Rivaroxaban Denk 2.5 mg film-coated tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

RIVAROXABAN

Dostupné z:

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

ATC kód:

B01AF01

INN (Medzinárodný Name):

RIVAROXABAN 2.5 mg

Forma lieku:

FILM-COATED TABLET

Zloženie:

RIVAROXABAN 2.5 mg

Typ predpisu:

POM

Terapeutické oblasti:

ANTITHROMBOTIC AGENTS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2017-10-23

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN DENK 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 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
You have been given Rivaroxaban Denk 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.
Rivaroxaban Denk 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.
Rivaroxaban Denk 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.
Rivaroxaban Denk contains the active substance rivaroxaban and belongs
to a group of medi-
cines 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 ar

Súhrn charakteristických

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Denk 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 23.9 mg lactose monohydrate, see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, biconvex film-coated tablet, engraved with “RVX” on
one side, plain on the
other with a diameter of 6.1 mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rivaroxaban Denk, co-administered with acetylsalicylic acid (ASA)
alone or with ASA plus
clopidogrel or ticlopidine, is indicated for the prevention of
atherothrombotic events in adult
patients after an acute coronary syndrome (ACS) with elevated cardiac
biomarkers (see sec-
tions 4.3, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2.5 mg twice daily.
Patients taking Rivaroxaban Denk 2.5 mg twice daily should also take a
daily dose of 75 - 100
mg ASA or a daily dose of 75 - 100 mg ASA in addition to either a
daily dose of 75 mg
clopidogrel or a standard daily dose of ticlopidine.
Treatment should be regularly evaluated in the individual patient
weighing the risk for is-
chaemic events against the bleeding risks. Extension of treatment
beyond 12 months should be
done on an individual patient basis as experience up to 24 months is
limited (see section 5.1).
Treatment with Rivaroxaban Denk should be started as soon as possible
after stabilisation of
the ACS event (including revascularisation procedures); at the
earliest 24 hours after admission
to hospital and at the time when parenteral anticoagulation therapy
would normally be discon-
tinued.
2
_ _
_Co-administration with antiplatelet therapy _
In patients with an acute thrombotic event or vascular procedure and a
need for dual antiplatelet
therapy, the continuation of rivaroxaban 2.5 mg twice daily should be
evaluated depend