CoPlavix 75100mg Film-Coated Tablet

Country: Malaysia

Language: English

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

Active ingredient:

CLOPIDOGREL HYDROGEN SULPHATE; ACETYLSALICYLIC ACID

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

CLOPIDOGREL HYDROGEN SULPHATE; ACETYLSALICYLIC ACID

Units in package:

14tablet Tablets; 28tablet Tablets; 30tablet Tablets

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
_ _
MY/COP/0822/SmPC1121
COPLAVIX
® 75/100 MG FILM-COATED TABLETS
_ _
Clopidogrel (75 mg) / Acetylsalicylic acid (100 mg)
_ _
WHAT IS IN THIS LEAFLET
1.
What CoPlavix is used for
2.
How CoPlavix works
3.
Before you use CoPlavix
4.
How to take CoPlavix
5.
While you are using CoPlavix
6.
Side effect
7.
Storage and Disposal of CoPlavix
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT COPLAVIX IS USED FOR
CoPlavix is taken by adult to prevent
blood clots forming in hardened arteries
which
can
lead
to
atherothrombotic
events (such as stroke, heart attack, or
death).You
have
been
prescribed
CoPlavix in place of the two separate
medicines, clopidogrel and ASA, to help
prevent blood clots because you have
experienced a severe type of chest pain
known
as
‘unstable
angina’
or
heart
attack (myocardial infarction). For the
treatment of this condition your doctor
may have placed a stent in the blocked
or narrowed artery to restore effective
blood flow.
HOW COPLAVIX WORKS
CoPlavix
contains
clopidogrel
and
acetylsalicylic
acid
(ASA)
and
belongs to a group of medicines called
antiplatelet medicinal products. Platelets
are very small structures in the blood
which
clump
together
during
blood
clotting. By preventing this clumping in
some
types
of
blood
vessels
(called
arteries), antiplatelet medicinal products
reduce
the
chances
of
blood
clots
forming
(a
process
called
atherothrombosis).
BEFORE YOU USE COPLAVIX
-_WHEN YOU MUST NOT USE IT _
DO NOT TAKE COPLAVIX:
•
If you are allergic (hypersensitive)
to clopidogrel, acetylsalicylic acid
(ASA)
or
any
of
the
other
ingredients of CoPlavix.
•
If you are allergic to other products
called
non-steroidal
anti-
inflammatory
products
usually used to treat painful and/or
inflammatory
conditions
of
muscles or joints.
•
If you have a medical condition that
include the combination of asthma,
nasal
discharge
(runny
nose)
and
polyps
(a
type
of
growth
in
the
nose).
•
If you have a medica

Summary of Product characteristics

MY/COP/0722/CCDSv21
NAME OF THE MEDICINAL PRODUCT
CoPlavix 75 mg/100 mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 100 mg of
acetylsalicylic acid (ASA).
Excipients with known effect: Each film-coated tablet contains 8 mg of
lactose and 3.3 mg of
hydrogenated castor oil.
For a full list of excipients, see _list of excipients_.
PHARMACEUTICAL FORM
Film-coated tablet.
Light pink, oval, slightly biconvex, engraved with «C75» on one side
and «A100» on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
CoPlavix is indicated for the secondary prevention of atherothrombotic
events in adult patients already
taking both clopidogrel and acetylsalicylic acid (ASA). CoPlavix is a
fixed-dose combination medicinal
product for continuation of therapy in:
•
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
•
ST segment elevation acute myocardial infarction in medically treated
patients eligible for
thrombolytic therapy
For further information please refer to _Pharmacodynamic properties_.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
•
Adults and elderly:
CoPlavix should be given as a single daily 75 mg/100 mg dose.
CoPlavix fixed-dose combination is used following initiation of
therapy with clopidogrel and ASA given
separately, and replaces the individual clopidogrel and ASA products.
-
_In patients with non-ST segment elevation acute coronary syndrome_
(unstable angina or non-
Q-wave myocardial infarction): The optimal duration of treatment has
not been formally
established. Clinical trial data support use up to 12 months, and the
maximum benefit was
seen at 3 months (see Pharmacodynamic properties). If the use of
CoPlavix is discontinued,
patients may benefit with continuation of one antiplatelet medicinal
product.
-
_In patients with ST segment elevation acute myoca