COVERAM 5MG5MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

AMLODIPINE BESILATE; PERINDOPRIL ARGININE

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

AMLODIPINE BESILATE; PERINDOPRIL ARGININE

Units in package:

30Tablet Tablets

Manufactured by:

SERVIER ( IRELAND) INDUSTRIES LTD

Patient Information leaflet

_Consumer Medication Information Leaflet (RIMUP)_
COVERAM TABLET
Perindopril arginine / amlodipine (5mg/5mg, 5mg/10mg, 10mg/5mg &
10mg/10mg)
1
WHAT IS IN THIS LEAFLET
1.
What is Coveram used for
2.
How Coveram works
3.
Before you use Coveram
4.
How to use Coveram
5.
While you are using Coveram
6.
Side effects
7.
Storage
and
Disposal
of
Coveram
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT COVERAM IS USED FOR
Coveram is prescribed for treatment
of high blood pressure (hypertension)
and/or treatment of stable coronary
artery disease (a condition where the
blood supply to the heart is reduced
or blocked).
Patients
already
taking
perindopril
and amlodipine from separate tablets
may
instead
receive
one
tablet
of
Coveram
which
contains
both
ingredients.
HOW
COVERAM WORKS
Coveram
is
a
combination
of
two
active
ingredients,
perindopril
and
amlodipine.
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 COVERAM
-
_When you must not use it _
DO NOT TAKE COVERAM
-
if you are allergic 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 Section 8),
-
if
you
are
more
than
3
months
pregnant (It is also better to avoid
Coveram in early pregnancy – see
pregnancy section),
-
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 diabetes or impaired
kidney function and you are treated
with
a
blood
pressure
lowering
medicine containing
a

Summary of Product characteristics

Final PI_Coveram_16.12.2022
1
1.
NAME OF THE MEDICINAL PRODUCT
Coveram 5mg/5mg tablets
Coveram 5mg/10mg tablets
Coveram 10mg/5mg tablets
Coveram 10mg/10mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.395 mg perindopril equivalent to 5 mg
perindopril arginine and 6.935 mg amlodipine
besilate equivalent to 5 mg amlodipine.
One tablet contains 3.395 mg perindopril equivalent to 5 mg
perindopril arginine and 13.870 mg amlodipine
besilate equivalent to 10 mg amlodipine
One tablet contains 6.790 mg perindopril equivalent to 10 mg
perindopril arginine and 6.935 mg amlodipine
besilate equivalent to 5 mg amlodipine
One
tablet
contains
6.790
mg
perindopril
equivalent to
10
mg
perindopril
arginine
and
13.870 mg
amlodipine besilate equivalent to 10 mg amlodipine
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet engraved with 5/5 on one face and
on the other face.
White, square-shaped tablet engraved with 5/10 on one face and
on the other face.
White, triangular-shaped tablet engraved with 10/5 on one face and
on the other face.
White, round tablet engraved with 10/10 on one face and
on the other face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Coveram is indicated as substitution therapy for treatment of
essential hypertension and/or stable coronary
artery disease, in patients already controlled with perindopril and
amlodipine given concurrently at the same
dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_ _
Oral route.
One tablet per day as a single dose, preferably to be taken in the
morning and before a meal.
The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, the dose of Coveram could be
modified or individual titration with free
combination may be considered.
Final PI_Coveram_16.12.2022
2
_Special populations _
_ _
_Renal impairment and elderly (see sections 4.4 and 5.2) _
Elimination of perindoprilat is decrease