Prasugrel Mylan

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

prasugrel besilate

Saatavilla:

Mylan Pharmaceuticals Limited

ATC-koodi:

B01AC22

INN (Kansainvälinen yleisnimi):

prasugrel

Terapeuttinen ryhmä:

Antithrombotic agents

Terapeuttinen alue:

Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable

Käyttöaiheet:

Prasugrel Mylan, 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).

Tuoteyhteenveto:

Revision: 8

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-05-15

Pakkausseloste

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B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PRASUGREL VIATRIS 5 MG FILM-COATED TABLETS
PRASUGREL VIATRIS 10 MG 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 Viatris is and what it is used for
2.
What you need to know before you take Prasugrel Viatris
3.
How to take Prasugrel Viatris
4.
Possible side effects
5.
How to store Prasugrel Viatris
6.
Contents of the pack and other information
1.
WHAT PRASUGREL VIATRIS IS AND WHAT IT IS USED FOR
Prasugrel Viatris, which contains the active substance prasugrel,
belongs to a group of medicines
called antiplatelet 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 Viatris inhibits the clumping of platelets and so reduces
the chance of a blood clot forming.
You have been prescribed Prasugrel Viatris 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

Valmisteyhteenveto

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Prasugrel Viatris 5 mg film-coated tablets
Prasugrel Viatris 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prasugrel Viatris 5 mg
_ _
Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Prasugrel Viatris 10 mg
_ _
Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Excipient with known effect
Each tablet contains 0.016 mg of sunset yellow FCF aluminium lake
(E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Prasugrel Viatris 5 mg
Yellow film-coated, capsule shaped, biconvex tablet, of dimensions
8.15 mm × 4.15 mm, debossed
with ‘PH3’ on one side and ‘M’ on the other side.
Prasugrel Viatris 10 mg
Beige film-coated, capsule shaped, biconvex tablet, of dimensions
11.15 mm × 5.15 mm, debossed
with ‘PH4’ on one side and ‘M’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prasugrel Viatris, 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 Viatris 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
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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 Viatris 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 Prasugrel
Viatris,