Xarelto 2.5mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Rivaroxaban

Sẵn có từ:

Bayer Plc

Mã ATC:

B01AF01

INN (Tên quốc tế):

Rivaroxaban

Liều dùng:

2.5mg

Dạng dược phẩm:

Tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: ; GTIN: 5010605180149 5010605180156

Tờ rơi thông tin

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 2.5 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
You have been given Xarelto because you have been diagnosed with an
acute coronary syndrome (a
group of conditions that includes heart attack and unstable angina, a
severe type of chest pain) and
have been shown to have had an increase in certain cardiac blood
tests.
Xarelto reduces the risk in adults of having another heart attack or
reduces the risk of dying from a
disease related to your heart or your blood vessels.
Page 2 of 8
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Xarelto contains the active substance rivaroxaban and belongs to a
group of medi

Đặc tính sản phẩm

OBJECT 1
XARELTO 2.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 12-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 2.5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 2.5 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 33.92 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).
Light yellow, round biconvex tablets (6 mm diameter, 9 mm radius of
curvature) marked with the
BAYER-cross on one side and "2.5" and a triangle on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with
ASA plus clopidogrel or
ticlopidine, is indicated for the prevention of atherothrombotic
events in adult patients after an acute
coronary syndrome (ACS) with elevated cardiac biomarkers (see sections
4.3, 4.4 and 5.1).
4.2 Posology and method of administration
Posology
The recommended dose is 2.5 mg twice daily.
Patients should also take a daily dose of 75 - 100 mg ASA or a daily
dose of 75 - 100 mg ASA in addition
to either a daily dose of 75 mg clopidogrel or a standard daily dose
of ticlopidine.
Treatment should be regularly evaluated in the individual patient
weighing the risk for ischaemic events
against the bleeding risks. Extension of treatment beyond 12 months
should be done on an individual
patient basis as experience up to 24 months is limited (see section
5.1).
Treatment with Xarelto should be started as soon as possible after
stabilisation of the ACS event
(including revascularisation procedures); at the earliest 24 hours
after admission to hospital and at the
time when parenteral anticoag