Enalaprilmaleaat 40 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ENALAPRILMALEAAT SAMENSTELLING overeenkomend met ; ENALAPRIL

Beschikbaar vanaf:

Hexal AG

ATC-code:

C09AA02

INN (Algemene Internationale Benaming):

Enalapril maleate COMPOSITION corresponding to ; ENALAPRIL

farmaceutische vorm:

Tablet

Samenstelling:

IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; TALK (E 553 B),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Enalapril

Product samenvatting:

Hulpstoffen: IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMWATERSTOFCARBONAAT (E 500 (II)); TALK (E 553 B);

Autorisatie datum:

2006-07-18

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENALAPRILMALEAAT 30 MG, TABLETTEN
ENALAPRILMALEAAT 40 MG, TABLETTEN
enalaprilmaleaat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT ENALAPRIL MALEATE IS AND WHAT IT IS USED FOR
ENALAPRIL MALEATE IS USED

to reduce high blood pressure (hypertension)

for insufficient pumping power of the heart with symptoms of disease
(symptomatic heart
failure)

for insufficient pumping power of the heart (heart failure) before
symptoms occur, to prevent
the occurrence of these symptoms (such as breathlessness, swollen
ankles and feet, and fatigue
after slight exertion such as walking).
Enalapril maleate belongs to the ACE inhibitor (angiotensin conversion
inhibitors) group of
medicines. Enalapril blocks the formation of a blood
pressure-increasing substance by the body. As a
result, the pressure falls and/or the action of the heart improves.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL MALEATE
DO NOT TAKE ENALAPRIL MALEATE:

if you are allergic to:
-
enalapril or any of the other ingredients of this medicine (listed in
section 6)
-
other ACE-inhibitors.

if you had sudden fluid accumulation in the skin and mucous membranes
(e.g. throat or
tongue), breathing d

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Enalaprilmaleaat 30 mg, tabletten
Enalaprilmaleaat 40 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg enalapril maleate.
Each tablet contains 40 mg enalapril maleate.
Excipient with known effect: Each tablet contains 167.9 mg lactose (as
lactose monohydrate).
Excipient with known effect: Each tablet contains 223.8 mg lactose (as
lactose monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
[Nationally completed name] 30 mg tablet is an oblong, convex, orange
tablet with two breaking
notches, both sides scored with markings ‘EN 30’.
The tablet can be divided into three equal doses.
[Nationally completed name] 40 mg tablet is an oblong, convex, orange
tablet with three breaking
notches, both sides scored with markings ‘EN 40’.
The tablet can be divided into four equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Treatment of hypertension.

Treatment of symptomatic heart failure.

Prevention of symptomatic heart failure in patients with asymptomatic
left ventricular
dysfunction (ejection fraction

35%) (see section 5.1)
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The absorption of enalapril maleate is not affected by food.
The dose should be individualised 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
maleate 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 maleate 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) may experien