Rivaroxaban Sandoz 20 mg, filmomhulde tabletten

Country: Holland

Tungumál: hollenska

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

Virkt innihaldsefni:

RIVAROXABAN 20 mg/stuk

INN (Alþjóðlegt nafn):

RIVAROXABAN 20 mg/stuk

Lyfjaform:

Filmomhulde tablet

Samsetning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Stjórnsýsluleið:

Oraal gebruik

Leyfisdagur:

1900-01-01

Upplýsingar fylgiseðill

Sandoz B.V.
Page 1/12
Rivaroxaban Sandoz 15 mg, filmomhulde tabletten
Rivaroxaban Sandoz 20 mg, filmomhulde tabletten
RVG 127717-127718
1313-V4
1.3.1.3 Bijsluiter
Januari 2024
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
[Nationally completed name] 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
injecta

Vara einkenni

Sandoz
Page 1/33
Rivaroxaban Sandoz 20 mg, filmomhulde tabletten
RVG 127718
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Sandoz 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg rivaroxaban.
Excipient(s) with known effect
Each film-coated tablet contains 29 mg lactose, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
[Nationally completed name] <20 mg> :
Brown-red, round biconvex tablets of 6.6 mm diameter, debossed with
‘20’ on one side and plain on the
other side.
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
within the same day to
make u