Effient

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Prasugrel hydrochloride 10.98mg

Available from:

Eli Lilly and Company (NZ) Limited

INN (International Name):

Prasugrel hydrochloride 10.98 mg

Dosage:

10 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Prasugrel hydrochloride 10.98mg Excipient: Croscarmellose sodium Glycerol Hypromellose Iron oxide red Iron oxide yellow Lactose Magnesium stearate Mannitol Microcrystalline cellulose Purified talc Titanium dioxide

Units in package:

Blister pack, PVC, 6 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Ube Industries Limited

Therapeutic indications:

EFFIENT, co-administered with aspirin, is indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (UA), non ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI)) who are to undergo percutaneous coronary intervention (PCI).

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC - 6 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture. Store in original container - Blister pack, PVC - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture. Store in original container

Authorization date:

2008-08-22

Patient Information leaflet

EFFIENT
®
 CMI_v5.0 
1 
EFFIENT
®
 EF'-FEE-ENT 
_Prasugrel hydrochloride _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Effient. 
It does not contain all the available 
information. 
It does not take the place of talking to 
your doctor or pharmacist. 
The information in this leaflet was 
last updated on the date shown on the 
final page.  More recent information 
on this medicine may be available.  
Make sure you speak to your 
pharmacist, nurse or doctor to obtain 
the most up to date information on 
this medicine.  You can also 
download the most up to date leaflet 
from www.lilly.com.au. The updated 
leaflet may contain important 
information about this medicine and 
its use that you should be aware of. 
All medicines have risks and 
benefits. Your doctor or pharmacist 
has weighed the risks of you taking 
this medicine against the benefits 
they expect it will have for you. 
ALWAYS FOLLOW THE INSTRUCTIONS THAT 
YOUR DOCTOR OR PHARMACIST GIVE YOU 
ABOUT EFFIENT. 
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
WHAT EFFIENT IS USED 
FOR 
Effient is used to prevent blood cells 
from clotting.  
It contains the active ingredient, 
prasugrel.  
It is used by people who have had a 
PCI (percutaneous coronary 
intervention) because of unstable 
angina or a heart attack. 
PCI is a procedure where a balloon-
tipped tube is used to open a blocked 
artery, with or without a stent being 
placed in the artery. 
Effient belongs to the group of 
medicines called antiplatelet agents. 
It works by reducing the ability of 
blood cells to clot. By preventing 
blood cells from clumping, it reduces 

Summary of Product characteristics

NEW ZEALAND DATA SHEET
vA13_30apr19
SUPERSEDES: vA12_25mar19
Page 1 of 26
1. EFFIENT
®
EFFIENT
5 mg film coated tablets
EFFIENT 10 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is prasugrel hydrochloride.
Each beige 10 mg tablet is manufactured with 10.98 mg prasugrel
hydrochloride, equivalent
to 10 mg of prasugrel and each yellow 5 mg tablet with 5.49 mg
prasugrel hydrochloride,
equivalent to 5 mg of prasugrel.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Prasugrel is available for oral administration as a 5 mg or 10 mg
double-arrow shaped, film-
coated, not scored tablet, debossed on each side.
EFFIENT 10 mg tablets are beige, double-arrow shaped, not scored and
debossed with
“10 MG” on one side and with “4759” on the other side.
EFFIENT 5 mg tablets are yellow, double-arrow shaped, not scored and
debossed with
“5 MG” on one side and “4760” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EFFIENT, co-administered with aspirin, is indicated for the prevention
of atherothrombotic
events (myocardial infarction, stroke and cardiovascular death) in
patients with acute
coronary syndromes (moderate to high risk unstable angina (UA), non
ST-segment elevation
myocardial infarction (NSTEMI) or ST-segment elevation myocardial
infarction (STEMI))
who are to undergo percutaneous coronary intervention (PCI).
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
USE IN ADULTS (≥ 18 YEARS)
EFFIENT should be initiated with a single 60 mg loading dose (LD) and
then continued at a
10 mg once daily dose maintenance dose (MD). In NSTEMI patients, the
loading dose should
generally be given at the time of PCI (see 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE and
4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). Patients taking prasugrel
should also take
aspirin (75 mg to 325 mg) daily.
EFFIENT may be taken with or without food (see 5 PHARMACOLOGICAL
PROPERTIES).
vA13_30apr19
SUPERSEDES:vA12_25mar19
Page 2 of 26
USE IN ELDERLY