PLIDOGREL clopidogrel (as besilate) 75 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

17-11-2020

Summary of Product characteristics (SPC)

17-11-2020

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

clopidogrel besilate, Quantity: 112.1 mg (Equivalent: clopidogrel, Qty 75 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

clopidogrel besilate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; polyethylene glycol monomethyl ether; iron oxide red; stearic acid; hyprolose; purified talc; citric acid monohydrate; hypromellose; lactose monohydrate; microcrystalline cellulose; triacetin; crospovidone; titanium dioxide

Administration route:

Oral

Units in package:

30, 28, 4, 84, 50, 7, 112, 14, 56, 280

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: Plidogrel 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). Plidogrel 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, Plidogrel 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 tablet; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-10-16

Patient Information leaflet

PLIDOGREL- Consumer Medicine Information
Page 1 of 4
PLIDOGREL
TABLETS
_Clopidogrel besilate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Plidogrel tablets.
It does not contain all 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
Plidogrel, your doctor has weighed
the risks of you taking Plidogrel
against the expected benefits it will
have for you.
ALWAYS FOLLOW THE INSTRUCTIONS
THAT YOUR DOCTOR AND PHARMACIST
GIVE YOU ABOUT PLIDOGREL TABLETS
.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING PLIDOGREL.
YOU MAY WISH TO KEEP IT TO READ
AGAIN.
WHAT IS PLIDOGREL USED
FOR
PLIDOGREL CONTAINS THE MEDICINE
CLOPIDOGREL BESILATE. PLIDOGREL
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).
Plidogrel 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
Plidogrel 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 HEART
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.
Plidogrel is only available on a
doctor's prescription.
BEFOR

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Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – PLIDOGREL (CLOPIDOGREL
BESILATE ) TABLETS
1
NAME OF THE MEDICINE
Clopidogrel besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PLIDOGREL tablets contain 75mg of clopidogrel besilate
EXCIPIENTS WITH KNOWN EFFECT
:
PLIDOGREL tablets contain lactose monohydrate. For the full list of
excipients, see SECTION 6.1 LIST OF
EXCIPIENTS.
3
PHARMACEUTICAL FORM
PLIDOGREL film coated tablets are pink, round, biconvex tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
PLIDOGREL 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). PLIDOGREL 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, PLIDOGREL 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
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 loading dose and then continued
long-term at 75 mg once a day
(with aspirin 75 mg-325 mg daily).
•
ST segment elevation acute myocardial infarction – clopidogrel
treatment should be given as a
single daily dose of 75 m

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