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

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

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

Commercializzato da:

Southern Cross Pharma Pty Ltd

INN (Nome Internazionale):

clopidogrel besilate

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: mannitol; microcrystalline cellulose; colloidal anhydrous silica; stearic acid; hypromellose; titanium dioxide; iron oxide red

Via di somministrazione:

Oral

Confezione:

28 tablet

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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 is indicated in combination with aspirin for patients with,-Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-termatherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Clopidogrel 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 thispopulation, 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.

Dettagli prodotto:

Visual Identification: Pink, round, biconvex tablets with smooth surfaces; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2010-09-09

Foglio illustrativo

CLOPIDOGREL APOTEX TABLETS
CLOPIDOGREL APOTEX
TABLETS
_Contains the active ingredient clopidogrel (as besilate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Clopidogrel APOTEX contains the
active ingredient clopidogrel (as
besilate).
Clopidogrel belongs to a group of
medicines known as antiplatelet
medicines.
Antiplatelet medicines prevent the
clumping of very small blood cells
(platelets) to reduce the chances of
blood clots forming.
Clopidogrel is used to prevent blood
clots forming in hardened blood
vessels as they can lead to events
such as stroke, heart attack or death.
You may have been prescribed
clopidogrel 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)
•
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
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
This medicine should not be used in
children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
clopidogrel
•
other antiplatelet medicines (su

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION
CLOPIDOGREL APOTEX (CLOPIDOGREL) 75 MG TABLET
_ _
1. NAME OF THE MEDICINE
Clopidogrel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CLOPIDOGREL APOTEX film coated tablets contain the active ingredient
Clopidogrel (as besilate).
Each CLOPIDOGREL APOTEX film coated tablet contains 75 mg of
Clopidogrel (as besilate).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
CLOPIDOGREL APOTEX 75 mg tablets are pink coloured, round biconvex
film coated with a smooth surface.
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 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
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.
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