Raxivanol 15 mg film-coated tablets

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

RIVAROXABAN

Dostępny od:

Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece

Kod ATC:

B01AF01

INN (International Nazwa):

RIVAROXABAN 15 mg

Forma farmaceutyczna:

FILM-COATED TABLET

Skład:

RIVAROXABAN 15 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTITHROMBOTIC AGENTS

Podsumowanie produktu:

Licence number in the source country: NOT APPLICAPABLE

Status autoryzacji:

Authorised

Data autoryzacji:

2021-07-21

Ulotka dla pacjenta

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

Charakterystyka produktu

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1.
NAME OF THE MEDICINAL PRODUCT
Raxivanol 15 mg film-coated tablets
Raxivanol 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ Raxivanol 15 mg film-coated tablets: _
Each film-coated tablet contains 15 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 21.75 mg lactose, see section 4.4.
_ Raxivanol 20 mg film-coated tablets: _
Each film-coated tablet contains 20 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 29.00 mg lactose, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_ Raxivanol 15 mg film-coated tablets: _
Red, round biconvex tablets, debossed with “15” on one side and
plain on the other side.
_Raxivanol 20 mg film-coated tablets: _
Brown-red, round biconvex tablets, debossed with “20” on one side
and plain on the 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/
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_
_ _
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The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with Raxivanol should be continued long term provided the
benefit of prevention of
stroke and systemic embolism outweighs the risk of bleed