RIVAXORED (Rivaroxaban Tablets 2.5 mg)

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

RIVAROXABAN

Dostupné s:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Mezinárodní Name):

RIVAROXABAN

Jednotky v balení:

30 Tablets; 60 Tablets

Výrobce:

Dr Reddys Laboratories Limited

Informace pro uživatele

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RIVAXORED (RIVAROXABAN TABLETS 2.5MG)
_RIVAROXABAN _(2.5MG)
1
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 and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _RIVAXORED _IS USED FOR
You have been given Rivaxored because
(1) You have been diagnosed with a high
risk
of
getting
a
blood
clot
due
to
a
coronary artery disease and/or peripheral
artery disease which causes symptoms.
Rivaxored reduces the risk in adults of
getting
blot
clots
[major
atherothrombotic events (cardiovascular
death, myocardial infarction and stroke)].
Rivaxored will not be given to you on its
own. Your doctor will also tell you to
take acetylsalicylic acid.
HOW _RIVAXORED _WORKS
Rivaxored contains the active substance
rivaroxaban and 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 an acute coronary
syndrome and previously had a
bleeding or a blood clot in your brain
(stroke)
-
if you have coronary artery disease
and/or peripheral artery disease and
previously had a bleeding in your br

Charakteristika produktu

PACK INSERT
1
1. NAME OF THE MEDICINAL PRODUCT
RIVAXORED (Rivaroxaban Tablets 2.5 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
Excipient with known effect
Each 2.5mg film-coated tablet contains lactose monohydrate, see
section 4.4.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Light Yellow colored, round biconvex film coated tablets, engraved
with ‘2,5’ on one side and
plain on other side
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rivaxored, co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention of
major atherothrombotic events (cardiovascular death, myocardial
infarction & stroke) in adult
patients with coronary artery disease (CAD) and/or symptomatic
peripheral artery disease (PAD)
at high risk of ischaemic events.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2.5 mg twice daily.
_CAD _
and
_/_
or
_PAD _
Patients taking Rivaxored 2.5 mg twice daily should also take a daily
dose of 100 mg ASA.
Duration of treatment should be determined for each individual patient
based on regular
evaluations and should consider the risk for thrombotic events versus
the bleeding risks.
If a dose is missed the patient should continue with the regular dose
as recommended at the next
scheduled time. The dose should not be doubled to make up for a missed
dose
_ _
_Converting from Vitamin K Antagonists (VKA) to Rivaxored _
When converting patients from VKAs to Rivaxored, International
Normalised Ratio (INR) values
could be falsely elevated after the intake of Rivaxored. The INR is
not valid to measure the
anticoagulant activity of Rivaxored, and therefore should not be used
(see section 4.5).
_Converting from Rivaxored to Vitamin K antagonists (VKA) _
There is a potential for inadequate anticoagulation during the
transition from Rivaxored to VKA.
Continuous adequate anticoagulation should be ensured during any
transition to an alternate
anticoagulant. It should be noted that Rivaxored c