COPLAVIX 75 mg/100 mg clopidogrel (as hydrogen sulfate)/aspirin tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aspirin, Quantity: 100 mg; clopidogrel hydrogen sulfate, Quantity: 97.875 mg (Equivalent: clopidogrel, Qty 75 mg)

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Aspirin,clopidogrel hydrogen sulfate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; mannitol; Carnauba Wax; colloidal anhydrous silica; maize starch; microcrystalline cellulose; hydrogenated castor oil; stearic acid; macrogol 6000; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CoPlavix is a fixed-dose combination product intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products: 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). CoPlavix 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, CoPlavix 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: Light Pink, oval, slightly biconvex, film-coated, engraved with "C75" on one side and "A100" on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-09-24

Patient Information leaflet

COPLAVIX
®
_Clopidogrel (clop-id-o(h)-grel) and Aspirin (as-per-in)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CoPlavix 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
CoPlavix, your doctor has weighed
the risks of you taking CoPlavix
against the expected benefits it will
have for you.
Always follow the instructions that
your doctor and pharmacist give you
about CoPlavix tablets.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Please read this leaflet carefully
before you start taking CoPlavix.
You may wish to keep it to read
again.
WHAT COPLAVIX IS USED
FOR
COPLAVIX CONTAINS THE MEDICINES
CLOPIDOGREL AND ASPIRIN. COPLAVIX
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).
CoPlavix 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
CoPlavix to help prevent blood clots
forming and to reduce the risk of
heart attack, stroke or death, because
you have suffered a severe type of
chest pain called unstable angina, or
had a heart attack.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
CoPlavix is only available on a
doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
YOU SHOULD NOT TAKE COPLAVIX IF:
•
YOU ARE ALLERGIC TO CLOPIDOGREL,
ASPIRIN, SALICYLATES, ANTI-
INFLAMMATORIES (NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS) OR
ANY OF THE INGREDIENTS LISTED
UNDER 'PRODUCT DESCRIPTION' AT
THE END OF

Summary of Product characteristics

coplavix-ccdsv27-ccds20-piv17-4aug20
1
AUSTRALIAN PRODUCT INFORMATION – COPLAVIX
®
(CLOPIDOGREL (AS HYDROGEN SULFATE)/ ASPIRIN) FILM
COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel (as hydrogen sulfate) and aspirin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CoPlavix 75mg/75mg containing clopidogrel 75 mg (as clopidogrel
hydrogen sulfate) and
aspirin 75 mg
CoPlavix 75mg/100mg containing clopidogrel 75 mg (as clopidogrel
hydrogen sulfate) and
aspirin 100 mg
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
CoPlavix 75mg/75mg tablets are yellow, oval, slightly biconvex,
film-coated, engraved with
“C75” on one side and “A75” on the other side.
CoPlavix 75mg/100mg tablets are light pink, oval, slightly biconvex,
film-coated, engraved
with “C75” on one side and “A100” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CoPlavix is a fixed-dose combination product.
CoPlavix is intended as continuation of therapy in patients with acute
coronary syndrome
already initiated with separate clopidogrel and aspirin products:
•
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). CoPlavix 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, CoPlavix 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.
coplavix-ccdsv27-ccds20-piv17-4aug20
2
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
CoPlavix is given as a single tablet (75mg/75mg or 75mg/100mg) once a
day taken with
adequate water.