Casodex 50 mg Film-coated Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Bicalutamide
Available from:
Imbat Limited
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 number:
PPA1151/104/001
Authorization date:
2009-04-24

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:

What Casodex is and what it is used for

What you need to know before you take Casodex

How to take Casodex

Possible side effects

How to store Casodex

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 have problems with your liver.

if you have diabetes and are already taking an ‘LHRH

analogue’. These include goserelin, buserelin, leuprorelin

and triptorelin.

if you go into hospital, tell the medical staff that you are

taking Casodex.

if you are taking Casodex, you and/or your partner

should use birth control while you are taking Casodex

and for 130 days after stopping Casodex. Talk to your

doctor if you have any questions about birth control.

Other medicines and Casodex

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines. This includes

medicines obtained without a prescription and herbal

medicines. This is because Casodex can affect the way other

medicines work. Also some other medicines can affect the

way Casodex works.

Do not take Casodex if you are already taking any of the

following medicines:

Cisapride (used for some types of indigestion).

Certain anti-histamine medicines (terfenadine or

astemizole).

Casodex might interfere with some medicines used to treat

heart rhythm problems (e.g. quinidine, procainamide,

amiodarone and sotalol) or might increase the risk of heart

rhythm problems when used with some other drugs (e.g.

methadone (used for pain relief and part of drug addiction

detoxification), moxifloxacin (an antibiotic), antipsychotics

used for serious mental illnesses).

Also, tell your doctor or pharmacist if you are taking any of

the following medicines:

Medicines taken by mouth to prevent blood clots (oral

anti-coagulants). Your doctor may do blood tests before

and during your treatment with Casodex.

Ciclosporin (to suppress your immune system).

Calcium channel blockers (to treat high blood pressure

or some heart conditions).

Cimetidine (for stomach problems).

Ketoconazole (to treat infections caused by a fungus).

Driving and using machines

Casodex is not likely to affect you being able to drive or

use any tools or machines.

However, some people may occasionally feel sleepy

while taking Casodex. If this happens to you, ask your

doctor or pharmacist for advice.

Casodex contains lactose monohydrate

Lactose is a type of sugar. If you have been told by your

doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicinal product.

3.

How to take Casodex

Always take this medicine exactly as your doctor has told

you. Check with your doctor or pharmacist if you are not

sure.

The recommended dose for an adult is one tablet each

day.

Swallow the tablet whole with a drink of water.

Try to take your tablet at the same time each day.

Do not stop taking this medicine even if you feel well,

unless your doctor tells you to.

If you take more Casodex than you should

If you take more Casodex than prescribed by your doctor,

talk to a doctor or go to a hospital straight away.

If you forget to take Casodex

If you forget to take a dose, skip the missed dose and

take the next dose as usual.

Do not take a double dose (two doses at the same time)

to make up for a forgotten dose.

If you have any further questions on the use of this medicine,

ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Allergic reactions

These are uncommon (may affect up to 1 in 100 people). The

symptoms can include sudden onset of:

Rash, itching or hives on the skin.

Swelling of the face, lips, tongue, throat or other parts

of the body.

Shortness of breath, wheezing or trouble breathing.

If this happens to you, see a doctor straight away.

Also tell your doctor straight away if you notice any

of the following:

Very common (may affect more than 1 in 10

people):

Pain in your abdomen.

Blood in your urine.

Common (may affect up to 1 in 10 people):

Yellowing of the skin or whites of your eyes (jaundice).

These may be signs of liver problems or in rare cases

(may affect up to 1 in 1,000 people) liver failure.

Page 2 of 2

Uncommon (may affect up to 1 in 100 people):

Serious shortness of breath or shortness of breath which

suddenly gets worse. This may be with a cough or high

temperature (fever). These may be signs of an

inflammation of the lungs called ‘interstitial lung

disease’.

Not known (frequency cannot be estimated from

the available data):

Changes in ECG (QT prolongation).

Other possible side effects:

Very common (may affect more than 1 in 10

people)

Dizziness.

Swelling and tenderness of your breasts.

Hot flushes.

Constipation.

Feeling sick (nausea).

Feeling weak.

Swelling.

Low levels of red blood cells (anaemia). This may make

you feel tired or look pale.

Common (may affect up to 1 in 10 people)

Itching.

Loss of appetite.

Reduced sex drive.

Depression.

Feeling sleepy.

Indigestion.

Wind (flatulence).

Hair loss.

Hair re-growth or growth of extra hair.

Dry skin.

Skin rash.

Being unable to get an erection (impotence).

Weight gain.

Chest pain.

Reduced heart function.

Heart attack.

Rare (may affect up to 1 in 1,000 people)

Increased skin sensitivity to sunlight.

Your doctor may do blood tests to check for any changes to

your blood.

Do not be concerned by this list of possible side effects. You

may not get any of them.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or

nurse. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517

Website: www.hpra.ie E-mail: medsafety@hpra.ie

By reporting side effects, you can help provide more

information on the safety of this medicine.

5.

How to store Casodex

Keep this medicine out of the sight and reach of

children.

Do not use this medicine after the expiry date (Exp)

which is marked on the carton and blister strips. This

refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw

away any medicines you no longer use. These measures

will help protect the environment.

6.

Contents of the pack and other

information

What Casodex contains

The name of your medicine is Casodex.

Each film-coated tablet contains 50mg of bicalutamide as the

active ingredient.

Other ingredients: lactose monohydrate,

sodium starch glycollate (type A), povidone, magnesium

stearate, hypromellose, macrogol 300 and titanium dioxide

(E171).

What Casodex looks like and contents of the pack

Casodex are round, white, biconvex tablets intagliated with

“Cdx50” on one face and a logo on the reverse.

Casodex tablets are supplied in blister packs of 28 tablets.

Manufacturer

Manufactured by: Corden Pharma GmbH, Plankstadt,

Germany

AstraZeneca Reims, Cedex, France

CIT S.r.l., 20040 Burago di Molgora (MB), Italy.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,

Doncaster, DN3 1QR, UK.

PPA holder: Imbat Ltd., Unit L2, North Ring Business Park,

Santry, Dublin 9.

Distributed by: Eurodrug Ltd., Unit L2,

North Ring Business Park, Santry, Dublin 9.

PPA No: 1151/104/1

Leaflet revision and issue date (ref): 15.03.17

Casodex

is a registered trademark of AstraZeneca group of

companies.

Blind or partially sighted?

Is this leaflet hard to see or

read?

Call +44 (0) 1302 365000

(Regulatory)

Please be ready to give the

following information:

Product name: Casodex

50mg Film-coated Tablets

Reference No: 1151/104/1

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 Limited

Unit L2

North Ring Business Park

Santry

Dublin 9

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1151/104/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 24th April 2009

10 DATE OF REVISION OF THE TEXT

January 2015

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