Enzalutamide Sandoz 40 mg film-coated tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Commercializzato da:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

Codice ATC:

L02BB04

INN (Nome Internazionale):

ENZALUTAMIDE 40 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

ENZALUTAMIDE 40 mg

Tipo di ricetta:

POM

Area terapeutica:

ENDOCRINE THERAPY

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2023-08-09

Foglio illustrativo

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Enzalutamide Sandoz 40 mg film-coated tablets
Enzalutamide Sandoz 80 mg film-coated tablets
enzalutamide
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.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Enzalutamide Sandoz is and what it is used for
2.
What you need to know before you take Enzalutamide Sandoz
3.
How to take Enzalutamide Sandoz
4.
Possible side effects
5.
How to store Enzalutamide Sandoz
6.
Contents of the pack and other information
1.
WHAT ENZALUTAMIDE SANDOZ IS AND WHAT IT IS USED FOR
Enzalutamide Sandoz contains the active substance enzalutamide.
Enzalutamide Sandoz is used
to treat adult men with prostate cancer that:
-
No longer responds to a hormone therapy or surgical treatment to lower
testosterone
Or
-
Has spread to other parts of the body and responds to a hormone
therapy or surgical treatment
to lower testosterone.
HOW ENZALUTAMIDE SANDOZ WORKS
Enzalutamide Sandoz is a medicine that works by blocking the activity
of hormones called
androgens (such as testosterone). By blocking androgens, enzalutamide
stops prostate cancer
cells from growing and dividing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENZALUTAMIDE SANDOZ
DO NOT TAKE ENZALUTAMIDE SANDOZ
-
If you are allergic to enzalutamide or any of the other ingredients of
this medicine (listed
in section 6).
-
If you are pregnant or may become pregnant (see ‘Pregnancy,
breast-feeding and fertility’)
WARNINGS AND PRECAUTIONS
Seizures
Seizures were reported in 5 in every 1,000 people taking Enzalutamide
Sandoz, and fewer than one
in every

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Enzalutamide Sandoz 40 mg film-coated tablets
Enzalutamide Sandoz 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enzalutamide Sandoz 40 mg film-coated tablets
Each film-coated tablet contains 40 mg of enzalutamide.
Excipient(s) with known effect
Each film-coated tablet contains 58 mg lactose (as monohydrate).
Enzalutamide Sandoz 80 mg film-coated tablets
Each film-coated tablet contains 80 mg of enzalutamide.
Excipient(s) with known effect
Each film-coated tablet contains 116 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Enzalutamide Sandoz 40 mg film-coated tablets
Yellow, round, biconvex film-coated tablet debossed with “EN” on
one side and “40” on the other
side; diameter 10.5 – 11.3 mm.
Enzalutamide Sandoz 80 mg film-coated tablets
Yellow, oval, biconvex film-coated tablet debossed with “EN” on
one side and “80” on the other side;
length 16.9 – 17.7 mm; width 8.9 – 9.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Enzalutamide Sandoz is indicated for:
•
the treatment of adult men with metastatic hormone-sensitive prostate
cancer (mHSPC)
in combination with androgen deprivation therapy (see section 5.1).
•
the treatment of adult men with high-risk non-metastatic
castration-resistant prostate
cancer (CRPC) (see section 5.1).
•
the treatment of adult men with metastatic CRPC 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 adult men with metastatic CRPC whose disease has
progressed on or
after docetaxel therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2
Treatment with enzalutamide should be initiated and supervised by
specialist physicians
experienced in the medical treatment of prostate cancer.
Posology
The recommended dose is 160 mg enzalutamide (four 40 mg film-coated
table