Rivaroxaban Denk 15 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemščina

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivna sestavina:

RIVAROXABAN 15 mg/stuk

Dostopno od:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

Koda artikla:

B01AF01

INN (mednarodno ime):

RIVAROXABAN 15 mg/stuk

Farmacevtska oblika:

Filmomhulde tablet

Sestava:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171),

Pot uporabe:

Oraal gebruik

Terapevtsko območje:

Rivaroxaban

Povzetek izdelek:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); TITAANDIOXIDE (E 171);

Datum dovoljenje:

2018-01-16

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN DENK 15 MG, FILMOMHULDE TABLETTEN
RIVAROXABAN DENK 20 MG, FILMOMHULDE TABLETTEN
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 [Product Name] is and what it is used for
2.
What you need to know before you take [Product Name]
3.
How to take [Product Name]
4.
Possible side effects
5.
How to store [Product Name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product Name] 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.
[Product Name] 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 [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]
•
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 bleeding in th

Lastnosti izdelka

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Denk 15 mg, filmomhulde tabletten
Rivaroxaban Denk 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product Name] 15 mg: Each film-coated tablet contains 15 mg
rivaroxaban.
[Product Name] 20 mg: Each film-coated tablet contains 20 mg
rivaroxaban.
Excipient with known effect:
[Product Name] 15 mg: Each film-coated tablet contains 16.32 mg
lactose monohydrate.
[Product Name] 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.
[Product Name] 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.
[Product Name] 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
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 [Product Name] should be continued long term provided the
benefit of
prevention of stroke and systemic embolism outweighs the risk of
bleeding (see section 4.4).
2
_ _
If a dose is missed the patient should take [Product Name] immediately
and continue on the
following day with the once daily intake as recommended. The dose
should not be doubled
within the sam