Prospect: information for the user

Casodex 150 mg film-coated tablets

bicalutamide

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 adult males to treat prostate cancer without metastasis, in cases where there is a high risk of progression of the same. 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 that may affect your liver. 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 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 severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in these cases.
• If you have a heart disease. Your doctor may choose to check your heart 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 150 mg 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.

In case you are admitted to a hospital, inform the healthcare staff that you are taking Casodex 150 mg.

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 medications or may need to take any other medication, including those obtained without a prescription and herbal remedies.

Do not takebicalutamide with the following medications:

• Terfenadine or astemizol (for hay fever or allergy).
• 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 medications that thin the blood, 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 (for example, 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 150 mg may interfere with some medications used to treat heart rhythm problems (for example: quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (for example: 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 plan 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 an intolerance to certain sugars, consult with him 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.

If in doubt, consult your doctor or pharmacist again.

• The recommended dose is 1 tablet per day.
• Swallow the tablet whole with water.
• Try to take the tablet at the same time every day.

If you take more Casodex than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Casodex

Do not take a double dose to make up for the missed doses, simply continue with your regular 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, inform your doctor immediately or go to the nearest hospital emergency department. These side effects are very serious.

• Skin rash, severe skin itching (with blisters), hives, skin peeling, or formation of blisters or scabs.
• Swelling of the face or neck, lips, tongue, 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

• Skin rash.
• Weakness.
• 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.
• Anemia.
• Dizziness, drowsiness.
• Abdominal pain, constipation, indigestion, flatulence (gas), nausea (urge to vomit).
• Blood in the urine.
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Loss of appetite.
• Confusion.
• Chest pain, swelling.
• 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 1,000 patients

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

Rare: between 1 and 10 in 10,000 patients

• Liver failure.Fatalities have been reported.
• Sensitivity to sunlight.

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 leaflet. 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Casodex

• The active ingredient is bicalutamide. Each tablet contains 150 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 contents of the packaging

This medication 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 150” on the other.

Casodex 150 mg coated tablets are presented in packaging of 30 tablets in a blister.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratoires Juvisé Pharmaceuticals

149 boulevard Bataille de Stalingrad

69100 Villeurbanne

France

Responsible for manufacturing

AstraZeneca AB Global External Sourcing (GES)

AstraZeneca

Gärtunaporten (B 674:5)

Södertälje, 151 85

Sweden

or

Corden Pharma GmbH

Otto-Hahn-Strasse

D-68723 Plankstadt

Germany

Last review date of thisleaflet:June 2020

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