Casodex 50 mg Film-coated Tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Bicalutamide

MAH:

Imbat Limited

ATC_code:

L02BB; L02BB03

INN:

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:

2009-04-24

PIL

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASODEX
® 50MG FILM-COATED TABLETS
(bicalutamide)
Your medicine is available using the above name but will be
referred to as Casodex throughout this leaflet.
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 medicin

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Casodex 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg bicalutamide.
Excipient: contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy._
Round, white, biconvex tablet intagliated with “Cdx50” on one face
and a logo on the reverse.
4 CLINICAL PARTICULARS
As per PA0970/004/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0970/004/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose Monohydrate
Sodium Starch Glycollate (Type A)
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
blister strips and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
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6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips.
Pack size: 28
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
Imbat Limite