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ANDROCUR 50MG TABLETS

Active substance(s): CYPROTERONE ACETATE

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Packaging Technology Berlin sgsof
page 1
Bayer Pharma AG
client: JS86
material-no.: 85239635
PZ: 2599F-4
code-no.: 88
name: LF-Androcur 50MG TAB GB
country: GB/-/BPH
colors: Black
version: 07.06.2016/02
approval:
dimension: 160 x 594 mm

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
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.
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:
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.
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 lifethreatening. 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.

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Packaging Technology Berlin sgsof
page 2
Bayer Pharma AG
client: JS86
material-no.: 85239635
PZ: 2599F-4
code-no.: 88
name: LF-Androcur 50MG TAB GB
country: GB/-/BPH
colors: Black
version: 07.06.2016/02
approval:
dimension: 160 x 594 mm

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
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

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 60 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 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
Androcur 50 mg

Reference number
00010/0519

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

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.

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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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