Rivaroxaban Viatris (previously Rivaroxaban Mylan)

País: Unió Europea

Idioma: anglès

Font: EMA (European Medicines Agency)

ingredients actius:

rivaroxaban

Disponible des:

Mylan Ireland Limited

Codi ATC:

B01AF01

Designació comuna internacional (DCI):

rivaroxaban

Grupo terapéutico:

Antithrombotic agents

Área terapéutica:

Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation

indicaciones terapéuticas:

Rivaroxaban Mylan 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. Rivaroxaban Mylan 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. ------Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.-------Adults Prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. 

Resumen del producto:

Revision: 4

Estat d'Autorització:

Authorised

Data d'autorització:

2021-11-12

Informació per a l'usuari

186
B. PACKAGE LEAFLET
187
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN VIATRIS 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.
IMPORTANT: The Rivaroxaban Viatris pack includes a Patient Alert Card
which contains
important safety information. Keep this card with you at all times
WHAT IS IN THIS LEAFLET
1.
What Rivaroxaban Viatris is and what it is used for
2.
What you need to know before you take Rivaroxaban Viatris
3.
How to take Rivaroxaban Viatris
4.
Possible side effects
5.
How to store Rivaroxaban Viatris
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN VIATRIS IS AND WHAT IT IS USED FOR
You have been given Rivaroxaban Viatris 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 Viatris
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 Viatris 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 Viatris reduces the risk in adults of getting blot clots
(atherothrombotic eve

Fitxa tècnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Viatris 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 19.24 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 to yellow coloured, film-coated, round, biconvex, beveled
edge tablet (5.4 mm diameter)
marked with
“RX”
on one side of the tablet and
“1”
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rivaroxaban Viatris 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 Viatris 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 Viatris 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 Viatris should be started as soon as
possible after stabilisation of the
ACS event (including revascularisation procedures); at the earliest 24
hours after