PIL
PLAVIX
®
TABLETS
_Clopidogrel_
CONSUMER MEDICINE INFORMATION
Please read this leaflet carefully before you start taking Plavix. You
may wish to keep it to read again.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Plavix tablets.
It does not contain all the available
information. Some of the information
it contains may not apply to you.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. In deciding to give you Plavix,
your doctor has weighed the risks of
you taking Plavix against the
expected benefits it will have for
you.
Always follow the instructions that
your doctor and pharmacist give you
about Plavix tablets.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT IS PLAVIX USED
FOR
PLAVIX CONTAINS THE MEDICINE
CLOPIDOGREL. PLAVIX BELONGS TO A
GROUP OF MEDICINES CALLED ANTI-
PLATELET MEDICINES.
Platelets are very small blood cells
which clump together during blood
clotting. By preventing this
clumping, anti-platelet medicines
reduce the chances of blood clots
forming (a process called
thrombosis).
Plavix is used to prevent blood clots
forming in hardened blood vessels (a
process known as atherothrombosis)
which can lead to events such as
stroke, heart attack or death.
You may have been prescribed
Plavix to help prevent blood clots
forming and to reduce the risk of
stroke, heart attack and death
because:
•
YOU HAVE PREVIOUSLY SUFFERED A
HEART ATTACK, STROKE OR HAVE A
CONDITION KNOWN AS PERIPHERAL
ARTERIAL DISEASE (LEG PAIN ON
WALKING OR AT REST).
•
YOU HAVE SUFFERED ACUTE
CORONARY SYNDROME (EITHER A
SEVERE TYPE OF CHEST PAIN CALLED
UNSTABLE ANGINA, OR A HEART
ATTACK). IN THIS CASE YOU MAY
ALSO BE PRESCRIBED ASPIRIN.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
Plavix is only available on a doctor's
prescription.
BEFORE YOU TAKE PLAVIX
_WHEN YOU MUST NOT TAKE IT_
YOU SHOULD NOT TAKE PLAVIX IF:
•
YOU ARE ALLE
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SPC
plavix-ccdsv17piv11-31may13
1
PRODUCT INFORMATION
PLAVIX
NAME OF THE MEDICINE
PLAVIX
Clopidogrel hydrogen sulfate
DESCRIPTION
Clopidogrel hydrogen sulfate is designated chemically as methyl (+)-(S)-
-(2-chlorophenyl)-6,7-
dihydrothieno[3,2-c] pyridine-5(4H)-acetate sulfate (1:1).
The empirical formula of clopidogrel hydrogen sulfate is C
16
H
16
ClNO
2
S.H
2
SO
4
and its molecular
weight is 419.9.
Clopidogrel hydrogen sulfate has the following chemical structure:
_ _
C O
O
S
N
H
Cl
,H
2
SO
4
CH
3
CAS Number:
120202-66-6 (Clopidogrel hydrogen sulfate),
113 665-84-2 (Clopidogrel base).
Clopidogrel hydrogen sulfate is a white to off-white powder. It is practically insoluble in water at
neutral pH but freely soluble at pH 1. It is freely soluble in methanol, sparingly soluble in
methylene chloride and is practically insoluble in ethyl ether. It has a specific optical rotation of
about + 56
.
Each tablet contains mannitol, macrogol 6000, microcrystalline cellulose, hydrogenated castor
oil, hydroxypropylcellulose. The coating contains lactose, hypromellose, titanium dioxide,
glycerol triacetate, iron oxide red and carnauba wax.
PHARMACOLOGY
PHARMACODYNAMICS
Clopidogrel is a specific and potent inhibitor of platelet aggregation. Platelets have an
established role in the pathophysiology of atherosclerotic disease and thrombotic events. Long
term use of anti-platelet drugs has shown consistent benefit in the prevention of ischaemic
stroke, myocardial infarction and vascular death in patients at increased risk of such outcomes,
including those with
established atherosclerosis or a history of atherothrombosis.
The active metabolite, a
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