CLOPIDOGREL SANOFI clopidogrel (as hydrogen sulfate) 300 mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

clopidogrel hydrogen sulfate

Beschikbaar vanaf:

Sanofi-Aventis Australia Pty Ltd

INN (Algemene Internationale Benaming):

clopidogrel hydrogen sulfate

Bijsluiter

CLOPIDOGREL SANOFI
1
CLOPIDOGREL SANOFI* TABLETS
_Clopidogrel _
_ _
_ _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Clopidogrel Sanofi
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
Clopidogrel Sanofi, your doctor has
weighed the risks of you taking
Clopidogrel Sanofi against the
expected benefits it will have for
you.
Always follow the instructions that
your doctor and pharmacist give you
about Clopidogrel Sanofi tablets.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING
CLOPIDOGREL SANOFI. YOU MAY WISH
TO KEEP IT TO READ AGAIN.
WHAT IS CLOPIDOGREL
SANOFI USED FOR
CLOPIDOGREL
SANOFI
CONTAINS
THE
MEDICINE CLOPIDOGREL. CLOPIDOGREL
SANOFI 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).
Clopidogrel Sanofi 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
Clopidogrel Sanofi 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.
Clopidogre

Productkenmerken

PRODUCT INFORMATION
CLOPIDOGREL SANOFI -Clopidogrel hydrogen sulfate
clopidogrel-sanofi-ccdsv23-piv12-13sep17
Page 1
PRODUCT INFORMATION
CLOPIDOGREL SANOFI

NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Clopidogrel hydrogen sulfate
CHEMICAL STRUCTURE
Clopidogrel hydrogen sulfate has the following chemical structure:
C
O
O
S
N
H
Cl
,H
2
SO
4
CH
3
Molecular Formula: C
16
H
16
ClNO
2
S.H
2
SO
4
Molecular Weight: 419.9.
Chemical Name: methyl (+)-(S)-
α
-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c] pyridine-5(4H)-
acetate sulfate (1:1)
CAS REGISTRY NUMBER
120202-66-6
(Clopidogrel hydrogen sulfate),
113 665-84-2 (Clopidogrel base)
DESCRIPTION
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,
hyprolose.
The
coating
contains
lactose,
hypromellose,
titanium
dioxide,
glycerol
triacetate, iron oxide red and carnauba wax.
PRODUCT INFORMATION
CLOPIDOGREL SANOFI -Clopidogrel hydrogen sulfate
clopidogrel-sanofi-ccdsv23-piv12-13sep17
Page 2
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
MECHANISM OF ACTION
The
active
metabolite,
a
thiol
derivative,
is
formed
by
oxidation
of
clopidogrel
to
2-
oxoclopidogrel and subsequent hydrolysis. The active metabolite of
clopidogrel selectively
inhibits the binding of ADP to its platelet P2Y
12
.receptor a