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CYPROSTAT 100MG TABLETS

Active substance(s): CYPROTERONE ACETATE

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Package leaflet: Information for the user

Cyprostat® 100 mg tablet
cyproterone acetate
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your doctor or
pharmacist.
R 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.
R 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. What Cyprostat is and what it is used for
2. What you need to know before you take
Cyprostat
3. How to take Cyprostat
4. Possible side effects
5. How to store Cyprostat
6. Contents of the pack and other information

1. What Cyprostat is and what it is used for
What is Cyprostat?
Cyprostat is a medicine containing cyproterone acetate.
It is an anti-androgen therapy. It blocks the actions of
male sex hormones (androgens) and reduces the
amount of male sex hormones produced by the body.
What is Cyprostat used for?
Cyprostat is used in men to treat prostate cancer.
This medicine is used:
1. to reduce the possible worsening of the disease which
may occur when you start other treatments used for
prostate cancer
2. for long term treatment of prostate cancer when
surgery or other medicines are not suitable
3. to treat hot flushes which may occur during
treatments with other medicines used for prostate
cancer or following surgery.

2. What you need to know before you take
Cyprostat
Do not take Cyprostat:
R If you have liver diseases (including previous or
existing liver tumours (unless these are due to
secondary cancers caused by prostate cancer),
Dubin-Johnson Syndrome or Rotor Syndrome)
R If you have any type of cancer (other than cancer of
the prostate gland)
R If you have ever been diagnosed with a meningioma
(a generally benign tumour of the tissue layer
between the brain and the skull). You should ask
your doctor if you are in doubt
R If you have wasting diseases (diseases involving an
unintended loss of weight or muscle) except for
prostate cancer that cannot be operated on
R If you have blood clots (thrombosis or embolism)
or:
R If you are allergic to cyproterone acetate or any of
the other ingredients of this medicine (listed in
section 6)
R if you are under 18 years old or if your testes or
bones are not yet fully formed.
Warnings and precautions
Talk to your doctor before taking Cyprostat
Several blood tests or checks may be required while
you are taking this medicine:
R liver problems, some of them severe or even fatal,
have been reported with cyproterone acetate
treatment. Your doctor may arrange for you to have
regular liver tests before and during treatment to
monitor this and may stop your treatment if
necessary. See also section 4.
R using medicines such as Cyprostat has very rarely
been linked to the development of benign (nonmalignant) liver tumours and with some forms of
liver cancer (malignant liver tumours). Liver tumours
may lead to bleeding in the abdomen, which can be
life-threatening. If you have any new stomach
discomfort or pain that does not go away quickly,
you must tell your doctor straightaway

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R medicines such as ritonavir used to treat HIV
infections
R cholesterol-lowering drugs such as statins.
Cyprostat may make the side effects of statins
worse, for example the breakdown of muscle
R medicines such as glitazones used to treat diabetes.
If you are diabetic your doctor may need to alter the
dose of medicine required to treat your diabetes. See
also section 2 ‘Warnings and precautions’.
Driving and using machines
You may feel tired and weak during treatment. If
affected, do not drive, operate machinery or do
anything where these symptoms may put either
yourself or others at risk.
Important information about some of the
ingredients in Cyprostat
Cyprostat 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 Cyprostat
Your doctor will decide what dose you will take. Always
take this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
Take the tablets after meals and swallow them whole
with a drink of water.
The usual dose range is from 1 tablet once a day
(100 mg) up to 1 tablet three times a day (300 mg).
If you take more Cyprostat than you should
As soon as you can, talk to your doctor who will tell
you what you need to do. There have been no reports of
serious illness from taking too much Cyprostat in a
single dose.
If you forget to take Cyprostat
If you forget to take a dose, take it as soon as you
remember and take the next dose when it is due. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Cyprostat
Do not reduce the dose or stop taking your tablets
unless your doctor tells you to.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: GV04
item-no.: 84656186
PZ: 9307A-4A
code-no.: 178
name: LF-Cyprostat 100MG TAB 21 H6
country: GB/-/BPH
colors: Black
version: 09.06.2015/03
approval:
dimension: 180 x 210 mm

R blood clots have been reported in patients taking
this medicine which may also be linked to the
reason you are taking Cyprostat. Tell your doctor if
any of the following apply to you, as you may be at
an increased risk of getting a blood clot. If you have:
P a history of blood clots, strokes or heart attacks
P abnormal red blood cells (sickle –cell anaemia)
P severe diabetes that affects your blood circulation
R if you suffer from severe depression, this may get
worse whilst you are taking Cyprostat. (See your
doctor if you are affected by this)
R effects on the blood (anaemia) have been reported
rarely during long term treatment with this
medicine. See also section 4.
R shortness of breath has been reported in patients
taking this medicine at high doses (300 mg daily)
R Cyprostat can alter the sugar levels in your blood. If
you are diabetic, check your blood sugar levels
regularly. Your doctor may alter the dose of
medicine used to treat your diabetes
R Your doctor will check the function of your adrenal
glands, as they may become suppressed during
treatment with Cyprostat. Symptoms may include
tiredness, fatigue, loss of appetite, weight loss, low
blood sugar, low blood pressure, dehydration,
headache, irritability and depression, aching
muscles, abdominal pain, a craving for salty foods,
feeling or being sick and diarrhoea.
Other medicines and Cyprostat
Tell your doctor if you are taking, have recently taken
or might take any other medicines.
Some medicines may stop Cyprostat from working
properly. Also, Cyprostat may change the way other
medicines you are taking are broken down in your
body.
Tell your doctor if you take any other medicines
regularly, especially:
R medicines such as rifampicin for the treatment of
tuberculosis
R medicines such as phenytoin used to treat epilepsy
or other illnesses
R products containing the herbal remedy commonly
known as St John’s wort (Hypericum perforatum)
R medicines such as ketoconazole, itraconazole,
clotrimazole for the treatment of fungal conditions

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you have trouble breathing or swallowing, this
may be a sign of a rare allergic reaction - contact your
doctor or go to a hospital straight away.
These are the possible side effects of Cyprostat, starting
with the more common ones:
Very common - may affect more than 1 in 10 people
R decreased sex drive
R impotence
R reduced sperm count
R reduced volume of ejaculate
Common - may affect up to 1 in 10 people
R weight decrease or increase, which can be associated
with fluid retention
R depressed mood
R restlessness
R breast swelling sometimes with tenderness
R hot flushes, sweating
R tiredness
R shortness of breath
R liver problems, some of them severe or even fatal,
have been reported with dosages of 100 mg and
above of cyproterone acetate treatment. Your doctor
may arrange for you to have regular liver tests
during treatment to monitor this and may stop your
treatment if necessary
Uncommon - may affect up to 1 in 100 people
R rash
Rare - may affect up to 1 in 1,000 people
R allergic reaction (possibly causing a rash, itching or
more rarely shortness of breath. If you have trouble
breathing or swallowing, contact your doctor or go
to a hospital straight away)
R tender lumps in the breasts and oozing of milky
fluid from the nipples. These effects usually
disappear if treatment is stopped or if the dose of
Cyprostat is reduced
Very rare - may affect up to 1 in 10,000 people
R benign (non-malignant) liver tumours, see also
section 2 ‘Warnings and precautions’

R some forms of liver cancer (malignant
liver tumours). Liver tumours may lead to bleeding
in the abdomen, which can be life-threatening. If
you have any new stomach discomfort or pain that
does not go away quickly, you must tell your doctor
straightaway
Effects of Cyprostat on sperm
After you have been taking this medicine for some
months, you may not have any sperm in your ejaculate.
You will probably become unable to make anyone
pregnant, but note that this does not happen at once.
Do not rely on this medicine for contraception at any
time. While the overall number of sperm that you
produce will be reduced, more of your sperm than
usual will be abnormal in shape. Some people think
these abnormal sperm might possibly produce
abnormal babies. Your doctor will be able to advise
you further if you are thinking of having children.
Other changes that have been reported include:
R blood clots have been reported in patients taking
this medicine but they have not definitely been
linked to Cyprostat. See also section 2 ‘Warnings
and precautions’
R the occurrence of meningiomas (a generally benign
tumour of the tissue layer between the brain and the
skull) has been reported in association with longer
term use (years) of Cyprostat at doses of 25 mg per
day and above
R dry skin and improvement in acne
R temporary patchy loss of body hair, a reduction in
hair growth on the body, an increased growth of hair
on the head, lightening of hair colour, a female type
of pubic hair growth
R effects on the blood (anaemia) have been reported
rarely during long term treatment with this
medicine. Your doctor may arrange for you to have
regular blood tests during treatment to monitor this
R thinning of the bones (osteoporosis)
R tiredness, fatigue, loss of appetite, weight loss, low
blood sugar, low blood pressure, dehydration,
headache, irritability and depression, aching
muscles (often muscle weakness), abdominal pain, a
craving for salty foods, feeling or being sick and
diarrhoea (suppressed adrenal glands).

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After stopping treatment
After stopping treatment, the decrease in sex drive,
reduction in sperm count and breast swelling will
generally go back to normal.
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 at:
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 Cyprostat
R Keep this medicine out of the sight and reach of
children.
R Do not use this medicine after the expiry date which
is stated on both the outer carton and on each
blister strip of tablets after EXP. The expiry date
refers to the last day of that month.
R 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 Cyprostat contains
R the active ingredient is cyproterone acetate. Each
tablet contains 100 mg of cyproterone acetate.
R the other ingredients are: maize starch,
povidone 25000, magnesium stearate (E572),
lactose.
What Cyprostat looks like and contents of the pack
Each pack of Cyprostat 100 mg contains 84 tablets as
4 blister strips of 21 tablets.
The tablets are white and oblong with one side scored
and embossed with “LA” on both sides of the score. The
other side of the tablet is embossed with a regular
hexagon.

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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire, RG14 1JA
United Kingdom
Manufacturer:
Bayer Pharma AG
Berlin
Germany
or
Delpharm Lille SAS
Lys Lez Lannoy
France
This leaflet was last revised in May 2015.
Other formats:
To listen or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Cyprostat 100 mg

Reference number
00010/0524

This is a service provided by the Royal National
Institute of the Blind.

09.06.2015 14:34:01

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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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