Axcel Clopidogrel-75mg Tablet

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

CLOPIDOGREL BISULPHATE

Sẵn có từ:

KOTRA PHARMA (M) SDN. BHD.

INN (Tên quốc tế):

CLOPIDOGREL BISULPHATE

Các đơn vị trong gói:

30 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets

Sản xuất bởi:

KOTRA PHARMA (M) SDN. BHD.

Tờ rơi thông tin

AXCEL CLOPIDOGREL-75MG TABLET
Clopidogrel Bisulphate equivalent to Clopidogrel 75mg
1
_CUSTOMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Clopidogrel-75mg
Tablet is used for.
2.
How
Axcel
Clopidogrel-75mg
Tablet works.
3.
Before
you
use
Axcel
Clopidogrel-75mg Tablet.
4.
How to use Axcel Clopidogrel-
75mg Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Clopidogrel-75mg Tablet.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
11.
Serial number
WHAT
AXCEL
CLOPIDOGREL-75MG
TABLET IS USED FOR
Axcel
Clopidogrel-75mg
Tablet
is
indicated for the prevention of blood
clot formation inside blood vessels
incidents in:
•
Person
with
history
of
heart
attack,
stroke
and
peripheral
arterial
disease
(leg
pain
on
walking or at rest).
•
Person suffering a severe type of
chest
pain
known
as
unstable
angina or heart attack.
•
Person
with
an
irregular
heartbeat,
a
condition
called
'atrial
fibrillation',
and
not
suitable to take medicines known
as 'oral anticoagulants' (vitamin
K
antagonists)
which
prevent
new
clots
from
forming
and
prevent
existing
clots
from
growing.
HOW
AXCEL
CLOPIDOGREL-75MG
TABLET WORK
Clopidogrel tablets belong to a group
of
medicines
called
antiplatelet.
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.
BEFORE YOU USE AXCEL CLOPIDOGREL-
75MG TABLET
−
_When you must not use it _
Do not take Axcel Clopidogrel-75mg
Tablet:
•
If
you
are
allergic
(hypersensitivity) to clopidogrel
or
any
ingredients
in
this
medicine.
•
If you have ulcer in stomach or
intestine.
•
If you have bleeding within the
skull.
•
If
you
have
severe
liver
impairment.
−
_Before you start to use it _
You need to tell your doctor:
•
If you have a risk of bleeding
such as serious injury, surgery,
risk of internal bleeding (such

Đặc tính sản phẩm

start and continued for at least four weeks. The benefit of the
combination
of clopidogrel with ASA beyond four weeks has not been studied in this
setting.
In patients with atrial fibrillation, clopidogrel should be given as a
single
daily dose of 75mg. ASA (75-100mg daily) should be initiated and
continued
in combination with clopidogrel. If a dose is missed:
_• Within less than 12 hours after regular scheduled time: _
patients should
take the dose immediately and then take the next dose at the regular
scheduled time.
_• For more than 12 hours:_ patients should take the next dose at
the regular
scheduled time and should not double the dose.
_Paediatric Population: _
Clopidogrel should not be used in children because of efficacy
concerns.
_Renal Impairment: _
Therapeutic experience is limited in patients with renal impairment.
_Hepatic Impairment: _
Therapeutic experience is limited in patients with moderate hepatic
disease
who may have bleeding diatheses.
CONTRAINDICATIONS:
• Hypersensitivity to clopidogrel or to any of the excipients
• Severe hepatic impairment.
• Active
pathological
bleeding
such
as
peptic
ulcer
or
intracranial
hemorrhage.
PRECAUTION:
_Bleeding and Haematological Disorders:_
Due to the risk of bleeding and haematological adverse reactions,
blood cell
count determination and/or other appropriate testing should be
promptly
considered whenever clinical symptoms suggestive of bleeding arise
during
the course of treatment. As with other antiplatelet agents,
clopidogrel
should be used with caution in patients who may be at risk of
increased
bleeding from trauma, surgery or other pathological conditions and in
patients
receiving
treatment
with ASA,
heparin,
glycoprotein
IIb/IIIa
inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including
Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs),
or other
medicinal products associated with bleeding risk such as
pentoxifylline.
Patients should be followed carefully for any signs of bleeding
including
occult bleeding, esp