Viacoram 7mg5mg tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PERINDOPRIL ARGININE; AMLODIPINE BESILATE

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

PERINDOPRIL ARGININE; AMLODIPINE BESILATE

Unit dalam pakej:

10 Tablets; 30 Tablets

Dikeluarkan oleh:

SERVIER ( IRELAND) INDUSTRIES LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
VIACORAM TABLETS_ _
_Perindopril arginine/amlodipine _
_3.5mg/2.5mg, 7mg/5mg _
WHAT IS IN THIS LEAFLET
1.
What VIACORAM is used for
2.
How VIACORAM works
3.
Before you use VIACORAM
4.
How to use VIACORAM
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
VIACORAM
8.
Product description
9.
Manufacturer
and
Product
registration holder
10. Date of revision
WHAT VIACORAM IS USED FOR
VIACORAM is a combination of two
active
ingredients,
perindopril
and
amlodipine. Both of these substances
help
to
control
your
high
blood
pressure.
VIACORAM is used to treat mild to
moderate
high
blood
pressure
(hypertension) in adults.
HOW VIACORAM WORKS
Perindopril
is
an
ACE
(Angiotensin
Converting
Enzyme)
inhibitor.
Amlodipine
is
a
calcium
antagonist
(which belongs to a class of medicines
called dihydropyridines). Together they
work
to
widen
and
relax
the
blood
vessels so that blood passes through
them more easily and makes it easier
for your heart to maintain a good blood
flow.
BEFORE YOU USE VIACORAM
_When you must not use it_
_DO NOT TAKE VIACORAM_:
-
if you are allergic (hypersensitive) to
perindopril
or
any
other
ACE
inhibitor, or to amlodipine or any
other calcium antagonists, or any of
the other ingredients of this medicine
(listed in ingredients section),
-
if you have severe kidney problems,
-
if you have experienced symptoms
such as wheezing, swelling of the
face
or
tongue,
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 have narrowing of the aortic
heart
valve
(aortic
stenosis)
or
cardiogenic shock (a condition where
your
heart
is
unable
to
supply
enough blood to the body),
-
if you have severe low blood pressure
(hypotension),
-
if you suffer from heart failure after a
heart attack,
-
if
you
are
more
than
3
months
pregnant (it is also better to avoid
VIACORAM in early pregnancy –
see pregnancy sec

Ciri produk

Proposed_PI_Viacoram_22.12.2022
1
1.
NAME OF THE MEDICINAL PRODUCT
Viacoram 3.5 mg/2.5 mg tablets
Viacoram 7 mg/5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Viacoram 3.5 mg/2.5 mg tablets: One tablet contains 2.378 mg
perindopril equivalent to 3.5 mg perindopril
arginine and 3.4675 mg amlodipine besilate equivalent to 2.5 mg
amlodipine.
Excipient with known effect: 31.62 mg lactose monohydrate.
Viacoram 7 mg/5 mg tablets: One tablet contains 4.756 mg perindopril
equivalent to 7 mg perindopril
arginine and 6.935 mg amlodipine besilate equivalent to 5 mg
amlodipine
Excipient with known effect: 63.23 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Viacoram 3.5 mg/2.5 mg tablets: White, round tablet, 5 mm diameter.
Viacoram 7 mg/5 mg tablets: White, round tablet, 6 mm diameter,
engraved with
on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Viacoram is indicated for the treatment of mild to moderate essential
hypertension in patients for whom
combination therapy is appropriate.
Viacoram
3.5mg/2.5mg
is
indicated
for
initial
therapy
in
patients
with
mild
to
moderate
essential
hypertension.
Viacoram is
not
indicated
for switching therapy
from
the
individual
drugs
currently on
the
market
(perindopril as erbumine or arginine salt, amlodipine).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Oral use.
Viacoram 3.5 mg/2.5 mg is intended for initial therapy in patients
with mild to moderate essential
hypertension.
The recommended starting dose of Viacoram is 3.5 mg/2.5 mg once daily.
After at least four weeks of treatment, the dose may be increased to 7
mg/5 mg once daily in patients whose
blood pressure is not adequately controlled with Viacoram 3.5 mg/2.5
mg.
Proposed_PI_Viacoram_22.12.2022
2
_SPECIAL POPULATIONS _
_ _
_Patients with renal impairment (see sections 4.3, 4.4 and 5.2) _
Viacoram is contraindicated in patients with severe renal impairment
(Creatinine clearance below 30 ml/min)
(see section 4.3).
In patients with moderate ren