Patient Information Leaflet: Information for the User

Bicalutamide Ibigen 50 mg Film-coated Tablets

Bicalutamide
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Bicalutamide Ibigen 50 mg is and what it is used for
What you need to know before taking Bicalutamide Ibigen 50 mg
How to take Bicalutamide Ibigen 50 mg
Possible side effects
How to store Bicalutamide Ibigen 50 mg
Contents of the pack and other information

1. What Bicalutamide Ibigen 50 mg is and what it is used for

Bicalutamide Ibigen 50 mg is a medicine containing the active substance bicalutamide.
Bicalutamide belongs to a group of medicines called anti-androgens.

Bicalutamide is used to treat prostate cancer
Bicalutamide works by blocking the effects of male hormones such as testosterone

2. What you need to know before taking Bicalutamide Ibigen 50 mg

Do not take Bicalutamide Ibigen 50 mg

if you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6)
if you are taking terfenadine or astemizole, which are used to treat allergies, or cisapride, used to treat heartburn or acid reflux
if you are a woman

Bicalutamide Ibigen 50 mg must not be given to children or adolescents.
Do not take Bicalutamide Ibigen 50 mg if any of the above contraindications apply to you. If you are unsure, talk to your doctor or pharmacist before taking Bicalutamide Ibigen 50 mg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide Ibigen 50 mg

if you have heart or vascular diseases, including heart rhythm disorders (arrhythmia), or if you are taking medicines for these conditions. The risk of heart rhythm problems may increase when taking Bicalutamide Ibigen 50 mg
if you have liver problems. Your doctor may request blood tests to monitor liver function during treatment with this medicine
if you have diabetes. Treatment with bicalutamide in combination with luteinizing hormone-releasing hormone (LHRH) analogues may alter your blood sugar levels. Your insulin and/or oral antidiabetic dosage may need to be adjusted.
if you are admitted to hospital, inform the medical staff that you are taking Bicalutamide Ibigen 50 mg

Other medicines and Bicalutamide Ibigen 50 mg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal products.
Bicalutamide Ibigen 50 mg may affect the action of other medicines. Conversely, other medicines may alter the action of Bicalutamide Ibigen 50 mg.

Cyclosporine (used to suppress the immune system to prevent or treat rejection of a transplanted organ or bone marrow). This is because bicalutamide may increase blood levels of a substance called creatinine, and your doctor may request tests to monitor this.
Midazolam (a medicine used to reduce anxiety before surgery or certain procedures, or as an anaesthetic before and during surgery). You must inform your doctor or dentist that you are taking bicalutamide if you require surgery or are experiencing severe anxiety in hospital.
Terfenadine or astemizole, used for allergies.
Cisapride, used to treat heartburn or acid reflux (see section 2, “Do not take Bicalutamide Ibigen 50 mg”)
Certain medicines called calcium channel blockers, such as diltiazem or verapamil, used to treat heart conditions, angina, and high blood pressure.
Medicines used to prevent blood clotting, such as warfarin.
Cimetidine, used to treat acid reflux or stomach ulcers
Ketoconazole, a medicine used to treat fungal infections
Bicalutamide Ibigen 50 mg may interfere with certain medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disturbances when used together with other medicines (e.g., methadone (used to treat pain and in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics used for severe mental disorders).

Bicalutamide Ibigen 50 mg with food and drink
The tablets do not need to be taken with food, but must be swallowed whole with a glass of water.
Pregnancy and breastfeeding
Women must never take this medicine.
Driving and using machines
This medicine should not affect your ability to drive or operate machinery. However, some people may experience drowsiness while taking this medicine. If you experience drowsiness, inform your doctor or pharmacist before driving or operating machinery.
Sunlight or ultraviolet light
Avoid excessive direct exposure to sunlight or ultraviolet (UV) light while taking bicalutamide.
Bicalutamide Ibigen 50 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Bicalutamide Ibigen 50 mg

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose is one tablet daily. The tablet should be swallowed whole with a glass of water. Try to take the medicine at approximately the same time each day.
You must start treatment at least 3 days before beginning treatment with LHRH analogues, such as gonadorelin, or simultaneously with surgical removal of the testes.

If you take more Bicalutamide Ibigen 50 mg than you should
If you think you have taken more tablets than you should, contact your doctor or the nearest hospital as soon as possible. Take the remaining tablets or the packaging with you so that the doctor can identify what you have taken. The doctor may decide to keep you under observation until the effects of bicalutamide have passed.

If you forget to take Bicalutamide Ibigen 50 mg
If you think you have missed a daily dose, inform your doctor or pharmacist. Do not take a double dose to make up for the forgotten tablet. Take your usual dose at the scheduled time.

If you stop taking Bicalutamide Ibigen 50 mg
Do not stop taking this medicine even if you feel better, unless your doctor tells you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you notice any of the following symptoms, inform your doctor immediately or go to the nearest hospital.
Allergic reactions
These adverse reactions are uncommon (may affect up to 1 in 100 people).
Symptoms may include sudden onset of:

Skin rash, itching or hives
Swelling of the face, lips, tongue, throat or other parts of the body
Shortness of breath, wheezing and breathing difficulties

If this happens to you, seek immediate medical attention.
Also, tell your doctor immediately if you notice any of the following:

Adverse reactions very common (may affect more than 1 in 10 people)

Abdominal pain
Blood in the urine

Adverse reactions common (may affect up to 1 in 10 people)

Yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver problems or, in rare cases (may affect up to 1 in 1,000 people), liver failure.

Adverse reactions uncommon (may affect up to 1 in 100 people)

Severe difficulty in breathing or sudden worsening of breathing. This may present with cough or high temperature (fever). These may be signs of lung inflammation known as "interstitial lung disease".
Not known (frequency cannot be estimated from the available data)
Changes in ECG (prolongation of the QT interval).

Other possible adverse reactions
Adverse reactions very common (may affect more than 1 in 10 people)
• Dizziness
• Constipation
• Feeling unwell (nausea)
• Breast swelling and tenderness
• Breast development in males
• Hot flushes
• Feeling weak
• Swelling
• Low red blood cell count (anaemia). This may make you feel tired or look pale.

Adverse reactions common (may affect up to 1 in 10 people)
• Loss of appetite
• Reduced sex drive
• Depression
• Drowsiness
• Indigestion
• Gas (flatulence)
• Hair loss
• Increased hair growth or growth of extra hair
• Dry skin
• Itching
• Skin rash
• Inability to achieve an erection (impotence)
• Weight gain
• Chest pain
• Reduced heart function
• Heart attack

Adverse reactions rare (may affect up to 1 in 1,000 people)
• Increased sensitivity to sunlight.

Your doctor may request blood tests to check for any possible changes. Do not be alarmed by this list of possible adverse reactions. You may not experience any of them.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

How to store Bicalutamide Ibigen 50 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after 'Exp'. The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bicalutamide Ibigen 50 mg contains

The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
The other components of the tablet core are monohydrate lactose, magnesium stearate, crospovidone, povidone K-29/32, sodium lauryl sulfate.

The components of the film coating are monohydrate lactose, hypromellose, macrogol 4000,
titanium dioxide (colouring agent E171).
Description of the appearance of Bicalutamide Ibigen 50 mg and contents of the pack
White, round, biconvex film-coated tablet marked with "BCM 50" on one side.
Blister packs containing 5, 7, 10, 14, 20, 28, 30, 50, 84, 90, 98, 100, 140, 200 or 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ibigen S.r.l.
Via Fossignano, 2
04011 Aprilia
Latina
Italy
Manufacturer
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania
Castello 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain