Rivaroxaban Sandoz 10mg film coated Tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

RIVAROXABAN

Saatavilla:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC-koodi:

B01AF01

INN (Kansainvälinen yleisnimi):

RIVAROXABAN 10 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

RIVAROXABAN 10 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTITHROMBOTIC AGENTS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-01-05

Pakkausseloste

Page 1 of 8
Package leaflet: Information for the patient
Rivaroxaban Sandoz 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 Rivaroxaban Sandoz is and what it is used for
2.
What you need to know before you take Rivaroxaban Sandoz
3.
How to take Rivaroxaban Sandoz
4.
Possible side effects
5.
How to store Rivaroxaban Sandoz
6.
Contents of the pack and other information
1.
What Rivaroxaban Sandoz is and what it is used for
Rivaroxaban Sandoz 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.
Rivaroxaban Sandoz 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 Rivaroxaban Sandoz
Do not take Rivaroxaban Sandoz
-
if you are allergic to rivaroxaban or any of the other ingredients of
this medicine (listed
in section 6)
-
if you are bleeding excessively
-
if you have a disease or condition in an organ of the body that
increases the risk of serious
bleeding (e.

Valmisteyhteenveto

Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Sandoz 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of rivaroxaban.
Excipients with known effect
Each film-coated tablet contains 46.050 mg of lactose (as monohydrate)
and 0.081 mg of sunset yellow
FCF aluminium lake (E 110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Peach coloured, round, biconvex film-coated tablets marked with
‘10’ on one side, with a diameter of 6
mm
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.
Page 2 of 28

For patients undergoing major knee surgery, a treatment duration of 2
weeks is recommended.
If a dose is missed the patient should take rivaroxaban 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 the