Rivaroxaban Denk 20 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RIVAROXABAN

Available from:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 München , 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

Authorization status:

Authorised

Authorization date:

2017-10-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN DENK 15 MG FILM-COATED TABLETS
RIVAROXABAN DENK 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 Rivaroxaban Denk is and what it is used for
2.
What you need to know before you take Rivaroxaban Denk
3.
How to take Rivaroxaban Denk
4.
Possible side effects
5.
How to store Rivaroxaban Denk
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN DENK IS AND WHAT IT IS USED FOR
Rivaroxaban Denk 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 Denk 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 DENK
DO NOT TAKE RIVAROXABAN DENK
•
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 ble

Summary of Product characteristics

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Denk 15 mg film-coated tablets
Rivaroxaban Denk 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rivaroxaban Denk 15 mg: Each film-coated tablet contains 15 mg
rivaroxaban.
Rivaroxaban Denk 20 mg: Each film-coated tablet contains 20 mg
rivaroxaban.
Excipient with known effect:
Rivaroxaban Denk 15 mg: Each film-coated tablet contains 16.32 mg
lactose monohydrate.
Rivaroxaban Denk 20 mg: Each film-coated tablet contains 21.76 mg
lactose monohydrate.
See section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Rivaroxaban Denk 15 mg are red, round, biconvex film-coated tablets,
engraved with ‘15’ on
one side, plain on the other with a diameter of 6.1 mm approximately.
Rivaroxaban Denk 20 mg are brown – red, round, biconvex film-coated
tablets, engraved with
‘20’ on one side, plain on the other with a diameter of 6.1 mm
approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrilla-
tion 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.
2
_ _
Therapy with Rivaroxaban Denk should be continued long term provided
the benefit of pre-
vention of stroke and systemic embolism outweighs the risk of bleeding
(see section 4.4).
If a dose is missed the patient should take Rivaroxaban Denk
immediately and continue on the
following day with the once daily intake as recommended. The dose
should not be doub