Placta Tablet 75mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOPIDOGREL BISULPHATE

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CLOPIDOGREL BISULPHATE

Unit dalam pakej:

10 x 10 Tablets; 3 x 10 Tablets

Dikeluarkan oleh:

Actavis Ltd.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
PLACTA TABLET 75MG
Clopidogrel (75 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Placta is used for
2.
How Placta works
3.
Before you use Placta
4.
How to take Placta
5.
While you are using Placta
6.
Side Effects
7.
Storage
and
Disposal
of
Placta
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT PLACTA IS USED FOR
Placta
is
indicated
for
prevention of thrombotic (blood
clotting) incidents in:
• Person with history of heart
attack,
stroke
and
peripheral
arterial
disease
(leg
pain
on
walking or at rest).
•
Person
suffering
chest
pain
(unstable
angina),
in
combination with acetylsalicylic
acid (for example, aspirin).
HOW PLACTA WORKS
Placta
is
a
medicinal
product
containing
active
ingredient
clopidogrel,
which
inhibits
aggregation
(adhesion)
of
platelets
in
blood
vessels
and
thus
preventing
the
blood
platelets
to
clump
together
to
reduce
the
danger
from
development of blood clots.
BEFORE YOU USE PLACTA
_-When you must not take it_
Do not use Placta if you have or
if you are:
• Allergy to the active substance
or any of the other ingredients;
• Active bleeding (like in gastric
ulcer or bleeding in the brain);
• Liver disease or damage;
• Pregnant and breast-feeding;
• Children.
_-Before you start to take it _
Consult
your
doctor
or
pharmacist before taking Placta
if:
• You have trauma, operation or
internal bleeding (especially in
the stomach and the eye) before
this.
• You are taking acetylsalicylic
acid
(Aspirin),
nonsteroidal
anti-inflammatory
medicines
(NSAIDS),
heparin,
glycoprotein
IIb/IIIa
inhibitors
or thrombolytics. As they can
increase your risk of bleeding if
taken together with Placta.
•
You
have
planned
for
any
operation
and
the
blood
thinning effect is not desirable.
You
doctor
may
ask
you
to
discontinue the treatment with
Placta 5 days prior to operation.
• You will be undergoing dental
surgery and before starting the
treatment
with
new
medicinal
product.
_-Taking other medicines _
Placta
may
i

Ciri produk

NAME OF THE MEDICINAL PRODUCT
Placta Tablet 75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Clopidogrel Bisulphate 97.87 mg
(equivalent to 75.0 mg Clopidogrel base) as active substance.
PHARMACEUTICAL FORM
Film-coated tablets.
Placta tablets are pink, round, biconvex film-coated tablets, 9.0
mm in diameter, with a ‘I’ engraved on one side of the tablets.
THERAPEUTIC INDICATIONS
Clopidogrel is indicated for the prevention of atherothrombotic
events in:
•
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.
•
Patients suffering non-ST segment elevation acute coronary
syndrome (unstable angina or non-Q-wave myocardial
infarction), in combination with acetylsalicylic acid (ASA).
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 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.
Children and adolescents:
Safety and efficacy in subjects below the age of 18 have not been
established.
For oral administration.
CONTRAINDICATIONS
•
Allergy to the active substance or any of the other ingredients;
•
Active pathological bleeding (like in gastric ulcer or intracranial
hemorrhage);
•
Severe hepatic failure;
•
Pregnancy and breast-feeding;
•
Children.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Due to risk of bleedin