Abirateron Vipharm 500 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ABIRATERONACETAAT 500 mg/stuk

Beschikbaar vanaf:

Vipharm S.A. ul. A. i F. Radziwillow 9 05-850 OZARÓW MAZOWIECKI (POLEN)

INN (Algemene Internationale Benaming):

ABIRATERONACETAAT 500 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) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2021-06-18

Bijsluiter

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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abirateron Vipharm 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of abiraterone acetate.
Excipients with known effect
Each tablet contains 241 mg of lactose and 12 mg sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Oval-shaped purple film-coated tablet, approximately 19 mm long by 11
mm wide and debossed with
“A7TN” on one side and “500” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abirateron Vipharm 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, Abirateron Vipharm is used with 5 mg prednisone or
prednisolone daily.
For mCRPC, Abirateron Vipharm 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 monitoring_
Serum transaminases should be measured prior to starting tr