Pays: Israël
Langue: anglais
Source: Ministry of Health
ENALAPRIL MALEATE
DEXCEL LTD, ISRAEL
C09AA02
TABLETS
ENALAPRIL MALEATE 5 MG
PER OS
Required
DEXCEL LTD, ISRAEL
ENALAPRIL
ENALAPRIL
Treatment of essential hypertension, renovascular hypertension congestive heart failure and to reduce mortality in patients with all degrees of heart failure. To retard the development of symptomatic heart failure in asymptomatic patients with left ventricular dysfunction.
2014-11-11
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ENALADEX 5mg ENALADEX 10mg ENALADEX 20mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ENALADEX 5mg Each tablet contains Enalapril maleate 5 mg Excipient with known effect: Each tablet contains approximately 282 mg Lactose ENALADEX 10mg Each tablet contains Enalapril maleate 10 mg Excipient with known effect: Each tablet contains approximately 130 mg Lactose ENALADEX 20mg Each tablet contains Enalapril maleate 20 mg Excipient with known effect: Each tablet contains approximately 260 mg Lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet ENALADEX 5mg are white, round, biconvex tablets, bisected on one side. The tablet can be divided into equal doses. ENALADEX 10mg / 20mg are pink, round, biconvex tablets, quadrisected on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of essential hypertension Treatment of renovascular hypertension Treatment of congestive heart failure and to reduce mortality in patients with all degrees of heart failure To retard the development of symptomatic heart failure in asymptomatic patients with left ventricular dysfunction 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The absorption of Enalapril is not affected by food. The dose should be individualized according to patient profile (see section 4.4) and blood pressure response. Paediatric population There is limited clinical trial experience of the use of Enalapril in hypertensive paediatric patients (see sections 4.4, 5.1 and 5.2). Hypertension The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). Enalapril is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system, (e.g. renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) m Lire le document complet