PRASUGREL LUPIN prasugrel 10 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prasugrel, Quantity: 10 mg

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; crospovidone; microcrystalline cellulose; croscarmellose sodium; sucrose stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

6 (starter pack), 28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prasugrel, 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:

Visual Identification: Each orange 10 mg tablet is oblong, biconvex and has "F2" debossed on one side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 28 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-06-26

Patient Information leaflet

PRASUGREL SCP
_Prasugrel _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Prasugrel SCP.
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.
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 PRASUGREL SCP.
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 PRASUGREL SCP
IS USED FOR
Prasugrel SCP 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.
Prasugrel SCP 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 the chances of blood clots
forming (a process called
thrombosis), thereby decreasing or
even stopping blood supply to the
heart muscle.
Prasugrel SCP is always taken with
aspirin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed
this medicine for another use. If you
want more information, ask your
doctor.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
PRASUGREL SCP
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PRASUGREL SCP

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –PRASUGREL SCP (PRASUGREL)
FILM COATED TABLETS
1
NAME OF THE MEDICINE
Prasugrel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orange 10 mg
tablet is manufactured with 10.0 mg prasugrel, and each yellow 5 mg
tablet with
5.0 mg prasugrel.
Excipients with known effect: contains sugars as lactose and sucrose.
For the full list of excipients, see Section 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.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prasugrel, 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
D
OSE AND METHOD OF ADMINISTRATION
GENERAL
USE IN ADULTS (≥ 18 YEARS)
Prasugrel 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 Section 4.4 Special Warnings and
Precautions for Use, and Section 4.8
Adverse Effects (Undesirable Effects)). Patients taking prasugrel
should also take aspirin (75 mg to
325 mg) daily.
Prasugrel may be taken with or without food (see
Section
5.2
Pharmacokinetic
Properties-
Absorption).
USE IN ELDERLY (≥ 75 YEARS)
Prasugrel is generally not recommended in patients ≥75 years of age
(see Section 4.4 Special
Warnings and Precautions for Use Precautions). Prasugrel should be
given as a single 60 mg LD and
consideration may be given to a 5 mg once daily maintenance dose. The
10 mg MD is not
recommended. The evidence for the 5 mg dose is based on
pharmacodynamic/pharmacokinetic
analyses only and