ENAHEXAL 5MG TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ENALAPRIL MALEATE

Available from:

IDAMAN PHARMA SDN. BHD.

INN (International Name):

ENALAPRIL MALEATE

Units in package:

100Tablet Tablets; 30Tablet Tablets; 50Tablet Tablets

Manufactured by:

Salutas pharma GmbH

Patient Information leaflet

1
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ENAHEXAL® TABLET
_Enalapril maleate _
_ _
ENAHEXAL® 5MG TABLET
ENAHEXAL® 20MG TABLET
_The products Enahexal® 5mg Tablet _
_and Enahexal® 20mg Tablet are _
_referred to as ENAHEXAL throughout _
_this leaflet. _
_ _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about
_ENAHEXAL_
. It does not
contain all the available information. It
does not take the place of talking to
your doctor or pharmacist. Please read
this entire leaflet carefully before you
start to take your medicine. This
medicine is for you. Never give it to
other people even if their condition
appears to be the same as yours. If you
have any questions about this medicine
ask your pharmacist. Keep this leaflet;
you may need to read it again.
1. What is
_ENAHEXAL _
used for
2. How
_ENAHEXAL _
works
3. Before you take
_ENAHEXAL _
4. How to take
_ENAHEXAL _
5. While you are using
_ENAHEXAL _
6. Possible side effects
7. How to store
_ENAHEXAL _
8. Product description
9. Marketing authorization holder and
manufacturer
1. WHAT _ ENAHEXAL _ IS USED
FOR
_ENAHEXAL _
is used to treat high blood
pressure (hypertension) and heart
failure.
_ENAHEXAL _
is often used with other
medicines called diuretics or fluid
tablets. These medicines help the
kidney get rid of excess fluid from the
body.
_ENAHEXAL _
is also commonly
used with digitalis, a medication for
heart failure.
Ask your doctor if you have any
questions about why this medicine has
been prescribed for you. Your doctor
may have prescribed it for another
reason.
2.
HOW _ ENAHEXAL _
WORKS
_ENAHEXAL _
belongs to a group of
medicines known as angiotensin
converting enzyme (ACE) inhibitors.
These medicines work by widening
your blood vessels to make it easier for
the heart to pump blood through them
to all parts of your body. This helps to
reduce high blood pressure and
increase the supply of oxygen to your
heart, so that when you place extra
demand on your heart, such as during
exercise, your heart may cope better
and you may not ge

Summary of Product characteristics

Each ENAHEXAL® 5MG_ _tablet and ENAHEXAL® 20MG_ _tablet contains
enalapril maleate 5mg
and 20mg respectively.
DESCRIPTION
ENAHEXAL® 5MG:_ _Oval,
convex,
white
snap
tab
tablets,
one
side
scored with marking of EN 5.
ENAHEXAL® 20MG:_ _Oval, convex, orange snap tab tablets, one
side scored with marking of EN 20.
MECHANISM(S) OF ACTION
Enalapril
maleate
is
a
prodrug
of
enalaprilat
and
has
little
pharmacologic activity until hydrolysed in vivo to enalaprilat. The
mechanism(s) of action of enalaprilat and enalapril maleate have not
been fully elucidated. The drugs appear to reduce blood pressure in
normotensive individuals and hypertensive patients and to produce
beneficial
hemodynamic
effects
in
patients
with
congestive
heart
failure
mainly
by
suppressing
the
renin-angiotensin-aldosterone
system. Following oral administration, enalapril is rapidly absorbed
and then hydrolysed to the active metabolite enalaprilat. Enalaprilat
exerts
its
effect
on
the
renin
angiotensin-aldosterone
system
by
inhibiting
the
angiotensin-converting
enzyme
(ACE).
It
reduces
peripheral arterial resistance. In heart failure, it reduces both
preload
and
afterload
and
the
cardiac
output
may
be
increased
without
significant change in heart rate.
ACE catalyses the conversion of angiotensin I to the vasoconstrictor
substance, angiotensin II. Angiotensin II also stimulates aldosterone
secretion by the adrenal cortex. The beneficial effects of enalapril
in
hypertension
and
heart
failure
appear
to
result
primarily
from
suppression of the renin-angiotensin-aldosterone system. Inhibition of
ACE
results
in
decreased
plasma
angiotensin
II,
which
leads
to
decreased
vasopressor
activity
and
to
decreased
aldosterone
secretion. Although the latter decrease is small, it results in small
increases of serum potassium.
ACE is identical to kininase, an enzyme that degrades bradykinin.
Whether
increased
levels
of
bradykinin,
a
potent
vasodepressor
peptide, play a role in the therapeutic effects of enalapril remains
to be
elucidated.
PHARMACOLOGY
Enalapril is st