Perinace Tablet 4 mg

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

PERINDOPRIL ERBUMINE

MAH:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN:

PERINDOPRIL ERBUMINE

units_in_package:

30 Tablets; 100 Tablets

manufactured_by:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

PIL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
PERINACE TABLET
Perindopril erbumine (4mg, 8mg)
Page 1 of 5
WHAT IS IN THIS LEAFLET
1.
What PERINACE TABLET is
used for
2.
How PERINACE TABLET works
3.
Before you take PERINACE
TABLET
4.
How to take PERINACE
TABLET
5.
While you are taking PERINACE
TABLET
6.
Side effects
7.
Storage and Disposal of
PERINACE TABLET
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT PERINACE TABLET IS USED
FOR
Perinace is an angiotensin converting
enzyme (ACE) inhibitor.
Perinace is used:
- to treat arterial hypertension,
- to treat heart failure (when the heart
is
unable
to pump
enough blood
to
meet the body’s needs),
- to reduce the risk of cardiac events,
such as heart attack, in patients with
stable
coronary
artery
disease
(a
condition where the blood supply to
the heart is reduced or blocked) and
who have already had a heart attack
and/or
an
operation
to
improve
the
blood supply to the heart by widening
the vessels that supply it.
HOW PERINACE TABLET WORKS
Perindopril
belongs
to
a
class
of
medicines
called
ACE
inhibitors.
These
work
by
widening
the
blood
vessels, which makes it easier for your
heart to pump blood through them.
BEFORE YOU TAKE PERINACE
TABLET
-
_When you must not take it _
_ _
DO NOT TAKE PERINACE
-
if you are allergic (hypersensitive)
to perindopril or any of the other
ingredients of this medicine, or to
any other ACE inhibitor.
-
if you have experienced symptoms
such as wheezing, swelling of the
face,
tongue
or
throat,
intense
itching or severe skin rashes with
previous ACE inhibitor treatment
or if you or a member of your
family have had these symptoms
in
any
other
circumstances
(a
condition called angioedema).
-
if
you
are
more
than 3
months
pregnant (It is also better to avoid
Perinace in early pregnancy – see
pregnancy section).
-
if you have diabetes or impaired
kidney
function
and
you
are
treated
with
a
blood
pressure
lowering
medicine
containing
aliskiren.
-
if you are having dialysis

SPC

Page 1 of 10
PERINACE TABLET
DESCRIPTION & COMPOSITION
PERINACE TABLET 4MG
An oblong shape, scored, white to off-white tablet
Each tablet contains 4 mg of perindopril erbumine.
PERINACE TABLET 8MG
A white oval biconvex shape tablet, plain on one side and score line
on the other side.
The tablet can be divided into equal halves.
Each tablet contains 8 mg of perindopril erbumine.
PHARMACODYNAMICS
Pharmacotherapeutic group: ACE inhibitor, plain, ATC code: C09A A04
MECHANISM OF ACTION
Perindopril is an inhibitor of the enzyme that converts angiotensin I
into angiotensin II (Angiotensin Converting Enzyme ACE). The
converting
enzyme, or kinase, is an exopeptidase that allows conversion of
angiotensin I into the vasoconstrictor angiotensin II as well as
causing the
degradation of the vasodilator bradykinin into an inactive
heptapeptide. Inhibition of ACE results in a reduction of angiotensin
II in the plasma,
which leads to increased plasma renin activity (by inhibition of the
negative feedback of renin release) and reduced secretion of
aldosterone. Since
ACE inactivates bradykinin, inhibition of ACE also results in an
increased activity of circulating and local kallikrein-kinin systems
(and thus also
activation of the prostaglandin system).
It is possible that this mechanism contributes to the blood
pressure-lowering action of ACE inhibitors and is partially
responsible for certain of their
side effects (e.g., cough).
Perindopril acts through its active metabolite, perindoprilat. The
other metabolites show no inhibition of ACE activity in vitro.
CLINICAL EFFICACY AND SAFETY
Hypertension:
Perindopril is active in all grades of hypertension: mild, moderate,
severe; a reduction in systolic and diastolic blood pressures in both
supine and
standing positions is observed.
Perindopril reduces peripheral vascular resistance, leading to blood
pressure reduction. As a consequence, peripheral blood flow increases,
with
no effect on heart rate.
Renal blood flow increases as a rule, while the glomerular filtration
rate (GFR) is usu