CASODEX 50 mg FILM-COATED TABLETS

Introduction

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.

Contents of the pack and other information

1. What is Casodex and what is it used for
2. What you need to know before you take Casodex
3. How to take Casodex
4. Possible side effects
5. Storage of Casodex

1. Contents of the pack and other information

1. What is Casodex and what is it used for

Casodex belongs to a group of medicines called anti-androgens, which means that it interferes with some of the actions of male sex hormones (androgens) in the body.

This medicine is used in the treatment of advanced prostate cancer (daily dose of 50 mg) in combination with a medicine called luteinizing hormone-releasing hormone (LHRH) analogue - an additional hormonal treatment - or in combination with surgical removal of the testicles.

It is also used in the treatment of prostate cancer without metastases, in cases where there is a high risk of progression of the disease (daily dose of 150 mg). It can be used alone or in combination with other therapeutic methods such as surgical removal of the prostate gland or radiotherapy.

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 a woman.
• If you are taking terfenadine or astemizole, which are used to treat allergies, or cisapride, which is used to treat heartburn and acid reflux.

Casodex should not be given to children and adolescents under 18 years of age.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Casodex:

• If you have any liver problems. This medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor will need to perform regular liver function tests. Serious liver damage and liver failure have been reported.
• If you have a lung disease called interstitial lung disease. Symptoms may include severe difficulty breathing with cough or fever. Serious cases have been reported.
• If you are taking any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicines that thin the blood or medicines to prevent blood clots.
• If you have diabetes. The combined treatment of bicalutamide with LHRH analogues may affect your blood sugar levels. Your doctor will need to adjust your insulin dose and/or your anti-diabetic medicines.
• If you have severe kidney problems. Caution is necessary as there is no experience with the use of bicalutamide in these cases.
• If you are taking a daily dose of 150 mg of bicalutamide and have heart disease.

Your doctor may decide to check your heart function periodically.

Tell your doctor if you have any heart or blood vessel problems or are being treated for them, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Casodex.

If any of the above applies to you, tell your doctor, who will take it into account during your treatment with Casodex.

If you are admitted to hospital, inform the medical staff that you are taking Casodex.

If you are taking Casodex, you and/or your partner should use a contraceptive method while you are taking Casodex and for 130 days after the end of treatment.

Ask your doctor if you have any questions about contraceptive methods.

Children and adolescents

Casodex should not be given to children and adolescents under 18 years of age.

Other medicines and Casodex

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription and herbal medicines.

Do not take bicalutamide with the following medicines:

• Terfenadine or astemizole (for hay fever or allergy).
• Cisapride (for stomach problems).

If you take Casodex with any of the following medicines, the effect of this medicine and the other medicine may be affected. Tell your doctor before taking any of these medicines with bicalutamide:

• In particular, tell your doctor if you are taking medicines that thin the blood, such as warfarin.
• Ciclosporin (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures or as an anaesthetic before and during surgery).
• Calcium channel blockers (e.g. diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart diseases).
• Cimetidine (for stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Casodex may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (e.g. methadone (used for pain relief and for detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

Please note that these warnings may also apply to medicines that you have used in the past.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Casodex should not be taken by women, including pregnant or breast-feeding women.

Casodex may have an effect on male fertility, which may be reversible.

Driving and using machines

Casodex may make you feel drowsy. Be careful when driving or using machines.

Casodex contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Casodex contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Casodex

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose for adults is 1 tablet a day (equivalent to 50 mg of bicalutamide) or 3 tablets a day (equivalent to 150 mg of bicalutamide).
• Swallow the tablet(s) whole with a glass of water.
• Try to take the tablet(s) at the same time each day.

For patients with prostate cancer without metastases who are at high risk of disease progression, another presentation (Casodex 150 mg) is available, which facilitates therapeutic compliance, as you would take the 150 mg dose in a single tablet.

If you take more Casodex than you should

If you have taken more than the prescribed dose, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Casodex

Do not take a double dose to make up for forgotten doses. Simply continue with your normal treatment.

If you stop taking Casodex

Do not stop taking this medicine unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, tell your doctor immediately or go to the casualty department of your nearest hospital. These serious side effects are very rare.

• Skin rash, severe itching of the skin (with lumps), hives, skin peeling or blistering.
• Swelling of the face or neck, lips, tongue and/or throat, which may cause difficulty breathing or swallowing.
• Breathing difficulties or sudden worsening of breathing difficulties, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine.
• Abdominal pain.
• Yellowing of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine include:

Very common: in more than 1 in 10 patients

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Hot flushes.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after stopping therapy, particularly after prolonged treatment.

Common: in less than 1 in 10 patients but more than 1 in 100 patients

• Weight gain.
• Somnolence.
• Myocardial infarction (serious cases have been reported), heart failure.
• Indigestion, flatulence (wind).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes).
• Erectile dysfunction.
• Decreased libido.
• Depression.

Uncommon: in less than 1 in 100 patients but more than 1 in 1,000 patients

• Interstitial lung disease (a lung disease). Serious cases have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

Rare: in less than 1 in 1,000 patients but more than 1 in 10,000 patients

• Liver failure. Serious cases have been reported.
• Increased sensitivity to sunlight.

Frequency not known: cannot be estimated from the available data

• Changes in the electrocardiogram (ECG) (prolongation of the QT interval).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Casodex

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Casodex

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other ingredients are: Core; lactose monohydrate, potato starch, povidone (E1201), magnesium stearate (E470b). Coating; hypromellose (E464), macrogol 300 and titanium dioxide (E171).

Appearance and packaging

This medicine is presented as film-coated tablets. The tablets are white, round, biconvex, printed with the Casodex logo on one side and with "Cdx 50" on the other.

Casodex 50 mg film-coated tablets are presented in packs of 30 tablets in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratoires Juvisé Pharmaceuticals

149 boulevard Bataille de Stalingrad

69100 Villeurbanne

France

Manufacturer

AstraZeneca AB Global External Sourcing (GES)

Astraallén

Gärtunaporten (B 674:5)-Södertälje, 151 85

Sweden

or

Corden Pharma GmbH

Otto-Hahn-Strasse

D-68723 Plankstadt

Germany

Date of last revision of this leaflet:June 2020

Detailed information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/