Xartil 15 mg filmomhulde tabletten

Country: Belanda

Bahasa: Belanda

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

Bahan aktif:

RIVAROXABAN 15 mg/stuk

INN (Nama Antarabangsa):

RIVAROXABAN 15 mg/stuk

Borang farmaseutikal:

Filmomhulde tablet

Komposisi:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; 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 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171)

Laluan pentadbiran:

Oraal gebruik

Tarikh kebenaran:

2023-12-22

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
XARTIL 15 MG FILMOMHULDE TABLETTEN
XARTIL 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 [PRODUCT NAME] is and what it is used for
2.
What you need to know before you take [PRODUCT NAME]
3.
How to take [PRODUCT NAME]
4.
Possible side effects
5.
How to store [PRODUCT NAME]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[PRODUCT NAME] contains the active substance rivaroxaban.
[PRODUCT 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.
[PRODUCT 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.
[PRODUCT NAME] 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 [PRODUCT NAME]
DO NOT TAKE [PRO

Ciri produk

ANNEX I
0B
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Xartil 15 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 16.3 mg lactose (as monohydrate), see
section 4.4.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
Brown, round, biconvex tablets (6 mm diameter, 9 mm radius of
curvature) with the
inscription “L3” on one 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 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 [PRODUCT NAME] 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 [PRODUCT NAME] 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 tw