Rivaroxaban Medichem 2.5mg film-coated tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

RIVAROXABAN

Dostopno od:

Medichem, S.A. Fructuós Gelabert 6-8, 08970, Sant Joan Despí, (Barcellona), Spain

Koda artikla:

B01AF01

INN (mednarodno ime):

RIVAROXABAN 2.5 mg

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

RIVAROXABAN 2.5 mg

Tip zastaranja:

POM

Terapevtsko območje:

ANTITHROMBOTIC AGENTS

Status dovoljenje:

Authorised

Datum dovoljenje:

2019-03-13

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN MEDICHEM 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 Rivaroxaban Medichem is and what it is used for
2.
What you need to know before you take Rivaroxaban Medichem
3.
How to take Rivaroxaban Medichem
4.
Possible side effects
5.
How to store Rivaroxaban Medichem
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN MEDICHEM IS AND WHAT IT IS USED FOR
You have been given Rivaroxaban Medichem 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 Medichem 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
Medichem 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 Medichem reduces the r

Lastnosti izdelka

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
Rivaroxaban Medichem 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 31.65 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 marked with "III" on
one side.
The specific tablet dimensions are 5.95- 6.05 mm of diameter and 2.65
- 2.85 mm of thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rivaroxaban Medichem, 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 Rivaroxaban Medichem 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).