Rivarolto 20 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 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

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:

2020-05-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIVAROLTO 15 MG FILM-COATED TABLETS
RIVAROLTO 20 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. Rivarolto is used
in adults to:
-
prevent blood clots in brain (stroke) and other blood vessels in your
body if you have a form of
irregular heart rhythm called non-valvular atrial fibrillation.
-
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 is used in children and adolescents below 18 years and with
a body weight of 30 kg
or more to:
-
treat blood clots and prevent re-occurrence of blood clots in the
veins or in the blood
vessels of the lungs, following initial treatment of at least 5 days
with injectable
medicines used to treat blood clots.
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 o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivarolto 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg rivaroxaban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pink to dark pink, round, slightly biconvex, film-coated tablets,
engraved with mark 20 on one side of
the tablet.
Dimensions: diameter approximately 7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults _
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation with
one or more risk factors, such as congestive heart failure,
hypertension, age ≥ 75 years, diabetes
mellitus, prior stroke or transient ischaemic attack.
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.)
_ _
_Paediatric population _
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing more than 50 kg after
at least 5 days of initial
parenteral anticoagulation treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of stroke and systemic embolism in adults_
The recommended dose is 20
mg
once daily, which is also the recommended maximum dose.
Therapy with Rivarolto should be continued long term provided the
benefit of prevention of stroke and
systemic embolism outweighs the risk of bleeding (see section 4.4).
If a dose is missed the patient should take Rivarolto immediately and
continue on the following day
with the once daily intake as recommended. The dose should not be
doubled within the same day to
make up for a missed dose.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE in adults_
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 tre