CLOPIDOGREL/ASPIRIN SANDOZ 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg uncoated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
17-12-2019
Summary of Product characteristics
(SPC)
17-12-2019
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
aspirin,clopidogrel hydrogen sulfate
Available from:
Sandoz Pty Ltd
INN (International Name):
Aspirin,clopidogrel hydrogen sulfate
Authorization status:
Registered
Patient Information leaflet
CLOPIDOGREL/ASPIRIN SANDOZ 75/100 TABLETS CMI 180315 V.1
1
CLOPIDOGREL/
ASPIRIN SANDOZ
®
75/100
_clopidogrel and aspirin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about
CLOPIDOGREL/ASPIRIN
SANDOZ 75/100 tablets.
It does not contain all of 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
CLOPIDOGREL/ASPIRIN
SANDOZ 75/100, your doctor has
weighed the risks of you taking
CLOPIDOGREL/ASPIRIN
SANDOZ 75/100 against the
expected benefits it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Please read this leaflet carefully
before you start taking
CLOPIDOGREL/ASPIRIN
SANDOZ 75/100.
You may need to read it again.
WHAT IS
CLOPIDOGREL/
ASPIRIN SANDOZ
75/100 USED FOR
CLOPIDOGREL/ASPIRIN
SANDOZ 75/100 CONTAINS THE
MEDICINES CLOPIDOGREL AND ASPIRIN.
CLOPIDOGREL/ASPIRIN
SANDOZ 75/100 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/ASPIRIN
SANDOZ 75/100 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/ASPIRIN
SANDOZ 75/100 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 had a heart attack.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
CLOPIDOGREL/ASPIRIN
SANDOZ 75/100 is only available
on a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE
CLOPIDOGR
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Summary of Product characteristics
191211-clopidogrel-aspirin-sandoz-pi
Page 1 of 35
AUSTRALIAN PRODUCT INFORMATION
CLOPIDOGREL/ASPIRIN SANDOZ
® 75/100 (CLOPIDOGREL HYDROGEN
SULFATE AND ASPIRIN) TABLETS
1.
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate and aspirin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Clopidogrel/Aspirin Sandoz 75/100 contains clopidogrel 75 mg (as
clopidogrel hydrogen
sulfate) and aspirin 100 mg.
_Excipient with known effect: _
Lactose anhydrous.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Clopidogrel/Aspirin Sandoz 75/100 tablets are mottled purple, oval,
biconvex tablet, debossed
with‘CL7’ on one side and ’S1’ on the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC 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.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
Clopidogrel/Aspirin is given as a single tablet (75 mg/75 mg or 75
mg/100 mg).
_ACUTE CORONARY SYNDROME _
Clopidogrel/Aspirin is used following an initial loading dose of 300
mg clopidogrel in
combination with aspirin in patients with acute coronary syndrome:
191211-clopidogrel-aspirin-sandoz-pi
Page 2 of 35
•
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