Lixiana 60 mg Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Edoxaban Tosilate

Boleh didapati daripada:

A. MENARINI SINGAPORE PTE. LTD.

INN (Nama Antarabangsa):

Edoxaban Tosilate

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

DAIICHI SANKYO EUROPE GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
LIXIANA FILM-COATED TABLETS
Edoxaban (15, 30 and 60 mg)
What is in this leaflet?
1.
What Lixiana is used for
2.
How Lixiana works
3.
Before you use Lixiana
4.
How to use Lixiana
5.
While you are using Lixiana
6.
Side effects
7.
Storage and Disposal of Lixiana
8.
Product Description
9.
Manufacturer and
Product
Registration holder
10.
Date of revision
1. WHAT LIXIANA IS USED FOR
Lixiana is used in adults to:
-
prevent
blood
clots
in
the
brain
(stroke) and other blood vessels in
the
body if
you
have
a
form of
irregular
heart
rhythm
called
nonvalvular
atrial
fibrillation
and
at least one additional
risk
factor
such
as
congestive
heart
failure,
high
blood
pressure;treat
blood
clots in the veins of the
legs (deep
vein thrombosis) and in the
blood
vessels
in
the
lungs
(pulmonary
embolism),
and
to
prevent
blood
clots
from re-occurring in the blood
vessels
in the legs and/or lungs.
2. HOW LIXIANA WORKS
Lixiana
contains
the
active
substance
edoxaban and belongs to a group of
medicines
called
anticoagulants.
This
medicine helps to prevent blood clots
from forming. It works by blocking the
activity
of
factor
Xa,
which
is
an
important component of blood clotting.
3. BEFORE YOU USE LIXIANA
_- When you must not use it_
-
if you are allergic to edoxaban or
any of the other ingredients of this
medicine.
(listed
in
section
Ingredients);
-
if you are actively bleeding
-
if
you
have
a
disease
or
condition that increases the risk
of
serious
bleeding
(e.g.
stomach ulcer, injury or bleeding
in the brain, or recent surgery of
the brain or eyes)
-
if you are taking other medicines
to
prevent
blood
clotting
(e.g.
warfarin, dabigatran, rivaroxaban,
apixaban or heparin), except when
changing
anticoagulant
treatment
or while getting heparin through a
venous or arterial line to keep it
open
-
if you have a liver disease which
leads
to
an
increased
risk
of
bleeding
-
if
you
have
uncontrolled
high
blood pressure
-
if
you
are
pregnant
or
breast
feeding
_- Before you start to use it_
Talk to you

Ciri produk

1
LIXIANA PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Lixiana 15 mg film-coated tablets Lixiana 30 mg film-coated tablets
Lixiana 60 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lixiana 15 mg film-coated tablets:
Each film-coated tablet contains 15 mg edoxaban (as tosilate).
Lixiana 30 mg film-coated tablets:
Each film-coated tablet contains 30 mg edoxaban (as tosilate).
Lixiana 60 mg film-coated tablets:
Each film-coated tablet contains 60 mg edoxaban (as tosilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Lixiana 15 mg film-coated tablets:
Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed
with “DSC L15”.
Lixiana 30 mg film-coated tablets:
Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with
“DSC L30”.
Lixiana 60 mg film-coated tablets:
Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed
with “DSC L60”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lixiana is indicated in prevention of stroke and systemic embolism in
adult patients with nonvalvular
atrial fibrillation
(NVAF) with one or more risk factors, such as congestive heart
failure, hypertension,
age ≥ 75 years, diabetes mellitus, prior stroke or transient
ischaemic attack (TIA).
Lixiana is indicated in treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and
for the prevention of recurrent DVT and PE in adults (see section 4.4
for haemodynamically unstable
PE patients).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of stroke and systemic embolism_
The recommended dose is 60 mg edoxaban once daily.
Therapy with edoxaban in NVAF patients should be continued long term.
2
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE (VTE)_
The recommended dose is 60 mg edoxaban once daily following initial
use of parenteral anticoagulant
for at least 5 days (see section 5.1). Edoxaban and initial parenteral
anticoagulant should not be
administered simultaneously.
The