ENALADEX 5 MG

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

ENALAPRIL MALEATE

Dostupné s:

DEXCEL LTD, ISRAEL

ATC kód:

C09AA02

Léková forma:

TABLETS

Složení:

ENALAPRIL MALEATE 5 MG

Podání:

PER OS

Druh předpisu:

Required

Výrobce:

DEXCEL LTD, ISRAEL

Terapeutické skupiny:

ENALAPRIL

Terapeutické oblasti:

ENALAPRIL

Terapeutické indikace:

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.

Datum autorizace:

2014-11-11

Charakteristika produktu

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