Xarelto 10mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Rivaroxaban

थमां उपलब्ध:

Bayer Plc

ए.टी.सी कोड:

B01AF01

INN (इंटरनेशनल नाम):

Rivaroxaban

डोज़:

10mg

फार्मास्यूटिकल फॉर्म:

Tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 02080200; GTIN: 5010605180026 5010605180033 5010605180040

सूचना पत्रक

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 10 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 the veins after a hip or knee replacement
operation. Your doctor has
prescribed this medicine for you because after an operation you are at
an increased risk of
getting blood clots.
-
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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Xar

उत्पाद विशेषताएं

OBJECT 1
XARELTO 10 MG 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 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 26.51 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 red, round biconvex tablets (6 mm diameter, 9 mm radius of
curvature) marked with the BAYER-
cross on one side and "10" and a triangle on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or knee
replacement surgery.
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 VTE in adult patients undergoing elective hip or knee
replacement surgery_
The recommended dose is 10 mg rivaroxaban taken orally once daily. The
initial dose should be taken 6
to 10 hours after surgery, provided that haemostasis has been
established.
The duration of treatment depends on the individual risk of the
patient for venous thromboembolism
which is determined by the type of orthopaedic surgery.
• For patients undergoing major hip surgery, a treatment duration of
5 weeks is recommended.
• For patients undergoing major knee surgery, a treatment duration
of 2 weeks is recommended.
If a dose is missed the patient should take Xarelto immediately and
then continue the following day with
once daily intake as before.
_