ANDROCUR®
(ANNE·dro·cur)
cyproterone acetate
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
Androcur.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor
has weighed the risks of you taking Androcur against the benefits they expect
it will have for you.
If you have any concerns about taking this
medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT ANDROCUR IS USED FOR
Androcur is an anti-androgen medicine.
Androgens such as testosterone are natural male sex
hormones which are also produced, to a slight extent, in females.
MEN:
In men, androgens may help cancer cells to grow in some types of prostate
cancer. By blocking these hormones, Androcur may slow or stop the growth of
cancer. Androcur may also be used in combination with other medicines or
following surgical removal of the testes to treat side effects such as “hot
flushes” or “sweats” and to prevent any initial worsening of the disease.
Androcur is also used to reduce abnormal sex drive
in men.
WOMEN:
In women, androgens may increase hair growth, loss of scalp hair and secretion
of oil from the sweat glands. By blocking these hormones, Androcur may slow or
stop excessive hairiness, loss of scalp hair, acne, oily skin and dandruff.
Ask your doctor if you have any questions about why
this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s
prescription.
BEFORE YOU TAKE ANDROCUR
When you must not take it
Do not take Androcur if you have an allergy to:
cyproterone acetate, the active
ingredient in Androcurany of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic reaction may
include:
shortness of breathwheezing or difficulty breathingswelling of the face, lips, tongue
or other parts of the bodyrash, itching or hives on the skin
Androcur should not be taken by children and
adolescents below 18 years of age or girls who have not completed puberty.
Do not take this medicine if you are pregnant or
suspect you may be pregnant. It may
affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine. The active ingredient in Androcur passes into
breast milk and there is a possibility that your baby may be affected.
Do not take Androcur if you have any of the
following medical conditions:
liver disease, previous or existing
liver tumours unless they are caused by metastases from prostate cancer
(your doctor would have told you if you have this)Dubin-Johnson or Rotor syndrome
(your doctor would have told you if you have either of these conditions)history of jaundice (yellow skin or
eyes), herpes or persistent itching during a previous pregnancyprevious or existing benign brain
tumour (meningioma)wasting disease (a disease causing
muscle loss or loss of strength, with the exception of prostate cancer)severe and persistent depressionprevious or existing conditions
relating to formation of blood clotssevere diabetes with blood vessel
changes (your doctor would have told you if you have this)sickle-cell anaemia (your doctor
would have told you if you have this)
Androcur tablets contain lactose. If you have been
told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking Androcur.
Do not take this medicine after the expiry date
printed on the pack and blister. The
expiry date is printed on the carton and on each blister after “EXP” (e.g. 11
18 refers to November 2018). The expiry date refers to the last day of that
month. If it has expired return it to your pharmacist for disposal.
Do not take this medicine if the packaging is torn
or shows signs of tampering. If the
packaging is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking
this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other
medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any
medical conditions, especially the following:
diabeteshistory of blood clotting or sickle
cell anaemiaosteoporosis, a family history of
osteoporosis or risk factors for developing osteoporosis (such as smoking,
a diet low in calcium, poor mobility, a slight build or treatment with
steroid medicines)
Tell your doctor if you are pregnant or plan to
become pregnant or are breastfeeding. If taken during pregnancy, Androcur may lead to signs of
feminisation in the male foetus. Therefore, your doctor will check that you are
not pregnant before you start taking Androcur. Women should use a reliable form
of contraception while taking Androcur.
Tell your doctor if fertility after treatment is
important. For men it is recommended that
a sperm count is taken to establish fertility before commencing Androcur. It
can take 3-20 months for fertile sperm production to be re-established after
stopping this medicine.
The long-term effects of Androcur on female
fertility are not known.
If you have not told your doctor about any of the
above, tell them before you start taking Androcur.
Taking other medicines
Tell your doctor or pharmacist if you are taking
any other medicines, including any that you buy without a prescription from
your pharmacy, supermarket or health food shop.
Some medicines and Androcur may interfere with each
other. These include:
phenytoin, a medicine used to treat
epilepsymedicines used to treat fungal
infections, including ketoconazole, itraconazole, clotrimazoleritonavir, a medicine used in the
treatment of HIVrifampicin, an antibiotic used to
treat infections such as tuberculosis and leprosySt John'swort, a herbal remedy used to treat mood disordersStatins (HMGCoA inhibitors),
medicines used to lower cholesterol levels in people with or at risk of
cardiovascular diseasemedicines used to treat diabetes
These medicines may be affected by Androcur, or may
affect how well it works. You may need different amounts of your medicine, or
you may need to take different medicines.
Your doctor and pharmacist may have more
information on medicines to be careful with or avoid while taking this
medicine.
HOW TO TAKE ANDROCUR
Follow all directions given to you by your doctor
or pharmacist carefully. They may
differ from the information contained in this leaflet.
If you do not understand the instructions printed
on the pharmacist label, ask your doctor or pharmacist for help.
How much to take
Your doctor will advise of the most suitable dose
for you to take.
Do not alter the dose yourself. Your doctor will advise you if changing the
dose is necessary.
MEN:
Prostate cancer
The usual daily dose is 50-300 mg of Androcur. Your
doctor may request you take Androcur with other medicines and/or change your
dose during treatment.
Reduction of abnormal sex drive
Generally treatment is started with 50 mg of
Androcur twice daily and may be increased to 100 mg twice daily or three times
daily before reducing gradually to the lowest effective dose. Your doctor may
change your dose during treatment.
WOMEN:
If you are of childbearing age, you should commence
your tablet taking on the 1st day of your cycle (= 1st day
of bleeding). If you have no menstrual periods (amenorrhoea) your treatment can
start immediately. In this case, the first day of treatment is to be regarded
as the 1st day of the cycle.
Starting from day 1 take 50-100 mg (as advised by
your doctor) of Androcur daily from the 1stto the 10th day
of the cycle (= for 10 days). Additionally, your doctor will advise the most
appropriate contraceptive for you to take to provide the necessary
contraceptive protection and to stabilise your cycle.
Your doctor will re-evaluate your treatment when
you reach menopause. Long-term use (years) of Androcur should be avoided.
If you are postmenopausal or have had a
hysterectomy, Androcur may be administered alone. The usual dose is 25-50 mg of
Androcur once daily for 21 days, followed by a 7-day tablet-free interval.
Shortness of breath may occur at high doses.
How to take it
Swallow the tablets whole with some liquid after
meals.
When to take it
Take your medicine after meals at about the same
time each day. Taking it at the same
time each day will have the best effect. It will also help you remember when to
take it.
Missed Androcur tablets may diminish the
effectiveness of treatment and may lead to breakthrough bleeding in women.
How long to take it
Continue taking your medicine for as long as your
doctor tells you.
This medicine helps to control your condition, but
does not cure it. It is important to keep taking your medicine even if you feel
well.
If you forget to take it
If it is almost time for your next dose, skip the
dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and
then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose
that you missed. This may increase the
chance of you getting an unwanted side effect.
If you are also taking an oral contraceptive and
more than 12 hours has elapsed from the time Androcur was due to be taken, note
that contraceptive protection in this cycle may be reduced and thus there is an
increased risk of becoming pregnant.
If you are not sure what to do, ask your doctor or
pharmacist.
If you have trouble remembering to take your
medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons
Information Centre on 13 11 26 for advice, or go to Accident and Emergency at
the nearest hospital, if you think that you or anyone else may have taken too
much Androcur. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
WHILE YOU ARE TAKING ANDROCUR
Things you must do
If you are about to be started on any new medicine,
remind your doctor and pharmacist that you are taking Androcur.
Tell any other doctors, dentists, and pharmacists
who treat you that you are taking this medicine.
Keep all of your doctor’s appointments so that your
progress can be checked. Your
doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Your doctor will check your liver function during
treatment with Androcur and whenever any symptoms or signs suggesting liver
problems are observed.
If you have diabetes, your doctor will monitor you
to ensure that you receive the appropriate dose of oral antidiabetic or insulin
whilst taking Androcur.
Your doctor will also check your red-blood cell
count to ensure you do not become anaemic during treatment with Androcur.
If you are a female taking an oral contraceptive
during treatment, tell your doctor if your period does not occur during the
tablet-free / placebo interval. Your
doctor may need to check whether you are pregnant before you can continue
treatment.
If you are a male taking Androcur to reduce
abnormal sex drive, you should consider undertaking additional measures such as
therapy or counselling in order to take advantage of the period of reduced
drive. These measures may assist in
achieving personal and social re-orientation.
Things you must not do
Do not take Androcur to treat any other complaints
unless your doctor tells you to.
Do not give your medicine to anyone else, even if
they have the same condition as you.
Do not stop taking your medicine or lower the
dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen or you
may have unwanted side effects.
Things to be careful of
Be careful driving or operating machinery until you
know how Androcur affects you. This
medicine may cause tiredness and can impair the ability to concentrate. If you
have any of these symptoms, do not drive, operate machinery or do anything else
that could be dangerous.
Be careful when drinking alcohol while you are
taking this medicine. If you
drink alcohol, tiredness and the ability to concentrate may be worse. Alcohol
may prevent Androcur from working as well as it should in reducing abnormal sex
drive.
SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible
if you do not feel well while you are taking Androcur.
All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may need medical treatment if
you get some of the side effects.
Do not be alarmed by the following lists of side
effects. You may not experience any of
them.
Ask your doctor or pharmacist to answer any
questions you may have.
Tell your doctor or pharmacist if you notice any of
the following and they worry you:
tiredness, fatigueweight changeheadachedepressive moodnausea and other gastrointestinal
complaintsdecreased sexual drivebreast pain, change in breast size,
breast swelling and/or tendernessbreast enlargement in menmenstrual cycle irregularity,
spottinghot flushes, sweatingshortness of breathosteoporosis
If you were fertile before treatment, Androcur will
normally prevent sperm production in men and ovulation in women. In men,
fertility is usually regained within a few months of discontinuing therapy. The
long term effects on female fertility are not known.
In men Androcur will also normally result in the
inability to get or maintain an erection (impotence). This ability is usually
also regained within a few months of discontinuing therapy.
The above includes the more common side effects of
your medicine.
Tell your doctor immediately or go to Accident and
Emergency at your nearest hospital if you notice any of the following:
yellowing of the skin and/or eyes,
light coloured bowel motions, dark coloured urinesevere upper abdominal painvomiting blood or material that
looks like coffee grounds, bleeding from the back passage, black sticky
bowel motions (stools) or bloody diarrhoeasudden severe headache, loss of
vision, loss of coordination, slurred speech, shortness of breath, chest
pain, numbness, heat or swelling in the arms and legs
The above list includes serious side effects that
may require medical attention or hospitalisation. Serious side effects are
rare.
Tell your doctor or pharmacist if you notice
anything that is making you feel unwell. Other side effects not listed above may happen in some people.
AFTER TAKING ANDROCUR
Storage
Keep your tablets in the pack until it is time to
take them. If you take the tablets out of
the pack, they may not keep well.
Keep your tablets in a cool dry place where the
temperature stays below 30°C.
Do not store Androcur or any other medicine in the
bathroom, near a sink, or on a window-sill.
Do not leave it in the car. Heat and damp can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half
metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this
medicine or the expiry date has passed, ask your pharmacist what to do with any
medicine that is left over.
Return any unused medicine to your pharmacist.
PRODUCT DESCRIPTION
What it looks like
Androcur 50 mg tablets are white, round tablets,
scored on one side with “BV” marking in a hexagon on the other side, presented
in blisters containing 20 or 50 tablets.
Ingredients
Active ingredients per tablet:
Androcur 50 - 50 mg of cyproterone
acetate
Inactive ingredients:
lactosecorn starchpovidonemagnesium stearateaerosil
Supplier
Made inFrancefor:
Bayer Australia Limited
ABN22 000 138 714
875 Pacific Highway
Pymble, NSW 2073
Australian Registration Number
Androcur 50 mg tablets:
AUST R 10671, 156920
Date of preparation
October 2017
See TGA website (www.ebs.tga.gov.au) for latest
Australian Consumer Medicine Information.
© Bayer Australia Ltd
All rights reserved
® Registered Trademark of the Bayer Group,Germany
Published by MIMS January 2018
Consumers should be aware that the information
provided by the Consumer Medicines Information (CMI) search (CMI Search) is for
information purposes only and consumers should continue to obtain professional
advice from a qualified healthcare professional regarding any condition for
which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is
supplied by the relevant pharmaceutical company for each consumer medical
product. All copyright and responsibility for CMI is that of the relevant pharmaceutical
company. MIMS Australia uses its best endeavours to ensure that at the time of
publishing, as indicated on the publishing date for each resource (e.g.
Published by MIMS/myDr January 2007), the CMI provided was complete to the best
of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to
be used by consumers to diagnose, treat, cure or prevent any disease or for any
therapeutic purpose. Dr Me Pty Limited, its servants and agents shall not be
responsible for the continued currency of the CMI, or for any errors, omissions
or inaccuracies in the CMI and/or the CMI Search whether arising from
negligence or otherwise or from any other consequence arising there from.
