Prasugrel Aristo 5 mg, filmomhulde tabletten

מדינה: הולנד

שפה: הולנדית

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

מרכיב פעיל:

PRASUGRELBESILAAT SAMENSTELLING overeenkomend met ; PRASUGREL

זמין מ:

Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 BERLIJN (DUITSLAND)

קוד ATC:

B01AC22

INN (שם בינלאומי):

PRASUGRELBESILAAT COMPOSITION corresponding to ; PRASUGREL

טופס פרצבטיות:

Filmomhulde tablet

הרכב:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

מסלול נתינה (של תרופות):

Oraal gebruik

איזור תרפויטי:

Prasugrel

תאריך אישור:

2018-08-13

עלון מידע

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

מאפייני מוצר

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prasugrel Aristo 5 mg, filmomhulde tabletten
Prasugrel Aristo 10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prasugrel Aristo 5 mg film-coated tablets
Each tablet contains 5 mg prasugrel (as besylate).
Excipient with known effect: This medicine contains less than 1 mmol
sodium (23 mg) per tablet.
Prasugrel Aristo 10 mg film-coated tablets
Each tablet contains 10 mg prasugrel (as besylate).
Excipient with known effect: This medicine contains less than 1 mmol
sodium (23 mg) per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Prasugrel Aristo 5 mg film-coated tablets
Yellow double-arrow shaped tablets, debossed with “5” on one side,
9.81±0.1mm in length,
4.61±0.1mm in width, 2.5±0.3mm in thickness.
Prasugrel Aristo 10 mg film-coated tablets
Dark-beige double-arrow shaped tablets, debossed with “10 ” on one
side, 11.02±0.1mm in length,
5.20±0.1mm in width, 3.95±0.4mm in thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prasugrel Aristo, 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 Aristo 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 Aristo should also take ASA daily (75 mg to
325 mg).
2
In patients with acute coronary syndrome (ACS) who are managed with
P