Abiraterone Aristo 250 mg tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Abiraterone acetate

Disponible desde:

Aristo Pharma GmbH

Código ATC:

L02BX03

Designación común internacional (DCI):

Abiraterone acetate

Dosis:

250 milligram(s)

formulario farmacéutico:

Tablet

Área terapéutica:

abiraterone

Estado de Autorización:

Not marketed

Fecha de autorización:

2021-05-07

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABIRATERONE ARISTO 250 MG TABLETS
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 Abiraterone Aristo is and what it is used for
2.
What you need to know before you take Abiraterone Aristo
3.
How to take Abiraterone Aristo
4.
Possible side effects
5.
How to store Abiraterone Aristo
6.
Contents of the pack and other information
1.
WHAT ABIRATERONE ARISTO IS AND WHAT IT IS USED FOR
Abiraterone Aristo 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.
Abiraterone Aristo stops your
body from making testosterone; this can slow the growth of prostate
cancer.
When Abiraterone Aristo 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 ABIRATERONE ARISTO
DO NOT TAKE ABIRATERONE ARISTO
-
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. Abiraterone Aristo is for
use in male patient

Ficha técnica

Health Products Regulatory Authority
30 May 2022
CRN00CRTG
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abiraterone Aristo 250 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of abiraterone acetate.
Excipients with known effect
Each tablet contains 116.1 mg lactose (as monohydrate) and 5.8 mg of
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, oval, biconvex, uncoated tablets (15 mm long x 8
mm wide), debossed with "250" on one side and plain on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Abiraterone Aristo Tiefenbacher 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 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, abiraterone is used with 5 mg prednisone or prednisolone
daily. For mCRPC, abiraterone 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