Prasugrel CF 5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

PRASUGRELHYDROBROMIDE SAMENSTELLING overeenkomend met ; PRASUGREL

Beschikbaar vanaf:

Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR

ATC-code:

B01AC22

INN (Algemene Internationale Benaming):

PRASUGRELHYDROBROMIDE COMPOSITION corresponding to ; PRASUGREL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Prasugrel

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-05-15

Bijsluiter

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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Prasugrel CF 5 mg, filmomhulde tabletten
Prasugrel CF 10 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg prasugrel (as hydrobromide).
Excipient with known effect: Each tablet contains 1.21 mg lactose.
Each tablet contains 10 mg prasugrel (as hydrobromide).
Excipient with known effect: Each tablet contains 2.42 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
5 mg tablets are oval, biconvex, yellow film-coated
tablets with a length of
approximately 8.0 mm and a width of approximately 4.2 mm.
10 mg tablets are oval, biconvex, beige film-coated
tablets with a length of
approximately 10.0 mm and a width of approximately 5.1 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prasugrel, 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 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 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, could
result in an increased risk
of thrombosis, myocardial infarction or death due to the patient’s
underlying disease. A
treatment of up to 12 months