Lixiana

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

edoxaban tosilate

MAH:

Daiichi Sankyo Europe GmbH

ATC_code:

B01

INN:

edoxaban

therapeutic_group:

Antithrombotic agents

therapeutic_area:

Stroke; Venous Thromboembolism

therapeutic_indication:

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.

leaflet_short:

Revision: 18

authorization_status:

Authorised

authorization_date:

2015-06-19

PIL

59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIXIANA 15 MG FILM-COATED TABLETS
LIXIANA 30 MG FILM-COATED TABLETS
LIXIANA 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 Lixiana is and what it is used for
2.
What you need to know before you take Lixiana
3.
How to take Lixiana
4.
Possible side effects
5.
How to store Lixiana
6.
Contents of the pack and other information
1.
WHAT LIXIANA IS AND WHAT IT IS USED FOR
Lixiana 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.
Lixiana 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 LIXIANA
DO NOT TAKE LIXIANA
-
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 o

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lixiana 15 mg film-coated tablets
Lixiana 30 mg film-coated tablets
Lixiana 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lixiana 15 mg film-coated tablets
Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Lixiana 30 mg film-coated tablets
Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Lixiana 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
Lixiana 15 mg film-coated tablets
Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed
with “DSC L15”.
Lixiana 30 mg film-coated tablets
Pink, round-shaped film-coated tablets (8.5 mm diameter)
_ _
debossed with “DSC L30”.
Lixiana 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
Lixiana 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).
Lixiana 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 sho