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ANDROCUR 50MG TABLETS

Active substance(s): CYPROTERONE ACETATE

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Package leaflet: Information for the user

Androcur® 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.
RIf you have any further questions, ask your doctor
or pharmacist.
RThis 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.
RIf 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 Androcur is and what it is used for
2. What you need to know before you take
Androcur
3. How to take Androcur
4. Possible side effects
5. How to store Androcur
6. Contents of the pack and other information

1. What Androcur is and what it is
used for
What is Androcur?
Androcur 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 Androcur used for?
Androcur is used to control sexual desire in men who
have an increased sex drive (hypersexuality) and/or
sexual deviation.

2. What you need to know before
you take Androcur
RYour doctor may ask you to sign a witnessed
agreement to treatment before prescribing
Androcur. You may also have a test to check the
number and function of your sperm before you
start treatment as Androcur can affect this. The
overall number of sperm you

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produce will be reduced and more sperm than
usual will be abnormal in shape.
Do not take Androcur
If you have:
Rliver diseases (including previous or existing liver
tumours, Dubin-Johnson syndrome or Rotor
syndrome)
Rany type of cancer (other than cancer of the
prostate gland)
Rever 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
Rwasting diseases (diseases involving an
unintended loss of weight or muscle)
Rblood clots (thrombosis or embolism) or have ever
had these
Rsevere diabetes that affects your blood circulation
Rabnormal red blood cells (sickle-cell anaemia)
Rsevere depression which you have had for many
months
or if:
R you are allergic to cyproterone acetate or any of
the other ingredients of Androcur (listed in
section 6)
Ryou are under 18 years old or if your testes or
bones are not yet fully formed.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Androcur
Several blood tests or checks may be required while
you are taking this medicine:
Rliver 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.
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Rmedicines such as rifampicin for the treatment of
tuberculosis
Rmedicines such as phenytoin used to treat
epilepsy or other illnesses
Rproducts containing the herbal remedy
commonly known as St John’s wort (Hypericum
perforatum)
Rmedicines such as ketoconazole, itraconazole,
clotrimazole for the treatment of fungal
conditions
Rmedicines such as ritonavir used to treat HIV
infections
Rcholesterol-lowering drugs such as statins.
Androcur may make the side effects of statins
worse, for example the breakdown of muscle.
Rmedicines 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 section 2 ‘Warnings and precautions’.
Androcur with food, drink and alcohol
Androcur does not work well in men who regularly
drink a lot of alcohol.
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 Androcur
Androcur contains lactose.
If you have been told by your doctor that you have
an intolerance to some sugars, check with your
doctor before taking this medicinal product.

3. How to take Androcur
Your doctor will decide what dose you will take
depending on your treatment. Always take this
medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
RThe usual dose is 1 tablet twice a day. Once the
desired effect is achieved, your dose may be
gradually lowered.
RTake the tablet after your morning and evening
meals and swallow it whole with a drink of water.
Androcur is not for use in youths under 18 years old.

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Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: GV04
item-no.: 84387525
PZ: 9307A-4A
code-no.: 175
name: LF-Androcur 50MG TAB 14 H6
country: GB/-/BPH
colors: Black
version: 11.05.2015/04
approval:
dimension: 180 x 210 mm

Rusing medicines such as Androcur 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
Rblood clots have been reported in patients taking
this medicine which may also be linked to the
reason you are receiving Androcur. 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:
Pa history of blood clots, strokes or heart
attacks
Pcancer
P abnormal red blood cells (sickle–cell anaemia)
Psevere diabetes that affects your blood
circulation
Reffects on the blood (anaemia) have been
reported rarely during long term treatment with
this medicine. See also section 4.
Rshortness of breath has been reported in
patients taking this medicine at high doses
(300 mg daily)
RAndrocur 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.
RYour doctor will check the function of your
adrenal glands, as they may become suppressed
during treatment with Androcur. 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 Androcur
Tell your doctor if you are taking, have recently
taken or might take any other medicines.
Some medicines may stop Androcur from working
properly. Also Androcur 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:

If you take more Androcur 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
Androcur in a single dose.
If you forget to take Androcur
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 Androcur
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.
For information on drinking alcohol while taking
this medicine, see under Androcur with food, drink
and alcohol in section 2.
These are the possible side effects of Androcur,
starting with the more common ones:
Very common may affect more than 1 in 10 people
Rreduced sperm count
Rreduced volume of ejaculate
Common may affect up to 1 in 10 people
Rweight decrease or increase, which can be
associated with fluid retention
Rdepressed mood
Rrestlessness
Rbreast swelling sometimes with tenderness
Rhot flushes, sweating
Rtiredness
Rshortness of breath
Rliver problems, some of them severe or even fatal,
have been reported with dosages of 100 mg and
above of cyproterone acetate. 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
Rrash
Rare may affect up to 1 in 1,000 people
Rallergic 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)
Rtender 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
Androcur is reduced.
Very rare may affect up to 1 in 10,000 people
Rbenign (non-malignant) liver tumours, see also
section 2 ‘Warnings and precautions’
Rsome 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 Androcur 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:
Rblood clots have been reported in patients taking
this medicine but they have not definitely been
linked to Androcur. See also section 2 ‘Warnings
and precautions’
Rthe 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
Androcur at doses of 25 mg per day and above
Rdry skin and improvement in acne
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Rtemporary 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
during long term treatment with this medicine.
Your doctor may arrange for you to have regular
blood tests during treatment to monitor this
Rthinning of the bones (osteoporosis)
Rtiredness, 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).
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 (see details below). By reporting side
effects you can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Androcur
RKeep this medicine out of the sight and reach of
children.
RDo not use this medicine after the expiry date
which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
RDo 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 Androcur contains:
Rthe active ingredient is cyproterone acetate. Each
tablet contains 50 mg of cyproterone acetate
Rthe other ingredients are: maize starch, povidone
25000, magnesium stearate (E572), lactose,
silicon dioxide (aerosil) (E551).
What Androcur looks like and contents of the
pack
Each pack of Androcur contains 56 round, white
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 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
Androcur 50 mg

Reference number
00010/0519

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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