APO - Clopidogrel/Aspirin 75/100, Clopidogrel (as hydrogen sulfate)/Aspirin 75mg/100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aspirin,clopidogrel hydrogen sulfate

Available from:

Apotex Pty Ltd

INN (International Name):

Aspirin,clopidogrel hydrogen sulfate

Authorization status:

Registered

Patient Information leaflet

APO-CLOPIDOGREL/
ASPIRIN
FILM COATED TABLETS
_clopidogrel (as clopidogrel hydrogen sulfate) and aspirin_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about Clopidogrel/Aspirin.
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 using 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 your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Clopidogrel/Aspirin. It contains the
active ingredients clopidogrel (as
clopidogrel hydrogen sulfate) and
aspirin.
Clopidogrel/Aspirin 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.
Clopidogrel/Aspirin 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).
You may have been prescribed
clopidogrel/aspirin to help prevent
blood clots forming and to reduce the
risk of heart attack, stroke or death,
because you have suffered a severe
type of chest pain called unstable
angina or have had a heart attack.
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.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- CLOPIDOGREL/ASPIRIN (CLOPIDOGREL
HYDROGEN SULFATE/ASPIRIN) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Clopidogrel (as clopidogrel hydrogen sulfate) and Aspirin
(acetylsalicylic acid).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of APO-Clopidogrel/Aspirin 75/75 contains 75 mg
clopidogrel (as clopidogrel
hydrogen sulfate) and 75 mg aspirin.
Each tablet of APO- Clopidogrel/Aspirin 75/100 contains 75 mg
clopidogrel (as clopidogrel
hydrogen sulfate) and 100 mg aspirin.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-Clopidogrel/Aspirin 75/75 tablets:
Yellow, oval, biconvex coated tablet. Engraved “75-75” on one
side, “APO” on the other side.
APO- Clopidogrel/Aspirin 75/100 Tablets:
Light pink, oval biconvex coated tablets, engraved “APO” on one
side, “75-100” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clopidogrel/Aspirin is a fixed-dose combination product.
Clopidogrel/Aspirin is intended as continuation of therapy in patients
with acute coronary
syndrome already initiated with separate clopidogrel and aspirin
products:
•
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/Aspirin 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/Aspirin 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/Aspirin tablets are intended for oral administration.
2
DOSAGE
ADULTS
Clopidogre