Rivaroxaban 15 mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Rivaroxaban

Saatavilla:

Renata Pharmaceuticals (Ireland) Limited

ATC-koodi:

B01AF01

INN (Kansainvälinen yleisnimi):

Rivaroxaban

Lääkemuoto:

Film-coated tablet

Terapeuttinen alue:

rivaroxaban

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2024-01-05

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN 15 MG FILM-COATED TABLETS
RIVAROXABAN 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 is and what it is used for
2. What you need to know before you take Rivaroxaban
3. How to take Rivaroxaban
4. Possible side effects
5. How to store Rivaroxaban
6. Contents of the pack and other information
1. WHAT RIVAROXABAN IS AND WHAT IT IS USED FOR
Rivaroxaban Tablets contains the active substance rivaroxaban.
Rivaroxaban 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 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 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
DO NOT TAKE RIVAROXABAN
-
if you

Valmisteyhteenveto

Health Products Regulatory Authority
05 January 2024
CRN00CV7Z
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivaroxaban 15 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 63.604 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).
6 mm, round shaped, brown-red, biconvex film-coated tablets, engraved
"R3" on one side and plain on other side.
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_
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 recommende