high risk patients (in patients with salt and/or fluid deficiency, e.g. after dialysis, vomiting, in concomitant diuretic therapy, in patients with heart failure, severe or renal hypertension). Initiation of therapy requires, if possible, correction in salt and/or body fluids deficiencies, discontinuation or reduction of an existing diuretic therapy for two to three days before starting ACE inhi Læs hele dokumentet