Xabarem 15 mg film-coated tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Beschikbaar vanaf:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC-code:

B01AF01

INN (Algemene Internationale Benaming):

RIVAROXABAN 15 mg

farmaceutische vorm:

FILM-COATED TABLET

Samenstelling:

RIVAROXABAN 15 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTITHROMBOTIC AGENTS

Autorisatie-status:

Authorised

Autorisatie datum:

2023-01-16

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
XABAREM 15 MG FILM-COATED TABLETS
XABAREM 20 MG FILM-COATED TABLETS
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 Xabarem is and what it is used for
2.
What you need to know before you take Xabarem
3.
How to take Xabarem
4.
Possible side effects
5.
How to store Xabarem
6.
Contents of the pack and other information
1.
WHAT XABAREM IS AND WHAT IT IS USED FOR
Xabarem contains the active substance rivaroxaban.
Xabarem 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.
Xabarem 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.
Xabarem 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 XABAREM
DO NOT TAKE XABAREM
-
if you are allergic to rivaroxaban or any of the oth

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xabarem 15 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
15
m g rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 16.50 mg lactose (as monohydrate),
see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Red, round film-coated tablet debossed with ‘15’ on one side and
plain on the other
side, with diameter 6.1 mm ± 5%.
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 _
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The recommended dose is 20 mg once daily, which is also the
recommended maximum
dose.
Therapy with Xabarem 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 Xabarem 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