Rivaroxaban Clonmel 15 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Rivaroxaban

Disponibil de la:

Clonmel Healthcare Ltd

Codul ATC:

B01AF01

INN (nume internaţional):

Rivaroxaban

Forma farmaceutică:

Film-coated tablet

Zonă Terapeutică:

rivaroxaban

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2023-01-13

Prospect

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rivaroxaban Clonmel 15 mg film-coated tablets
Rivaroxaban Clonmel 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 Clonmel is and what it is used for
2. What you need to know before you take Rivaroxaban Clonmel
3. How to take Rivaroxaban Clonmel
4. Possible side effects
5. How to store Rivaroxaban Clonmel
6. Contents of the pack and other information
1. WHAT RIVAROXABAN CLONMEL IS AND WHAT IT IS USED FOR
Rivaroxaban Clonmel contains the active substance rivaroxaban.
Rivaroxaban Clonmel 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 Clonmel 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 your
lungs, following initial treatment of at least 5 days with injectable
medicines used to treat blood clots
Rivaroxaban Clonmel 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 bloo

Caracteristicilor produsului

Health Products Regulatory Authority
20 November 2023
CRN00DV9S
Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Clonmel 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 43 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)
Red, round, biconvex film-coated tablets, with a diameter of
approximately 6 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 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 Rivaroxaban Clonmel 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 Clonmel
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 in