Enzalutamide Rowex 80 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Enzalutamide

متاح من:

Rowex Ltd

ATC رمز:

L02BB04

INN (الاسم الدولي):

Enzalutamide

الشكل الصيدلاني:

Film-coated tablet

المجال العلاجي:

Enzalutamide

الوضع إذن:

Not marketed

تاريخ الترخيص:

2023-11-24

نشرة المعلومات

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENZALUTAMIDE ROWEX 40 MG FILM-COATED TABLETS
ENZALUTAMIDE ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you take Enzalutamide Rowex
3.
How to take Enzalutamide Rowex
4.
Possible side effects
5.
How to store Enzalutamide Rowex
6.
Contents of the pack and other information
1.
WHAT ENZALUTAMIDE ROWEX IS AND WHAT IT IS USED FOR
Enzalutamide Rowex contains the active substance enzalutamide.
Enzalutamide Rowex 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 ROWEX WORKS
Enzalutamide Rowex 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 ROWEX
DO NOT TAKE ENZALUTAMIDE ROWEX
-
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
Rowex, and fewer than one in
every 1,000 people

خصائص المنتج

Health Products Regulatory Authority
16 January 2024
CRN00DW0Y
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enzalutamide Rowex 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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 Rowex 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
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
tablets or two 80 mg film-coated tablets) as a single
oral daily dose.
Medical castration with a luteinising hormone-releasing hormone (LHRH)
analogue should be continued during treatment of
patients not surgically castrated.
If a patient misses taking Enzalutamide Rowex at the usual time, the
prescribed dose should be taken as close as possible to
the usual time. If a patient misses a dose for a whole day, treatment
should be resumed the following day with the