RIVALTO 20 MG TABLETS

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

RIVAROXABAN

Verfügbar ab:

GENPHARMA SDN. BHD

INN (Internationale Bezeichnung):

RIVAROXABAN

Einheiten im Paket:

30 Tablets

Hergestellt von:

Alembic Pharmaceuticals Limited (Formulation Division)

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RIVALTO TABLETS
Rivaroxaban 15 mg and 20 mg
_
WHAT IS IN THIS LEAFLET
1.
What
_RIVALTO _
is used for
2.
How
_RIVALTO _
works
_3._
_ _
Before you use
_RIVALTO _
_4._
_ _
How to use
_RIVALTO _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and disposal of
_RIVALTO _
8.
Product description
9.
Manufacturer
and
Product Registration Holder
10.
Date of revision
11.
Serial number
WHAT RIVALTO 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
Rivalto for another reason.
Rivalto is a prescription medicine. It
should only be used in adults under
medical supervision.
HOW RIVALTO 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 RIVALTO
-
_When you must not take it _
Do not take Rivalto:
•
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 are pregnant or

Fachinformation

1.
NAME OF THE MEDICINAL PRODUCT
RIVALTO 15 MG TABLETS
RIVALTO 20 MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
Each film-coated tablet contains 20 mg rivaroxaban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Rivalto 15 mg film-coated tablets are Round, brown, film-coated
biconvex tablets debossed with ‘504’
on one side and plain on the other side.
Rivalto 20 mg film-coated tablets are Triangle shaped, brown,
film-coated tablets debossed with ‘505’
on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.)
4.2
POSOLOGY AND METHOD 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 (see section
4.4).
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 PE as indicated in the table below.
DOSING SCHEDULE
MAXIMUM DAILY DOSE
Day 1-