Rivaroxaban PharOS 15mg / Rivaroxaban PharOS 20mg 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 RIVAROXABAN 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RIVAROXABAN 15 mg RIVAROXABAN 20 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
TREATMENT INITIATION PACK
Not for use in children.
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 and is
used in adults to:
-
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 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 PHAROS
DO NOT TAKE RIVAROXABAN PHAROS
-
if you are allergic to rivaroxaban or any of the other ingredients of
this medicine
(listed in section 6)
-
if you are bleeding excessively
-
if you have a disease or condition in an organ of the body that
increases the risk of
serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain,
recent surgery
of the brain or eyes)
-
if you are taking medicines to prevent

Summary of Product characteristics

TREATMENT INITIATION PACK
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
Each 15 mg film-coated tablet contains 15 mg rivaroxaban.
Each 20 mg film-coated tablet contains 20 mg rivaroxaban.
Excipient with known effect
Each 15 mg film-coated tablet contains 21.75 mg lactose, see section
4.4.
Each 20 mg 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).
15 mg film-coated tablet: Red, round biconvex tablets, debossed with
“15” on one side
and plain on the other side.
20 mg film-coated tablet: Brown-red, round biconvex tablets, debossed
with “20” on one
side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE_
_ _
The recommended dose for the initial treatment of acute DVT or PE is
15 mg twice daily
for the first three weeks followed by 20 mg once daily for the
continued treatment and
prevention of recurrent DVT and PE.
Short duration of therapy (at least 3 months) should be considered in
patients with DVT
or PE provoked by major transient risk factors (i.e. recent major
surgery or trauma).
Longer duration of therapy should be considered in patients with
provoked DVT or PE not
related to major transient risk factors, unprovoked DVT or PE, or a
history of recurrent
DVT or PE.
When extended prevention of recurrent DVT and PE is indicated
(following completion of
at least 6 months therapy for DVT or PE), the recommended dose is 10
mg once daily. In
patients in whom the risk of recurrent DVT or PE is considered high,
such as those with
complicated comorbidi