Rivaroxaban Rowex 20 mg Film-coated tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Rivaroxaban

Доступна з:

Rowex Ltd

Код атс:

B01AF; B01AF01

ІПН (Міжнародна Ім'я):

Rivaroxaban

Дозування:

20 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Direct factor Xa inhibitors; rivaroxaban

Статус Авторизація:

Not marketed

Дата Авторизація:

2017-12-22

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVAROXABAN ROWEX 15 MG FILM-COATED TABLETS
RIVAROXABAN ROWEX 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 Rivaroxaban Rowex is and what it is used for
2.
What you need to know before you take Rivaroxaban Rowex
3.
How to take Rivaroxaban Rowex
4.
Possible side effects
5.
How to store Rivaroxaban Rowex
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN ROWEX IS AND WHAT IT IS USED FOR
Rivaroxaban Rowex contains the active substance rivaroxaban and is
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.
Rivaroxaban Rowex is 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.
Rivaroxaban Rowex 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

Характеристики продукта

Health Products Regulatory Authority
27 March 2024
CRN00F7C0
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Rowex 20 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg rivaroxaban.
Excipients with known effects
Each film-coated tablet contains 56.999 mg of lactose (as monohydrate)
and 0,720 mg of sunset yellow FCF aluminium lake
(E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange coloured, round, biconvex film coated tablet marked with
‘20’ on one side, with a diameter of 7 mm.
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 more than 50 kg after at least 5 days of initial
parenteral anticoagulation treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of stroke and systemicembolism in adults_
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with rivaroxaban 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 rivaroxaban 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 DVTand