Abirateron Normon 500 mg filmomhulde tabletten

País: Países Bajos

Idioma: neerlandés

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

Ingredientes activos:

ABIRATERONACETAAT 500 mg/stuk

Designación común internacional (DCI):

ABIRATERONACETAAT 500 mg/stuk

formulario farmacéutico:

Filmomhulde tablet

Composición:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Vía de administración:

Oraal gebruik

Fecha de autorización:

1900-01-01

Información para el usuario

1
LF-ABIRATERONE ACETATE-CC-NL.H. 5371.001.DC-D205
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
ABIRATERON NORMON 500 MG FILMOMHULDE TABLETTEN
abirateron acetaat
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains a medicine called abiraterone acetate. It is
used to treat prostate cancer in adult
men that has spread to other parts of the body. stops
your body from making
testosterone; this can slow the growth of prostate cancer.
When is prescribed for the early stage of disease
where it is still responding to hormone
therapy, it is used with a treatment that lowers testosterone
(androgen deprivation therapy).
When you take this medicine your doctor will also prescribe another
medicine called prednisone or
prednisolone. This is to lower your chances of getting high blood
pressure, having too much water in
your body (fluid retention), or having reduced levels of a chemical
known as potassium in your blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE

-
if you are allergic to abiraterone acetate or any of the other
ingredients of this medicine (listed in
section 6).
-
if you are a woman, especially if pregnant. is

Ficha técnica

SPC-ABIRATERONE ACETATE-CC-NL.H.5371.001.DC-D160
- 1 -
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Abirateron Normon 500 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of abiraterone acetate.
Excipients with known effect
Each film-coated tablet contains 259 mg of lactose and maximum 12 mg
of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Red-beige, oval, film-coated tablets, debossed with “500” on one
side, with a dimensions of 19 mm
length and 11 mm width approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated with prednisone or prednisolone for:
•
the treatment of newly diagnosed high risk metastatic hormone
sensitive prostate cancer (mHSPC)
in adult men in combination with androgen deprivation therapy (ADT)
(see section 5.1)
•
the treatment of metastatic castration resistant prostate cancer
(mCRPC) in adult men who are
asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy in whom
chemotherapy is not yet clinically indicated (see section 5.1)
•
the treatment of mCRPC in adult men whose disease has progressed on or
after a docetaxel-based
chemotherapy regimen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be prescribed by an appropriate
healthcare professional.
Posology
The recommended dose is 1,000 mg (two 500 mg tablets) as a single
daily dose that must not be taken
with food (see “Method of administration” below). Taking the
tablets with food increases systemic
exposure to abiraterone (see sections 4.5 and 5.2).
_Dosage of prednisone or prednisolone _
For mHSPC, is used with 5 mg prednisone or
prednisolone daily.
For mCRPC, is used with 10 mg prednisone or
prednisolone daily.
Medical castration with luteinising hormone releasing hormone (LHRH)
analogue should be continued
during treatment in patients not surgically castrated.
_Recommended