Rivarolto 10 mg film-coated tablets

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

RIVAROXABAN

Mevcut itibaren:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC kodu:

B01AF01

INN (International Adı):

RIVAROXABAN 10 mg

Farmasötik formu:

FILM-COATED TABLET

Kompozisyon:

RIVAROXABAN 10 mg

Reçete türü:

POM

Terapötik alanı:

ANTITHROMBOTIC AGENTS

Ürün özeti:

Licence number in the source country: NOT APPLICAPABLE

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2020-05-11

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVAROLTO 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 Rivarolto is and what it is used for
2.
What you need to know before you take Rivarolto
3.
How to take Rivarolto
4.
Possible side effects
5.
How to store Rivarolto
6.
Contents of the pack and other information
1.
WHAT RIVAROLTO IS AND WHAT IT IS USED FOR
Rivarolto 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.
Rivarolto 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 RIVAROLTO
DO NOT TAKE RIVAROLTO:
-
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 tak

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivarolto 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Brownish red, round, slightly biconvex, film-coated tablets, engraved
with mark 10 on one side of the
tablet.
Dimensions: diameter approximately 6.5 mm.
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 Rivarolto 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 factors (i.e. recent major surgery o