Xarelto 15mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Rivaroxaban

可用日期:

Bayer Plc

ATC代码:

B01AF01

INN（国际名称）:

Rivaroxaban

剂量:

15mg

药物剂型:

Tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: ; GTIN: 5010605180088 5010605180095 5010605180057 5010605180125

资料单张

Page 1 of 8
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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
XARELTO 15 MG FILM-COATED TABLETS
XARELTO 20 MG FILM-COATED TABLETS
rivaroxaban
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 Xarelto is and what it is used for
2.
What you need to know before you take Xarelto
3.
How to take Xarelto
4.
Possible side effects
5.
How to store Xarelto
6.
Contents of the pack and other information
1.
WHAT XARELTO IS AND WHAT IT IS USED FOR
Xarelto 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.
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Xarelto

产品特点

OBJECT 1
XARELTO 15MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 13-Jun-2018 | Bayer plc
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
Xarelto 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 24.13 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 tablets (6 mm diameter, 9 mm radius of curvature)
marked with the BAYER-cross
on one side and “15” and a triangle on the other side.
4. Clinical particulars
4.1 Therapeutic indications
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.)
4.2 Posology and method of administration
Posology
_Prevention of stroke and systemic embolism _
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with Xarelto 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 Xarelto 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_
The recomm