Rivaroxaban PharOS 10mg film-coated Tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

RIVAROXABAN

थमां उपलब्ध:

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

ए.टी.सी कोड:

B01AF01

INN (इंटरनेशनल नाम):

RIVAROXABAN 10 mg

फार्मास्यूटिकल फॉर्म:

FILM-COATED TABLET

रचना:

RIVAROXABAN 10 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANTITHROMBOTIC AGENTS

उत्पाद समीक्षा:

Licence number in the source country: NOT APPLICAPABLE

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2020-02-05

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN PHAROS 10 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 and is
used in adults to
-
prevent blood clots in the veins after a hip or knee replacement
operation. Your
doctor has prescribed this medicine for you because after an operation
you are at an
increased risk of getting blood clots.
-
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,

उत्पाद विशेषताएं

1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban PharOS 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 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).
Light red, round biconvex tablets debossed with “10” on one side
and plain on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or
knee replacement surgery.
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
_Prevention of VTE in adult patients undergoing elective hip or knee
replacement surgery_
_ _
The recommended dose is 10 mg rivaroxaban taken orally once daily. The
initial dose
should be taken 6 to 10 hours after surgery, provided that haemostasis
has been
established.
The duration of treatment depends on the individual risk of the
patient for venous
thromboembolism which is determined by the type of orthopaedic
surgery.
•
For patients undergoing major hip surgery, a treatment duration of 5
weeks is
recommended.
•
For patients undergoing major knee surgery, a treatment duration of 2
weeks is
recommended.
If a dose is missed the patient should take Rivaroxaban PharOS
immediately and then
continue the following day with once daily intake as before.
_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 fac