Abirateron Devatis 500 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ABIRATERONACETAAT 500 mg/stuk

INN (Algemene Internationale Benaming):

ABIRATERONACETAAT 500 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) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYVINYLALCOHOL (E 1203) ; 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 ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2023-04-18

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABIRATERON DEVATIS 500 MG, FILMOMHULDE TABLETTEN
abiraterone acetate
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 Abirateron Devatis is and what it is used for
2.
What you need to know before you take Abirateron Devatis
3.
How to take Abirateron Devatis
4.
Possible side effects
5.
How to store Abirateron Devatis
6.
Contents of the pack and other information
1.
WHAT ABIRATERON DEVATIS IS AND WHAT IT IS USED FOR
Abirateron Devatis 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. Abirateron
Devatis stops your body from making
testosterone; this can slow the growth of prostate cancer.
When Abirateron Devatis 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 ABIRATERON DEVATIS
DO NOT TAKE ABIRATERON DEVATIS
-
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. Abirateron Devatis is for
use in

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abirateron Devatis 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of abiraterone acetate.
Excipients with known effect
Each tablet contains 240.5 mg of lactose and 11.8 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Purple coloured, oval, biconvex film-coated tablets (21.1 mm long x
9.6 mm wide)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abirateron Devatis 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 acetate (see sections 4.5 and 5.2).
_Dosage of prednisone or prednisolone _
For mHSPC, abiraterone acetate is used with 5 mg prednisone or
prednisolone daily.
For mCRPC, abiraterone acetate is used with 10 mg prednisone or
prednisolone daily.
2
Medical castration with luteinising hormone releasing hormone (LHRH)
analogue should be continued
during treatment in patients not surgically castrated.
_Recommended monitoring _
Serum transaminases should be measured prior to starting treatment,
every two weeks for the first
thr