DUO PLAVIX 75 mg/75 mg clopidogrel (as hydrogen sulfate)/aspirin tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

aspirin,clopidogrel hydrogen sulfate

Доступна с:

Sanofi-Aventis Australia Pty Ltd

ИНН (Международная Имя):

Aspirin,clopidogrel hydrogen sulfate

Статус Авторизация:

Registered

тонкая брошюра

CLOPIDOGREL WINTHROP PLUS ASPIRIN
®
1
DUOPLAVIX
®
_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 DuoPlavix 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
DuoPlavix, your doctor has weighed
the risks of you taking DuoPlavix
against the expected benefits it will
have for you.
Always follow the instructions that
your doctor and pharmacist give you
about DuoPlavix tablets.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Please read this leaflet carefully
before you start taking DuoPlavix.
You may wish to keep it to read
again.
WHAT DUOPLAVIX IS
USED FOR
DUOPLAVIX CONTAINS THE MEDICINES
CLOPIDOGREL AND ASPIRIN. DUOPLAVIX
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).
DuoPlavix 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
DuoPlavix 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.
DuoPlavix is only available on a
doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
YOU SHOULD NOT TAKE DUOPLAVIX IF:
•
you are allergic to clopidogrel,
aspirin, salicylates, anti-
inflammatories (Non-Steroidal
Anti-Inflammatory Drugs) or
any of the ingred

Характеристики продукта

duoplavix-ccdsv27-ccds20-piv15-4aug20
1
AUSTRALIAN PRODUCT INFORMATION – DUOPLAVIX
®
(CLOPIDOGREL (AS HYDROGEN SULFATE)/ ASPIRIN) FILM
COATED TABLET
1
NAME OF THE MEDICINE
Clopidogrel (as hydrogen sulfate) and aspirin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Duoplavix 75mg/75mg containing clopidogrel 75 mg (as clopidogrel
hydrogen sulfate) and
aspirin 75 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
Duoplavix 75mg/75mg tablets are yellow, oval, slightly biconvex,
film-coated, engraved with
“C75” on one side and “A75” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duoplavix is a fixed-dose combination product.
Duoplavix 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). Duoplavix 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, Duoplavix 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.
duoplavix-ccdsv27-ccds20-piv15-4aug20
2
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Duoplavix is given as a single tablet (75mg/75mg) once a day taken
with adequate water.
ACUTE CORONARY SYNDROME
Duoplavix is used following an initial loading dose of 300 mg
clopidogrel in combination
with aspirin in patients with acute coronary syndrome:
•
Unstable angina or non-ST-elevation myocardial infarction:
-
Treatment should be init