ONECLAPZ 75 (Clopidogrel Tablets 75mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CLOPIDOGREL BISULPHATE

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

CLOPIDOGREL BISULPHATE

Unit dalam pakej:

3x10tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ONECLAPZ 75 (CLOPIDOGREL TABLETS 75MG)
Clopidogrel Bisulphate equivalent to Clopidogrel 75mg
1
WHAT IS IN THIS LEAFLET
1.
What ONECLAPZ 75 is used
for
2.
How ONECLAPZ 75 works
3.
Before you use ONECLAPZ 75
4.
How to use ONECLAPZ 75
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ONECLAPZ 75
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IS ONECLAPZ 75 USED FOR
ONECLAPZ 75 is indicated for the
prevention of blood clot formation
inside blood vessels, such as:

You suffer from heart attack
(from a few days until less
than 35 days), stroke (from
7 days until less than 6
months) or condition known
as artery narrowing disease

You have experienced a
severe type of chest pain
known as unstable angina or
heart attack. The treatment
of this condition may
require your doctor to place
a stent in the blocked or
narrowed artery to restore
effective blood flow

You have irregular heart
rhythm called fibrillation
where your doctor may
combine with another drug
called acetyl salicylic acid
to prevent stroke
HOW ONECLAPZ 75 WORKS
ONECLAPZ 75 belongs to a group
of medicines called anti-platelets.
Platelets are very small structures in
the blood, which clump together
during blood clotting. By preventing
this clumping, anti-platelets reduce
the chances of blood clots from
forming (a process called
thrombosis).
BEFORE YOU USE ONECLAPZ 75
_-When you must not use it _
Do not take ONECLAPZ 75 if:

You are allergic to
Clopidogrel or any of the
ingredients in this product

You have a medical
condition that is currently
causing bleeding such as a
stomach ulcer, bleeding
within the brain or any other
bleeding disorders

You suffer from severe liver
disease
If you think any of the above applies
to you or you are in doubt, please
consult your doctor before
consuming this medication.
_-Before you start to use it _
Special care should be taken before
you start taking ONECLAPZ 75. If
any of the below apply t

Ciri produk

NAME OF THE MEDICINAL PRODUCT :
Clopidogrel Tablets 75 mg
(TRADE) NAME OF THE PRODUCT
:
ONCLAPZ 75
STRENGTH
:
75 mg
ROUTE OF ADMINISTRATION
:
Oral
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Clopidogrel bisulphate Equivalent to Clopidogrel Tablets 75 mg.
PHARMACEUTICAL FORM
Clopidogrel Tablets 75 mg:
Pink colored, round, biconvex, beveled edge, film-coated tablets
debossed with 'E'
on one side and '34' on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
PREVENTION OF ATHEROTHROMBOTIC EVENTS, CLOPIDOGREL IS INDICATED IN:
•
Adult patients suffering from myocardial infarction (from a few days
until less
than 35 days), ischaemic stroke (from 7 days until less than 6 months)
or
established peripheral arterial disease.
•
Adult patients suffering from acute coronary syndrome:
-
Non-ST segment elevation acute coronary syndrome (unstable angina
or non-Q-wave myocardial infarction), including patients undergoing a
stent placement following percutaneous coronary intervention.
-
ST segment elevation acute myocardial infarction, in combination with
acetylsalicylate acid (ASA) in medically treated patients eligible for
thrombolytic therapy.
PREVENTION
OF
ATHEROTHROMBOTIC
AND
THROMBOEMBOLIC
EVENTS
IN
ATRIAL
FIBRILLATION
In adult patients with atrial fibrillation who have at least one risk
factor for vascular
events, are not suitable for treatment with Vitamin K antagonists
(VKA) and who
have a low bleeding risk, clopidogrel is indicated in combination with
ASA for the
prevention of atherothrombotic and thromboembolic events, including
stroke.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND OLDER PEOPLE
Clopidogrel should be given as a single daily dose of 75mg.
In patients suffering from acute coronary syndrome:
-
Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave myocardial infarction): Clopidogrel treatment should be
initiated
with a single 300mg loading dose and then continued at 75mg once a day
(with acetylsalicylic acid (ASA) 75mg-325mg daily). Si