Roteas

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

edoxaban tosilate

Available from:

Berlin-Chemie AG

ATC code:

B01AF03

INN (International Name):

edoxaban

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Stroke; Venous Thromboembolism

Therapeutic indications:

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Product summary:

Revision: 11

Authorization status:

Authorised

Authorization date:

2017-04-19

Patient Information leaflet

59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROTEAS 15 MG FILM-COATED TABLETS
ROTEAS 30 MG FILM-COATED TABLETS
ROTEAS 60 MG FILM-COATED TABLETS
edoxaban
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 Roteas is and what it is used for
2.
What you need to know before you take Roteas
3.
How to take Roteas
4.
Possible side effects
5.
How to store Roteas
6.
Contents of the pack and other information
1.
WHAT ROTEAS IS AND WHAT IT IS USED FOR
Roteas contains the active substance edoxaban and belongs to a group
of medicines called
anticoagulants. This medicine helps to prevent blood clots from
forming. It works by blocking the
activity of factor Xa, which is an important component of blood
clotting.
Roteas is used in adults to:
-
PREVENT BLOOD CLOTS IN THE BRAIN (stroke) AND OTHER BLOOD VESSELS IN
THE BODY if you have a
form of irregular heart rhythm called nonvalvular atrial fibrillation
and at least one additional
risk factor, such as heart failure, previous stroke or high blood
pressure;
-
TREAT BLOOD CLOTS IN THE VEINS OF THE LEGS (deep vein thrombosis) AND
IN THE BLOOD VESSELS IN
THE LUNGS (pulmonary embolism), and to PREVENT BLOOD CLOTS FROM
RE-OCCURRING in the blood
vessels in the legs and/or lungs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROTEAS
DO NOT TAKE ROTEAS
-
if you are allergic to edoxaban or any of the other ingredients of
this medicine (listed in
section 6);
-
if you are actively bleeding;
-
if you have a disease or condition that increases the risk of serious
bl

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Roteas 15 mg film-coated tablets
Roteas 30 mg film-coated tablets
Roteas 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Roteas 15 mg film-coated tablets
Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Roteas 30 mg film-coated tablets
Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Roteas 60 mg film-coated tablets
Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Roteas 15 mg film-coated tablets
Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed
with “DSC L15”.
Roteas 30 mg film-coated tablets
Pink, round-shaped film-coated tablets (8.5 mm diameter)
_ _
debossed with “DSC L30”.
Roteas 60 mg film-coated tablets
Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed
with “DSC L60”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Roteas is indicated in prevention of stroke and systemic embolism in
adult patients with nonvalvular
atrial fibrillation (NVAF) with one or more risk factors, such as
congestive heart failure, hypertension,
age ≥ 75 years, diabetes mellitus, prior stroke or transient
ischaemic attack (TIA).
Roteas is indicated in treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and
for the prevention of recurrent DVT and PE in adults (see section 4.4
for haemodynamically unstable
PE patients).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of stroke and systemic embolism _
The recommended dose is 60 mg edoxaban once daily.
Therapy with edoxaban in NVAF patients should be continued long term.
_ _
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE (VTE) _
The recommended dose is 60 mg edoxaban once daily following initial
use of parenteral anticoagulant
for at least 5 days (see section 5.1). Edoxaban and initial parenteral
anticoagulant should not be