Prasugrel Vocate 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PRASUGREL

Available from:

Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece

ATC code:

B01AC22

INN (International Name):

PRASUGREL 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PRASUGREL 10 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2019-11-05

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRASUGREL VOCATE 5 MG AND 10MG 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 Prasugrel Vocate is and what it is used for
2.
What you need to know before you take Prasugrel Vocate
3.
How to take Prasugrel Vocate
4.
Possible side effects
5.
How to store Prasugrel Vocate
6.
Contents of the pack and other information
1.
WHAT PRASUGREL VOCATE IS AND WHAT IT IS USED FOR
Prasugrel Vocate 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).
Prasugrel Vocate inhibits the clumping of platelets and so reduces the
chance of a blood clot
forming.
You have been prescribed Prasugrel Vocate 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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Prasugrel Vocate 5 mg film-coated tablets
Prasugrel Vocate 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prasugrel
Each film-coated tablet contains 5 mg prasugrel
Each film-coated tablet contains 10 mg prasugrel
Excipient with known effect:
5mg: Each tablet contains 55.69 mg lactose monohydrate
10mg: Each tablet contains 111.38 mg lactose monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
5 MG:
The tablets are yellow, oblong, biconvex film-coated tablet with
‘F1’ debossed on one side
with a major diameter of 10.55±0.25 mm and a minor diameter of
5.35±0.25 mm.
10 MG:
The tablets are orange, oblong, biconvex film-coated tablet with
‘F2’ debossed on one side
with a major diameter of 13.25±0.25 mm and a minor diameter of
6.75±0.25 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prasugrel Vocate, 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 _
Prasugrel Vocate 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 Prasugrel Vocate should also take ASA daily (75
mg to 325 mg).
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In
patients
with
acute
coronary
syndrome
(ACS)
who
are
managed
with
PCI,
premature
discontinuation of any antiplatelet agent, including ,
could result in an
increased risk o