PLAVIX 75 mg Tablet

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

SANOFI-SYNTHELABO (PTY) LTD

Pharmaceutical form:

Tablet

Composition:

Each tablet contains CLOPIDOGREL HYDROGEN SULPHATE equivalent to CLOPIDOGREL 75,0 mg

Authorization date:

2004-06-02

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S3
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
PLAVIX
® 75 MG Film-coated tablets
Clopidogrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PLAVIX.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

PLAVIX has been prescribed for you personally and you should not share
your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT PLAVIX CONTAINS:
The active substance is clopidogrel.
Each film-coated tablet contains clopidogrel hydrogen sulphate (form
II) equivalent to 75 mg of
the clopidogrel base.
The other inactive ingredients are mannitol (sugar), hydrogenated
castor oil, microcrystalline
cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in
the tablet core, and
lactose (milk sugar), hypromellose, triacetin, red iron oxide (E172),
titanium dioxide (E171) and
carnauba wax in the tablet coating.
WHAT PLAVIX IS USED FOR:
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You have been prescribed PLAVIX to help prevent blood clots and reduce
the risk of these 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). In this case you should also 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.
BEFORE YOU TAKE PLAVIX:
DO NOT TAKE PLAVIX:

if you are hypersensitive (allergic) to the active ingredient
clopidogrel or to any of the other
ingredients of PLAVIX.

if you are hypersensitive (allergic) to other anti-platelet medicines
called thienopyridine (such
as ticlopidine, prasugrel), used to prevent blood clots.

if you have a medical condition that

Summary of Product characteristics

1
SCHEDULING STATUS:
S3
PROPRIETARY NAME AND DOSAGE FORM:
PLAVIX® 75 MG FILM-COATED TABLETS
COMPOSITION:
Each film-coated tablet contains:
Clopidogrel hydrogen sulphate (form II) equivalent to 75 mg of
clopidogrel base.
Inactive excipients: Mannitol (sugar), hydrogenated castor oil,
microcrystalline cellulose,
macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet
core, and lactose (milk
sugar), hypromellose, triacetin, red iron oxide (E172), titanium
dioxide (E171), and carnauba
wax in the tablet coating.
Contains sugar and lactose monohydrate.
CATEGORY AND CLASS:
A 8.2 Anticoagulants
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
Clopidogrel is a specific and potent inhibitor of platelet
aggregation.
Clopidogrel selectively inhibits the binding of adenosine diphosphate
(ADP) to its platelet
receptor, and the subsequent ADP-mediated activation of the
glycoprotein GPIIb/IIIa complex,
thereby inhibiting platelet aggregation. Biotransformation of
clopidogrel is necessary to produce
2
inhibition of platelet aggregation. However, an active metabolite
responsible for the activity of
the drug has not been isolated.
Clopidogrel also inhibits platelet aggregation induced by other
agonists by blocking the
amplification of platelet activation by released ADP. Clopidogrel acts
by irreversibly modifying
the platelet ADP receptor. Consequently, platelets exposed to
clopidogrel are affected for the
remainder of their lifespan and recovery of normal platelet function
occurs at a rate consistent
with platelet turnover (approximately 7 days).
Dose-dependent inhibition of platelet aggregation was noted 2 hours
after single oral doses of
clopidogrel.
Repeated doses of 75 mg per day produced inhibition of ADP-induced
platelet aggregation from
the first day; this increased progressively and reached steady state
between Day 3 and Day 7.
At steady state, the average inhibition level observed with a dose of
75 mg per day was
between 40 % and 60 %. Platelet aggregation and bleeding time
gradually returned to baselin