Casodex 50 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Bicalutamide

זמין מ:

Laboratoires Juvise Pharmaceuticals

קוד ATC:

L02BB; L02BB03

INN (שם בינלאומי):

Bicalutamide

כמות:

50 milligram(s)

טופס פרצבטיות:

Film-coated tablet

איזור תרפויטי:

Anti-androgens; bicalutamide

מצב אישור:

Marketed

תאריך אישור:

2000-04-21

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
CASODEX 50 MG FILM-COATED TABLETS
Bicalutamide
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 Casodex is and what it is used for
2.
What you need to know before you take Casodex
3.
How to take Casodex
4.
Possible side effects
5.
How to store Casodex
6.
Contents of the pack and other information
1. WHAT CASODEX IS AND WHAT IT IS USED FOR
Casodex contains a medicine called bicalutamide. This belongs to a
group of medicines called
‘anti-androgens’.

Casodex is used together with other treatments to treat prostate
cancer.

It works by blocking the effects of male hormones such as
testosterone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CASODEX
DO NOT TAKE CASODEX:

if you are allergic to bicalutamide or any of the other ingredients of
this medicine (listed in
section 6).

if you are already taking a medicine called cisapride or certain
anti-histamine medicines
(terfenadine or astemizole).

if you are a woman.
Do not take Casodex if any of the above apply to you. If you are not
sure, talk to your doctor
or pharmacist before taking Casodex.
Casodex must not be given to children.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Casodex:

if you have any of the following: any heart or blood vessel
conditions, including heart
rhythm problems (arrhythmia), or are being treated with medicines for
these conditions. The
risk of heart rhythm problems may be increased when using Casodex.

if you are taking blood

מאפייני מוצר

Health Products Regulatory Authority
27 August 2021
CRN00C32R
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Casodex 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg of bicalutamide.
Excipient(s) with known effect:
61 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, white, biconvex tablet intagliated with “CDX50” on one face
and a logo on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with
luteinizing-hormone releasing hormone (LHRH) analogue therapy
or surgical castration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult males including the elderly: One tablet (50 mg) once a day.
Treatment with Casodex should be started at the same time as treatment
with an LHRH analogue or surgical castration.
Renal impairment: No dosage adjustment is necessary for patients with
renal impairment.
Hepatic Impairment: No dosage adjustment is necessary for patients
with mild hepatic impairment. Increased accumulation
may occur in patients with moderate to severe hepatic impairment (see
section 4.4).
Paediatric population: Casodex is contraindicated for use in children
(see section 4.3).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Casodex is contraindicated in females and children (see section 4.6).
Co-administration of terfenadine, astemizole or cisapride with Casodex
is contraindicated (see section 4.5).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialist.
Health Products Regulatory Authority
27 August 2021
CRN00C32R
Page 2 of 7
Casodex is extensively metabolised in the liver. Data suggests that
its elimination may be slower in subjects with severe hepatic
impairment and this could lead to increasedaccumulation of Casodex.
Therefore, Caso