Blomensy 15 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rivaroxaban

Available from:

EGIS Pharmaceuticals PLC

ATC code:

B01AF01

INN (International Name):

Rivaroxaban

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

rivaroxaban

Authorization status:

Marketed

Authorization date:

2023-01-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BLOMENSY 15 MG FILM-COATED TABLETS
BLOMENSY 20 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
Blomensy film-coated tablet contains the active substance rivaroxaban.
Blomensy 15 mg and 20 mg film-coated tablets are used in adults to:
-
prevent blood clots in brain (stroke) and other blood vessels in your
body if you have a form of
irregular heart rhythm called non-valvular atrial fibrillation.
-
treat blood clots in the veins of your legs (deep vein thrombosis) and
in the blood vessels of your
lungs (pulmonary embolism), and to prevent blood clots from
re-occurring in the blood vessels of
your legs and/or lungs.
Blomensy 15 mg and 20 mg film-coated tablets are used in children and
adolescents below 18 years
and with a body weight of 30 kg or more to:
-
treat blood clots and prevent re-occurrence of blood clots in the
veins or in the blood vessels of
the lungs, following initial treatment of at least 5 days with
injectable medicines used to treat
blood clots.
Blomensy belongs to a group of medicines called antithrombotic agents.
It works by blocking a blood
clotting factor (factor Xa) and thus reducing the tendency of the
blood to form clots.
2.
WHAT YOU NEED TO KNOW BEFORE Y

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2023
CRN00DM9D
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blomensy 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, biconvex reddish-brown coloured film-coated tablet with E843
sign on one side and no sign on the other side with
approximately 8.1 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_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.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT and PE in adults.
(See section 4.4 for haemodynamically unstable PE patients.)
_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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of stroke and systemic embolism in adults_
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with Blomensy should be continued long term provided the
benefit of prevention of stroke and systemic embolism
outweighs the risk of bleeding (see section 4.4).
If a dose is missed the patient should take Blomensy immediately and
continue on the following day with the once daily intake
as recommended. The dose should not be doubled within the same day to
make up for a missed dose.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE in adults_
The recommended dose for the initial treatment of acute DVT or PE is
15 mg twice daily for the first three wee