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CASODEX 50 mg FILM-COATED TABLETS

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About the medicine

How to use CASODEX 50 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

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/

Online doctors for CASODEX 50 mg FILM-COATED TABLETS

Discuss questions about CASODEX 50 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Doctor

Giorgi Eremeishvili

Urology 22 years exp.

Giorgi Eremeishvili is a top-category urologist, a Candidate of Medical Sciences, and a licensed physician in Spain. He provides expert assistance in the diagnosis and treatment of a wide range of urological conditions in both men and women, employing a comprehensive approach and evidence-based principles.

Key areas of expertise:

  • Erectile dysfunction, decreased libido, premature ejaculation.
  • Male infertility: comprehensive diagnosis and modern treatment methods.
  • Prostate gland diseases: acute and chronic prostatitis, prostatic adenoma (benign prostatic hyperplasia), prostate cancer.
  • Inflammatory diseases of the genitourinary system: acute and chronic cystitis, pyelonephritis, epididymitis, orchitis, urethritis.
  • Sexually transmitted infections (STIs): chlamydia, ureaplasmosis, mycoplasmosis, gardnerellosis, candidiasis, herpetic infections, HPV, CMV, trichomoniasis, and others.
  • Urination disorders: urinary retention, frequent urination, urinary incontinence, overactive bladder, neurogenic bladder.
  • Neoplasms: cysts, tumors of the kidneys, bladder, testicles, prostate gland (including prostate cancer).
  • Surgical interventions: determining indications and selecting optimal minimally invasive methods.

Dr. Eremeishvili applies an integrated approach to each case. This includes thorough preoperative preparation, postoperative observation, and regular dynamic follow-up during the treatment process to achieve the best possible outcomes. All diagnostic and therapeutic recommendations are based on current evidence-based medicine and comply with the recommendations of the European Association of Urology, guaranteeing high-quality and effective care.

If you are seeking qualified assistance in diagnosing or treating urological conditions, book an online consultation with Dr. Giorgi Eremeishvili. Get expert support, accurate diagnosis, and a personalized treatment plan from the comfort of your home.

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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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€60
5.0 (29)
Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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€60

Frequently Asked Questions

Is a prescription required for CASODEX 50 mg FILM-COATED TABLETS?
CASODEX 50 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CASODEX 50 mg FILM-COATED TABLETS?
The active ingredient in CASODEX 50 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
How much does CASODEX 50 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for CASODEX 50 mg FILM-COATED TABLETS is around 42.37 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CASODEX 50 mg FILM-COATED TABLETS?
CASODEX 50 mg FILM-COATED TABLETS is manufactured by Laboratoires Juvise Pharmaceuticals. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CASODEX 50 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CASODEX 50 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CASODEX 50 mg FILM-COATED TABLETS?
Other medicines with the same active substance (bicalutamide) include BICALUTAMIDE ACCORD 50 mg FILM-COATED TABLETS, BICALUTAMIDE ALMUS 50 mg FILM-COATED TABLETS, BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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