Xabarem 10 mg film-coated tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Dostopno od:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

Koda artikla:

B01AF01

INN (mednarodno ime):

RIVAROXABAN 10 mg

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

RIVAROXABAN 10 mg

Tip zastaranja:

POM

Terapevtsko območje:

ANTITHROMBOTIC AGENTS

Status dovoljenje:

Authorised

Datum dovoljenje:

2023-01-16

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
XABAREM 10 MG FILM-COATED TABLETS
rivaroxaban
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 Xabarem is and what it is used for
2.
What you need to know before you take Xabarem
3.
How to take Xabarem
4.
Possible side effects
5.
How to store Xabarem
6.
Contents of the pack and other information
1.
WHAT XABAREM IS AND WHAT IT IS USED FOR
Xabarem 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.
Xabarem belongs to a group of medicines called antithrombotic agents.
It works by
blocking a blood clotting factor (factor Xa) and thus reducing the
tendency of the blood
to form clots.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XABAREM
DO NOT TAKE XABAREM
-
if you are allergic to rivaroxaban or any of the other ingredients of
this medicine
(listed in section 6).
-
if you are bleeding excessively.
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if you have a disease or condition in an organ of the body that
increases the risk
of seriou

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xabarem 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 93 mg lactose (as monohydrate), see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light red, round film-coated tablets, debossed with ‘10’ on one
side and plain on the other side,
with diameter 9.1 mm ± 5%.
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.
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If a dose is missed the patient should take Xabarem immediately and
then continue the
following day with once daily intake as before.
_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 cons