Rivaroxaban Denk 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RIVAROXABAN 10 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

B01AF01

INN (Algemene Internationale Benaming):

RIVAROXABAN 10 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rivaroxaban

Product samenvatting:

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);

Autorisatie datum:

2018-01-16

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN DENK 10 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 the veins after a hip or knee replacement
operation. Your doctor
has prescribed this medicine for you because after an operation you
are at an
increased risk of getting blood clots.
-
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 the b

Productkenmerken

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Denk 10 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 95.6 mg lactose monohydrate, see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pink, round, biconvex film-coated tablets, engraved with “10” on
one side, plain on the other
with a diameter of 9.1 mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or
knee replacement surgery.
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 VTE in adult patients undergoing elective hip or knee
replacement surgery _
The recommended dose is 10 mg rivaroxaban taken orally once daily. The
initial dose should
be taken 6 to 10 hours after surgery, provided that haemostasis has
been established.
The duration of treatment depends on the individual risk of the
patient for venous
thromboembolism which is determined by the type of orthopaedic
surgery.
•
For patients undergoing major hip surgery, a treatment duration of 5
weeks is
recommended.
2
_ _
•
For patients undergoing major knee surgery, a treatment duration of 2
weeks is
recommended.
If a dose is missed the patient should take [Product Name] immediately
and then continue the
following day with once daily intake as before.
_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 first three weeks followed by 20 mg once daily for the continued
treatment and
prevention of recurrent DVT and PE.
Short duration of therapy (at least 3 months) sho