Abiraterone Mylan

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

abiraterone acetate

Tilgængelig fra:

Mylan Ireland Limited

ATC-kode:

L02BX03

INN (International Name):

abiraterone acetate

Terapeutisk gruppe:

Endocrine therapy, Other hormone antagonists and related agents

Terapeutisk område:

Prostatic Neoplasms

Terapeutiske indikationer:

Abiraterone Mylan 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).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.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Produkt oversigt:

Revision: 4

Autorisation status:

Authorised

Autorisation dato:

2021-08-20

Indlægsseddel

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABIRATERONE MYLAN 500 MG FILM-COATED TABLETS
ABIRATERONE MYLAN 1000 MG FILM-COATED 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 Mylan is and what it is used for
2.
What you need to know before you take Abiraterone Mylan
3.
How to take Abiraterone Mylan
4.
Possible side effects
5.
How to store Abiraterone Mylan
6.
Contents of the pack and other information
1.
WHAT ABIRATERONE MYLAN IS AND WHAT IT IS USED FOR
Abiraterone Mylan 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
Mylan stops your body from making
testosterone; this can slow the growth of prostate cancer.
When Abiraterone Mylan 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 MYLAN
DO NOT TAKE ABIRATERONE MYLAN
-
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, e

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Abiraterone Mylan 500 mg film-coated tablets
Abiraterone Mylan 1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abiraterone Mylan 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of abiraterone acetate
equivalent to 446 mg abiraterone.
Abiraterone Mylan 1000 mg film-coated tablets
Each film-coated tablet contains 1000 mg of abiraterone acetate
equivalent to 893 mg abiraterone.
Excipient(s) with known effect
Abiraterone Mylan 500 mg film-coated tablets
Each 500 mg film-coated tablet contains 68 mg lactose monohydrate (see
section 4.4).
Abiraterone Mylan 1000 mg film-coated tablets
Each 1000 mg film-coated tablet contains 136 mg lactose monohydrate
(see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Abiraterone Mylan 500 mg film-coated tablets
Brown, oval-shaped film-coated tablet, debossed with “500” on one
side, with dimensions 19 mm
long x 10 mm wide.
Abiraterone Mylan 1000 mg film-coated tablets
White to off-white, oval-shaped film-coated tablet, with a break line
on one side and plain on the other
side, with dimensions 23 mm long x 11 mm wide. The score line is only
to facilitate breaking for ease
of swallowing and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abiraterone Mylan 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 MET