Abirateron Zentiva 500 mg filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

ABIRATERONACETAAT 500 mg/stuk

Dostopno od:

Zentiva a.s. U. Kabelovny 130 10237 PRAGUE (TSJECHIË)

INN (mednarodno ime):

ABIRATERONACETAAT 500 mg/stuk

Farmacevtska oblika:

Filmomhulde tablet

Sestava:

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 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYETHYLEENGLYCOL (E 1521) ; 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 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)

Pot uporabe:

Oraal gebruik

Datum dovoljenje:

1900-01-01

Navodilo za uporabo

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

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abirateron Zentiva 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 Zentiva 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 (four 250 mg tablets or 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 Zentiva is used with 5 mg prednisone or
prednisolone daily.
For mCRPC, Abirateron Zentiva 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