Rivax 20mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RIVAROXABAN

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

RIVAROXABAN

Unit dalam pakej:

6 x 10 Tablets; 3 x 10 Tablets; 1 x 10 Tablets; 10 x 10 Tablets; 50 x 10 Tablets; 100 x 10 Tablets; 2 x 14 Tablets; 1 x 14 Table

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RIVAX 20MG FILM COATED TABLETS
Rivaroxaban 20mg
1
WHAT IS IN THIS LEAFLET
1.
What Rivax is used for
2.
How Rivax works
3.
Before you use Rivax
4.
How to use Rivax
5.
While you are using Rivax
6.
Side effects
7.
Storage and Disposal of Rivax
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT RIVAX IS USED FOR
Rivax contains the active substance
Rivaroxaban and 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.
HOW RIVAX WORKS
Rivax
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 RIVAX
−
_When you must not use it _
Do not take Rivax
-
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
breast-
feeding
-
do not take Rivax and tell your
doctor if any of these apply to
you.
-
_Before you start to use it_
_Warnings and precautions _
Talk to your doctor or pharmacist
before taking Rivax.
_Take special care with Rivax _
-
if you have

Ciri produk

RIVAX 20MG FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Rivax 20mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg of Rivaroxaban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Brown red, round biconvex film-coated tablet debossed with ‘E3’ 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of stroke and systemic embolism _
The recommended dose is 20mg once daily, which is also the recommended
maximum dose.
Therapy with Rivax 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 Rivax 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
15mg twice daily for the
first three weeks followed by 20mg once daily for the continued
treatment and prevention of
recurrent DVT and PE.
Short duration of therapy (at least 3 months) should be considered in
patients with DVT or PE
provoked by major transient risk factors (i.e. recent major surgery or
trauma). Longer duration
of therapy should be considered in patients with provoked DVT or PE
not related to major
transient risk factors, unprovoked DVT or PE, or a history of
recurrent DVT or PE.
When extended prevention of recurrent D