Efient
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
16-11-2022
Karatteristiċi tal-prodott
(SPC)
16-11-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
18-02-2016
Ingredjent attiv:
prasugrel
Disponibbli minn:
Substipharm
Kodiċi ATC:
B01AC22
INN (Isem Internazzjonali):
prasugrel
Grupp terapewtiku:
Antithrombotic agents
Żona terapewtika:
Acute Coronary Syndrome; Angina, Unstable; Myocardial Infarction
Indikazzjonijiet terapewtiċi:
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Sommarju tal-prodott:
Revision: 25
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2009-02-24
Fuljett ta 'informazzjoni
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
EFIENT 10 MG FILM-COATED TABLETS
EFIENT 5 MG FILM-COATED TABLETS
prasugrel
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 Efient is and what it is used for
2.
What you need to know before you take Efient
3.
How to take Efient
4.
Possible side effects
5.
How to store Efient
6.
Contents of the pack and other information
1.
WHAT EFIENT IS AND WHAT IT IS USED FOR
Efient, which contains the active substance prasugrel, belongs to a
group of medicines called anti-
platelet agents. Platelets are very small cell particles that
circulate in the blood. When a blood vessel is
damaged, for example if it is cut, platelets clump together to help
form a blood clot (thrombus).
Therefore, platelets are essential to help stop bleeding. If clots
form within a hardened blood vessel
such as an artery they can be very dangerous as they can cut off the
blood supply, causing a heart attack
(myocardial infarction), stroke or death. Clots in arteries supplying
blood to the heart may also reduce
the blood supply, causing unstable angina (a severe chest pain).
Efient inhibits the clumping of platelets and so reduces the chance of
a blood clot forming.
You have been prescribed Efient because you have already had a heart
attack or unstable angina and
you have been treated with a procedure to open blocked arteries in the
heart. You may also have had
one or more stents placed to keep open a blocked or narrowed artery
supplying blood to the heart.
Efient redu
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Efient 10 mg film-coated tablets.
Efient 5 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Efient 10 mg: _
Each tablet contains 10 mg prasugrel (as hydrochloride).
Excipient(s) with known effect
Each tablet contains 2.1 mg lactose monohydrate.
_ _
_Efient 5 mg: _
Each tablet contains 5 mg prasugrel (as hydrochloride).
Excipient(s) with known effect
Each tablet contains 2.7 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_Efient 10 mg: _
Beige and double-arrow shaped tablets, debossed with “10 MG” on
one side and “4759” on the other.
_ _
_ _
_Efient 5 mg: _
Yellow and double-arrow shaped tablets, debossed with “5 MG” on
one side and “4760” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS_ _
Efient, co-administered with acetylsalicylic acid (ASA), is indicated
for the prevention of
atherothrombotic events in adult patients with acute coronary syndrome
(i.e. unstable angina, non-ST
segment elevation myocardial infarction [UA/NSTEMI] or ST segment
elevation myocardial
infarction [STEMI]) undergoing primary or delayed percutaneous
coronary intervention (PCI).
For further information please refer to section 5.1.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION_ _
Posology
_Adults _
Efient should be initiated with a single 60 mg loading dose and then
continued at 10 mg once a day. In
UA/NSTEMI patients, where coronary angiography is performed within 48
hours after admission, the
loading dose should only be given at the time of PCI (see sections
4.4, 4.8 and 5.1). Patients taking
Efient should also take ASA daily (75 mg to 325 mg).
3
In patients with acute coronary syndrome (ACS) who are managed with
PCI, premature
discontinuation of any antiplatelet agent, including Efient, could
result in an increased risk of
thrombosis, myocardial infarction or death due to the patient’s
underlying disease. A treatment of up
to 12
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