PLAVIX clopidogrel (as hydrogen sulfate) 75 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clopidogrel hydrogen sulfate

Available from:

Sanofi-Aventis Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

PLAVIX
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PLAVIX?
Plavix contains the active ingredient clopidogrel. 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. For more information, see Section 1.
Why am I using Plavix? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PLAVIX?
Do not use if you have ever had an allergic reaction to Plavix or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use Plavix? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Plavix and affect how it works. A
list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PLAVIX?
•
Take Plavix only as prescribed by your doctor and follow his or her
directions carefully.
More instructions can be found in Section 4. How do I use Plavix? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PLAVIX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Plavix. Plavix may increase the risk
of bleeding during an operation or some dental work.
•
Tell your doctor immediately if you are injured while taking Plavix.
It may take longer than usual to stop
bleeding while you are taking Plavix.
•
Tell your doctor that you are taking Plavix if you are about to start
on any new medicine.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take Plavix if you have a medical condition that is causing
bleeding such as a stomach ulcer or
bleeding within your head.
DRIVING
OR

Summary of Product characteristics

plavix-ccdsv29-piv21-25oct21
1
AUSTRALIAN PRODUCT INFORMATION – PLAVIX
® (CLOPIDOGREL
HYDROGEN SULFATE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plavix 75 mg contains 97.875 mg of clopidogrel hydrogen sulfate which
is the molar
equivalent of 75 mg of clopidogrel base. Plavix 300 mg contains 391.5
mg of clopidogrel
hydrogen sulfate which is the molar equivalent of 300 mg of
clopidogrel base.
Excipient with known effect: the coating contains lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
75 mg film coated tablets - pink round slightly biconvex film coated
tablets, engraved “75”
on one side and “1171” on the other side.
300 mg film coated tablets - pink oblong film coated tablets, engraved
“300” on one side and
“1332” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of vascular ischaemia associated with atherothrombotic
events (myocardial
infarction, stroke and vascular death) in patients with a history of
symptomatic
atherosclerotic disease.
ACUTE CORONARY SYNDROME
Plavix is indicated in combination with aspirin for patients with:
•
Unstable angina or non-ST-elevation myocardial infarction in order to
prevent early
and long-term atherothrombotic events (myocardial infarction, stroke,
vascular death
or refractory ischaemia). Plavix is indicated for the treatment of
acute coronary
syndrome whether or not patients undergo cardiac revascularisation
(surgical or PCI,
with or without stent).
•
ST-segment elevation acute myocardial infarction in order to prevent
atherothrombotic events. In this population, Plavix has been shown to
reduce the rate
plavix-ccdsv29-piv21-25oct21
2
of death from any cause and the rate of a combined endpoint of death,
re-infarction or
stroke in medically treated patients eligible for thrombolytic
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Clopidogrel should be taken once a day with or without food.
AD