Rivaroxaban Sandoz 20 mg, filmomhulde tabletten

Ülke: Hollanda

Dil: Hollandaca

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

Aktif bileşen:

RIVAROXABAN 20 mg/stuk

Mevcut itibaren:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

INN (International Adı):

RIVAROXABAN 20 mg/stuk

Farmasötik formu:

Filmomhulde tablet

Kompozisyon:

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

Uygulama yolu:

Oraal gebruik

Yetkilendirme tarihi:

2020-12-18

Bilgilendirme broşürü

Sandoz B.V.
Page 1/10
Rivaroxaban Sandoz
®
15 mg, 20 mg, filmomhulde
tabletten
RVG 125800-801
1313-V5
1.3.1.3 Bijsluiter
Mei 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 C

Ürün özellikleri

Sandoz B.V.
Page 1/35
Rivaroxaban Sandoz 20 mg filmomhulde tabletten
RVG 125801
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
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 of rivaroxaban.
Excipients with known effects:
Each film-coated tablet contains 57 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.
Sandoz B.V.
Page 2/35
Rivaroxaban Sandoz 20 mg filmomhulde tabletten
RVG 125801
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
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