CLOPIDOGREL GH clopidogrel (as besilate) 75mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clopidogrel besilate, Quantity: 111.86 mg (Equivalent: clopidogrel, Qty 75 mg)

Available from:

Generic Health Pty Ltd

INN (International Name):

clopidogrel besilate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose; microcrystalline cellulose; crospovidone; glyceryl behenate; purified talc; titanium dioxide; iron oxide red; polyvinyl alcohol; macrogol 3350; lecithin

Administration route:

Oral

Units in package:

30 tablets, 50 tablets, 28 tablets, 10 tablets, 14 tablets, 56 tablets, 60 tablets, 7 tablets, 90 tablets, 20 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 GH 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 GH 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.

Product summary:

Visual Identification: Pink, round, biconvex, film-coated tablet with 'II' engraved on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-10-21

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
CLOPIDOGREL GH
(CLOPIDOGREL BESILATE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Clopidogrel GH.
It does not contain all 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 risks and
benefits. In deciding to give you
Clopidogrel GH, your doctor has
weighed the risks of you taking
Clopidogrel GH against the
expected benefits it will have for
you.
Always follow the instructions
that your doctor and pharmacist
give you about Clopidogrel GH
tablets.
IF YOU HAVE ANY CONCERNS
ABOUT THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET
CAREFULLY BEFORE YOU START
TAKING CLOPIDOGREL GH.
YOU MAY WISH TO KEEP IT TO
READ AGAIN.
WHAT CLOPIDOGREL GH IS
USED FOR
CLOPIDOGREL GH CONTAINS THE
MEDICINE CLOPIDOGREL (AS
BESILATE). CLOPIDOGREL GH
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 GH 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 GH TO
HELP PREVENT BLOOD CLOTS
FORMING AND TO REDUCE THE RISK
OF STROKE, HEART ATTACK AND
DEATH 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).
•
YOU HAVE SUFFERED ACUTE
CORONARY SYNDROME (EITHER
A SEVERE TYPE OF CHEST PAIN
CALLED UNSTABLE ANGINA, OR A
HEARTBEAT ATTACK). IN THIS
CASE YOU MAY ALSO BE
PRESCRIBED ASPIRIN.
Your doctor may have
prescribed this medicine for
another use. If you want more
information, ask your doctor.
Clopidogrel GH is only available
on a doctor's prescription.
BEFO

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – CLOPIDOGREL GH
(CLOPIDOGREL BESILATE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg clopidogrel (as besilate).
List of excipients with known effect: Lactose and soya bean products.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Clopidogrel GH 75 mg film coated tablets - pink, round, biconvex,
film-coated tablets, with “II” engraved
on one 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 GH 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 GH 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
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.
Clopidogrel GH v6.1
Page 2 of 25
(clopidogrel besilate) film coated tablet
In patients with acute coronary syndrome:
•
unstable angina or non-ST-elevation myocardial infarction -
clopidogrel treatment should be
initiated with 300 mg loading dose and then continued long-term at 75
mg once a day (with aspirin
75 mg