RIROXATOR 15MG FILM COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RIVAROXABAN

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

RIVAROXABAN

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

Torrent Pharmaceuticals Ltd. - Indrad Plant

Risalah maklumat

RIROXATOR 15MG/20MG FILM COATED
TABLETS
Rivaroxaban 15 mg and 20 mg tablets
Consumer Medication Information Leaflet (RiMUP)
WHAT IS IN THIS LEAFLET
1.
What RIROXATOR is used for
2.
How RIROXATOR works
3.
Before you use RIROXATOR
4.
How to use RIROXATOR
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
RIROXATOR
8.
Product description
9.
Manufacturer
and
Product Registration Holder
10.
Date of revision
11.
Serial number
WHAT RIROXATOR IS USED FOR
Prevents blood clots in brain (stoke)
and other blood vessels in your body if
you
have
a
irregular
form
of
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 blood clots of your
legs and/or lungs.
Ask
your
doctor
if
you
have
any
questions about why this medicine has
been prescribed for you.
Your doctor may have prescribed
Riroxator for another reason.
Riroxator is a prescription medicine. It
should only be used in adults under
medical supervision.
HOW RIROXATOR WORKS
The active substance is rivaroxaban. It
belongs to a group of medicines called
antithrombotic. It works by inhibiting
the blood clotting protein called Factor
Xa, thus reducing the tendency of blood
to form clots.
BEFORE YOU USE RIROXATOR
-
_When you must not take it _
Do not take Riroxator:
•
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 keep it open
•
if you have a liver disease which
leads
to
an
increased
risk
of
bleeding
•
if
you

Ciri produk

PROPOSED PRESCRIBING INFORMATION
FOR THE USE OF A REGISTERED MEDICINAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY
RIROXATOR 15MG FILM COATED
TABLETS &
RIROXATOR 20MG FILM COATED
TABLETS
(RIVAROXABAN TABLETS 15MG &
20MG)
COMPOSITION
Each film coated tablet contains:
Rivaroxaban …………………15 mg
Colour: Red oxide of Iron
Excipients…………. q.s.
Each film coated tablet contains:
Rivaroxaban …………………20 mg
Colour: Red oxide of Iron
Excipients…………. q.s.
PRODUCT
DESCRIPTION
RIROXATOR 15MG FILM COATED TABLETS
Round, red, biconvex film-coated tablets having “A2” debossed on
one side and plain on other side.
RIROXATOR 20MG FILM COATED TABLETS
Dark red colored, oval shaped, biconvex film coated tablets with
“A3” debossed on one side and
plain on other side.
INDICATION(S)
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. DOSAGE AND MODE OF ADMINISTRATION
Posology
_Prevention of stroke and systemic embolism _
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with Rivaroxaban should be continued long term provided the
benefit of prevention
of stroke and systemic embolism outweighs the risk of bleeding.
If a dose is missed the patient should take Rivaroxaban 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 _
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 and prevention of
recurrent DVT and