Brilinta Tablet 90 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ticagrelor

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

B01AC24

Dosage:

90 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Ticagrelor 90 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

AstraZeneca AB

Authorization status:

ACTIVE

Authorization date:

2012-03-13

Patient Information leaflet

1 

NAME OF MEDICINAL PRODUCT

BRILINTA
™
 (ticagrelor), 90 mg, film-coated tablets. 
QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each tablet contains 90 mg of ticagrelor. 
PHARMACEUTICAL FORM  
90 mg - Round, biconvex, yellow, film-coated tablets. The tablets are
marked with “90” above 
“T” on one side and plain on the other. 
CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
BRILINTA, co-administered with acetylsalicylic acid (ASA),

is indicated for the prevention of 
thrombotic events (cardiovascular death, myocardial infarction and
stroke) in patients with 
Acute Coronary Syndromes [ACS] (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). 
POSOLOGY AND METHOD OF ADMINISTRATION  
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. 

For oral use. BRILINTA can be taken with or without food. For
patients who are unable to 
swallow the tablet(s) whole, Brilinta tablets (90 mg and 2x90 mg) can
be crushed to a fine 
powder and mixed in half a glass of water and drunk immediately. The
glass should be rinsed 
with a further half glass of water and the contents drunk. The mixture
can also be administered 
via a nasogastric tube (CH8 or greater). It is important to flush the
nasogastric tube through 
with water after administration of the mixture. 

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 Pharmacodynamics Properties). 

Lapses in therapy should be avoided. A patient who misses a dose of
BRILINTA should take 
one 90 mg tablet (their next dose) at its scheduled time. 
2 
Physicians who desire to swi

Summary of Product characteristics

1
BRILINTA
® 90MG
(TICAGRELOR)
1.
NAME OF MEDICINAL PRODUCT
BRILINTA
®
(ticagrelor), 90 mg, film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 90 mg of ticagrelor.
For excipients, see section List of excipients.
3.
PHARMACEUTICAL FORM
90 mg - Round, biconvex, yellow, film-coated tablets. The tablets are
marked with “90”
above “T” on one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BRILINTA,
co-administered
with
acetylsalicylic
acid
(ASA),
is
indicated
for
the
prevention of thrombotic events (cardiovascular death, myocardial
infarction and stroke) in
patients
with
Acute
Coronary
Syndromes
(ACS)
(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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
In patients with Acute Coronary Syndromes, 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.
Treatment
is
recommended
for
at
least
12
months
unless
discontinuation
of
BRILINTA is clinically indicated (see section Pharmacodynamic
properties). After one
year, patients with MI initiated on 90 mg may continue treatment with
60 mg without
interruption if they have a high risk of an atherothrombotic event.
Patients taking BRILINTA should also take a daily low maintenance dose
of acetylsalicylic
acid (ASA) of 75-150 mg, unless specifically contraindicated. An
initial loading dose of
ASA is recommended for patients with ACS (see section Pharmacodynamics
properties).
MISSED DOSE
Lapses in therapy should be avoided. A patient who misses a dose of
BRILINTA should
take their next dose at its scheduled time.
2
SWITCHING
Physicians who desire to switch patients, with a prior ACS event to
BRILINTA, should
administer the first 90 mg dose of BRILINTA 24 hours following t