PLAVIX TABLET 75MG

Country: Malaysia

Language: English

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

Active ingredient:

CLOPIDOGREL

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

CLOPIDOGREL

Units in package:

14Tablet Tablets

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Patient Information leaflet

_ _
_MY/PLA/0622/CCDSv29,30 _
_ _
_ _
_ _
_ _
_1 _
_ _
_Consumer Medication Information Leaflet (RiMUP)_
PLAVIX
®
_ _
TABLET
_ _
Clopidogrel 75mg & 300mg
_ _
WHAT IS IN THIS LEAFLET
1. What Plavix is used for
2. How Plavix works
3. Before you use Plavix
4. How to use Plavix
5. While you are using it
6. Side effects
7. Storage and Disposal of Plavix
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT PLAVIX IS USED FOR
Plavix
is
taken
by
adult
to
prevent
blood
clots
(thrombi)
forming
in
hardened
blood
vessels
(arteries),
a
process
known
as
atherothrombosis,
which
can
lead
to
atherothrombotic
events (such as stroke, heart attack, or
death).
You
have been
prescribed Plavix
to
help prevent blood clots and reduce the
risk of these severe events because:
- You have a condition of hardening of
arteries
(also
known
as
atherosclerosis), and
- You have previously experienced a
heart attack, stroke or have a condition
known as peripheral arterial disease, or
- You have experienced a severe type
of
chest
pain
known
as
‘unstable
angina’
or
‘myocardial
infarction’
(heart attack). For the treatment of this
condition your doctor may have placed
a
stent
in
the
blocked
or
narrowed
artery to restore effective blood flow.
You mayalso be given acetylsalicylic
acid
(a
substance
present
in
many
medicines
used
to
relieve
pain
and
lower fever as well as to prevent blood
clotting) by your doctor.
-
You have experienced symptoms of a
stroke which go away within a short
period of time (also known as transient
ischemic attack) or an ischemic stroke
mild
in
severity.
You
may
also
be
given
acetylsalicylic
acid
by
your
doctor
starting
within
the
first
24
hours.
- You have an irregular heartbeat, a
condition called 'atrial fibrillation', and
you cannot take medicines known as
'oral
anticoagulants'
(vitamin
K
antagonists) which prevent new clots
from
forming
and
prevent
existing
clots from growing.
You should have been told that 'oral
anticoagulants' are more effective than
acetylsalicylic aci

Summary of Product characteristics

MY/PLA75/0622/CCDSv29, 30
1.
NAME OF THE MEDICINAL PRODUCT
Plavix 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipients with known effect: each film-coated tablet contains 3 mg of
lactose and 3.3 mg of
hydrogenated castor oil.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex, engraved with «75» on one side and «1171»
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_SECONDARY PREVENTION OF ATHEROTHROMBOTIC EVENTS _
Clopidogrel is indicated in:
•
Adult patients suffering from myocardial infarction (from a few days
until less than 35 days),
ischemic stroke (from 7 days until less than 6 months) or established
peripheral arterial disease.
•
Adult patients suffering from acute coronary syndrome:
−
Non-ST
segment
elevation
acute
coronary
syndrome
(unstable
angina
or
non-Q-wave
myocardial infarction), including patients undergoing a stent
placement following percutaneous
coronary intervention, in combination with acetylsalicylic acid (ASA).
−
ST segment elevation acute myocardial infarction, in combination with
ASA in medically treated
patients eligible for thrombolytic therapy.
_IN PATIENTS WITH MODERATE TO HIGH-RISK_ _TRANSIENT ISCHEMIC ATTACK
(TIA) OR MINOR ISCHEMIC STROKE (IS) _
Clopidogrel in combination with ASA is indicated in:
-
Adult patients with moderate to high-risk TIA (ABCD2
1
score ≥4) or minor IS (NIHSS
2
≤3) within
24 hours of either the TIA or IS event.
_PREVENTION OF ATHEROTHROMBOTIC AND THROMBOEMBOLIC EVENTS IN ATRIAL
FIBRILLATION _
In adult patients with atrial fibrillation who have at least one risk
factor for vascular events, are not
suitable for treatment with Vitamin K antagonists (VKA) and who have a
low bleeding risk, clopidogrel
is indicated in combination with ASA for the prevention of
atherothrombotic and thromboembolic events,
including stroke.
For further information please refer to s