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CYPROSTAT 50MG TABLETS

Active substance(s): CYPROTERONE ACETATE

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Package leaflet: Information for the user

Cyprostat® 50 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

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
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 (except for
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 straight away
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

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 (50 mg) up to 2 tablets 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.

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 lifethreatening. 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 be 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 50 mg of cyproterone
acetate
R the other ingredients are: maize starch,
povidone 25000, magnesium stearate (E572),
lactose, colloidal anhydrous silica.
What Cyprostat looks like and contents of the
pack
Each pack of Cyprostat 50 mg contains
160 tablets as 16 blister strips of 10 tablets.

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
or
Bayer Weimar GmbH und Co KG
Weimar
Germany
This leaflet was last revised in July 2016.
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 50 mg

Reference number
00010/0525

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

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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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