BIKADER

Package leaflet: Information for the user

Bikader 50 mg film-coated tablets

Bicalutamide
Equivalent 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bikader 50 mg is and what it is used for
2. What you need to know before taking Bikader 50 mg
3. How to take Bikader 50 mg
4. Possible side effects
5. How to store Bikader 50 mg
6. Contents of the pack and other information

1. What Bikader 50 mg is and what it is used for

Bikader 50 mg is a medicine that contains the active substance called bicalutamide.
Bicalutamide is an antiandrogen. This means that it blocks the action of male hormones (androgens) in the body. Bicalutamide also reduces the amount of male hormones produced in the body.
Bikader 50 mg is used in adult men for the treatment of prostate cancer when they are also taking medicines known as luteinizing hormone-releasing hormone (LHRH) analogues, such as gonadorelin, or when they have undergone or are shortly going to undergo surgical castration.

2. What you need to know before taking Bikader 50 mg

Do not take Bikader 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 already taking terfenadine or astemizole, used in allergy treatments, or cisapride, used in the treatment of heartburn and gastro-oesophageal reflux.
• if you are a woman.
• if the tablets are to be administered to a child.

Do not take Bikader 50 mg if any of the above situations apply to you. If you are unsure,
consult your doctor or pharmacist before taking Bikader 50 mg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bikader 50 mg:

• if you have any heart or blood vessel disorders, including problems with heart rhythm (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of Bikader 50 mg.
• if you have a liver disease. Your doctor may decide to carry out blood tests to check whether your liver is functioning properly while you are taking this medicine.
• if you have diabetes. Treatment with bicalutamide in combination with luteinizing hormone-releasing hormone (LHRH) analogues may alter your blood sugar levels. It may become necessary to adjust the dose of insulin and/or oral antidiabetic medicines.
• if you go to hospital, inform the medical staff that you are taking Bikader 50 mg.
• if you are taking Bikader 50 mg, you and/or your partner must use an effective contraceptive method from the start of treatment with bicalutamide and continue until 130 days after the end of treatment with bicalutamide. Consult your doctor or pharmacist if you have any doubts about appropriate contraception.

Children
Bikader 50 mg must not be given to children.
Other medicines and Bikader 50 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. This includes medicines obtained without a prescription and herbal medicines. This
is because Bikader 50 mg may affect the action of other medicines. In addition, some other medicines
may interfere with the proper functioning of Bikader 50 mg:

• Cyclosporine (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow). This is because bicalutamide may increase the plasma concentration of a substance called creatinine, and your doctor may require blood tests to monitor it.
• Midazolam (a medicine used to reduce anxiety before surgical procedures or diagnostic tests, or as an anaesthetic before and during surgery). You must inform your doctor or dentist that you are taking bicalutamide if you are undergoing surgery or if you are particularly anxious in a hospital setting.
• Terfenadine or astemizole, used to treat allergies (see section 2, “Do not take Bikader 50 mg”).
• Cisapride, used in the treatment of heartburn and gastro-oesophageal reflux (see section 2, “Do not take Bikader 50 mg”).
• A class of medicines called calcium channel blockers, e.g. diltiazem or verapamil. These are used to treat heart problems, angina, and high blood pressure.
• Anticoagulant medicines, e.g. warfarin.
• Cimetidine for gastro-oesophageal reflux or gastric ulcers.
• Ketoconazole, an antifungal medicine.
• Bikader 50 mg 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 certain other medicines (e.g. methadone (used to relieve pain and as part of treatment in drug detoxification programmes), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses). Taking bicalutamide together with certain blood thinners or anticoagulants (e.g. coumarin derivatives) may affect blood clotting. It is important that your doctor is aware of this so that they can monitor your blood clotting.

Bikader 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, breastfeeding and fertility
Women must never take this medicine.
Bicalutamide may have an effect on male fertility, which may be reversible.
Driving and using machines
This medicine should not affect your ability to drive or use machines,
although some people may experience drowsiness while taking this medicine.
If you feel that this medicine causes drowsiness, consult your doctor or pharmacist before
driving or using machines.
Bikader 50 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
Bikader 50 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Bikader 50 mg

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once 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 should start taking the tablets at least 3 days before starting treatment with LHRH analogues,
e.g. gonadorelin, or simultaneously with surgical castration.

If you take more Bikader 50 mg than you should
If you think you have taken more tablets than prescribed, contact your doctor or
the nearest hospital immediately. Take the remaining tablets or the packaging
with you so that the doctor can identify what you have taken. The doctor may decide
to monitor your vital functions until the effects of bicalutamide have disappeared.

If you forget to take Bikader 50 mg
If you think you have missed a dose of bicalutamide, contact your doctor or pharmacist.
Do not take a double dose to make up for the missed dose. Simply take your next
normal dose at the usual time.

If you stop taking Bikader 50 mg
Do not stop taking this medicine even if you feel well, unless your doctor tells you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, inform your doctor immediately or go to the nearest hospital. These are very serious side effects:

• Skin rash, itching, hives, skin peeling, blisters or crusts on the skin;
• Swelling of the face or neck, lips, tongue or throat which may interfere with breathing or swallowing;
• Breathing problems with or without cough and fever;
• Yellowing of the skin or eyes.

Other possible side effects of this medicine are:
Very common side effects (may affect more than 1 in 10 people):

• Low red blood cell count (anaemia), breast pain, breast development in males, hot flushes, dizziness, stomach or pelvic pain, constipation, nausea, presence of blood in the urine (haematuria), feeling weak, swelling of the hands, feet, arms or legs (oedema).

Common side effects (may affect up to 1 in 10 people):

• Decreased sexual desire, depression, drowsiness, acid indigestion, flatulence, changes in liver function including yellowing of the skin and whites of the eyes (jaundice), hepatobiliary disorders, hair loss, increased hair growth, dry skin, skin rash, skin itching, difficulty achieving erection, weight gain, reduced appetite, chest pain, myocardial infarction (fatal outcomes have been reported), heart problems which could cause shortness of breath or ankle swelling.

Uncommon side effects (may affect up to 1 in 100 people):

• Allergic reactions (hypersensitivity reactions). Symptoms may include: skin rash, itching, hives, skin peeling, blisters or crusts on the skin, swelling of the face or neck, lips, tongue or throat which may cause breathing or swallowing difficulties, a lung inflammation known as interstitial lung disease (fatal outcomes have been reported). Symptoms of this disease may include severe shortness of breath with cough or fever.

Rare side effects (may affect up to 1 in 1,000 people):

• Liver failure (fatal outcomes have been reported), increased sensitivity of the skin to sunlight.

Side effects not known (frequency cannot be estimated from the available data):

• Changes in the ECG trace (QT prolongation).

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bikader 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 following the word “EXP”. The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of the mentioned month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bikader 50 mg contains

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other components of the tablet core are: lactose monohydrate, magnesium stearate, crospovidone, povidone K-29/32, sodium lauryl sulfate. The components of the tablet coating are: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171).

Description of the appearance of Bikader 50 mg and package contents
The tablets are white, round, biconvex, film-coated, with "BCM 50" engraved on one side.
Available in blisters containing 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200 and 280 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder:
Ecupharma S.r.l.
Via Mazzini 20
20123 Milano (Italy)

Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Synthon Hispania S.L.
Castello 1
Polígono Industrial Las Salinas
08830 Sant Boi de Llobregat (Barcelona)
Spain

This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Germany Bicalut 50 mg Filmtabletten
Finland Bikalutamidi medac 50 mg
Italy Bikader 50 mg film-coated tablets
Netherlands Biluron 50 mg, filmomhulde tabletten
Portugal Bicastad 50 mg comprimidos revestidos por película

Package leaflet: Information for the user

Bikader 150 mg film-coated tablets

Bicalutamide
Equivalent medicine
Please read this leaflet carefully before taking this medicine as it contains important information for you.
Keep this leaflet. You may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful. If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bikader 150 mg is and what it is used for
2. What you need to know before taking Bikader 150 mg
3. How to take Bikader 150 mg
4. Possible side effects
5. How to store Bikader 150 mg
6. Package contents and other information

1. What Bikader 150 mg is and what it is used for

Bikader 150 mg is a medicine that contains the active substance called bicalutamide.
Bicalutamide belongs to the group of antiandrogens. Antiandrogens work against the effects
of androgens (male sex hormones).
Bikader 150 is used in adult men for the treatment of non-metastatic prostate cancer, when surgical castration or other types of treatment are contraindicated or unacceptable.
It may be taken in combination with radiotherapy or prostate surgery in the early stages of treatment.

2. What you need to know before taking Bikader 150 mg

Do not take Bikader 150 mg
if:

• you are already taking terfenadine or astemizole, used in allergy treatments, or cisapride, used to treat heartburn and gastro-oesophageal reflux.
• you are a woman.
• the tablets are to be administered to a child.

Do not take Bikader 150 mg if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before taking Bikader 150 mg.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bikader 150 mg:

• if you have any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when taking Bikader 150 mg.
• if you have liver disease. Your doctor may decide to perform blood tests to check that your liver is functioning properly while you are taking this medicine.
• if you go to hospital, inform medical staff that you are taking Bikader 150 mg.
• if you are taking Bikader 150 mg, you and/or your partner must use an effective contraceptive method from the start of treatment with bicalutamide and continue for 130 days after stopping bicalutamide treatment. Speak to your doctor or pharmacist if you have any doubts about appropriate contraception.

Children
Bikader 150 mg must not be given to children.

Other medicines and Bikader 150 mg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal products. This is because Bikader 150 mg may affect the action of other medicines. In addition, some other medicines may interfere with the proper functioning of Bikader 150 mg:

• Cyclosporine (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow). Bicalutamide may increase plasma levels of a substance called creatinine, and your doctor may require blood tests to monitor this.
• Midazolam (a medicine used to reduce anxiety before surgical procedures or diagnostic tests, or as an anaesthetic before and during surgery). You must inform your doctor or dentist that you are taking bicalutamide if you are undergoing a procedure or if you are particularly anxious in a hospital setting.
• Terfenadine or astemizole used to treat allergies (see section 2, "Do not take Bikader 150 mg").
• Cisapride used for heartburn and gastro-oesophageal reflux (see section 2, "Do not take Bikader 150 mg").
• A class of medicines called calcium channel blockers, e.g. diltiazem or verapamil. These are used to treat heart conditions, angina, and high blood pressure.
• Anticoagulant medicines, e.g. warfarin.
• Cimetidine for gastro-oesophageal reflux or gastric ulcers.
• Ketoconazole, an antifungal medicine.
• Bikader 150 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 problems when used with certain other drugs (e.g. methadone, used to relieve pain and as part of treatment programmes for opioid dependence, moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses). Taking bicalutamide together with certain blood thinners or anticoagulants (e.g. coumarin derivatives) may affect blood clotting. It is important that your doctor is aware of this so that they can monitor your blood clotting.

Bikader 150 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, breast-feeding and fertility
Women must never take this medicine.
Bicalutamide may affect male fertility, which may be reversible.

Driving and using machines
This medicine should not affect your ability to drive or operate machinery, although some people may experience drowsiness while taking this medicine. If you feel that this medicine causes drowsiness, consult your doctor or pharmacist before driving or operating machinery.

Bikader 150 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Bikader 150 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Bikader 150 mg

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once daily. The tablet should be swallowed whole with a glass of water. Try to take the medicine at approximately the same time each day.
If you take more Bikader 150 mg than you should
If you think you have taken more tablets than prescribed, contact your doctor or the nearest hospital immediately. Bring the remaining tablets or the pack with you so the doctor can identify what you have taken. This is because the doctor may decide to monitor your vital functions until the effects of bicalutamide have disappeared.
If you forget to take Bikader 150 mg
If you think you have forgotten to take a dose of bicalutamide, contact your doctor or pharmacist. Do not take a double dose to make up for the forgotten dose. Simply take your next dose as usual at the regular time.
If you stop taking Bikader 150 mg
Do not stop taking this medicine even if you feel well, unless your doctor tells you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms, inform your doctor immediately or go to the nearest
hospital. These are the very serious side effects:

• Skin rash, itching, hives, skin peeling, blisters or crusts on the skin;
• Swelling of the face or neck, lips, tongue or throat which may interfere with breathing or swallowing;
• Breathing problems with or without cough and fever;
• Yellowing of the skin or eyes.

Other possible side effects of this medicine are:
Very common side effects (may affect more than 1 in 10 people):

• Rash, breast pain, breast development in males, feeling of weakness.

Common side effects (may affect up to 1 in 10 people):

• Hot flushes, reduction in red blood cells (anaemia), decreased appetite, reduced sexual desire, depression, dizziness, drowsiness, stomach or chest pain, constipation and flatulence, acid indigestion, nausea, changes in liver function including yellowing of the skin and whites of the eyes (jaundice), hepatobiliary disorders, hair loss, increased hair growth, dry skin, skin itching, presence of blood in urine (haematuria), difficulty achieving erection, swelling of the hands, feet, arms or legs (oedema), weight gain.

Uncommon side effects (may affect up to 1 in 100 people):

• Allergic reactions (hypersensitivity reactions). Symptoms may include: skin rash, itching, hives, skin peeling, blisters or crusts on the skin, swelling of the face or neck, lips, tongue or throat which may cause breathing or swallowing difficulties, and lung inflammation known as interstitial lung disease (fatal outcomes have been reported). Symptoms of this disease may include severe shortness of breath with cough or fever.

Rare side effects (may affect up to 1 in 1,000 people):

• Liver failure (fatal outcomes have been reported), increased sensitivity of the skin to sunlight.

Side effects not known (frequency cannot be estimated from available data):

• Changes in ECG trace (QT prolongation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bikader 150 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 following the word “EXP”. The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of the stated month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bikader 150 mg contains
The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.
The other components contained in the tablet core are: monohydrate lactose, magnesium stearate, crospovidone, povidone K-29/32, sodium lauryl sulfate.
The components contained in the tablet coating are: monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E171).

Description of the appearance of Bikader 150 mg and contents of the pack
The tablets are white, round, biconvex, film-coated, marked with "BCM 150" on one side. They are available in blisters containing 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200, and 280 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder:
Ecupharma S.r.l.
Via Mazzini 20
20123 Milan (Italy)

Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Synthon Hispania S.L.
Castello 1
Polígono Industrial Las Salinas
08830 Sant Boi de Llobregat (Barcelona)
Spain

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
Austria Bicalutamid STADA 150 mg Filmtabletten
Denmark Bicalustad 150 mg
Finland Bikalutamidi medac 150 mg
Hungary Bicalutamid Actavis 150 mg filmtabletta
Iceland Bicalutamid Actavis 150 mg
Italy Bikader 150 mg film-coated tablets
Lithuania Sapro 150 mg plėvele dengtos tabletės
Netherlands Biluron 150 mg filmomhulde tabletten
Portugal Bicalutamida Stada 150 mg comprimidos revestidos por película
Slovakia Bicusan 150 mg
Slovenia Bicusan 150 mg filmsko obložene tablete
Sweden Bikalutamid Actavis 150 mg