APO- CLOPIDOGREL clopidogrel 75mg (as hydrogen sulfate) tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clopidogrel hydrogen sulfate

Available from:

Apotex Pty Ltd

INN (International Name):

clopidogrel hydrogen sulfate

Authorization status:

Registered

Patient Information leaflet

APO-CLOPIDOGREL FILM
COATED TABLETS
_Contains the active ingredient clopidogrel_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Clopidogrel. It contains the active
ingredient clopidogrel.
Clopidogrel 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 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 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)
•
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
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
This medicine should not be used in
children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- CLOPIDOGREL (CLOPIDOGREL HYDROGEN
SULFATE) FILM COATED
TABLETS
1
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg clopidogrel (as clopidogrel hydrogen
sulfate), as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Reddish brown, round biconvex film-coated tablets, engraved “APO”
on one side and “CL”
over “75” 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 history of
symptomatic atherosclerotic
disease.
ACUTE CORONARY SYNDROME
Clopidogrel 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). Clopidogrel 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, Clopidogrel 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 in medically
treated patients eligible for thrombolytic therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Clopidogrel tablets are intended for oral administration.
DOSAGE
Clopidogrel should be taken once a day with or without food.
2
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