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BICALUTAMIDE 50 MG FILM-COATED TABLETS

Active substance(s): BICALUTAMIDE

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Package leaflet: Information for the user
Bicalutamide 50 mg, film-coated tablets
bicalutamide
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. 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 pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

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

1.

What Bicalutamide 50 mg is and what it is used for

Bicalutamide 50 mg is a medicine containing the active substance called bicalutamide. This belongs to
a group of medicines called ‘antiandrogens’.

Bicalutamide is used to treat prostate cancer.

It works by blocking the effects of male hormones such as testosterone.

2.

What you need to know before you take Bicalutamide 50 mg

Do not take Bicalutamide 50 mg

if you are allergic to bicalutamide or 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 which
is used to treat heartburn and acid reflux.

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

if you have any heart or blood vessel conditions, including heart rhythm problems
(arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm
problems may be increased when using Bicalutamide 50 mg.

if you have a liver disease. Your doctor may decide to do blood tests to check your liver is
working properly while you are taking this medicine.

if you have diabetes. Treatment with bicalutamide in combination with luteinising hormonereleasing hormone (LHRH) analogues may alter your blood sugar level. Your dosage of insulin
and/or oral antidiabetic medicines may need to be adjusted.



if you go into a hospital, tell the medical staff that you are taking Bicalutamide 50 mg.

Other medicines and Bicalutamide 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 medicines. This is
because Bicalutamide 50 mg can affect the way other medicines work. Also some other medicines can
affect the way Bicalutamide 50 mg works.











Cyclosporin (used to supress the immune system to prevent and treat rejection of a transplanted
organ or bone marrow). This is because bicalutamide may increase the concentration of a
substance called creatinine in your plasma and your doctor may take blood samples to monitor
this.
Midazolam (a medicine which is used to relieve anxiety before surgery or certain procedures or
as an anaesthetic before and during surgery). You must tell your doctor or dentist you are taking
bicalutamide if you need an operation or are very anxious in hospital.
Terfenadine or astemizole which are used to treat allergies
Cisapride which is used to treat heartburn and acid reflux (See section 2, Do not take
Bicalutamide Synthon 50 mg).
A type of medicine called a calcium channel blocker e.g. diltiazem or verapamil. These are
used to treat heart problems, angina and high blood pressure.
Medicines to thin your blood e.g. warfarin.
Cimetidine for acid reflux or stomach ulcers
Ketoconazole an antifungal medicine.
Bicalutamide 50 mg might interfere with some medicines used to treat heart rhythm
problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk
of heart rhythm problems when used with some other drugs(e.g. methadone (used for pain
relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics
used for serious mental illnesses).

Bicalutamide 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 breast-feeding
This medicine must never be taken by women.
Driving and using machines
This medicine should not affect your ability to drive or use machines however some people may feel
sleepy while taking this medicine. If you think your medicine is making you feel sleepy you must talk
to your doctor or pharmacist before driving or using machines.
Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV-light while you are taking bicalutamide.
Bicalutamide 50 mg contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3.

How to take Bicalutamide 50 mg

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
pharmacist if you are not sure.
The recommended dose of this medicine is one tablet, once a day. This must be swallowed whole with
a glass of water. Try to take the medicinal product approximately at the same time each day.

You should start taking these tablets at least 3 days before starting treatment with LHRH analogues
e.g. gonadorelin, or at the same time as undergoing surgical castration.
If you take more Bicalutamide 50 mg than you should
If you think that you may have taken more tablets than you should, contact your doctor or the nearest
hospital as soon as possible. Take with you the remaining tablets or the pack so the doctor can identify
what you have taken. He or she may decide to monitor your body function until the effects of
bicalutamide have worn off.
If you forget to take Bicalutamide 50 mg
If you think that you may have missed a dose of bicalutamide talk to your doctor or pharmacist. Do
not take a double dose to make up for a forgotten dose. Just take the normal dose at the usual time.
If you stop taking Bicalutamide 50 mg
Do not stop taking this medicine even if you are feeling well unless your doctor tells you to.
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 get any of the following symptoms tell your doctor immediately or go to the nearest hospital.
Allergic reactions
These are uncommon side effects(may affect up to 1 in 100 people):
The symptoms can include sudden onset of:

Rash, itching or hives on the skin.

Swelling of the face, lips, tongue, throat or other parts of the body.

Shortness of breath, wheezing or trouble breathing.
If this happens to you, see a doctor straight away.
Also tell your doctor straight away if you notice any of the following:
Very common side effects (may affect more than 1 in 10 people):

Pain in your abdomen.

Blood in your urine.
Common side effects (may affect up to 1 in 10 people):

Yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver problems
or in rare cases (may affect up to 1 in 1,000 people) liver failure.
Uncommon side effects (may affect up to 1 in 100 people):

Serious shortness of breath or shortness of breath which suddenly gets worse. This may be with
a cough or high temperature (fever). These may be signs of an inflammation of the lungs called
‘interstitial lung disease’.
Not known side effects (frequency cannot be estimated from the available data):

Changes in ECG (QT prolongation).
Other possible side effects:
Very common side effects (may affect more than 1 in 10 people)
Dizziness • Constipation • Feeling sick (nausea) • Swelling and tenderness of your breasts •
Development of breasts in males • Hot flushes • Feeling weak • Swelling • Low levels of red blood
cells (anaemia). This may make you feel tired or look pale
Common side effects (may affect up to 1 in 10 people)

Loss of appetite • Reduced sex drive • Depression • Feeling sleepy • Indigestion • Wind (flatulence) •
Hair loss • Hair re-growth or growth of extra hair • Dry skin • Itching • Skin rash • Being unable to get
an erection (impotence) • Weight gain • Chest pain • Reduced heart function • Heart attack.
Rare side effects (may affect up to 1 in 1,000 people)
Increased skin sensitivity to sunlight.
Your doctor may do blood tests to check for any changes to your blood.
Do not be concerned by this list of possible side effects. You may not get any of them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme; website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

5.

How to store Bicalutamide 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 carton after ‘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 that month.
This medicinal product does not require any special storage condition.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Bicalutamide 50 mg contains
• The active substance is bicalutamide. Each tablet contains 50 mg bicalutamide.
• The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate,
crospovidone, povidone K-29/32, sodium laurilsulfate
The ingredients in the tablet coating are: lactose monohydrate, hypromellose, macrogol 4000,
titanium dioxide (E171).
What Bicalutamide 50 mg looks like and contents of the pack
The tablets are white, round, biconvex film-coated tablets, debossed with BCM50 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 Manufacturer
Marketing Authorisation Holder
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Manufacturer
G.L. Pharma GmbH

Schlossplatz 1
8502 Lannach
Austria
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain

PL 14048/0022; Bicalutamide 50 mg, film-coated tablets
This leaflet was last revised in 02.2018

Package leaflet: Information for the user

Bicalutamide 50 mg, film-coated tablet
bicalutamide

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. 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 pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1. What Bicalutamide 50 mg is and what it is used
for
2. What you need to know before you take
Bicalutamide 50 mg
3. How to take Bicalutamide 50 mg
4. Possible side effects
5. How to store Bicalutamide 50 mg
6. Contents of the pack and other information

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

Bicalutamide is an antiandrogen. This means it
blocks the actions of male hormones (androgens)
in the body. It also reduces the amount of male
hormones made in the body.
Bicalutamide Synthon 50 mg is used in adult men
to treat prostate cancer if you are also taking
medicines called luteinising hormone-releasing
hormone (LHRH)-analogues e.g. gonadorelin or
have had or will soon have a surgical castration.

2. What you need to know before you take
Bicalutamide 50 mg

Do not take Bicalutamide Synthon 50 mg
• if you are allergic to bicalutamide or any of the
other ingredients of this medicine (listed in
section 6).
• if you are female
• if the tablets are to be given to a child
• if you are taking terfenadine or astemizole which
are used to treat allergies or cisapride which is
used to treat heartburn and acid reflux.
Warning and precautions
Take special care with Bicalutamide 50 mg
• if you have a liver disease. Your doctor may decide
to do blood tests to check your liver is working
properly while you are taking this medicine.
• if you have diabetes. Treatment with bicalutamide
in combination with luteinising hormonereleasing hormone (LHRH) analogues may alter
your blood sugar level. Your dosage of insulin
and/or oral antidiabetic medicines may need to
be adjusted.
If any of these apply to you and you have not
already discussed these with your doctor, talk to
your doctor or pharmacist before taking these
tablets.
Other medicines and Bicalutamide 50 mg
Other medicines may be affected by bicalutamide.
They, in turn, may affect how well bicalutamide
works. Bicalutamide can interact with:

AAAE5568

•C
 yclosporin (used to supress the immune system
to prevent and treat rejection of a transplanted
organ or bone marrow). This is because
bicalutamide may increase the concentration of
a substance called creatinine in your plasma and
your doctor may take blood samples to monitor
this.
• Midazolam (a medicine which is used to relieve
anxiety before surgery or certain procedures or
as an anaesthetic before and during surgery). You
must tell your doctor or dentist you are taking
bicalutamide if you need an operation or are very
anxious in hospital.
• Terfenadine or astemizole which are used to
treat allergies or cisapride which is used to treat
heartburn and acid reflux (See section 2, Do not
take Bicalutamide Synthon 50 mg).
• a type of medicine called a calcium channel
blocker e.g. diltiazem or verapamil. These are
used to treat heart problems, angina and high
blood pressure.
• medicines to thin your blood e.g. warfarin.
• Cimetidine for acid reflux or stomach ulcers, or
ketoconazole an antifungal medicine.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take of the medicines
listed above or any other medicines.
Bicalutamide 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 breast-feeding
This medicine must never be taken by women.
Ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
This medicine should not affect your ability to drive
or use machines however some people may feel
sleepy while taking this medicine. If you think your
medicine is making you feel sleepy you must talk to
your doctor or pharmacist before driving or using
machines.
Important information about the ingredients of
Bicalutamide Synthon 50 mg
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Bicalutamide Synthon 50 mg

Always take this medicine exactly as your doctor
has told you. Check with your pharmacist if you are
not sure.
The recommended dose of this medicine is one
tablet, once a day. This must be swallowed whole
with a glass of water. Try to take the medicinal
product approximately at the same time each day.
You should start taking these tablets at least 3 days
before starting treatment with LHRH analogues
e.g. gonadorelin, or at the same time as
undergoing surgical castration.
If you take more Bicalutamide Synthon 50 mg
than you should
If you think that you may have taken more tablets
than you should, contact your doctor or the nearest
hospital as soon as possible. Take with you the
remaining tablets or the pack so the doctor can
identify what you have taken. He or she may decide
to monitor your body function until the effects of
bicalutamide have worn off.

If you forget to take Bicalutamide Synthon 50 mg
If you think that you may have missed a dose of
bicalutamide talk to your doctor or pharmacist. Do
not take a double dose to make up for a forgotten
dose. Just take the normal dose at the usual time.
If you stop taking Bicalutamide Synthon 50 mg
Do not stop taking this medicine even if you are
feeling well unless your doctor tells you to.
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.

5. How to store Bicalutamide 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 carton after ‘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 that month.
This medicinal product does not require any
special storage condition. Do not throw away any
medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.

If you get any of the following symptoms tell
your doctor immediately or go to the casualty
department at your nearest hospital. These are
very serious side effects.
• Skin rash, itching, hives, peeling, blistering or
crusting of the skin
• Swelling of the face or neck, lips, tongue or
throat which may cause difficulty in breathing or
swallowing
• Breathing problems with or without a cough and
fever
• Yellow coloration of the skin or the eyes

6. Contents of the pack and other
information

Other possible side-effects of the medicine are:
Very common side effects (may affect more than 1
in 10 people):
• Low numbers of red blood cells (anaemia)
• Breast soreness
• Developments of breasts in males
• Hot flushes
• Dizziness
• Pain in the stomach or pelvis
• Constipation
• Feeling sick
• Presence of blood in the urine (haematuria)
• Feeling weak
• Swelling of the hands, feet, arms or legs (oedema)

What Bicalutamide 50 mg looks like and contents
of the pack
The tablets are white, round, biconvex film-coated
tablets, debossed with BCM50 on one side.

Common side effects (may affect up to 1 in 10
people):
• Lower sex drive
• Depression
• Sleepiness
• Acid indigestion
• Wind
• Changes to liver function including yellowing of
the skin and whites of the eyes (jaundice)
• Hair loss
• Increased hair growth
• Dry skin
• Rash
• Itching of the skin
• Difficulty in gaining an erection
• Weight increase
• Decreased appetite
• Pain in the chest
• Heart attack (fatal outcomes have been reported)
• Heart problems which can cause shortness of
breath or ankle swelling

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

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
Manufacturer
Marketing Authorisation Holder
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Manufacturer
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
PL 14048/0022; Bicalutamide 50 mg, film-coated
tablets
This leaflet was last revised in November 2012

Uncommon side effects (may affect up to 1 in 100
peoples:
Allergic reactions (hypersensitivity reactions).
The symptoms of these may include: skin rash,
itching, hives, peeling, blistering or crusting of the
skin, swelling of the face or neck, lips, tongue or
throat which may cause difficulty in breathing or
swallowing
• An inflammation of the lungs called interstitial
lung disease (fatal outcomes have been
reported). The symptoms of this may include
severe breathlessness with a cough or fever
Rare side effects (may affect up to 1 in 1,000
peoples:
• Liver failure (fatal outcomes have been reported.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.
AAAE5568

Actavis, Barnstaple, EX32 8NS, UK

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