Rivarolto 2.5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RIVAROXABAN

Available from:

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

ATC code:

B01AF01

INN (International Name):

RIVAROXABAN 2.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RIVAROXABAN 2.5 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-05-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVAROLTO 2.5 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
You have been given Rivarolto because
-
you have been diagnosed with an acute coronary syndrome (a group of
conditions that includes
heart attack and unstable angina, a severe type of chest pain) and
have been shown to have had
an increase in certain cardiac blood tests.
Rivarolto reduces the risk in adults of having another heart attack or
reduces the risk of dying
from a disease related to your heart or your blood vessels.
Rivarolto will not be given to you on its own. Your doctor will also
tell you to take either:
-
acetylsalicylic acid or
-
acetylsalicylic acid plus clopidogrel or ticlopidine.
or
-
you have been diagnosed with a high risk of getting a blood clot due
to a coronary artery disease
or peripheral artery disease which causes symptoms.
Rivarolto reduces the risk in adults of getting blot clots
(atherothrombotic events).
Rivarolto will not be given to you on its own. Your doctor will also
tell you to take
acetylsalicylic acid.
In some cases, if you get Rivarolto after a procedure to open a
narrowed or closed artery of your
leg to restore blood flow, your doctor may also prescribe clopidogrel
f

Summary of Product characteristics

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