Blomensy 2.5 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Rivaroxaban

Boleh didapati daripada:

EGIS Pharmaceuticals PLC

Kod ATC:

B01AF01

INN (Nama Antarabangsa):

Rivaroxaban

Borang farmaseutikal:

Film-coated tablet

Kawasan terapeutik:

rivaroxaban

Status kebenaran:

Marketed

Tarikh kebenaran:

2023-01-06

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
BLOMENSY 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 Blomensy is and what it is used for
2.
What you need to know before you take Blomensy
3.
How to take Blomensy
4.
Possible side effects
5.
How to store Blomensy
6.
Contents of the pack and other information
1.
WHAT BLOMENSY IS AND WHAT IT IS USED FOR
You have been given Blomensy 2.5 mg film-coated tablets 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.
Blomensy 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.
Blomensy 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.
Blomensy reduces the risk in adults of getting blot clots
(atherothrombotic events). Blomensy
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 Blomensy after a procedure to open a
narrowed or closed artery of
your leg to restore blood flow, your doctor may also prescr

Ciri produk

Health Products Regulatory Authority
28 August 2023
CRN00DM9D
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blomensy 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex light pink coloured film-coated tablet with E841 sign
on one side and no sign on the other side with
approximately 8.1 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Blomensy 2.5 mg film-coated tablets, 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).
Blomensy 2.5 mg film-coated tablets, 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 Blomensy 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 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 discont