PHARMANIAGA ENALAPRIL TABLET 5MG

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

ENALAPRIL MALEATE

Fáanlegur frá:

PHARMANIAGA MANUFACTURING BERHAD

INN (Alþjóðlegt nafn):

ENALAPRIL MALEATE

Einingar í pakka:

250 Tablets; 100 Tablets; 30 Tablets; 10 Tablets

Framleitt af:

PHARMANIAGA MANUFACTURING BERHAD

Upplýsingar fylgiseðill

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
PHARMANIAGA ENALAPRIL TABLET
Enalapril maleate (5mg/ 20mg)
1
WHAT IS IN THIS LEAFLET
1.
What Pharmaniaga Enalapril
Tablet is used for
2.
How Pharmaniaga Enalapril
Tablet works
3.
Before you use Pharmaniaga
Enalapril Tablet
4.
How to use Pharmaniaga Enalapril
Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Pharmaniaga Enalapril Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT PHARMANIAGA ENALAPRIL
TABLET IS USED FOR
Pharmaniaga Enalapril Tablet is
used to treat:
•
High blood pressure – also
called hypertension.
•
Heart failure – where the heart
has difficulty pumping blood
around your body
•
The signs of heart failure. The
signs include: shortness of
breath, tiredness after light
physical activity such as
walking, or swelling of the
ankles and feet.
HOW PHARMANIAGA ENALAPRIL
TABLET WORKS
Pharmaniaga Enalapril Tablet works
by widening your blood vessels. This
lowers your blood pressure. It also
makes it easier for your heart to pump
blood around your body.
BEFORE YOU USE PHARMANIAGA
ENALAPRIL TABLET
-_When you must not use it_
•
You have ever had an allergic
reaction
with
swelling
of
the
face, lips, tongue or throat with
difficulty in swallowing or
•
breathing.
•
You
think
you
are
(or
might
become) pregnant, Pharmaniaga
Enalapril
Tablet
is
not
recommended in early pregnancy,
and must not be taken if you are
more than 3 months pregnant, as
it may cause serious harm to your
baby if used at that stage.
_- Before you start to use it _
Check with your doctor or
pharmacist before taking your
medicine if:
•
You have a heart problem.
•
You have a condition involving
the blood vessels in the brain.
•
You have a blood problem such
as low or lack of white blood
cells (neutropenia/
agranulocytosis), low blood
platelet count (thrombocytopenia)
or a decreased number of red blood
cells (anaemia).
•
You have a liver problem.
•
You have a kidney problem
(including kidney

Vara einkenni

ENALAPRIL
_ _
_ _
_ _
COMPOSITION
_PHARMANIAGA ENALAPRIL TABLET 5 MG _
Each tablet contains Enalapril maleate 5 mg.
_PHARMANIAGA ENALAPRIL TABLET 20 MG _
Each tablet contains Enalapril maleate 20 mg.
ACTIONS
Enalapril after hydrolysis to enalaprilat, inhibits angiotensin-
converting enzyme (ACE) in human subjects and animals.
ACE is a peptidyl dipeptidase that catalyses the conversion of
angiotensin I to the vasoconstrictor substance, angiotensin ll.
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 ll,
which
leads
to
decreased
vasopressor
activity
and
to
decreased aldosterone secretion.
While the mechanism through which enalapril lowers blood
pressure is believed to be primarily suppression of the renin-
angiotensin-aldosterone system, enalapril is antihypertensive
even in patients with low-renin hypertension.
Following oral administration of enalapril maleate peak serum
concentrations of enalapril occur within about one hour. Based
on urinary recovery, the extent of absorption of enalapril is
approximately 60%. Enalapril absorption is not influenced by
the presence of food in the gastrointestinal tract. Following
absorption, enalapril is hydrolysed to enalaprilat, which is a
more
potent
angiotensin
converting
enzyme
inhibitor
than
enalapril; enalaprilat is poorly absorbed when administered
orally.
Peak serum concentrations of enalaprilat occur three to four
hours after an oral dose of enalaprilat maleate. Excretion of
enalapril maleate is primarily renal. Approximately 94% of the
dose is recovered in the urine and faeces as enalaprilat or
enalapril. The principal components in urine are enalaprilat,
accounting for about 40% of the dose, and intact enalapril.
There is no evidence of metabolites of enalapril, other than
enalaprilat. Enalaprilat is 50 to 60% bound to plasma p