Brilique
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
03-08-2023
Charakterystyka produktu
(SPC)
03-08-2023
Sprawozdanie z oceny publicznego
(PAR)
29-03-2016
Składnik aktywny:
Ticagrelor
Dostępny od:
AstraZeneca AB
Kod ATC:
B01AC24
INN (International Nazwa):
ticagrelor
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Peripheral Vascular Diseases; Acute Coronary Syndrome
Wskazania:
Brilique, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients withacute coronary syndromes (ACS) ora history of myocardial infarction (MI) and a high risk of developing an atherothrombotic eventBrilique, co-administered with acetyl salicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event.
Podsumowanie produktu:
Revision: 21
Status autoryzacji:
Authorised
Data autoryzacji:
2010-12-03
Ulotka dla pacjenta
84
B. PACKAGE LEAFLET
85
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRILIQUE 60 MG FILM-COATED TABLETS
ticagrelor
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Brilique is and what it is used for
2.
What you need to know before you take Brilique
3.
How to take Brilique
4.
Possible side effects
5.
How to store Brilique
6.
Contents of the pack and other information
1.
WHAT BRILIQUE IS AND WHAT IT IS USED FOR
WHAT BRILIQUE IS
Brilique contains an active substance called ticagrelor. This belongs
to a group of medicines called
antiplatelet medicines.
WHAT BRILIQUE IS USED FOR
Brilique 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.
It reduces the chances of you having another heart attack, stroke or
dying from a disease related to
your heart or blood vessels.
HOW BRILIQUE WORKS
Brilique 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 c
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Brilique 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg ticagrelor.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Round, biconvex, pink tablets marked with ‘60’ above ‘T’ on
one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brilique, co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention of
atherothrombotic events in adult patients with
-
acute coronary syndromes (ACS) or
-
a history of myocardial infarction (MI) and a high risk of developing
an atherothrombotic event
(see sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients taking Brilique should also take a daily low maintenance dose
of ASA 75-150 mg, unless
specifically contraindicated.
_Acute coronary syndromes_
Brilique 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 with Brilique 90 mg
twice daily is recommended for
12 months in ACS patients unless discontinuation is clinically
indicated (see section 5.1).
_History of myocardial infarction_
Brilique 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 5.1). Treatment may be started without interruption as
continuation therapy after the initial
one-year treatment with Brilique 90 mg or other adenosine diphosphate
(ADP) receptor inhibitor
therapy in ACS patients with a high risk of an atherothrombotic event.
Treatment can also be initiated
up to 2 years from the MI, or within one year after stopping previous
ADP receptor inhibitor
treatment. There are limited data on the efficacy and safety of
ticagrelor beyond 3 years of extended
treatment.
If a switch is needed, the first dose of Brilique
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