Rivaroxaban PharOS 2.5mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

RIVAROXABAN

Tilgængelig fra:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

ATC-kode:

B01AF01

INN (International Name):

RIVAROXABAN 2.5 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

RIVAROXABAN 2.5 mg

Recept type:

POM

Terapeutisk område:

ANTITHROMBOTIC AGENTS

Produkt oversigt:

Licence number in the source country: NOT APPLICAPABLE

Autorisation status:

Authorised

Autorisation dato:

2020-02-05

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN PHAROS
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 PharOS is and what it is used for
2.
What you need to know before you take Rivaroxaban PharOS
3.
How to take Rivaroxaban PharOS
4.
Possible side effects
5.
How to store Rivaroxaban PharOS
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN PHAROS IS AND WHAT IT IS USED FOR
You have been given Rivaroxaban PharOS 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 PharOS 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 PharOS
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 PharOS
reduces the risk in adults of getting blot clots
(atherothrombotic events).
Rivaroxaban PharOS
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 PharOS after a procedure to ope

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban PharOS 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 29.00 mg lactose, 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 tablets, debossed with “2.5” on one
side and plain on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rivaroxaban PharOS, 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 PharOS, 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 PharOS 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 PharOS 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 the time when parenteral
anticoagulation therapy
would normally be discontinued.
-
_CAD/PAD_