Brilinta 60 mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TICAGRELOR

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

TICAGRELOR

Unit dalam pakej:

14 Tablets; 60 Tablets

Dikeluarkan oleh:

ASTRAZENECA AB

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BRILINTA FILM-COATED TABLET_ _
Ticagrelor (60mg)
1
WHAT IS IN THIS LEAFLET
1.
What Brilinta is used for
2.
How Brilinta works
3.
Before you use Brilinta
4.
How to use Brilinta
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Brilinta
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT BRILINTA IS USED FOR
Brilinta contains an active substance
called ticagrelor. This belongs to a
group of medicines called antiplatelet
medicines.
Brilinta in combination with
acetylsalicylic acid (another
antiplatelet agent) is to be used in
adults only. You have been given this
medicine because you have:
•
Had a heart attack, over a year ago.
•
coronary artery disease and type 2
diabetes, with no previous heart
attacks, and have previously had a
procedure to open a blocked or
narrowed heart blood vessel
(percutaneous coronary
intervention or PCI). This may
have included placement of a small
tube (stent) to keep the blocked or
narrowed blood vessel open.
It reduces the chances of you having
another heart attack, stroke or dying
from a disease related to your heart or
blood vessels.
HOW BRILINTA WORKS
Brilinta affects cells called ‘platelets’
(also called thrombocytes). These very
small blood cells help stop bleeding
by clumping together to plug tiny
holes in blood vessels that are cut or
damaged.
However, platelets can also form clots
inside diseased blood vessels in the
heart and brain. This can be very
dangerous because:
•
the clot can cut off the blood
supply completely; this can cause a
heart attack (myocardial infarction)
or stroke, or
•
the clot can partly block the blood
vessels to the heart; this reduces
the blood flow to the heart and can
cause chest pain which comes and
goes (called ‘unstable angina’).
Brilinta helps stop the clumping of
platelets. This reduces the chance of a
blood clot forming that can reduce
blood flow.
BEFORE YOU USE BRILINTA
-
_When you must not use it:

Ciri produk

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BRILINTA
®
60 MG FILM-COATED TABLETS
Ticagrelor
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg ticagrelor.
Brilinta contains less than 1 mmol sodium (23 mg) per dose, i.e. is
essentially ‘sodium-free’.
For the full list of excipients, see section “List of excipients”.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Round, biconvex, pink tablets marked with ‘60’ above ‘T’ on
one side and plain on the other.
THERAPEUTIC INDICATIONS
HISTORY OF MYOCARDIAL INFARCTION (AT LEAST ONE YEAR AGO)
Brilinta, co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention of
atherothrombotic events (cardiovascular death, myocardial infarction
and stroke) in adult patients
with a history of myocardial infarction (MI) (MI occurred at least one
year ago), and a high risk of
developing an atherothrombotic event (see sections “Posology and
method of administration” and
“Pharmacodynamic properties”).
CORONARY ARTERY DISEASE, TYPE 2 DIABETES MELLITUS AND HISTORY OF
PERCUTANEOUS CORONARY
INTERVENTION
Brilinta, co-administered with low-dose acetylsalicylic acid (ASA:
75-150mg), is indicated to reduce
the risk of a first myocardial infarction or stroke in patients with
Coronary Artery Disease (CAD),
Type 2 Diabetes Mellitus (DM) and a history of percutaneous coronary
intervention (PCI), who are
also at high risk of developing an atherothrombotic events (see
section “Posology and method of
administration”, “Special warnings and precautions for use” and
“Pharmacodynamic properties”).
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_HISTORY OF MYOCARDIAL INFARCTION (_AT LEAST ONE YEAR AGO_) _
Patients taking Brilinta should also take a daily low maintenance dose
of ASA 75-150 mg, unless
specifically contraindicated.
Brilinta 60 mg twice daily is the recommended dose when an extended
treatment is required for
patients with a history of MI of at least one year and a high risk of
an atherothrombotic event (see
section
“Pharmacodynamic
propert