Casodex 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Casodex 50 mg film-coated tablets

bicalutamide

Read the entire leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Casodex is and what it is used for
2. What you need to know before taking Casodex
3. How to take Casodex
4. Possible side effects
5. How to store Casodex
6. Contents of the pack and other information

1. What Casodex is and what it is used for

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

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

It is also used in the treatment of non-metastatic prostate cancer in cases where there is a high risk of disease progression (150 mg daily dose). It may 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 taking 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, used to treat allergies, or cisapride, used to treat heartburn and acid reflux.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Casodex:

• If you have any liver disorder or liver disease. The medicine should only be taken after your doctor has carefully considered the potential benefits and risks. In such cases, your doctor should regularly monitor your liver function. Deaths (severe liver changes and liver failure) have been reported.
• If you have a lung inflammation called interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Deaths have been reported.
• If you are taking any medicines, including those obtained without a prescription. In particular, if you are taking medicines that thin the blood or medicines to prevent blood clots.
• If you have diabetes. Combination treatment with bicalutamide and LHRH analogues may alter your blood sugar levels. Your doctor must adjust your dose of insulin and/or antidiabetic medicines.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in such cases.
• If you are taking a daily dose of 150 mg bicalutamide and have heart disease.

Your doctor may decide to periodically check your heart function.

Inform your doctor if you have any heart or blood vessel condition or are being treated for one, including medicines 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 them into account during your treatment with Casodex.

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

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

Talk to your doctor if you have any questions about contraceptive methods.

Children and adolescents

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

Other medicines and Casodex

Tell your doctor or pharmacist if you are using or have recently used any other medicines, or if you may need to take any other medicine, including over-the-counter medicines and herbal remedies.

Do not take bicalutamide together with the following medicines:

• Terfenadine or astemizole (for hay fever or allergies).
• Cisapride (for stomach disorders).

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

• In particular, inform your doctor if you are taking blood-thinning medicines such as warfarin.
• Cyclosporine (used to suppress the immune system to prevent and treat rejection of transplanted organs or bone marrow).
• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures, or as an anesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart conditions).
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Casodex may interfere with some medicines used to treat heart rhythm disorders (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 detoxification from other drugs), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

Please note that these warnings may also apply to medicines you have taken some time ago.

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 medicine.

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

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

Driving and using machines

Casodex may make you feel drowsy, so you should be cautious 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 medicine.

Casodex contains sodium

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

3. How to take Casodex

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

For patients with non-metastatic prostate cancer who are at high risk of disease progression, another formulation is available on the market (Casodex 150 mg) that 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 ingest a higher than normal dose, contact your doctor or nearest hospital.

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

If you forget to take Casodex

Do not take a double dose to make up for missed doses; simply continue with your usual treatment.

If you stop taking Casodex

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you notice any of the following symptoms, inform your doctor immediately or go to the nearest hospital emergency department. These adverse effects are very serious.

• Skin rash, severe skin itching (with lumps), hives, skin peeling, or blistering or crusting.
• Swelling of the face or neck, lips, tongue and/or throat, which may cause difficulty breathing or swallowing.
• Difficulty breathing or sudden worsening of breathing problems, 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 adverse effects of this medicine are:

Very common: in more than 1 out of 10 patients

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Hot flush.
• 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 between 1 and 10 out of 100 patients

• Weight gain.
• Drowsiness.
• Heart attack (fatalities have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching.
• Loss of appetite.
• Chest pain.
• Liver toxicity, elevated transaminase levels (liver enzymes), jaundice (yellowing of skin and eyes).
• Erectile dysfunction.
• Decreased sexual desire.
• Depression.

Uncommon: in between 1 and 10 out of 1,000 patients

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

Rare: in between 1 and 10 out of 10,000 patients

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

Frequency not known: cannot be estimated from available data

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 packaging.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This 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 components are: Core; lactose monohydrate, potato starch, povidone (E1201), magnesium stearate (E470b). Coating; hypromellose (E464), macrogol 300 and titanium dioxide (E171).

Nature and contents of the container

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

Casodex 50 mg film-coated tablets are supplied in packs of 30 tablets in blister packs.

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 latest revision of this product information: June 2020

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