Xiltess 15 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RIVAROXABAN 15 mg/stuk

INN (Algemene Internationale Benaming):

RIVAROXABAN 15 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-12-05

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
XILTESS 15 MG FILMOMHULDE TABLETTEN
XILTESS 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 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
Xiltess film-coated tablet contains the active substance rivaroxaban.
Xiltess 15 mg and 20 mg film-coated tablets are 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.
Xiltess 15 mg and 20 mg film-coated tablets are 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.
Xiltess 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

Productkenmerken

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xiltess 15 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Round, biconvex reddish-brown coloured film-coated tablet with E843
sign on one side and no sign
on the other side with
approximately 8.1 mm diameter.
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 from 30 kg to 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 Xiltess 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 Xiltess 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 up for a missed dose.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE in adults _
The recommended dose for the initial treatment of acute DVT or PE is
15 mg twice daily for the first
three weeks followed by 20 mg once daily for the continued treatment