Ramtace Tablet 5mg

Land: Malaysia

Språk: engelsk

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

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Preparatomtale Preparatomtale (SPC)
05-09-2016

Aktiv ingrediens:

RAMIPRIL

Tilgjengelig fra:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (International Name):

RAMIPRIL

Enheter i pakken:

500tablet Tablets; 30tablet Tablets; 1000tablet Tablets; 100tablet Tablets

Produsert av:

Y.S.P. INDUSTRIES (M) SDN BHD

Informasjon til brukeren

                                _Consumer Medication Information Leaflet (RiMUP) _
1 | P a g e
RAMTACE TABLET
Ramipril 5mg & 10mg
WHAT IS IN THIS LEAFLET
This leaflet contains information below:
1.
What RAMTACE TABLET is used
for.
2.
How RAMTACE TABLET works
3.
Instructions
before
you
use
RAMTACE TABLET.
4.
How to take RAMTACE TABLET.
5.
Instruction
while
you
are
using
RAMTACE TABLET
6.
Side effects
7.
Storage and disposal of RAMTACE
TABLET
8.
Product description
9.
MAL No.
10.
Address of Manufacturer
11.
Address
of
Product
Registration
Holder
WHAT RAMTACE TABLET
IS USED FOR
RAMTACE TABLET is used to treat high
blood pressure (hypertension) and treat the
heart when it cannot pump enough blood to
the rest of the body (congestive heart failure).
It is used as treatment following heart attack
(myocardial
infarction)
complicated
with
heart failure and to reduce the risk of having
a
heart
attack
or
stroke.
It
is
used
for
prevention of worsening of kidney problems
in
patients
with
persistent
proteinuria
(presence of excess protein in urine).
HOW RAMTACE TABLET
WORKS
RAMTACE
TABLET
is
an
ACE
(angiotensin-converting
enzyme)
Inhibitor.
RAMTACE
TABLET
prevents
the
ACE
enzyme from converting the angiotensin 1 to
angiotensin II. This action also prevents the
breakdown of bradykinin. These inhibition
results in a direct relaxant effect on blood
vessels and therefore reducing the blood
pressure.
BEFORE YOU USE RAMTACE TABLET
WHEN YOU MUST NOT TAKE IT
When
you
are
allergic
to
RAMTACE
TABLET or any other ingredient listed at the
end of this leaflet. Please avoid taking this
medication
if
you
have
any
kidney
impairment, liver impairment or if you are
pregnant.
BEFORE YOU START TO TAKE IT
Tell your doctor if you are allergic to any
other medicines or have any other medical
conditions.
TAKING OTHER MEDICINES
Tell your doctor if you are taking any other
medication. Interaction with other
medications.
•Potassium: hyperkalaemia may occur;
therefore close monitoring of serum
potassium is required.
• Sparing diuretic and other
antihypertensive medications: may dec
                                
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Preparatomtale

                                RAMTACE
TABLET
INGREDIENT(S):
Ramtace Tablet 10mg
Each tablet contains:
Ramipril
.......................................................................................................
10mg
Ramtace Tablet 5mg
Each tablet contains:
Ramipril
.........................................................................................................
5mg
PHARMACOLOGY
(SUMMARY
OF
PHARMACODYNAMIC
AND
PHARMACOKINETIC):
PHARMACODYNAMIC:
_Mechanism of action_
Ramiprilat, the active metabolite of the prodrug ramipril, inhibits
the enzyme
dipeptidylcarboxypeptidase
I
(synonyms:
angiotensin-converting
enzyme;
kininase
II
). In plasma and tissue this enzyme catalyses the conversion of
angiotensin
I
to the active vasoconstrictor substance angiotensin
II
, as well as
the breakdown of the active vasodilator bradykinin. Reduced
angiotensin
II
formation and inhibition of bradykinin breakdown lead to vasodilation.
Since
angiotensin
II
also stimulates the release of aldosterone, ramiprilat causes a
reduction in aldosterone secretion. The average response to ACE
inhibitor
monotherapy was lower in black (Afro-Caribbean) hypertensive patients
(usually
a low-renin hypertensive population) than in non-black patients.
_Pharmacodynamic effects_
_Antihypertensive properties:_
Administration of ramipril causes a marked reduction in peripheral
arterial
resistance. Generally, there are no major changes in renal plasma
flow and
glomerular filtration rate. Administration of ramipril to patients
with hypertension
leads to a reduction in supine and standing blood pressure without a
compensa-
tory rise in heart rate. In most patients the onset of the
antihypertensive effect of
a single dose becomes apparent 1 to 2 hours after oral administration.
The peak
effect of a single dose is usually reached 3 to 6 hours after oral
administration.
The antihypertensive effect of a single dose usually lasts for 24
hours. The
maximum antihypertensive effect of continued treatment with ramipril
is generally
apparent after 3 to 4 weeks. It has been shown that the
a
                                
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