EFFIENT FILM-COATED TABLETS 10 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PRASUGREL HYDROCHLORIDE

Boleh didapati daripada:

ELI LILLY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PRASUGREL HYDROCHLORIDE

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

ELI LILLY & CO

Risalah maklumat

EFFIENT
® FILM COATED TABLETS
Prasugrel (5 dan 10mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Effient is used for
2.
How Effient works
3.
Before you use Effient
4.
How to use Effient
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Effient
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT EFFIENT IS USED FOR
Effient is a prescription medicine used
to treat people who:
•
have had a heart attack or severe
chest pain that happens when
your heart does not get enough
oxygen, and
•
have been treated with
a procedure to open a
blocked artery in the heart, with
or without a stent (small mesh
tube) being placed in the artery
Effient is used to lower your chance of
having another serious problem with
your heart or blood vessels, such as
another heart attack, a stroke, blood
clots in your stent, or death.
HOW EFFIENT WORKS
Effient, which contains the active
substance prasugrel, belongs to a
group of medicines called antiplatelet
agents. Platelets are blood cells that
help with normal blood clotting.
Effient helps prevent platelets from
sticking together and forming a clot
that can block an artery or a stent.
BEFORE YOU USE EFFIENT
_- When you must not use it _
Do not take Effient

If you are allergic
(hypersensitive) to prasugrel
or any of the other
ingredients of Effient. An
allergic reaction may be
recognized as a rash, itching,
a swollen face, swollen lips
or shortness of breath. If this
has happened to you, tell
your doctor immediately.

If you have a medical
condition that is currently
causing bleeding, such as
bleeding from your stomach
or intestines.

If you have ever has a stroke
or a transient ischaemic
attack (TIA, also known as
“mini-stroke”, where stroke
symptoms [see section SIDE
EFFECTS] happen suddenly and
disappear within 24 hours).

If you have severe liver
disease.
_- Before you start to use it _
Effient may not be right for you. Tell
your doctor about all of your medical
condi

Ciri produk

Effient PI_USPI Mar 2018_04 Apr 2018 1
HIGHLIGHTS OF PRESCRIBING INFORMATION These hig hlights do not include all the informatio n nee ded to use Effient
safely and effectively. See full prescribing information for Effient.
Effient (prasugrel) tablets , for oral use
WARNING: BLEEDING RISK See full prescribing information for complete boxed warning.
• Effient can cause significant, sometimes fatal, bleeding (5.1, 5.2, 6.1).
• Do not use Effient in patie nts with active pathological bleeding or a
history of transient ischemic attack or stroke (4.1 , 4.2).
• In patients ≥ 75 years of age, Effient is generally not recommended ,
except in high-risk patients (diabetes or prior MI), where its use may
be c onsidered (8.5).
• Do not start Effie nt in patients like ly to undergo urgent coronar y
artery bypass graft surgery (CABG). When possible, discontinue
Effient at least 7 days prior to any surgery (5.2) .
• Additional risk factors for bleeding include: body weight < 60 kg;
propensity to bleed; concomitant use of medications that increase the
risk of bleeding (5.1) .
• Suspect blee ding in any patie nt who is hypotensive and has recently
undergone invasive or surgical procedures (5.1).
• If possible, manage bleeding without discontinuing Effie nt. Sto pping
Effient increases the risk of subsequent cardiovascular events (5.3).
-------------------------INDICATIONS AND U SAGE-------------------
Effient is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic
cardiovascular events (including stent thrombosis) in patients with acute
coronary syndrome who are to be managed with PCI as follows:
• Patients with u nstable angina or non -ST-elevation myocardial infarction
(NSTEMI) (1.1).
• Patients with ST-elevation myocardial infarction (STEMI) when
mana ged with either primary or dela yed PCI (1.1).
-------------------- DOSAGE AND ADMINISTRATION -------------- • Initiate treatment with a single 60 mg oral loading dose (2).
• Continue at 10 mg once daily with or without food. Consider 5 mg