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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 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

• 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 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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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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