CLOPIDOGREL WINTHROP 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

INN (International Name):

clopidogrel hydrogen sulfate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; Carnauba Wax; mannitol; macrogol 6000; hyprolose; hydrogenated castor oil; 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: CLOPIDOGREL WINTHROP 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 WINTHROP 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 WINTHROP 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:

Licence status A

Authorization date:

2008-08-05

Patient Information leaflet

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

Summary of Product characteristics

clopidogrel-winthrop-ccdsv-29-piv-17-25oct21
1
AUSTRALIAN PRODUCT INFORMATION – CLOPIDOGREL-
WINTHROP
® (CLOPIDOGREL HYDROGEN SULFATE) FILM
COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel hydrogen sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clopidogrel Winthrop 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
Clopidogrel Winthrop 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 Winthrop 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 Winthrop 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.
clopidogrel-winthrop-ccdsv-29-piv-17-25oct21
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-e