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

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

clopidogrel hydrogen sulfate

Disponible desde:

Sanofi-Aventis Australia Pty Ltd

Designación común internacional (DCI):

clopidogrel hydrogen sulfate

Información para el usuario

CLOPIDOGREL WINTHROP
®
TABLETS
_Clopidogrel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Clopidogrel
Winthrop 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 Winthrop, your doctor
has weighed the risks of you taking
Clopidogrel Winthrop against the
expected benefits it will have for
you.
Always follow the instructions that
your doctor and pharmacist give you
about Clopidogrel Winthrop 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
WINTHROP. YOU MAY WISH TO KEEP IT
TO READ AGAIN.
WHAT IS CLOPIDOGREL
WINTHROP USED FOR
CLOPIDOGREL WINTHROP CONTAINS THE
MEDICINE CLOPIDOGREL. CLOPIDOGREL
WINTHROP 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 Winthrop 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 Winthrop 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.
Clopidogrel Wint

Ficha técnica

PRODUCT INFORMATION
CLOPIDOGREL WINTHROP -Clopidogrel hydrogen sulfate
clopidogrel-winthrop-ccdsv23-piv12-13sep17
Page 1
TITLE PAGE
PRODUCT INFORMATION
CLOPIDOGREL WINTHROP

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)-

-(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 WINTHROP -Clopidogrel hydrogen sulfate
clopidogrel-winthrop-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 plat