COVERSYL OD 5MG, orodispersible tablets

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

PERINDOPRIL ARGININE

Inapatikana kutoka:

SERVIER MALAYSIA SDN BHD

INN (Jina la Kimataifa):

PERINDOPRIL ARGININE

Vitengo katika mfuko:

30tablet Tablets

Viwandani na:

SERVIER ( IRELAND) INDUSTRIES LTD

Taarifa za kipeperushi

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
COVERSYL 2.5MG & 5MG ORODISPERSIBLE TABLETS
_Perindopril Arginine (2.5mg, 5mg) _
WHAT IS IN THIS LEAFLET
1.
What Coversyl is used for
2.
How Coversyl works
3.
Before you use Coversyl
4.
How to use Coversyl
5.
While you are using Coversyl
6.
Side effects
7.
Storage
and
Disposal
of
Coversyl
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT COVERSYL IS USED FOR
Coversyl is used:
•
to
treat
_high _
_blood _
_pressure_
(hypertension),
•
to treat
_heart failure_
(a condition
where 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 COVERSYL WORKS
Coversyl is an angiotensin converting
enzyme (ACE) inhibitor. These work
by widening the blood vessels, which
makes it easier for your heart to pump
blood through them.
BEFORE YOU USE COVERSYL
-
_When you must not take Coversyl _
DO NOT TAKE COVERSYL
•
if you are allergic to perindopril,
or any of the other ingredients of
this medicine (listed in Section 8)
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
Coversyl in early pregnancy (see
section
‘Pregnancy
and
breast-
feeding’),
•
if you have diabetes mellitus or
kidney
problems
and
you
are
treated with aliskiren.
•
if you are having dialysis or any
other
type
of
blood
filtration.
Depending on the machine that is
used,

Tabia za bidhaa

Final _PI_Coversyl OD_5mg_ 05.06.2019 1
COVERSYL ® OD 5 mg
orodispersible tablets
1. NAME OF THE MEDICINAL PRODUCT
Coversyl OD 5 mg orodispersible tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One orodispersible tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine.
Excipients with known effect: 62.73 mg lactose, 0.2 mg aspartame.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Orodispersible tablet.
White, round tablet.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Hy pertension
Treatment of h ypertension.
Heart failure
Treatment of symptomatic heart failure.
Stable coronary artery disease
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or
revascularisation.
4.2 Posology and met hod of administration
Posology
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure
response.
Hypertension
Coversyl may be used in monotherapy or in combination with other classes of antihypertensive the rapy
(see sections 4.3, 4.4, 4.5 and 5.1) .
The recommended starting dose is 5 mg given once daily in the morning.
Patients with a strongly activated renin -angiotensin -aldosterone system (in particular, renovascular
hypertension, salt and/or volume depletio n, cardiac decompensation or severe hypertension) may
experience an excessive drop in blood pressure following the initial dose. A starting dose of 2.5 mg is
recommended in such patients and the initiation of treatment should take place under medical supe rvision.
The dose may be increased to 10 mg once daily after one month of treatment.