BRILINTA 90MG 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:

60Tablet Tablets; 14Tablet Tablets; 168 (12 x 14s) Tablets

Dikeluarkan oleh:

ASTRAZENECA AB

Risalah maklumat

BRILINTA
®
FILM-COATED TABLET
Ticagrelor 90 mg
_CONSUMER MEDICATION INFORMATION _
_LEAFLET (RIMUP)_
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
10.
Product Registration Holder
11.
Date of revision
12.
Serial number
WHAT BRILINTA IS USED FOR
Brilinta contains an active substance
called ticagrelor. This belongs to a
group of medicines called anti-platelet
medicines.
Brilinta in combination with
acetylsalicylic acid (another
antiplatelet agent) is to be used in
adults only. You have been given
Brilinta because you have had:
•
a heart attack, or
•
unstable angina (angina or chest
pain that is not well controlled).
•
Stroke (acute ischemic stroke) or
mini-stroke (transient ischemic
attack or TIA)
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 _
•
If
you are allergic to ticagrelor or
any of the other ingredients of this
medicine (listed in Section
“Ingredients”).
•
If you have are bleeding now.
•
If you have ha

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BRILINTA
® 90 MG FILM-COATED TABLETS
Ticagrelor
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 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, yellow tablets marked with ‘90’ above ‘T’ on
one side and plain on the
other.
THERAPEUTIC INDICATIONS
ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION
Brilinta, co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention of
atherothrombotic events in adult patients with Acute Coronary
Syndromes (unstable angina,
non ST elevation Myocardial Infarction [NSTEMI] or ST elevation
Myocardial Infarction
[STEMI]);
including
patients
managed
medically,
and
those
who
are
managed
with
percutaneous coronary intervention (PCI) or coronary artery by-pass
grafting (CABG).
ACUTE ISCHEMIC STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA)
BRILINTA is indicated to reduce the risk of stroke in patients with
acute ischemic stroke
(NIH Stroke Scale score ≤5) or high-risk transient ischemic attack
(TIA).
For further information, please refer to section “Pharmacodynamic
properties”.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION
Brilinta treatment should be initiated with a single 180 mg loading
dose (two tablets of 90
mg) and then continued at 90 mg twice daily.
Patients taking Brilinta should also take ASA daily, unless
specifically contraindicated.
Following an initial dose of ASA, Brilinta should be used with a
maintenance dose of ASA of
75-150 mg (see section “Pharmacodynamic properties”).
Treatment is recommended for up to 12 months unless discontinuation of
Brilinta is clinically
indicated (see section “Pharmacodynamic properties”). Experience
beyond 12 months is
limited.
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In patients with Acute Coronary Syndromes (ACS), premat