Rivaroxaban 2.5 mg film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Rivaroxaban

Fáanlegur frá:

Flynn Pharma Limited

ATC númer:

B01AF01

INN (Alþjóðlegt nafn):

Rivaroxaban

Lyfjaform:

Film-coated tablet

Lækningarsvæði:

rivaroxaban

Leyfisstaða:

Not marketed

Leyfisdagur:

2024-01-26

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN 2.5 MG FILM-COATED TABLETS
rivaroxaban
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rivaroxaban is and what it is used for
2.
What you need to know before you take Rivaroxaban
3.
How to take Rivaroxaban
4.
Possible side effects
5.
How to store Rivaroxaban
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN IS AND WHAT IT IS USED FOR
You have been given Rivaroxaban because
-
you have been diagnosed with an acute coronary syndrome (a group of
conditions that
includes heart attack and unstable angina, a severe type of chest
pain) and have been
shown to have had an increase in certain cardiac blood tests.
Rivaroxaban reduces the risk in adults of having another heart attack
or reduces the risk
of dying from a disease related to your heart or your blood vessels.
Rivaroxaban will not be given to you on its own. Your doctor will also
tell you to take
either:

acetylsalicylic acid or

acetylsalicylic acid plus clopidogrel or ticlopidine.
or
-
you have been diagnosed with a high risk of getting a blood clot due
to a coronary artery
disease or peripheral artery disease which causes symptoms.
Rivaroxaban reduces the risk in adults of getting blot clots
(atherothrombotic events).
Rivaroxaban will not be given to you on its own. Your doctor will also
tell you to take
acetylsalicylic acid.
In some cases, if you get Rivaroxaban after a procedure to open a
narrowed or closed
artery of your leg to restore blood flow, your doctor may a

Vara einkenni

Health Products Regulatory Authority
29 January 2024
CRN00CYYY
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivaroxaban 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 22.350 mg lactose (as monohydrate),
see section 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light yellow, round, biconvex, film-coated tablets (5 mm diameter),
plain on the one side and with impressing „2,5" on the
second side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rivaroxaban, co-administered with acetylsalicylic acid (ASA) alone or
with ASA plus clopidogrel or ticlopidine, is indicated for
the prevention of atherothrombotic events in adult patients after an
acute coronary syndrome (ACS) with elevated cardiac
biomarkers (see sections 4.3, 4.4 and 5.1).
Rivaroxaban, co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention of atherothrombotic events in adult
patients with coronary artery disease (CAD) 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.

_ACS_
Patients taking Rivaroxaban 2.5 mg twice daily should also take a
daily dose of 75 - 100 mg ASA or a daily dose of 75 - 100 mg
ASA in addition to either a daily dose of 75 mg clopidogrel or a
standard daily dose of ticlopidine.
Treatment should be regularly evaluated in the individual patient
weighing the risk for ischaemic events against the bleeding
risks. Extension of treatment beyond 12 months should be done on an
individual patient basis as experience up to 24 months
is limited (see section 5.1).
Treatment with Rivaroxaban should be started as soon as possible after
stabilisation of the ACS event (including
revascularisation procedures); at the earliest 24 hours after
admission to hospital and at th