Prasugrel Vocate 5mg film-coated Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

PRASUGREL

Disponible desde:

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

Código ATC:

B01AC22

Designación común internacional (DCI):

PRASUGREL 5 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

PRASUGREL 5 mg

tipo de receta:

POM

Área terapéutica:

ANTITHROMBOTIC AGENTS

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estado de Autorización:

Authorised

Fecha de autorización:

2019-11-05

Información para el usuario

Page 1 of 6
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

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
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).
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 of thrombosis,
myocardial infarction or