Kogrel 75mg film coated tablets

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

CLOPIDOGREL BISULPHATE

थमां उपलब्ध:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (इंटरनेशनल नाम):

CLOPIDOGREL BISULPHATE

पैकेज में यूनिट:

30 Tablets; 14 Tablets; 28 Tablets

द्वारा बनाया गया:

Sandoz Private Limited

सूचना पत्रक

KOGREL
® FILM COATED TABLETS
Clopidogrel bisulphate (75mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
_Kogrel_
is used for
2.
How
_ Kogre_
l works
_3._
_ _
Before you take
_ Kogrel _
4.
How to take
_Kogrel_
5.
While you are using
_Kogrel_
6.
Side effects
7.
Storage and Disposal of
_Kogrel _
8.
Product Description
9.
Manufacturer and Product
10.
Registration
Holder
11.
Date of Revision
WHAT _KOGREL_
IS USED FOR
You have been prescribed
_Kogrel_
to help
prevent blood clots and reduce the risk of
these severe events because:
•
You have a condition of hardening
of arteries (also known as
atherosclerosis), and
•
You have previously experienced a
heart attack, stroke or have a
condition known as peripheral
arterial disease, or
•
You have experienced a severe type
of chest pain known as ‘unstable
angina’ or ‘myocardial infarction’
(heart attack). For the treatment of
this condition your doctor may have
placed a stent in the blocked or
narrowed artery to restore effective
blood flow.
HOW _KOGREL_ WORKS
_Kogrel_
belongs to a group of medicines
called antiplatelet medicinal products.
Platelets are very small structures in the
blood, smaller than red or white blood
cells, which clump together during blood
clotting. By preventing this clumping,
antiplatelet medicinal products reduce
the chances of blood clots forming (a
process called thrombosis).
_Kogrel_
is taken to prevent blood clots
forming in hardened blood vessels
(arteries), a process known as
atherothrombosis, which can lead to
atherothrombotic events (such as stroke,
heart attack, or death).
BEFORE YOU TAKE _KOGREL_
-
_When you must not use it _
•
If you are allergic (hypersensitive)
to
_Kogrel_
or any of the other
ingredients of
_Kogrel_
•
If you have a medical condition that
is currently causing bleeding such as
a stomach ulcer or bleeding within
the brain
•
If you suffer from severe liver
disease
-
_Before you start to use it _
Tell your doctor or pharmacist before
starting to take
_KOGREL_
if you ha

उत्पाद विशेषताएं

KOGREL
®
1.
NAME OF THE MEDICINAL PRODUCT
Kogrel 75 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg clopidogrel.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Kogrel 75 mg film-coated tablets are pink colored, round shaped,
engraved with 'SZ' 75 on one side and
plain on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clopidogrel is indicated for the prevention of atherothrombotic events
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, in combination with acetylsalicylic acid (ASA).
-
ST segment elevation acute myocardial infarction, in combination with
ASA in medically treated
patients eligible for thrombolytic therapy.
For further information, please refer to section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and elderly
Clopidogrel should be given as a single daily dose of 75 mg with or
without food.
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
300 mg loading dose and then
continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg -
325 mg daily). Since higher
doses of ASA were associated with higher bleeding risk, it is
recommended that the dose of ASA
should not be higher than 100 mg. The optimal duration of treatment
has not been formally
established. Clinical trial data support use up to 12 months, and the
maximum benefit was seen at 3
months.
•
ST segment elevation acute myocardial infarction: