Prospect: information for the user

Casodex 50 mg film-coated tablets

bicalutamide

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. Contents of the pack and additional information

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

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

It is also used in the treatment of prostate cancer without metastasis, 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 radiation therapy.

Do not take Casodex

• If you are allergic to bicalutamide or any of the other components of this medication (listed in section 6).
• If you are a woman.
• If you are taking terfenadine or astemizol, which are used to treat allergies, or cisaprida, which is used to treat heartburn and acid reflux.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Casodex:

• If you have any liver disorder or disease. The medication should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor should regularly perform liver function tests. Fatal cases (severe liver changes and liver failure) have been reported.
• If you have a lung inflammation called interstitial lung disease. Symptoms of this condition may include severe difficulty breathing with cough or fever. Fatal cases have been reported.
• If you are taking any medication, including those obtained without a prescription. In particular, if you are taking medications that thin the blood or medications to prevent blood clotting.
• If you have diabetes. The combined treatment of bicalutamide with LHRH analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dose.
• 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 a heart disease.

Your doctor may choose to check your cardiac function periodically.

Inform your doctor if you have any heart or blood vessel disease or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when Casodex is used.

If any of the above situations apply to you, inform your doctor, who will take this into account during your treatment with Casodex.

Inform hospital staff that you are taking Casodex upon admission.

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

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

Children and adolescents

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

Other medications and Casodex

Inform your doctor or pharmacist if you are using or have recently used other medicationsor may need to take any other medication, including those obtained without a prescription and herbal remedies.

Do not take bicalutamide with the following medications:

• Terfenadine or astemizol (for hay fever or allergies).
• Cisaprida (for stomach disturbances).

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

• In particular, inform your doctor if you are taking blood-thinning medications such as warfarin.
• Ciclosporina (used to reduce the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (a medication used to alleviate anxiety before surgery or certain procedures or as an anesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medications are used to treat high blood pressure or certain heart diseases).
• Cimetidina (to treat stomach ulcers).
• Ketoconazol (used to treat fungal infections of the skin and nails).

Casodex may interfere with some medications used to treat heart rhythm problems (e.g., quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g., metadona (used to relieve pain and for detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant,consult your doctor or pharmacist before using any medication.

Casodex should not be taken by women, including pregnant women or breastfeeding mothers.

Casodex may have an effect on male fertility that may be reversible.

Driving and operating machinery

Casodex may make you feel drowsy, so you should be careful when driving or operating machinery.

Casodex contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Casodex contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

If you take more Casodex than you should

If you ingest a dose higher than the normal dose, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Casodex

Do not take a double dose to compensate for the missed doses, simply continue with your usual treatment.

If you interrupt treatment with Casodex

Do not stop taking this medication even if you feel well, unless your doctor tells you otherwise.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you notice any of the following symptoms, immediately inform your doctor or visit the nearest hospital's emergency service. These side effects are very serious.

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

Other possible side effects of this medicine are:

Very common: in more than 1 in 10 patients

• Anemia.
• Dizziness.
• Abdominal pain, constipation, nausea (urge to vomit).
• Confusion.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after treatment is stopped, particularly after prolonged treatment.

Common: between 1 and 10 in 100 patients

• Weight gain.
• Drowsiness.
• Myocardial infarction (fatalities have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated levels of liver enzymes, jaundice (yellow discoloration of skin and eyes).
• Erectile dysfunction.
• Decreased libido
• Depression.

Uncommon: between 1 and 10 in 1000 patients

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

Rare: between 1 and 10 in 10,000 patients

• Liver failure. Fatalities have been reported.
• Increased sensitivity to sunlight.

Frequency not known: cannot be estimated from available data

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this prospectus. You can also report them directlyto the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Casodex

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

Appearance of the product and content of the container

This medicine is presented in the form of coated tablets. The tablets are white, round, biconvex, and printed with the Casodex logo on one side and with “Cdx 50” on the other.

Casodex 50 mg coated tablets are presented in containers of 30 tablets conditioned in blister pack.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Juvisé Pharmaceuticals

149 boulevard Bataille de Stalingrad

69100 Villeurbanne

France

Responsible for manufacturing

AstraZeneca ABGlobal External Sourcing (GES)

Astraallén

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

Sweden

or

Corden Pharma GmbH

Otto-Hahn-Strasse

D-68723 Plankstadt

Germany

Last review date of thisleaflet:June2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/