Xarelto 15mg 20mg treatment initiation pack

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Предлага се от:

Bayer Plc

Лекарствена форма:

Not applicable

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: ; GTIN: 5010605180170

Листовка

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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
TREATMENT INITIATION PACK
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:
-
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 belongs to a group of medicines called antithrombotic agents.
It works by blocking a blood
clotting factor (factor Xa) and thus reducing

Данни за продукта

OBJECT 1
XARELTO 15-20MG FILM-COATED TABLETS TREATMENT
INITIATION PACK
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
Xarelto 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each 15 mg film-coated tablet contains 15 mg rivaroxaban.
Each 20 mg film-coated tablet contains 20 mg rivaroxaban.
Excipient with known effect
Each 15 mg film-coated tablet contains 24.13 mg lactose (as
monohydrate), see section 4.4.
Each 20 mg film-coated tablet contains 21.76 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).
15 mg film-coated 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.
20 mg film-coated tablet: brown-red, round biconvex tablets (6 mm
diameter, 9 mm radius of curvature)
marked with the BAYER-cross on one side and “20” and a triangle on
the other side.
4. Clinical particulars
4.1 Therapeutic indications
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
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE_
The recommended dose for the initial treatment of acute DVT or PE is
15 mg twice daily for the first
three weeks followed by 20 mg once daily for the continued treatment
and prevention of recurrent DVT
and PE.
Short duration of therapy (at least 3 months) should be considered in
patients with DVT or PE provoked
by major transient risk factors (i.e. r