Lixiana 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Edoxaban tosilate

Available from:

Daiichi Sankyo UK Ltd

ATC code:

B01AF03

INN (International Name):

Edoxaban tosilate

Dosage:

60mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080200; GTIN: 5015494601287

Patient Information leaflet

1
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
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
-
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
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 i

Summary of Product characteristics

OBJECT 1
LIXIANA 60MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 31-Jul-2017 | Daiichi
Sankyo UK Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Lixiana 60 mg film-coated tablets
2. Qualitative and quantitative composition
Each 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.
Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed
with “DSC L60”.
4. Clinical particulars
4.1 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 (see section 4.4 for haemodynamically unstable PE
patients).
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 administered
simultaneously.
The duration of therapy for treatment of DVT and PE (venous
thromboembolism, VTE), and prevention
of recurrent VTE should be individualised after careful assessment of
the treatment benefit against the
risk for bleeding (see section 4.4). Short duration of therapy (at
least 3 months)