Abibam 250 mg, tabletten

Land: Holland

Tungumál: hollenska

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

Virkt innihaldsefni:

ABIRATERONACETAAT

INN (Alþjóðlegt nafn):

ABIRATERONACETAAT

Lyfjaform:

Tablet

Samsetning:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551)

Stjórnsýsluleið:

Oraal gebruik

Leyfisdagur:

2021-09-13

Upplýsingar fylgiseðill

Common Technical Document
Abiraterone acetate
Tablet
M1.3.1_03.ATN.tab.003.02.core
Page 1 of 7
1.3.1
Package leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABIBAM 250 MG, TABLETTEN
ABIBAM 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 Abibam is and what it is used for
2.
What you need to know before you take Abibam
3.
How to take Abibam
4.
Possible side effects
5.
How to store Abibam
6.
Contents of the pack and other information
1.
WHAT ABIBAM IS AND WHAT IT IS USED FOR
Abibam 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. Abibam stops your body from making
testosterone; this can slow the growth
of prostate cancer.
When Abibam 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 ABIBAM
_ _
DO NOT TAKE ABIBAM:
-
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. Abibam is for u

Vara einkenni

Common Technical Document
Abiraterone acetate
Tablet
M1.3.1_01.ATN.tab.003.04.core
Page 1 of 26
1.3.1
Summary of Product Characteristics - Core
1.
NAME OF THE MEDICINAL PRODUCT
Abibam 250 mg, tabletten
Abibam 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of abiraterone acetate.
Excipients with known effect
Each tablet contains 180 mg of lactose.
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
Tablet
White to off-white oval tablet, approximately 16 mm long by 9.5 mm
wide, debossed with “ATN” on one side
and “250” on the other side.
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
Abibam 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.
Common Technical Document
Abiraterone acetate
Tablet
M1.3.1_01.ATN.tab.003.04.core
Page 2 of 26
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 syst