ISCOVER 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, Quantity: 97.875 mg (Equivalent: clopidogrel, Qty 75 mg)

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hydrogenated castor oil; Carnauba Wax; microcrystalline cellulose; macrogol 6000; hyprolose; mannitol; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

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: ISCOVER 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). ISCOVER 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, ISCOVER 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.

Product summary:

Visual Identification: Pink round slightly biconvex filmcoated tablets, engraved 75 on one side and 1171 on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2001-07-06

Patient Information leaflet

ISCOVER
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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 ISCOVER?
Iscover contains the active ingredient clopidogrel. Iscover 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 Iscover? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ISCOVER?
Do not use if you have ever had an allergic reaction to Iscover 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 Iscover? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Iscover 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 ISCOVER?
•
Take Iscover 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 Iscover? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ISCOVER?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Iscover.
•
Iscover may increase the risk of bleeding during an operation or some
dental work.
•
Tell your doctor immediately if you are injured while taking Iscover.
It may take longer than usual to stop
bleeding while you are taking Iscover.
•
Tell your doctor that you are taking Iscover if you are about to start
on any new medicine.
THINGS YOU
SHOULD NOT DO
•
Do not use Iscover during pregnancy.
•
Do not use Iscover if you are breast feeding or intend to breast feed.
•
Do not stop using this medicine suddenly.
•
Do not take Iscover if

Summary of Product characteristics

iscover-ccdsv29-piv17-02may22
1
AUSTRALIAN PRODUCT INFORMATION – ISCOVER
®
(CLOPIDOGREL HYDROGEN SULFATE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ISCOVER 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
75 mg film coated tablets - pink round slightly biconvex film coated
tablets, engraved “75”
on one side and “1171” 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
ISCOVER 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). ISCOVER 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, ISCOVER 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.
iscover-ccdsv29-piv17-02may22
2
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