EFFIENT 10 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

PRASUGREL AS HYDROCHLORIDE

Tilgjengelig fra:

ELI LILLY ISRAEL LTD

ATC-kode:

B01AC

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

PRASUGREL AS HYDROCHLORIDE 10 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

LILLY S.A., SPAIN

Terapeutisk gruppe:

PLATELET AGGREGATION INHIBITORS, EXCL. HEPARIN

Indikasjoner:

Effient, 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). The increased efficacy should be balanced with the increased risk in patients with bleeding tendencyin those who had TIA/CVA in the past and in those above the age of 75 or weight below 60 kg.

Autorisasjon dato:

2015-01-31

Informasjon til brukeren

Page 1 of 6
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
EFFIENT 10 MG
Coated tablets
EACH TABLET CONTAINS:
Prasugrel (as Hydrochloride) 10 mg
EFFIENT 5 MG
Coated tablets
COMPOSITION:
EACH TABLET CONTAINS:
Prasugrel (as Hydrochloride) 5 mg
For the list of inactive ingredients and allergens, please see section
“Additional information about
the ingredients of this medicine” and section 6 “Additional
information”.
The medication contains lactose and may cause an allergy in people who
are sensitive to
lactose.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This leaflet contains
concise information about the medicine. If you have any further
questions, please contact your
doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if it seems to you that their medical condition
is similar.
EFFIENT is not intended for children and adolescents below 18 years of
age, since there is no
information about the efficacy and safety of this medicine in this age
group.
1. WHAT IS THIS MEDICINE INTENDED FOR?
EFFIENT, co-administered with acetylsalicylic acid, is indicated for
the prevention of
atherothrombotic events in patients with acute coronary syndrome
(unstable angina, acute
myocardial infarction) who are undergoing initial or elective
catheterization, with or without stent
implantation.
THERAPEUTIC GROUP:
Platelet aggregation inhibitors.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients
contained in this medicine (see section 6). An allergic reaction may
appear as a rash,
itching, swelling of the face and lips or shortness of breath.
•
You suffer from active bleeding (such as bleeding from a peptic ulcer)
•
You have ever had a stroke or a transient ischemic attack (TIA).
•
You have severe li

Preparatomtale

X EFFITB A 05
_This leaflet format was set by MOH and its content has been reviewed
and approved on _
_March 2016 and updated according to the guidelines of the Ministry of
Health on January 2019. _
EFFIENT
1.
NAME OF THE MEDICINAL PRODUCT
Effient 5 mg film-coated tablets.
Effient 10 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg tablet contains: 5 mg prasugrel (as hydrochloride).
Excipient with known effect: Each tablet contains 2.7 mg lactose.
Each 10 mg tablet contains: 10 mg prasugrel (as hydrochloride).
Excipient with known effect: Each tablet contains 2.1 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The 5 mg tablets are: Yellow and double-arrow-shaped tablets, debossed
with “5 MG” on one side
and “4760” on the other.
The 10 mg tablets are: Beige and double-arrow shaped tablets, debossed
with “10 MG”on one side
and “4759” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Effient, 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).
The increased efficacy should be balanced with the increased risk in
patients with bleeding tendency
in those who had TIA/CVA in the past and in those above the age of 75
or weight below 60 kg.
For further information please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Page 2 of 16
Posology
_Adults _
Effient 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 Effient should also take ASA daily (75 mg to