Xabarem 2.5 mg film-coated tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Предлага се от:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

АТС код:

B01AF01

INN (Международно Name):

RIVAROXABAN 2.5 mg

Лекарствена форма:

FILM-COATED TABLET

Композиция:

RIVAROXABAN 2.5 mg

Вид предписание :

POM

Терапевтична област:

ANTITHROMBOTIC AGENTS

Статус Оторизация:

Authorised

Дата Оторизация:

2023-01-16

Листовка

Page
1
of
9
PACKAGE LEAFLET: INFORMATION FOR THE USER
XABAREM 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 Xabarem is and what it is used for
2.
What you need to know before you take Xabarem
3.
How to take Xabarem
4.
Possible side effects
5.
How to store Xabarem
6.
Contents of the pack and other information
1.
WHAT XABAREM IS AND WHAT IT IS USED FOR
You have been given Xabarem 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.
Xabarem 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.
Xabarem 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.
Xabarem reduces the risk in adults of getting blot clots
(atherothrombotic events).
Xabarem will not be given to you on its own. Your doctor will also
tell you to take
acetylsalicylic acid.
Page
2
of
9
In some cases, if you get Xabarem after a procedure to open a narrowed
or
closed artery of your leg to restore blood flow, your doctor may also
prescribe clopidogrel

Данни за продукта

Page
1
of
31
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xabarem 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 23.25 mg lactose (as monohydrate),
see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow, round film-coated tablets, debossed with ‘2.5’ on
one side and plain on
the other side, with diameter 6.1 mm ± 5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xabarem, 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).
Xabarem,
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 Xabarem 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
Page
2
of
31
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 Xabarem 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.