Package leaflet: Information for the patient

CASODEX 150 mg film-coated tablets

bicalutamide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CASODEX is and what it is used for
What you need to know before taking 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 bicalutamide, which belongs to a class of medicines called antiandrogens.
CASODEX 150 mg is indicated for the treatment of prostate cancer (a gland in men that produces seminal fluid), and works by reducing the amount of testosterone (a hormone) produced in your body.

CASODEX may be prescribed alone or in combination with other medicines:

following surgical removal of the prostate, or
following a course of radiotherapy (a medical technique that uses radiation to treat cancer).

CASODEX will be prescribed alone if:

the cancer has spread to other organs and cannot be surgically removed, or
the action of the testicles is suppressed.

Speak to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking CASODEX

Do not take CASODEX

if you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6);
if you are a woman or a child (see section Pregnancy and breastfeeding);
if you are taking terfenadine or astemizole, medicines prescribed to treat allergies (see section Other medicines and CASODEX);
if you are taking cisapride, a medicine prescribed to treat acid reflux from the stomach (see section Other medicines and CASODEX).

Warnings and precautions
Talk to your doctor before taking CASODEX.
Talk to your doctor if you have any of the following conditions:

any heart or blood vessel disorder, including problems with heart rhythm (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of CASODEX;
if you have liver disease, even severe (moderate to severe hepatic impairment). Your doctor may ask you to have frequent check-ups;
if you are taking blood thinners or medicines to prevent blood clots (e.g. warfarin) (see section Possible side effects and Other medicines and CASODEX);
if you are taking CASODEX, you and/or your partner must use contraception both during treatment with CASODEX and for 130 days after stopping treatment with CASODEX, as CASODEX may cause morphological changes in sperm. Consult your doctor if you have any doubts about contraception (see section Pregnancy, breastfeeding and fertility);
if your condition worsens and your blood tests show an increase in PSA (prostate-specific antigen). In such a case, your doctor might discontinue treatment with CASODEX 150 mg.

You must take CASODEX 150 mg exactly as prescribed by your doctor and must not stop treatment unless your doctor decides otherwise.
If you are admitted to hospital, inform medical staff that you are being treated with CASODEX 150 mg.
Children
The use of CASODEX 150 mg is contraindicated in children, as safety and efficacy have not been established.
Other medicines and CASODEX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
CASODEX may interfere with certain medicines used to treat heart rhythm problems (e.g. quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide) or may increase the risk of heart rhythm problems when used together with certain other medicines, such as methadone (used to relieve pain and in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses).
In particular, inform your doctor if you are taking:

anticoagulants, medicines that make the blood thinner, such as warfarin (see section Warnings and precautions and Possible side effects);
terfenadine or astemizole, for treating allergies;
cisapride, for treating acid reflux from the stomach;
cyclosporine, to reduce the immune system response (the body's defence system);
calcium channel blockers, for treating high blood pressure or certain heart conditions;
cimetidine, for treating stomach ulcers;
ketoconazole, for treating fungal infections;
midazolam, a sedative medicine.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine. CASODEX 150 mg is contraindicated in women, including pregnant women and those who are breastfeeding.
If you are taking CASODEX, you and/or your partner must use contraception both during treatment with CASODEX and for 130 days after stopping treatment with CASODEX. Consult your doctor if you have any questions about contraception (see section Warnings and precautions).
CASODEX may affect male fertility, which may be reversible.
Driving and using machines
CASODEX 150 mg does not impair the ability to drive or operate machinery.
However, if drowsiness occurs, exercise caution when driving.
CASODEX contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
CASODEX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take CASODEX

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 150 mg CASODEX tablet daily.
No dose adjustment is necessary in patients with mild renal and/or hepatic impairment.
In cases of moderate or severe liver dysfunction, your doctor may decide to discontinue treatment.
Improvement in your health condition should not lead to discontinuation of treatment unless decided by
your doctor.
If you take more CASODEX than you should
If you accidentally ingest or take an excessive dose of CASODEX, inform your doctor immediately or go
to the nearest hospital.
If you forget to take CASODEX
Do not take a double dose to make up for the missed tablet.
If you stop taking CASODEX
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In this section, side effects are classified according to their frequency:
Very common (may affect more than 1 in 10 people)

skin rash
breast enlargement (ginecomastia)
breast pain. This usually resolves upon discontinuation of treatment
weakness

Common (may affect up to 1 in 10 people)

reduction in haemoglobin, a protein that carries oxygen in the blood (anaemia)
decreased appetite
decreased sexual desire
depression
dizziness
somnolence
hot flushes
abdominal pain
constipation
nausea
difficulty digesting (dyspepsia)
passing gas from the intestine (flatulence)
nausea
decreased liver function (hepatic failure)
yellowing of the skin and eyes (jaundice)
increased liver enzyme levels. Liver abnormalities are usually transient.
hair loss
increased hair growth
dry skin
itching
presence of blood in the urine (haematuria)
erectile dysfunction
chest pain
weight gain
swelling (oedema)

Uncommon (may affect up to 1 in 100 people)

allergy
swelling of the face and lips
urticaria
severe lung disease that may lead to death (interstitial pneumonia)

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

liver disease (severe hepatic failure which may be fatal). In this case, your doctor will ask you to stop treatment with CASODEX
increased sensitivity of the skin to sunlight

Not known (frequency cannot be estimated from the available data)

changes in ECG pattern (QT prolongation)

If you are taking blood thinners or medicines to prevent blood clots (e.g. warfarin), an enhancement of the anticoagulant effect may occur (see section Warnings and Precautions and Other medicines and CASODEX).
The possible side effects listed above should not alarm you, as they may not occur at all.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CASODEX

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry
date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CASODEX contains

The active substance is bicalutamide 150 mg.
The other components are monohydrate lactose (see section 2, CASODEX contains lactose), sodium carboxymethyl starch A, povidone, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.

Description of the appearance of CASODEX and contents of the pack
CASODEX 150 mg is a white film-coated tablet.
CASODEX 150 mg is available in packs of 28 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Laboratoires Juvisé Pharmaceuticals
149 boulevard Bataille de Stalingrad
69100 Villeurbanne
France
Manufacturer
Corden Pharma GmbH
Otto-Hahn-Strasse
68723, Plankstadt,
Germany
Corden Pharma GmbH, Plankstadt, Germany
Or:
AstraZeneca Reims Production, Parc Industriel de la Pompelle, Chemin de Vrilly, 51100, Reims,
France
Or:
AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
September 2021