Euvalcor (40mg Atorvastatin / 5mg Perindopril) hard capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ATORVASTATIN CALCIUM TRIHYDRATE; PERINDOPRIL ARGININE

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

ATORVASTATIN CALCIUM TRIHYDRATE; PERINDOPRIL ARGININE

Unit dalam pakej:

30 Capsules

Dikeluarkan oleh:

LES LABORATOIRES SERVIER INDUSTRIE

Risalah maklumat

_Consumer Medication Information Leaflet (RIMUP)_
EUVALCOR HARD CAPSULES
Atorvastatin / Perindopril arginine (10mg/5mg, 20mg/5mg, 40mg/5mg,
10mg/10mg, 20mg/10mg & 40mg/10mg)
1
WHAT IS IN THIS LEAFLET
1.
What is Euvalcor used for
2.
How Euvalcor works
3.
Before you use Euvalcor
4.
How to use Euvalcor
5.
While you are using Euvalcor
6.
Side effects
7.
Storage
and
Disposal
of
Euvalcor
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT EUVALCOR IS USED FOR
Euvalcor
is
intended
for
adult
patients
already
on
treatment
with
atorvastatin and perindopril arginine
as
single
tablets
as
part
of
cardiovascular
risk
management.
Instead
of
taking
atorvastatin
and
perindopril arginine as single tablets
you
will
receive
one
capsule
of
Euvalcor
which
contains
the
two
active
ingredients
in
the
same
strength.
You
should
maintain
a
standard
cholesterol
lowering
diet
during
treatment.
HOW
EUVALCOR WORKS
Euvalcor
contains
two
active
ingredients,
atorvastatin
and
perindopril arginine in one capsule.
Atorvastatin belongs to a group of
medicines known as statins, which
are lipid (fat) regulating medicines.
Atorvastatin is used to lower lipids
known
as
cholesterol
and
triglycerides
in
the
blood
when
a
low-fat diet and life style changes on
their own have failed. If you are at an
increased
risk
of
heart
disease,
atorvastatin
can
also
be
used
to
reduce
such
risk
even
if
your
cholesterol levels are normal.
Perindopril arginine is an angiotensin
converting enzyme (ACE) inhibitor.
In patients with high blood pressure,
it
works
by
widening
the
blood
vessels,
which
makes
it
easier
for
your heart to pump blood through
them.
BEFORE YOU USE EUVALCOR
-
_When you must not use it _
DO NOT TAKE EUVALCOR
-
if you are allergic to atorvastatin
or to any similar medicines used
to
lower
blood
lipids,
to
perindopril
or
any
other
ACE
inhibitor, or to any of the other
ingredients of this medicine,
-
if
you
have
a
disease
which
affects the liver,
-
if
you
have
any
unexplained
abnormal
blood
tests
fo

Ciri produk

1
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Euvalcor 10 mg/5 mg, hard capsules
Euvalcor 20 mg/5 mg, hard capsules
Euvalcor 40 mg/5 mg, hard capsules
Euvalcor 10 mg/10 mg, hard capsules
Euvalcor 20 mg/10 mg, hard capsules
Euvalcor 40 mg/10 mg, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10.82 mg atorvastatin calcium trihydrate
equivalent to 10 mg atorvastatin, 5 mg
perindopril arginine equivalent to 3.395 mg perindopril
Each hard capsule contains 21.64 mg atorvastatin calcium trihydrate
equivalent to 20 mg atorvastatin, 5 mg
perindopril arginine equivalent to 3.395 mg perindopril
Each hard capsule contains 43.28 mg atorvastatin calcium trihydrate
equivalent to 40 mg atorvastatin, 5 mg
perindopril arginine equivalent to 3.395 mg perindopril
Each hard capsule contains 10.82 mg atorvastatin calcium trihydrate
equivalent to 10 mg atorvastatin, 10 mg
perindopril arginine equivalent to 6.79 mg perindopril
Each hard capsule contains 21.64 mg atorvastatin calcium trihydrate
equivalent to 20 mg atorvastatin, 10 mg
perindopril arginine equivalent to 6.79 mg perindopril
Each hard capsule contains 43.28 mg atorvastatin calcium trihydrate
equivalent to 40 mg atorvastatin, 10 mg
perindopril arginine equivalent to 6.79 mg perindopril
Excipient with known effect: sucrose (33.9 mg for Euvalcor 10/5 mg,
46.8 mg for Euvalcor 20/5 mg, 72.6 mg
for Euvalcor 40/5 mg, 54.9 mg for Euvalcor 10/10 mg, 67.8 mg for
Euvalcor 20/10 mg, 93.6 mg for Euvalcor
40/10 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard
Euvalcor 10/5 mg: Size 2 hard gelatin capsule, with black imprint
“10 5” on light blue body and black imprint
“
” on light blue cap, containing white to slightly white spherical
pellets.
Euvalcor 20/5 mg: Size 2 hard gelatin capsule, with black imprint
“20 5” on light blue body and black imprint
“
” on blue cap, containing white to slightly white spherical pellets.
Euvalcor 40/5 mg: Size 2 hard gelatin capsule, with black imprint
“40 5” on