Xiltess 2,5 mg filmomhulde tabletten

Ülke: Hollanda

Dil: Hollandaca

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

Aktif bileşen:

RIVAROXABAN 2,5 mg/stuk

INN (International Adı):

RIVAROXABAN 2,5 mg/stuk

Farmasötik formu:

Filmomhulde tablet

Kompozisyon:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Uygulama yolu:

Oraal gebruik

Yetkilendirme tarihi:

2022-12-05

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
XILTESS 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 Xiltess is and what it is used for
2.
What you need to know before you take Xiltess
3.
How to take Xiltess
4.
Possible side effects
5.
How to store Xiltess
6.
Contents of the pack and other information
1.
WHAT XILTESS IS AND WHAT IT IS USED FOR
You have been given Xiltess 2.5 mg film-coated tablets 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.
Xiltess 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.
Xiltess 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.
Xiltess reduces the risk in adults of getting blot clots
(atherothrombotic events). Xiltess will not
be given to you on its own. Your doctor will also tell you to take
acetylsalicylic acid.
In some cases, if you get Xiltess after a procedure to open a narrowed
or closed artery of your
leg to restore blood flow, your doctor may also prescribe clopid

Ürün özellikleri

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xiltess 2,5 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex light pink coloured film-coated tablet with E841 sign
on one side and no sign on the
other side with approximately 8.1 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xiltess 2.5 mg film-coated tablets, 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).
Xiltess 2.5 mg film-coated tablets, 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 _
Patients taking Xiltess 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 (see section
5.1).
Treatment with rivaroxaban should be started as soon as possible after
stabilisation of the ACS event
(including revascularisation procedures); at the earliest 24 hours
after admission to hospital and at the
time when parenteral anticoagulation therapy would normally be
discontinued.
_ _
•
_CAD/PAD _
Patients taking Xiltess 2.5 mg twice daily