Rivaroxaban Denk 2,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RIVAROXABAN 2,5 mg/stuk

Beschikbaar vanaf:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

ATC-code:

B01AF01

INN (Algemene Internationale Benaming):

RIVAROXABAN 2,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rivaroxaban

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-01-16

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN DENK 2,5 MG, FILMOMHULDE TABLETTEN
Rivaroxaban
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 [Product Name] is and what it is used for
2.
What you need to know before you take [Product Name]
3.
How to take [Product Name]
4.
Possible side effects
5.
How to store [Product Name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
You have been given [Product Name] because
-
you have been diagnosed with an acute coronary syndrome (a group of
conditions that
includes heart attack and unstable angina, a severe type of chest
pain) and have been
shown to have had an increase in certain cardiac blood tests.
[Product Name] reduces the risk in adults of having another heart
attack or reduces the
risk of dying from a disease related to your heart or your blood
vessels.
[Product Name] will not be given to you on its own. Your doctor will
also tell you to
take either:
•
acetylsalicylic acid or
•
acetylsalicylic acid plus clopidogrel or ticlopidine.
[Product Name] contains the active substance rivaroxaban and belongs
to a group of
medicines called antithrombotic agents. It works by blocking a blood
clotting factor (factor
Xa) and thus reducing the tendency of the blood to form clots.
bevat de werkzame stof rivaroxaban, dat ook bij de
behandeling van
aandoeningen wordt gebruikt die niet in deze bijsluiter staan vermeld.
Neem contact op met
uw arts of apotheker als u vragen heeft
2.
WHAT YOU NEED

Productkenmerken

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Denk 2,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 23.9 mg lactose monohydrate, see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, biconvex film-coated tablet, engraved with “RVX” on
one side, plain on the
other with a diameter of 6.1 mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product Name], co-administered with acetylsalicylic acid (ASA) alone
or with ASA plus
clopidogrel or ticlopidine, is indicated for the prevention of
atherothrombotic events in adult
patients after an acute coronary syndrome (ACS) with elevated cardiac
biomarkers (see
sections 4.3, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2.5 mg twice daily.
Patients taking [Product name] 2.5 mg twice daily should also take a
daily dose of 75 –
100 mg ASA or a daily dose of 75 – 100 mg ASA in addition to either
a daily dose of 75 mg
clopidogrel or a standard daily dose of ticlopidine.
Treatment should be regularly evaluated in the individual patient
weighing the risk for
ischaemic events against the bleeding risks. Extension of treatment
beyond 12 months should
be done on an individual patient basis as experience up to 24 months
is limited (see section
5.1).
2
_ _
Treatment with [Product Name] should be started as soon as possible
after stabilisation of the
ACS event (including revascularisation procedures); at the earliest 24
hours after admission
to hospital and at the time when parenteral anticoagulation therapy
would normally be
discontinued.
_Co-administration with antiplatelet therapy _
In patients with an acute thrombotic event or vascular procedure and a
need for dual
antiplatelet therapy, the continuation of [Product Name] 2.5 mg twice
daily should be
evaluated dependin