Rivaroxaban Medichem 20mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RIVAROXABAN

Available from:

Medichem, S.A. Fructuós Gelabert 6-8, 08970, Sant Joan Despí, (Barcellona), Spain

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

Authorization status:

Authorised

Authorization date:

2019-03-13

Patient Information leaflet

193
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN MEDICHEM 15 MG FILM-COATED TABLETS
RIVAROXABAN MEDICHEM 20 MG FILM-COATED TABLETS
rivaroxaban
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Medichem is and what it is used for
2.
What you need to know before you take Rivaroxaban Medichem
3.
How to take Rivaroxaban Medichem
4.
Possible side effects
5.
How to store Rivaroxaban Medichem
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN MEDICHEM IS AND WHAT IT IS USED FOR
Rivaroxaban Medichem contains the active substance rivaroxaban and 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.
Rivaroxaban Medichem 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 MEDICHEM
DO NOT TAKE RIVAROXABAN MEDICHEM
-
if you are

Summary of Product characteristics

This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Medichem 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg rivaroxaban.
Excipient with known effect:
Each film-coated tablet contains 22.90 mg lactose (as monohydrate),
see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Brown-red, round biconvex, film-coated tablets.
The specific tablet dimensions are 5.95- 6.05 mm of diameter and 2.75-
2.95 mm of thickness.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of stroke and systemic embolism_
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with Rivaroxaban Medichem 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 Rivaroxaban Medichem
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_
The recommended dose for the initial treatment of acute DVT or PE is
15 mg twice daily for the f