BIKADER 50 mg Film-Coated Tablets

Зміст інструкції

1. Bikader 50 mg film-coated tablets
   1. What is Bikader 50 mg and what is it used for
   2. What you need to know before using Bikader 50 mg
   3. How to take Bikader 50 mg
   4. Possible side effects
   5. How to store Bikader 50 mg
   6. Package contents and other information
2. Bikader 150 mg film-coated tablets
   1. What is Bikader 150 mg and what is it used for
   2. What you need to know before using 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

Bikader 50 mg film-coated tablets

Bicalutamide
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Bikader 50 mg and what is it 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 if they are also taking medicines known as luteinizing hormone-releasing hormone (LHRH) analogues, such as gonadorelina, or if they have been or will be soon subjected to surgical castration.

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

Do not take Bikader 50 mg

• if you are allergic to bicalutamide or to any ofthe other ingredientsof this medicine (listed in section 6)
• if you are already taking terfenadine or astemizoleused for allergy treatments, or cisaprideused in the treatment of heartburn and gastro-oesophageal reflux.
• if you are a woman.
• if the tablets are to be given to a child.

Do not take Bikader 50 mg if any of the situations mentioned above apply to you. If you are not sure,
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 irregular heartbeat (arrhythmias)or if you are being treated for these disorders. The risk of irregular heartbeat may increase with the use of Bikader 50 mg.
• if you have a liver disease. Your doctor may decide to perform blood tests to check if your liver is working properly while you are taking this medicine.
• if you have diabetes. Treatment with bicalutamide in combination with luteinising hormone-releasing hormone (LHRH) analogues may alter your blood sugar level. It may be necessary to adjust the dose of insulin and/or oral antidiabetic medicines.
• if you go to hospital, tell the medical staff that you are taking Bikader 50 mg.
• if you are using Bikader 50 mg, you and/or your partner must use effective contraception from the start of treatment with bicalutamide and continue for 130 days after the end of treatment with bicalutamide. Talk to your doctor or pharmacist if you have any doubts about adequate contraception.

Children
Bikader 50 mg should not be given to children.

Other medicines and Bikader 50 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 remedies. This
is because Bikader 50 mg can affect the action of other medicines. Also, some other medicines
can interfere with the correct functioning of Bikader 50 mg:

• Cyclosporine(used for immunosuppression to prevent and treat rejection of a transplanted organ or bone marrow). This is because bicalutamide can 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 procedures or as an anaesthetic before and during surgical procedures). You must inform your doctor or dentist that you are taking bicalutamide if you are to undergo surgery or if you are particularly anxious in a hospital setting.
• Terfenadineor astemizole, used for the treatment of 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. diltiazemor verapamil. These are used to treat heart problems, angina and high blood pressure.
• Anticoagulant medicines, e.g. warfarin.
• Cimetidinefor gastro-oesophageal reflux or stomach ulcers.
• Ketoconazole, an antifungal medicine.
• Bikader 50 mg may interfere with some medicines used to treat irregularheartbeat(e.g. quinidine, procainamide, amiodaroneand sotalol) or may increase the risk of irregular heartbeat when used with some other drugs (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 some blood thinners or anticoagulants (e.g. coumarin derivatives) may have effects on blood coagulation. It is important that your doctor is aware of this so that he/she can monitor your blood coagulation.

Bikader 50 mg with food and drink
The tablets do not necessarily have to be taken with food, but they must be swallowed whole
with a glass of water.

Pregnancy, breastfeeding and fertility
Women should never take this medicine.
Bicalutamide may have an effect on male fertility, which may be reversible.

Driving and using machines
This medicine should not alter your ability to drive vehicles or use machines,
although some people may experience drowsiness while taking this medicine.
If you feel that this medicine is causing you drowsiness, consult your doctor or pharmacist before
driving vehicles or using machines.

Bikader 50 mg contains lactose
If your doctor has diagnosed you as having intolerance to some sugars, contact him/her before taking this
medicine.

Bikader 50 mg contains sodium
This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Bikader 50 mg

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once a day. The tablet must 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 the start of therapy with LHRH analogues,
e.g. gonadorelina, 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 as soon as possible. Bring with you the remaining tablets or the packaging, 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 forgotten to take a dose of bicalutamide, contact your doctor or pharmacist.
Do not take a double dose to make up for a missed dose. Simply take a
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 on 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 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, peeling, blisters or scabs on the skin;
• Swelling of the face or neck, lips, tongue or throat that may obstruct breathing or swallowing;
• Breathing problems with or without cough and fever;
• Yellowing of the skin or eyes.

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

• Low number of red blood cells (anemia), breast pain, development of breast tissue in males, hot flushes, dizziness, pain in the stomach or pelvis, constipation, nausea, presence of blood in the urine (hematuria), feeling of weakness, swelling of the hands, feet, arms or legs (edema).

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/hair growth, dry skin, skin rash, skin itching, difficulty achieving an erection, weight gain, loss of appetite, chest pain, myocardial infarction (fatal outcomes have been reported), heart problems that may cause shortness of breath or swelling of the ankles.

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

• Allergic reactions (hypersensitivity reactions). Symptoms may include: skin rash, itching, hives, peeling, blisters or scabs on the skin, swelling of the face or neck, lips, tongue or throat that may cause problems with breathing or swallowing, inflammation of the lungs called 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 1000 people):

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

Side effects with unknown frequency(frequency cannot be estimated from available data):

• changes in the ECG tracing (QT prolongation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 the packaging after the
wording “EXP”. The first two digits indicate the month and the last four digits indicate the year. The expiry
date refers to the last day of the month indicated.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient 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 imprinted on
one side.
They are available in blisters of 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 authorisation holder and manufacturers
Marketing authorisation holder:
Ecupharma S.r.l.
Via Mazzini 20
20123 Milan (Italy)

Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania S.L.
Castello 1
Polígono Industrial Las Salinas
08830 Sant Boi de Llobregat (Barcelona)
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
GermanyBicalut 50 mg Filmtabletten

FinlandBikalutamidi medac 50 mg

ItalyBikader 50 mg film-coated tablets

NetherlandsBiluron 50 mg, filmomhulde tabletten

PortugalBicastad 50 mg film-coated tablets

Bikader 150 mg film-coated tablets

Bicalutamide
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful. If you get any side effects, even those not listed in this leaflet, tell 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 you take Bikader 150 mg
• 3. How to take Bikader 150 mg
• 4. Possible side effects
• 5. How to store Bikader 150 mg
• 6. Contents of the pack and other information

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

Bikader 150 mg is a medicine that contains the active substance called bicalutamide. Bicalutamide belongs to the group of antiandrogens. Antiandrogens act against the effects of androgens (male sex hormones).
Bikader 150 is used in adult men for the treatment of prostate cancer without
metastasis, when surgical castration or other types of treatment are contraindicated or unacceptable.
It can be taken in association with radiotherapy or prostate surgery in the early stages of
treatment.

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

Do not take Bikader 150 mg
if you

• are already taking terfenadineor astemizoleused in therapies for allergies or cisaprideused in the treatment of heartburn and gastro-esophageal reflux.
• are a woman.
• the tablets are to be administered to a child.

Do not take Bikader 150 mg if any of the situations just mentioned apply to you. If you are not
sure, ask 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 medications for these disorders. The risk of heart rhythm problems may increase with the use of Bikader 150 mg.
• if you have a liver disease. Your doctor may decide to perform blood tests to check if your liver is working properly while you are taking this medicine.
• if you go to hospital, tell the medical staff that you are taking Bikader 150 mg. if you are using Bikader 150 mg, you and/or your partner must/must use effective contraception from the start of treatment with bicalutamide and continue for 130 days after the end of treatment with bicalutamide. Ask your doctor or pharmacist if you have any doubts about adequate contraception.

Children
Bikader 150 mg should 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 remedies. This
is because Bikader 150 mg can affect the action of other medicines. Also, some other medicines
can interfere with the correct functioning of Bikader 150 mg:

• Cyclosporine(used for immunosuppression to prevent and treat rejection of a transplanted organ or bone marrow). This is because bicalutamide can raise 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 surgeries or diagnostic procedures or as an anesthetic before and during surgeries). You should inform your doctor or dentist that you are taking bicalutamide if you are to undergo surgery or if you are particularly anxious in a hospital setting.
• Terfenadineor astemizoleused for the treatment of allergies (see paragraph 2, “Do not take Bikader 150 mg”).
• Cisaprideused for heartburn and gastro-esophageal reflux (see paragraph 2, “Do not take Bikader 150 mg”).
• A class of medicines called calcium channel blockers, e.g. diltiazemor verapamil. These are used to treat heart problems, angina and high blood pressure.
• Anticoagulant medicines, e.g. warfarin.
• Cimetidinefor gastro-esophageal reflux or gastric ulcers.
• Ketoconazole, an antifungal medicine.
• Bikader 150 mg may interfere with some medicines used to treat heart rhythm problems(e.g. quinidine, procainamide, amiodaroneand sotalol) or may increase the risk of heart rhythm problems when used with some other drugs (e.g. methadoneused to relieve pain and as part of treatment in drug detoxification programs), moxifloxacin(an antibiotic), antipsychotics(used for severe mental illnesses). Taking bicalutamide together with some blood thinners or anticoagulants (e.g. coumarin derivatives) may have effects on blood coagulation. It is important that your doctor is aware of this so that they can monitor your blood coagulation. Bikader 150 mg with food and drinkThe tablets do not necessarily need to be taken with food, but they must be swallowed whole with a glass of water.

Pregnancy, breastfeeding and fertility
Women should never take this medicine.
Bicalutamide may have an effect on male fertility, which may be reversible.

Driving and using machines
This medicine should not alter your ability to drive vehicles or use machines,
although some people may experience drowsiness while taking this medicine.
If you feel that this medicine makes you drowsy, ask your doctor or pharmacist before
driving vehicles or using machines.

Bikader 150 mg contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him/her before taking this
medicine.

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

3. How to take Bikader 150 mg

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once a day. The tablet must 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 as soon as possible. Bring with you the remaining tablets or the packaging, so that 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 a missed dose. Simply take a normal
dose at the usual 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 on 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 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, peeling, blisters or scabs on the skin;
• Swelling of the face or neck, lips, tongue or throat that may obstruct breathing or swallowing;
• Breathing problems with or without cough and fever;
• Yellowing of the skin or eyes.

Other possible side effects of the medicine are:
Side effects very common(may affect more than 1 in 10 people):

• Skin rash, breast pain, development of breast tissue in males, feeling of weakness.

Side effects common(may affect up to 1 in 10 people):

• Hot flushes, decrease in red blood cells (anemia), loss of appetite, decreased 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/body hair growth, dry skin, itchy skin, presence of blood in the urine (hematuria), difficulty achieving an erection, swelling of the hands, feet, arms or legs (edema), weight gain.

Side effects uncommon(may affect up to 1 in 100 people):

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

Side effects rare(may affect up to 1 in 1000 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 tracing (QT prolongation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 the packaging after the
wording “EXP”. The first two digits indicate the month and the last four digits indicate the year. The expiry
date refers to the last day of the month indicated.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is bicalutamide. Each tablet contains 150 mg of bicalutamide.
The other components contained within the tablet are: lactose monohydrate, magnesium
stearate, crospovidone, povidone K-29/32, sodium lauryl sulfate
The components contained in the tablet coating are: lactose monohydrate, hypromellose,
macrogol 4000, titanium dioxide (E171).

Description of the appearance of Bikader 150 mg and package contents
The tablets are white, round, biconvex, film-coated, marked with BCM 150
on one side. They are available in blisters of 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 Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Ecupharma S.r.l.
Via Mazzini 20
20123 Milan (Italy)

Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania S.L.
Castello 1
Polígono Industrial Las Salinas
08830 Sant Boi de Llobregat (Barcelona)
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
AustriaBicalutamid STADA 150 mg Filmtabletten

DenmarkBicalustad 150 mg

FinlandBikalutamidi medac 150 mg

HungaryBicalutamid Actavis 150 mg filmtabletta

IcelandBicalutamid Actavis 150 mg

ItalyBikader 150 mg film-coated tablets

LithuaniaSapro 150 mg plėvele dengtos tabletės

NetherlandsBiluron 150 mg filmomhulde tabletten

PortugalBicalutamida Stada 150 mg comprimidos revestidos por película

SlovakiaBicusan 150 mg

SloveniaBicusan 150 mg filmsko obložene tablete

SwedenBikalutamid Actavis 150 mg