50 mg film-coated tablet 
bicalutamide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
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 packaging and other information 

1. What Casodex is and what it is used for

For the growth of prostate tumors, stimulation of male sex hormones ( androgens ) is needed. Casodex prevents that stimulation.

Casodex 50 mg tablets are used for prostate cancer in combination with castration therapy ( GnRH agonist ).

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 or a child.
  • if you are taking medicines containing any of the active substances terfenadine, astemizole, or cisapride.

Warnings and cautions

Talk to your doctor before taking Casodex:

  • if you have any of the following: cardiovascular disease, including heart rhythm problems ( arrhythmias ), or you are taking medication for this. The risk of heart rhythm disorders may be increased when using Casodex.
  • if you have any disease that affects the liver.
  • if you have diabetes (which may affect the amount of glucose in your blood).
  • if you are taking Casodex, you and/or your partner should use contraception while taking Casodex and 130 days after stopping taking Casodex. Talk to your doctor if you have any questions about contraception.

Other medicines and Casodex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Casodex may affect or be affected by certain medicines that contain the following active substances:

  • ciclosporin, used in transplants
  • calcium channel blockers, antihypertensives
  • cimetidine, antacids
  • ketoconazole, antifungal
  • warfarin, a blood thinner

Casodex may affect some other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines (eg methadone (used for pain and in case of treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).

Pregnancy, breastfeeding, and fertility

Casodex should not be used by women.

Casodex may transiently affect male fertility.

Driving and using machines

Casodex is likely to have no or negligible influence on your ability to drive or use machines. However, fatigue may occur during treatment with Casodex. You are responsible for assessing whether you can drive motor vehicles or perform work that requires sharpened vigilance. One of the factors that can affect this ability is the use of drugs due to their effects and/or side effects . A description of these effects and side effects can be found under other headings in the package leaflet. Therefore, read all information in this leaflet. If you are not sure, talk to your doctor or pharmacist.

Casodex contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Casodex

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dose one is determined by the doctor, who adjusts it individually for you.

The usual dose is one tablet a day. The tablets should be swallowed whole with liquid and can be taken with food. Try to take your medication at about the same time each day.

Do not stop taking your medicine, even if you feel well unless you are immediately told by your doctor to stop.

If you forget to take Casodex

If you miss a dose, skip it and take your usual dose at the next regular dosing session.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Casodex and contact a doctor immediately if you get any of the following symptoms ( angioedema ):

  • Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing.
    Angioedema is a less common side effect (affects less than 1 in 100 people treated with bicalutamide).

Contact a doctor or seek medical attention immediately if you experience any of the following:

  • Difficulty breathing or sudden shortness of breath, possibly with cough or fever. You may have pneumonia called “interstitial lung disease”, this is a less common side effect (affects less than 1 in 100 people treated with bicalutamide).

The following side effects may also occur:

Very common (more than 1 person in 10 affected): Anemia, dizziness, hot flashes, abdominal pain, constipation, nausea, blood in the urine, tenderness in the breasts, enlarged breasts, weakness, fluid accumulation in the tissues.

Common (more than 1 person in 100 affected): Decreased appetite, decreased sexual desire, depression, drowsiness, heart attack, heart failure, altered liver values, yellowed skin and eyes (jaundice), hair loss, increased body hair growth, dry skin, itching, rash, impotence, weight gain, chest pain, general stomach upset, flatulence.

Uncommon (less than 1 in 100 people affected): A hypersensitivity reaction.

Rare (less than 1 person in 1,000 affected): Photosensitivity reactions in the skin. Liver failure, deaths have been reported.

Has been reported: Changes ( QT prolongation) in ECG ( electrocardiogram ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Casodex

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is bicalutamide 50 mg per tablet.
  • The other ingredients are lactose monohydrate 61 mg, sodium starch glycolate, povidone, magnesium stearate, hypromellose, macrogol, titanium dioxide (dye E171).

What the medicine looks like and the contents of the pack

The tablet is white, marked with Cdx 50 on one side and with an arrow on the other side.

Packaging:

Pressure pack with 30 and 100 tablets.

Printed packaging with 28 and 98 tablets, calendar packaging.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sales: AstraZeneca AB, 151 85 Södertälje

Manufacturer: AstraZeneca AB, Södertälje, or AstraZeneca Limited, Macclesfield, United Kingdom

Muhammad Nadeem

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