Xarelto tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rivaroxaban

Available from:

Bayer AG

ATC code:

B01AF01

INN (International Name):

rivaroxaban

Dosage:

2,5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(56/4x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-01-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
XARELTO 2.5 MG FILM-COATED TABLETS
rivaroxaban
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Xarelto is and what it is used for
2.
What you need to know before you take Xarelto
3.
How to take Xarelto
4.
Possible side effects
5.
How to store Xarelto
6.
Contents of the pack and other information
1.
WHAT XARELTO IS AND WHAT IT IS USED FOR
You have been given Xarelto 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.
Xarelto 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.
Xarelto 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.
Xarelto reduces the risk in adults of getting blot clots
(atherothrombotic events).
Xarelto will not be given to you on its own. Your doctor will al

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 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 33.92 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 tablets (6 mm diameter, 9 mm radius of
curvature) marked with the
BAYER-cross on one side and "2.5" and a triangle on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xarelto, 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).
Xarelto, 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 Xarelto 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).
3