Rivaroxaban Sandoz 15mg 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 15 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

RIVAROXABAN 15 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTITHROMBOTIC AGENTS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-01-05

Pakkausseloste

Page 1 of 11
Package leaflet: Information for the patient
Rivaroxaban Sandoz 15 mg film-coated tablets
Rivaroxaban Sandoz 20 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 brain (stroke) and other blood vessels in your
body if you have a form
of irregular heart rhythm called non-valvular atrial fibrillation.

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 is used in children and adolescents below 18 years
and with a body weight of
30 kg or more to:

treat blood clots and prevent re-occurrence of blood clots in the
veins or in the blood vessels of
the lungs, following initial treatment of at least 5 days with
injectable medicines used to treat
blood clots.
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 yo

Valmisteyhteenveto

Page 1 of 37
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Sandoz 15 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg of rivaroxaban.
Excipients with known effect
Each film-coated tablet contains 42.749 mg of lactose (as monohydrate)
and 0.114 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.
Light orange coloured, round, biconvex film-coated tablet marked with
‘15’ on one side, with a
diameter of 6 mm.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Adults
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation
with one or more risk factors, such as congestive heart failure,
hypertension, age ≥ 75 years, diabetes
mellitus, prior stroke or transient ischaemic attack.
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.)
Paediatric population
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing from 30 kg to 50 kg
after at least 5 days of initial
parenteral anticoagulation treatment.
4.2
Posology and method of administration
Posology
Prevention of stroke and systemic embolism in adults
Page 2 of 37
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with rivaroxaban should be continued long term provided the
benefit of prevention of
stroke and systemic embolism outweighs the risk of bleeding (see
section 4.4).
If a dose is missed the patient should take rivaroxaban immediately
and continue on the following day
with
the once daily intake as recommended. The dose should not be doubled
within the same day to
make up for a missed dose.
Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE in adults
The recommended dose