Rivaroxaban Sandoz 2,5 mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

RIVAROXABAN 2,5 mg/stuk

INN (International Name):

RIVAROXABAN 2,5 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; MACROGOL 400 ; 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 GEEL (E 172) ; LACTOSE 0-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Administration route:

Oraal gebruik

Authorization date:

1900-01-01

Patient Information leaflet

Sandoz B.V.
Page 1/10
Rivaroxaban 2,5 mg Filmomhulde tabletten
RVG 127715
1313-V4
1.3.1.3 Bijsluiter
Januari 2024
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _ RIVAROXABAN SANDOZ 2,5 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
You have been given [Nationally completed name] because
•
you have been diagnosed with an acute coronary syndrome (a group of
conditions that includes
heart attack and unstable angina, a severe type of chest pain) and
have been shown to have had
an increase in certain cardiac blood tests.
[Nationally completed name] reduces the risk in adults of having
another heart attack or
reduces the risk of dying from a disease related to your heart or your
blood vessels.
[Nationally completed name] will not be given to you on its own. Your
doctor will also tell you
to take either:
-
acetylsalicylic acid or
-
acetylsalicylic acid plus clopidogrel or ticlopidine.
or
•
you have been diagnosed with a high risk of getting a blood clot due
to a coronary artery
disease or peripheral artery disease which causes symptoms.
[Nationally completed name] reduces the risk in adults of getting blot
clots (atherothro

Summary of Product characteristics

Sandoz
Page 1/36
Rivaroxaban Sandoz 2,5 mg, filmomhulde tabletten
RVG 127715
1311-V4a
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Sandoz 2,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 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).
Light yellow, round biconvex tablets of 8.6 mm diameter, debossed with
‘2.5’ on one side and
plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name], co-administered with acetylsalicylic acid
(ASA) alone or with ASA
plus clopidogrel or ticlopidine, is indicated for the prevention of
atherothrombotic events in adult
patients after an acute coronary syndrome (ACS) with elevated cardiac
biomarkers (see sections 4.3,
4.4 and 5.1).
[Nationally completed name], co-administered with acetylsalicylic acid
(ASA), is indicated for the
prevention of atherothrombotic events in adult patients with coronary
artery disease (CAD) or
symptomatic peripheral artery disease (PAD) at high risk of ischaemic
events.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2.5 mg twice daily.
•
_ACS _
Sandoz
Page 2/36
Rivaroxaban Sandoz 2,5 mg, filmomhulde tabletten
RVG 127715
1311-V4a
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2024
Patients taking rivaroxaban 2.5 mg twice daily should also take a
daily dose of 75 - 100 mg ASA or a
daily dose of 75 - 100 mg ASA in addition to either a daily dose of 75
mg clopidogrel or a standard
daily dose of ticlopidine.
Treatment should be regularly evaluated in the individual patient
weighing the risk for ischaemic
events against the bleeding risks. Extension of treatment beyond 12
months should be done on an
individual patient basis as experience up to 24 months is limited