Raxivanol 10 mg film-coated tablets

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

RIVAROXABAN

متاح من:

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

ATC رمز:

B01AF01

INN (الاسم الدولي):

RIVAROXABAN 10 mg

الشكل الصيدلاني:

FILM-COATED TABLET

تركيب:

RIVAROXABAN 10 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTITHROMBOTIC AGENTS

ملخص المنتج:

Licence number in the source country: NOT APPLICAPABLE

الوضع إذن:

Authorised

تاريخ الترخيص:

2021-07-21

نشرة المعلومات

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAXIVANOL 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 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 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.
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 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

خصائص المنتج

Page
1
of
25
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Raxivanol 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 Raxivanol 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 provok