Rivaroxaban Sandoz 20 mg, filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

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

Aktiva substanser:

RIVAROXABAN 20 mg/stuk

Tillgänglig från:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-kod:

B01AF01

INN (International namn):

RIVAROXABAN 20 mg/stuk

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (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),

Administreringssätt:

Oraal gebruik

Terapiområde:

Rivaroxaban

Produktsammanfattning:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (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);

Tillstånd datum:

2017-11-23

Bipacksedel

Sandoz B.V.
Rivaroxaban Sandoz 15 mg en 20 mg, filmomhulde tabletten
RVG 120075-6
1313-V16
1.3.1.3 Bijsluiter
Juni 2023
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
RIVAROXABAN SANDOZ 15 MG, FILMOMHULDE TABLETTEN
RIVAROXABAN SANDOZ 20 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 [Nationally Completed Name] is and what it is used for
2.
What you need to know before you take [Nationally Completed Name]
3.
How to take [Nationally Completed Name]
4.
Possible side effects
5.
How to store [Nationally Completed Name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally Completed Name] contains the active substance rivaroxaban
and 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.
[Nationally Completed Name] 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.
[Nationally Completed Name] belongs

Produktens egenskaper

Sandoz B.V.
Rivaroxaban Sandoz 20 mg, filmomhulde tabletten
RVG 120076
1311-V12
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2023
1.
NAAM VAN HET GENEESMIDDEL
Rivaroxaban Sandoz 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of rivaroxaban.
Excipients with known effects
Each film-coated tablet contains 56.999 mg of lactose (as monohydrate)
and 0.720 mg of sunset
yellow FCF aluminium lake (E 110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange coloured, round, biconvex film-coated tablet marked with
‘20’ on one side, with a
diameter of 7 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 more than 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
Sandoz B.V.
Rivaroxaban Sandoz 20 mg, filmomhulde tabletten
RVG 120076
1311-V12
1