Abirateron G.L. 250 mg, tabletten

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

ABIRATERONACETAAT 250 mg/stuk

Disponible depuis:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

DCI (Dénomination commune internationale):

ABIRATERONACETAAT 250 mg/stuk

forme pharmaceutique:

Tablet

Composition:

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

Mode d'administration:

Oraal gebruik

Date de l'autorisation:

1900-01-01

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
ABIRATERON G.L. 250 MG, 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 G.L. is and what it is used for
2.
What you need to know before you take Abirateron G.L.
3.
How to take Abirateron G.L.
4.
Possible side effects
5.
How to store Abirateron G.L.
6.
Contents of the pack and other information
1.
WHAT ABIRATERON G.L. IS AND WHAT IT IS USED FOR
Abirateron G.L. 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 G.L.
stops your body from making
testosterone; this can slow the growth of prostate cancer.
When Abirateron G.L. 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 G.L.
_ _
DO NOT TAKE ABIRATERON G.L.:
-
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 G.L. is for use
in male patients only.
-
if you have severe liver d

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abirateron G.L. 250 mg, 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.
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abirateron G.L. 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 G.L. is used with 5 mg prednisone or
prednisolone daily.
For mCRPC, Abirateron G.L. 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 treatment,
every two weeks for the first t