Xarelto 20 mg film-coated tablet

Country: Malasja

Lingwa: Ingliż

Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredjent attiv:

RIVAROXABAN

Disponibbli minn:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Isem Internazzjonali):

RIVAROXABAN

Unitajiet fil-pakkett:

14 Tablets; 28tablet Tablets

Manifatturat minn:

BAYER AG

Fuljett ta 'informazzjoni

XARELTO
®
Rivaroxaban (15 and 20 mg film-coated tablets)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Xarelto_
is used for
2.
How
_Xarelto_
works
3.
Before you use
_Xarelto_
4.
How to use
_Xarelto_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Xarelto_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _XARELTO_ IS USED FOR
Xarelto 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.
Xarelto 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.
HOW _XARELTO_ WORKS
Xarelto
_ _
contains
the
active
substance
rivaroxaban and 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.
BEFORE YOU USE _XARELTO _
- When you must not use it
DO NOT TAKE _XARELTO_
-
if you are allergic to rivaroxaban or
any of the other ingredients of this
medicine
-
if you are bleeding excessively
-
if you have a disease or condition in an
organ of the body that increases the
risk of serious bleeding (e.g. stomach
ulcer, injury or bleeding in the brain,
recent surgery of the brain or eyes)
-
if you are taking medicines to prevent
blood clotting (e.g. warfarin,
dabigatran, apixaban or heparin),
except when changing anticoagulant
treatment or while getting heparin
through a venous or arterial line to
k

Karatteristiċi tal-prodott

Date of text revision : Aug 2023
Reference :
E.Junior
1
XARELTO
®
FILM-COATED TABLET
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 15 mg film-coated tablet
Xarelto 20 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
XARELTO 15 MG
Each film-coated tablet contains 15 mg rivaroxaban.
Excipient(s):
Each 15 mg film-coated tablet contains 25.4 mg lactose monohydrate,
see section 4.4.
XARELTO 20 MG
Each film-coated tablet contains 20 mg rivaroxaban.
Excipient(s):
Each 20 mg film-coated tablet contains 22.9 mg lactose monohydrate,
see section 4.4.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
XARELTO 15 MG
Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature)
marked with the
BAYER-cross on one side and “15” and a triangle on the other side.
XARELTO 20 MG
Brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of
curvature) marked with the
BAYER-cross on one side and “20” and a triangle on the other 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.)
Date of text revision : Aug 2023
Reference :
E.Junior
2
_Paediatric population _
Xarelto 15 mg
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing from 30kg to 50 kg
after at least 5 days of initial
parenteral anticoagulation treatment.
Xarelto 20 mg
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing more than 50 kg after
at least 5 days of initial
parenteral a