Rivaroxaban Krka 20 mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Rivaroxaban

Saatavilla:

KRKA, d.d., Novo mesto

ATC-koodi:

B01AF01

INN (Kansainvälinen yleisnimi):

Rivaroxaban

Annos:

20 milligram(s)

Lääkemuoto:

Film-coated tablet

Terapeuttinen alue:

rivaroxaban

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2020-05-15

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVAROXABAN KRKA 15 MG FILM-COATED TABLETS
RIVAROXABAN KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Rivaroxaban Krka
3.
How to take Rivaroxaban Krka
4.
Possible side effects
5.
How to store Rivaroxaban Krka
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN KRKA IS AND WHAT IT IS USED FOR
Rivaroxaban Krka contains the active substance rivaroxaban.
Rivaroxaban Krka 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 Krka 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 Krka 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

Valmisteyhteenveto

Health Products Regulatory Authority
25 March 2024
CRN00F64Q
Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Krka 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg rivaroxaban.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pink to dark pink, round, slightly biconvex, film-coated tablets,
engraved with mark 20 on one side of the tablet.
Dimensions: diameter approximately 7 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 more than 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_
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with Rivaroxaban Krka 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 Krka
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 for the initial treatment of acute DVT or PE is
15 mg twi