Drullub 10 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PRASUGRELHYDROBROMIDE SAMENSTELLING overeenkomend met ; PRASUGREL

Beschikbaar vanaf:

Sigillata Limited Block A, 15 Castleforbes Square, Sheriff Street DUBLIN 1 (IERLAND)

ATC-code:

B01AC22

INN (Algemene Internationale Benaming):

PRASUGRELHYDROBROMIDE COMPOSITION corresponding to ; PRASUGREL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLDIBEHENAAT ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MANNITOL (D-) (E 421) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SUCROSESTEARAAT (E 473) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Prasugrel

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLDIBEHENAAT; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MANNITOL (D-) (E 421); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SUCROSESTEARAAT (E 473); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-04-25

Bijsluiter

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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Drullub 5 mg filmomhulde tabletten
Drullub 10 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_5 mg:_
Each film-coated tablet contains 5 mg prasugrel (as hydrobromide).
Excipient with known effect: Each film-coated tablet contains 2.75 mg
sucrose stearate which contains
0.11 mg sucrose.
_10 mg:_
Each film-coated tablet contains 10 mg prasugrel (as hydrobromide).
Excipient with known effect: Each film-coated tablet contains 5.5 mg
sucrose stearate which contains
0.22 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_5 mg:_
Yellow, oval film-coated tablets, debossed with "P5" on one side and
plain on the other side of
the tablet. Dimensions: approx. 9 x 4 mm.
_10 mg:_
Beige, oval film-coated tablets, debossed with "P10" on one side and a
score line on the other
side of the tablet. Dimensions: approx. 11 x 6 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Drullub, 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 _
Drullub 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
Drullub 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 Dr