Clopivas (Clopidogrel Tablets 75 mg)

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

CLOPIDOGREL BISULPHATE

Disponible depuis:

CIPLA MALAYSIA SDN BHD

DCI (Dénomination commune internationale):

CLOPIDOGREL BISULPHATE

Unités en paquet:

30Tablet Tablets

Fabriqué par:

CIPLA LTD

Notice patient

_CONSUM_
_ ER _
_MEDI_
_ _
_CATION I_
_ _
_NF_
_ _
_OR_
_ _
_M_
_ _
_ATION LEAFLET _
_(RIMUP)_
CLOPIVAS
® TABLETS
CLOPID
OGR
EL (75
MG)
Page 1
WHAT
IS IN THIS LEAFLET
1
W
hat
CLOPI
VAS
is used
fo
r
2
Ho
w C
LOPI
V
AS
works
3 Before
yo
u
use
C
LOP
IVAS
4
H
o
w to use
C
LOP
IVAS
5
W
hile
yo
u
are
usi
ng
it
6
S
i
d
e effects
7
S
t
o
r
a
ge and Disposal of
CLOP
IVAS
8
P
r
o
d
u
c
t Description
9 Manufacturer and
P
roduct
Regi
str atio
n Holder
10
Date of
Revisio
n
WHAT
CL
O
PIVA S IS
USED
FOR
Clopivas is taken to prevent blood
clots
(thro
mbi)
for
ming in hardened blood
vessels (arteries), a process known as
atherothro
mbosis,
whic
h can lead to
atherothro
mbotic events
(suc
h as
stroke,
heart attack,
or death).
You have been prescribed Clopivas to help
prevent blood clots and reduce the
risk
o
f
these
severe events
because:
•
You have a
conditio
n
o
f hardening
o
f arteries (also
kno
wn as
atherosclerosis)
and
•
You have
previousl
y experienced a
heart attack, stroke or have a conditio n
kno
wn as peripheral
arterial disease,
or
•
You have experienced a severe
t
yp
e of chest pain
kno
wn as ‘chest
pain’
or
‘myocardial
infarctio n’ (heart attack). For the
treat
ment of this
conditio
n y
o
ur
doctor
ma
y have placed a stent in the
blocked or
narro
wed
art er
y to restore
e
ffective blood
flo
w. You should also
be given
acet
ylsalic
ylic acid (a
substance present in
ma
ny medicines
used to relieve pain and
lo
wer
fe
ver
as well as to prevent blood clotting)
b
y your doctor.
HOW CLOPIVAS WORKS
Clopivas
belo
ngs to
a group
of
medicine s called antiplatelet medicinal
prod
ucts.
P
latelets are
ver
y s mall
structures in the
bloo
d, which clump
together
during blood clotting. By
preventing this clumping, antiplatelet
medicinal products reduce the changes of
blood clots forming (a process called
thrombosis).
BEFORE
YOU USE
CLO PIVAS
_- When _
_you _
_must _
_not use it_
DO NOT TAKE CLOPIVAS:
•
I
f
yo
u are allergic (hypersensitive) to
clopidogrel or any
o
f the other
ingredients
o
f Clopivas;
•
I
f
yo
u ha

Résumé des caractéristiques du produit

_For the use only of a Registered Medical Practitioner or a Hospital
or a Laboratory_
Clopidogrel Tablets 75 mg
CLOPIVAS
COMPOSITION
Each film-coated tablet contains
Clopidogrel bisulfate USP
equivalent to Clopidogrel ............... 75 mg
DOSAGE FORM
Oral
PRODUCT DESCRIPTION
Pink coloured circular, biconvex, film coated tablets plain on both
sides.
PHARMACODYNAMICS/PHARMACOKINETICS
PHARMACODYNAMICS
Pharmacotherapeutic group: platelet aggregation inhibitors excl.
heparin,
ATC Code: B01AC04.
Clopidogrel selectively inhibits the binding of adenosine diphosphate
(ADP) to its platelet receptor,
and the subsequent ADP-mediated activation of the GPIIb/IIIa complex,
thereby inhibiting platelet
aggregation.
Biotransformation
of
clopidogrel
is
necessary
to
produce
inhibition
of
platelet
aggregation. Clopidogrel also inhibits platelet aggregation induced by
other agonists by blocking the
amplification of platelet activation by released ADP. Clopidogrel acts
by irreversibly modifying the
platelet ADP receptor. Consequently, platelets exposed to clopidogrel
are affected for the remainder
of their lifespan and recovery of normal platelet function occurs at a
rate consistent with platelet
turnover.
Repeated doses of 75 mg per day produced substantial inhibition of
ADP-induced platelet
aggregation from the first day; this increased progressively and
reached steady state between Day
3 and Day 7. At steady state, the average inhibition level observed
with a dose of 75 mg per day was
between 40% and 60%. Platelet aggregation and bleeding time gradually
returned to baseline
values, generally within 5 days after treatment was discontinued.
The safety and efficacy of clopidogrel have been evaluated in 4
double-blind studies involving over
80,000 patients: one study compared clopidogrel to ASA, and other
three studies compared
clopidogrel to placebo, both medicinal products given in combination
with ASA and other standard
therapy.
_Recent myocardial infarction (MI), recent stroke or established
peripheral arterial disease_
The study i