Rivaroxaban Sandoz 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RIVAROXABAN 10 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

B01AF01

INN (Algemene Internationale Benaming):

RIVAROXABAN 10 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) ; TALK (E 553 B) ; 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); TALK (E 553 B); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);

Autorisatie datum:

2017-11-23

Bijsluiter

Sandoz B.V.
Rivaroxaban Sandoz 10 mg, filmomhulde tabletten
RVG 120074
1313-V15
1.3.1.3 Bijsluiter
Mei 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVAROXABAN SANDOZ 10 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 the
veins after a hip or knee replacement operation. Your
doctor has prescribed this medicine for you because after an operation
you are at an
increased risk of getting blood clots.
−
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] 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
-
if you are allergic to rivaroxaban or any of the other ingredients

Productkenmerken

Sandoz B.V.
Sandoz B.V.
Rivaroxaban Sandoz 10 mg, filmomhulde tabletten
1311-V11
RVG 120074
Mei 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Sandoz 10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of rivaroxaban.
Excipients with known effect
Each film-coated tablet contains 46.050 mg of lactose (as monohydrate)
and 0.081 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.
Peach coloured, round, biconvex film-coated tablets marked with
‘10’ on one side, with a
diameter of 6 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or
knee
replacement surgery.
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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of VTE in adult patients undergoing elective hip or knee
replacement surgery _
The recommended dose is 10 mg rivaroxaban taken orally once daily. The
initial dose should
be taken 6 to 10 hours after surgery, provided that haemostasis has
been established.
The
duration
of
treatment
depends
on
the
individual
risk
of
the
patient
for
venous
thromboembolism
which is determined by the type of orthopaedic surgery.
•
For
patients
undergoing
major
hip
surgery,
a
treatment
duration
of
5
weeks
is
recommended.
Sandoz B.V.
Sandoz B.V.
Rivaroxaban Sandoz 10 mg, filmomhulde tabletten
1311-V11
RVG 120074
Mei 2023
•
For
patients
undergoing
major
knee
surgery,
a
treatment
duration
of
2
weeks
is
recommended.
If a dose is missed the patient should take rivaroxaban immediately
and then continue the
following day with once daily intake as before.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE _
The recommended dose for the initial treatment