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.
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 for the reduction of drive in sexual deviations. This allows for better control in a predisposing stimulatory situation.
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.
Androcur should not be taken by children and adolescents below 18 years of age.
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 Androcur
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
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 breast-feed 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
history of jaundice (yellow skin or eyes), herpes or persistent itching during a previous pregnancy
existing blood clots
severe chronic depression
Dubin-Johnson or Rotor syndrome (your doctor would have told you if you have either of these conditions)
Wasting disease (with the exception of cancer of the prostate)
If you are female or taking this medicine for the reduction of drive in sexual deviations, do not take Androcur if you have the following medical conditions:
Severe diabetes with vascular changes
Sickle-cell anaemia (your doctor would have told you if you have this)
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 09 refers to November 2009). 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:
history of blood clotting or sickle cell anaemia
osteoporosis, 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 breast-feeding. 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. Your doctor may also prescribe another hormone known as ethinyloestradiol, probably in the form of the ‘Pill’ to be taken as well to minimise chance of becoming pregnant during the treatment. The ‘Pill’ also promotes regular menstruation.
Tell your doctor if fertility after treatment is important. In this case it is advisable to have a spermatogram before taking Androcur to establish your fertility before commencing therapy. 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 epilepsy
medicines used to treat fungal infections, including ketoconazole, itraconazole, clotrimazole
ritonavir, a medicine used in the treatment of HIV
rifampicin, a bactericidal antibiotic used to treat infections such as tuberculosis and leprosy
St John's wort, a herbal remedy used to treat mood disorders
Statins (HMGCoA inhibitors), medicines used to lower cholesterol levels in people with or at risk of cardiovascular disease
medicines 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 tell you the dose that you should take. The usual daily dose is 50-300 mg (half to three tablets) of Androcur-100. Your doctor may request you take Androcur-100 with other medicines and/or change your dose during treatment.
Reduction of drive in sexual deviations
Your doctor will tell you the dose that you should take. Generally treatment is started with one tablet of Androcur 50 mg twice daily. Your doctor may change your dose during treatment.
Do not alter the dose yourself.
Your doctor will advise you if changing the dose is necessary.
If you are of childbearing age, you should commence your tablet taking on the 1st day of your cycle (= 1st day of bleeding). Only if you have no menstrual periods (amenorrhoea) can treatment 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 1-2 tablets (as advised by your doctor) of Androcur 50 mg daily from the 1st to the 10th day of the cycle (= for 10 days). Additionally, your doctor will advise the most appropriate ‘Pill’ for you to take to provide the necessary contraceptive protection and to stabilise your cycle.
If you are postmenopausal or have had a hysterectomy, Androcur may be administered alone. Your doctor will advise the most suitable dose for you. The usual dose is ½-1 tablet of Androcur 50 mg once daily for 21 days, followed by a 7-day tablet-free interval.
Do not alter the dose yourself. Your doctor will advise you if changing the dose is necessary.
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 intermenstrual 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 the ‘Pill’ 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 bleeding fails to occur after a cycle where the ‘Pill’ was missed, you must see your doctor. Your doctor may need to check whether or not you are pregnant before you can continue treatment.
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.
If you are a female taking the ‘Pill’ during treatment, tell your doctor if no bleeding occurs 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 drive in sexual deviations, you should consider undertaking psychotherapeutic and socio-therapeutic measures 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, diminished vitality 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, diminished vitality and the ability to concentrate may be worse. Also, the sexual drive-reducing effect of Androcur in males can also be diminished under the influence of alcohol.
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:
decreased sexual drive
fast heart beat
nausea and other gastrointestinal complaints
breast pain, change in breast size, breast swelling and/or tenderness
menstrual cycle irregularity, spotting
The above includes the more common side effects of your medicine.
If you were fertile before treatment, Androcur will also normally result in your inability to produce sperm (males) or ovulate (females). In males, fertility is usually regained within a few months of discontinuing therapy. The long term effects on female fertility are not known.
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.
Tell your doctor as soon as possible if you notice any of the following:
yellowing of the skin and/or eyes, light coloured bowel motions, dark coloured urine
severe upper abdominal pain
shortness of breath
vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
If the following happens, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
sudden severe headache, loss of vision, loss of coordination, slurred speech, shortness of breath, chest pain, numbness heat or swelling
The above is a serious
side effect. You may need urgent medical attention or hospitalisation.
If you are taking the ‘Pill’ or another medicine with Androcur, you should also refer to the relevant Consumer Medicine Information for that product for information on possible side-effects.
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
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.
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.
What it looks like
Androcur 50 mg tablets are round, white, scored tablets presented in bottles or blisters containing 20 or 50 tablets.
Androcur-100 tablets are capsule shaped, white, scored tablets presented in blisters of 10. Each pack contains 50 tablets.
Active ingredients per tablet:
Androcur 50 - 50 mg of cyproterone acetate
Androcur 100 - 100 mg of cyproterone acetate
aerosil (50 mg tablet only)
Made in France for:
Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
Australian Registration Number
Androcur 50 mg tablets:
AUST R 10671, 156920
Androcur-100 100 mg tablets:
AUST R 51449
Date of preparation
This leaflet was prepared in September 2009
See Bayer Australia website (www.bayer.com.au) for latest Australian Consumer Medicine Information.
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® Registered Trademark of the Bayer group, Germany