Plavix

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clopidogrel bisulfate, form II 391.5mg equivalent to 300 mg clopidogrel;  ;  

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Clopidogrel bisulfate, form II 391.5 mg (equivalent to 300 mg clopidogrel)

Dosage:

300 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Clopidogrel bisulfate, form II 391.5mg equivalent to 300 mg clopidogrel     Excipient: Carnauba wax Hydrogenated castor oil Hyprolose Macrogol 6000 Mannitol Microcrystalline cellulose Opadry pink 32K14834

Units in package:

Blister pack, aluminium/aluminium, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

BASF Pharma (Evionnaz) SA

Product summary:

Package - Contents - Shelf Life: Blister pack, aluminium/aluminium - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2008-04-09

Patient Information leaflet

PLAVIX
®
1
PLAVIX
® TABLETS
_Clopidogrel _
CONSUMER MEDICINE INFORMATION
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.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING PLAVIX.
YOU MAY WISH TO KEEP IT TO READ
AGAIN.
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 ALLERGIC

Summary of Product characteristics

plavix-ccdsv27-dsv11-14aug20
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Plavix* 75mg film coated tablet
♦
* Registered trademark of sanofi-aventis
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.
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
Plavix 75 mg film coated tablets
♦
- pink, round, biconvex and engraved with ”75” on one side and
“1171” on the reverse.
♦
Not marketed in New Zealand
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of vascular ischaemia associated with secondary
atherothrombotic events (MI, 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 MI. Plavix is indicated for early
and long-term
reduction of atherothrombotic events (myocardial infarction, stroke,
vascular death and
refractory ischaemia) whether or not patients undergo cardiac
revascularisation (surgical
or PCI, with or without stent).
plavix-ccdsv27-dsv11-14aug20
Page 2
•
ST-segment elevation acute myocardial infarction. In this population,
PLAVIX has been
shown to reduce the rate of death from any cause and the rate of a
combined endpoint of
death, re-infarction or stroke.
4.2
DOSE AND METHOD OF ADMINISTRATION
Clopidogrel should be taken once a day with or without food.
ADULTS
Generally, Clopidogrel should be given as a single daily dose of 75
mg.
In patients with acute coronary syndrome:
•
unstable angina or non-ST elevation myocardial infarction –
clopidogrel treatment should
be initiated with a single 300 mg loading dose and then continued
long-term at 75 mg once
a day (with aspirin 75 mg-325 mg daily).
•
ST elevation acute myocardial infarction – clopidogrel treatment
should be given as a