Xaboplax 15 mg + 20 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RIVAROXABAN 20 mg/stuk ; RIVAROXABAN 15 mg/stuk

INN (Algemene Internationale Benaming):

RIVAROXABAN 20 mg/stuk ; RIVAROXABAN 15 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/9
XABOPLAX 15 mg + 20 mg, filmomhulde tabletten
RVG 127729
1313-V3
1.3.1.3 Bijsluiter
November 2023
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
XABOPLAX 15 MG + 20 MG, FILMOMHULDE TABLETTEN
TREATMENT INITIATION PACK
Not for use in children.
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance rivaroxaban
and is used in adults to:
-
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.
[Nationally completed 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
-
if you are allergic to rivaroxaban or any of the other ingredients of
this medicine (listed
in section 6)
Sandoz B.V.
Page 2/9
XABOPLAX 15 mg + 20 mg, filmomhulde tabletten
RVG 127729
1313-V3
1.3.1.3 Bijsluiter
November 202

Productkenmerken

Sandoz
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XABOPLAX 15 mg + 20 mg, filmomhulde tabletten
RVG 127729
1311-V3
1.3.1.1 Samenvatting van de Productkenmerken
November 2023
SUMMARY OF PRODUCT CHARACTERISTICS
TREATMENT INITIATION PACK
1.
NAME OF THE MEDICINAL PRODUCT
Xaboplax 15 mg + 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 mg film-coated tablet contains 15 mg rivaroxaban.
Each 20 mg film-coated tablet contains 20 mg rivaroxaban.
Excipient(s) with known effect
Each 15 mg film-coated tablet contains 22 mg lactose, see section 4.4.
Each 20 mg film-coated tablet contains 29 mg lactose, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
15 mg film-coated tablet: Red, round biconvex tablets of 5.6 mm
diameter, debossed with ‘15’ on
one side and plain on the other side.
20 mg film-coated tablet: Brown-red, round biconvex tablets of 6.6 mm
diameter, debossed with
‘20’ on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
_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
Sandoz
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XABOPLAX 15 mg + 20 mg, filmomhulde tabletten
RVG 127729
1311-V3
1.3.1.1 Samenvatting van de Productkenmerken
November 2023
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) should be considered in
patients with DVT or PE
provoked by major transient risk factors (i.e. recent major surgery or
trauma). Longer duration of
therapy should be considered in patients with provoked DVT or PE not
related to major transient risk
factors, unprovoked DVT or PE, or a history