Casodex 50 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bicalutamide

Available from:

PCO Manufacturing Ltd.

ATC code:

L02BB; L02BB03

INN (International Name):

Bicalutamide

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Anti-androgens; bicalutamide

Authorization status:

Authorised

Authorization date:

2004-07-02

Patient Information leaflet

_ _
_ _
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 tak

Summary of Product characteristics

Health Products Regulatory Authority
24 March 2022
CRN00CVHQ
Page 1 of 2
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 bicalutamide.
Excipient with known effect:
Lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Greece, Italy and Romania_:
Round, white, biconvex, intagliated with 'CDX50' on one face and a
logo on the reverse.
4 CLINICAL PARTICULARS
As per PA23154/002/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23154/002/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Sodium starch glycollate
Povidone
Magnesium stearate
Hypromellose
Macrogol 300
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original package.
Health Products Regulatory Authority
24 March 2022
CRN00CVHQ
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 28 film-coated tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/144/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisations: 02 July 2004
Date of last renewal: 02 July 2009
10 DATE OF REVISION OF THE TEXT
March 2022