RIVAXORED (Rivaroxaban Tablets 20mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RIVAROXABAN

Boleh didapati daripada:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

RIVAROXABAN

Unit dalam pakej:

14 Tablets; 28 Tablets

Dikeluarkan oleh:

DR. REDDY'S LABORATORIES LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Page 1
RIVAXORED (RIVAROXABAN TABLETS 20MG)
_RIVAROXABAN _(20MG)
WHAT IS IN THIS LEAFLET
1.
What Rivaxored is used for
2.
How Rivaxored works
3.
Before you use Rivaxored
4.
How to use Rivaxored
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Rivaxored
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT RIVAXORED IS USED FOR
Rivaxored 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 RIVAXORED WORKS
Rivaxored 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 RIVAXORED
-
_When you must not use it _
Do not take Rivaxored
- 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 Rivaxored 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 Riv

Ciri produk

PACK INSERT
Page 1 of 17
RIVAXORED (RIVAROXABAN TABLETS 20MG)
1.
NAME OF THE MEDICINAL PRODUCT
RIVAXORED (Rivaroxaban Tablets 20mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RIVAXORED (Rivaroxaban Tablets 20mg)
Each film-coated tablet contains 20 mg rivaroxaban.
Excipients: Each 20 mg film-coated tablet contains lactose
monohydrate, see section 4.4.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
RIVAXORED (Rivaroxaban Tablets 20mg) – Dark red colored, round
biconvex film coated tablets,
engraved with ‘20’ on one side and plain on other side
4.
CLINICAL INFORMATION
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 Rivaxored 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 Rivaxored 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 - 21
15 mg twice daily
30 mg
Day 22 and onwards