Rivaroxaban PharOS 15mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RIVAROXABAN

Available from:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

ATC code:

B01AF01

INN (International Name):

RIVAROXABAN 15 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RIVAROXABAN 15 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-02-05

Patient Information leaflet

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

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban PharOS 15 mg film-coated tablets
Rivaroxaban PharOS 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Rivaroxaban PharOS 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.
_Rivaroxaban PharOS 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).
_Rivaroxaban PharOS 15 mg film-coated tablets:_
Red, round biconvex tablets, debossed with “15” on one side and
plain on the other side.
_Rivaroxaban PharOS 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_
_ _
The recommended dose is 20 mg once daily, which is also the
recommended maximum
dose.
Therapy with Rivaroxaban PharOS should be continued long term provided
the benefit of
prevention of stroke and systemic embolis