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BICALUTAMIDE 150 MG FILM-COATED TABLETS

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Bicalutamide 150mg, 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.
•  you have any further questions, ask your
If
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.
•  you get any side effects, talk to your doctor
If
or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
W
1.  hat Bicalutamide 150 mg is and what it is used
for
2.  hat you need to know before you take
W
Bicalutamide 150 mg
3. How to take Bicalutamide 150 mg
4. Possible side effects
5. How to store Bicalutamide 150 mg
6. Contents of the pack and other information
1.  hat Bicalutamide 150 mg is and what it is
W
used for
Bicalutamide belongs to the group of antiandrogens. Anti-androgens act against the effects
of androgens (male sex hormones).
Bicalutamide is used in adult men for the treatment
of prostate cancer without metastates, when
castration or other types of treatment are not
indicated or unacceptable.
It may be used in combination with radiotherapy or
prostate surgery in early treatment programmes.
2.  hat you need to know before you take
W
Bicalutamide 150 mg
Do not take Bicalutamide 150 mg
• f you are allergic to bicalutamide or any of the
i
other ingredients of this medicine (listed in
section 6).
• f you are female
i
• f the tablets are to be given to a child
i
• f you are taking terfenadine or astemizole which
i
are used to treat allergies or cisapride which is
used to treat heartburn and acid reflux.
Warnings and precautions
Take special care with Bicalutamide 150 mg
• f you have a liver disease. Your doctor may
i
decide to do blood tests to check your liver
is working properly while you are taking this
medicine.
If this applies to you and you have not already
discussed this with your doctor, talk to your doctor
or pharmacist before taking these tablets.
Other medicines and Bicalutamide 150 mg
Other medicines may be affected by bicalutamide.
They, in turn, may affect how well bicalutamide
works. Bicalutamide can interact with:
•  yclosporin (used to supress the immune system
C
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.
•  idazolam (a medicine which is used to relieve
M
anxiety before surgery or certain procedures or
as an anaesthetic before and during surgery).
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You must tell your doctor or dentist you are
taking bicalutamide if you need an operation or
are very anxious in hospital.
T
 erfenadine 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 150 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.
m
 edicines to thin your blood e.g. warfarin.
C
 imetidine 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 any of the
medicines listed above or any other medicines.
Taking Bicalutamide 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 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.
Bicalutamide 150 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 150 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.
If you take more Bicalutamide 150 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 150 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 150 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 casualty
department at your nearest hospital. These are very
serious side effects.
•  kin rash, itching, hives, peeling, blistering or
S
crusting of the skin
•  welling of the face or neck, lips, tongue or
S
throat which may cause difficulty in breathing or
swallowing
B
•  reathing problems with or without a cough and
fever
•  ellow coloration of the skin or the eyes
Y
Other possible side-effects of the medicine are:
Very common side effects (may affect more than
1 in 10 people):
•  ash
R
•  reast soreness
B
D
•  evelopments of breasts in males
•  eeling weak
F
Common side effects (may affect up to 1 in 10
people):
•  ot flushes
H
•  ow numbers of red blood cells (anaemia)
L
•  ecreased appetite
D
•  ower sex drive
L
•  epression
D
•  izziness
D
•  leepiness
s
•  ain in the stomach or chest
P
•  onstipation and wind
C
•  cid indigestion
A
•  eeling sick
F
• 
Changes to liver function including yellowing of
the skin and whites of the eyes (jaundice)
•  air loss
H
•  ncreased hair growth
I
•  ry skin
D
•  tching of the skin
I
•  resence of blood in the urine (haematuria)
P
•  ifficulty in gaining an erection
D
•  welling of the hands, feet, arms or legs
S
(oedema)
•  eight increase
W
Uncommon side effects (may affect up to 1 in 100
people):
• 
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
•  inflammation of the lungs called interstitial
An
lung disease (fatal outcomes have been
reported). The symptoms of this may include
severe breathlessness with a cough or fever

This medicinal product does not require any special
storage condition.
Do not be 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 150 mg contains
•  he active substance is bicalutamide. Each tablet
T
contains 150 mg bicalutamide.
•  he other ingredients in the tablet core are:
T
lactose monohydrate, magnesium stearate,
crospovidone, povidone K-29/32, sodium
laurilsulfate.
 he ingredients in the tablet coating are: lactose
T
monohydrate, hypromellose, macrogol 4000,
titanium dioxide (E171).
What Bicalutamide 150 mg looks like and
contents of the pack
The tablets are white, round, biconvex film-coated
tablets, debossed with BCM150 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
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 14048/0023; Bicalutamide 150 mg, film-coated
tablets

This leaflet was last revised in November 2012

Rare side effects (may affect up to 1 in 1,000
people):
Liver failure (fatal outcomes have been reported)
Note: Treatment with Bicalutamide 50 mg plus
another hormonal treatment (LHRH analogues)
has been associated with the occurrence of heart
failure and heart attacks.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.
5. How to store Bicalutamide 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 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.
AAAE5570

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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