Casodex 150 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Casodex 150 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, and you should 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 they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Casodex is and what it is used for
- What you need to know before taking Casodex
- How to take Casodex
- Possible side effects
- How to store Casodex
- 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 adult males to treat non-metastatic prostate cancer in cases where there is a high risk of disease progression. 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 taking Casodex
Do not take Casodex
- If you are allergic to bicalutamide or to 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 gastric reflux and heartburn.
Casodex must not be given to children and adolescents under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Casodex:
- If you have any liver disorder or disease. This medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this applies to you, your doctor should regularly perform liver function tests. Deaths (due to 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 used to prevent blood clots.
- If you have severe kidney problems. Caution is needed, as there is no experience with the use of bicalutamide in such cases.
- If you have heart disease. Your doctor may decide to monitor your heart function periodically.
Inform your doctor if you have any heart or blood vessel condition or are being treated for such a condition, 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.
If you are admitted to hospital, inform the healthcare staff that you are taking Casodex 150 mg.
If you are taking Casodex, you and/or your partner must use an effective method of contraception during treatment and for 130 days after stopping treatment.
Talk to your doctor if you have any questions about contraception methods.
Children and adolescents
Casodex must not be given 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 might need to take any other medicines, 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 these medicines and of bicalutamide may be affected. Talk to 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 organ or bone marrow transplants).
- 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 conditions).
- Cimetidine (to treat stomach ulcers).
- Ketoconazole (used to treat fungal infections of the skin and nails).
Casodex 150 mg may interfere with some medicines used to treat heart rhythm problems (e.g., quinidine, procainamida, 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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning 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 use of this medicine as given 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 each day.
If you take more Casodex than you should
If you ingest a dose higher than normal, contact your doctor or nearest hospital.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.
If you forget to take Casodex
Do not take a double dose to make up for forgotten doses; simply continue with your regular treatment.
If you stop taking Casodex
Do not stop taking this medicine even if you feel well, unless your doctor tells you otherwise.
If you have any further questions about the use of this medicine, 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 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 lumps), 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, 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 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 stopping therapy, particularly after prolonged treatment.
Common: in between 1 and 10 of every 100 patients
- Weight gain.
- Anaemia.
- Dizziness, drowsiness.
- Abdominal pain, constipation, indigestion, flatulence (gas), nausea (feeling sick).
- Blood in the urine.
- Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching.
- Loss of appetite.
- Hot flush.
- Chest pain, swelling.
- 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 of every 1,000 patients
- Interstitial lung disease (a lung inflammation). Fatal cases have been reported.
- Allergic reactions (hypersensitivity), skin swelling, urticaria.
Rare: in between 1 and 10 of every 10,000 patients
- Liver failure. Fatal cases have been reported.
- Increased sensitivity to sunlight.
Cannot be estimated from available data
- Changes in electrocardiogram (ECG) (prolongation of 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 packaging.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should 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 are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. 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 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 medicinal product and contents of the pack
This medicine is presented as film-coated tablets. The tablets are white, round, biconvex, printed with the Casodex logo on one side and “Cdx 150” on the other.
Casodex 150 mg film-coated tablets are available 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 the most recent revision of this leaflet: June 2020
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/