Rivaroxaban AET 15 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RIVAROXABAN 15 mg/stuk

Beschikbaar vanaf:

Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)

ATC-code:

B01AF01

INN (Algemene Internationale Benaming):

RIVAROXABAN 15 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 ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),

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 ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);

Autorisatie datum:

2017-11-23

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR
THE USER
RIVAROXABAN AET 15 MG FILM-COATED TABLETS
RIVAROXABAN AET 20 MG FILM-COATED TABLETS
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 RIVAROXABAN AET
is and what it is used for?
2.
What you need to know before you take RIVAROXABAN AET
3.
How to take RIVAROXABAN AET?
4.
Possible side effects
5.
How to store RIVAROXABAN AET?
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN AET IS AND WHAT IT IS USED FOR
RIVAROXABAN AET contains the active substance rivaroxaban.
RIVAROXABAN AET is used in adults to:
-
prevent blood clots in brain (stroke) and other blood vessels in your
body if you have a
form of irregular heart rhythm called non valvular atrial
fibrillation.
-
treat blood clots in the veins of your legs (deep vein thrombosis) and
in the blood
vessels of your lungs (pulmonary embolism), and to prevent blood clots
from re-
occurring in the blood vessels of your legs and/or lungs.
RIVAROXABAN AET is used in children and adolescents below 18 years and
with a
body weight of 30 kg or more to:
•
treat blood clots and prevent re-occurrence of blood clots in the
veins or in the blood
vessels of the lungs, following initial treatment of at least 5 days
with injectable
medicines used to treat blood clots.
RIVAROXABAN AET 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
RIVAROXABAN AET 15 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
Excipients with known effect:
Each film-coated tablet contains 42.749 mg lactose (as monohydrate),
see section 4.4.
Each film-coated tablet contains 0.114 mg sunset yellow FCF aluminium
lake (E110), see section 4.4.
Each film-coated tablet contains 0.3146 mg sodium, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light orange coloured, round, biconvex film coated tablet marked with
‘15’ on one side, with a diameter of 6
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults _
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation with one or
more risk factors, such as congestive heart failure, hypertension, age
≥
75 years, diabetes mellitus, prior stroke
or transient ischaemic attack.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT
and PE in adults. (See section 4.4 for haemodynamically unstable PE
patients.)
_Paediatric population _
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing from 30 kg to 50 kg
after at least 5 days of initial
parenteral anticoagulation treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of stroke and systemic embolism in adults_
_ _
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with rivaroxaban should be continued long term provided the
benefit of prevention of stroke and
systemic embolism outweighs the risk of bleeding (see section 4.4).
If a dose is missed the patient should take rivaroxaban immediately
and continue on the following day with
the once daily intake as recommended. The dose should not be doubled
within the same day to make up for
a missed dose.
_Treatment of DVT, tre