APO-Cyproterone 100 mg2021-01-31
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
Contains the active ingredient cyproterone (as cyproterone acetate)
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about cyproterone. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Cyproterone 100 mg. It is an anti-androgen medication. It contains the active ingredient cyproterone (as cyproterone acetate).
It is used in men to treat cancer of the prostate gland.It can also be used in conjunction with other medications 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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor’s prescription.
How it works
Some types of cancer of the prostate gland require androgenic hormones to grow.This medicine works in two ways.Firstly it stops the androgen hormones (testosterone) present in your body from being able to attach to the cancer cells. Secondly by an effect on the hormonal mechanisms that control androgen production by the body, it decreases the amount of androgen hormone present in your blood stream.
This medicine should only be taken by men.It should not be taken by women or children.
There is no evidence that this medicine is addictive.
Before you take this medicine
When you must not take it
Do not take this medicine if you have or have had any of the following:
Liver disease or liver tumours
(except if you have cancer of the prostate and this is due to spread of the prostate cancer)
Dubin-Johnson or Rotor syndrome
(Your doctor would have told you this).
Meningioma, a type of brain tumour
A wasting disease or sickle cell disease
Severe and persistent depression
Problems with your blood clotting or blood clots
Severe diabetes which involves serious changes in blood flow through the veins
You have not yet completed puberty
You are hypersensitive to, or have had an allergic reaction to, cyproterone or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like symptoms
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
1.You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.You have or have had any medical conditions, especially the following:
problems with blood clotting or blood clots
heart attack or stroke
anaemia 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)
a wasting disease
the Lapp-Lactase deficiency or lactose intolerance. These tablets contain lactose.
3.You are planning to have surgery or an anaesthetic.
4.You are currently receiving or are planning to receive dental treatment.
5.You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with cyproterone. These include:
statins, used for lowering cholesterol
antibiotics such as rifampicin or penicillins
phenytoin, a medicine to control fits
medicines used to treat diabetes
medicines to treat fungal infections (ketoconazole, itraconazole, clotrimazole)
ritonavir, a medicine used to treat HIV infections
St John’s wort, a herbal remedy for mood disorders.
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with cyproterone.
You should be aware that cyproterone causes a decrease in sperm count.It may take 3 to 20 months for the sperm count to return to normal once therapy has been stopped. You may need to have a sperm count.
Most reported cases of liver damage are in men with prostate cancer. Liver damage may be fatal in some cases.Such effects are more likely to happen when taking high doses of cyproterone and develop, usually, several months after treatment has begun. Your doctor will order liver function tests before you start taking cyproterone and whenever any symptoms or signs that suggest you have liver damage, for example jaundice (yellow skin and/or eyes), dark coloured urine. If you develop any of these signs you should contact your doctor immediately.
If you suffer from diabetes, tell your doctor as you will need to be kept under close observation, and your requirements for oral antidiabetics or insulin can change.
If you are required to concentrate (e.g. road users, machine operators) you should note that cyproterone acetate can make you feel tired or lethargic and can impair your ability to concentrate.
How to take this medicine
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.
How much to take
Your doctor or pharmacist will tell you how much of this medicine you should take. The usual daily dose is 50-300 mg of APO-Cyproterone 100 mg. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
The tablets should be swallowed with some liquid (after food).
When to take it
Take this medicine at about the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
The tablets should be taken immediately after food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
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 to take your next dose, skip the missed dose and take your next dose at the usual time. 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 missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are about to have any blood tests
you are going to have surgery or an anaesthetic orare going into hospital.
Your doctor may do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Your doctor will check your liver function during treatment 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 cyproterone.
Your doctor will also check your red-blood cell count to ensure you do not become anaemic during treatment.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
If you develop any signs of liver toxicity – yellow skin or eyes – tell your doctor immediately.Your doctor will make sure this is not due to any other cause, e.g. metastatic disease (spread of cancer) and will decide if you should keep taking cyproterone.
In very rare cases liver tumours may lead to life-threatening intra-abdominal haemorrhage. If you develop severe upper abdominal complaints or tenderness tell your doctor immediately.
A sensation of shortness of breath may occur in some people who are taking high doses of cyproterone acetate.If this occurs, tell your doctor.
Things you must not do
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor tells you to
Stop taking your medicine, or change the dosage, without first checking with your doctor.
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects you.
This medicine may cause drowsiness and loss of concentration in some people.
Alcohol may stop cyproterone from working as well as it should.
Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking cyproteroneor if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Infertility and impotence are expected effects of cyproterone acetate and cannot generally be avoided.
Tell your doctor or pharmacist if you notice any of the following:
loss of concentration which may affect your ability to drive or operate machinery
change in sex drive
nausea, stomach upset
inability to get or maintain an erection
breast pain, breast enlargement and /or tenderness; oozing of milky fluid from the nipples .This usually goes away after reducing the dose or stopping the tablets
changes in body weight
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention.
blood clotting (which may lead to a clot on the lungs, stroke or heart attack)
fast heart rate
change in skin colour or appearance of rashes
shortness of breath
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects and you may need urgent medical attention or hospitalisation.
sudden severe headache, loss of vision, loss of coordination, slurred speech, shortness of breath, chest pain, numbness heat or swelling.
severe pain and/or swelling in the stomach and gut
pain in the groin, chest or leg
swelling of one leg with tenderness or pain
coughing up blood or sudden shortness of breath
upper abdominal pain, yellowing of the eyes or skin (jaundice), itching, dark urine, feeling generally unwell and having poor appetite.These may be due to problems with your liver.
If you were fertile before treatment, Androcur-100 will normally prevent sperm production. Fertility is usually regained within a few months of discontinuing therapy.
Androcur-100 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.
In men, long-term use of cyproterone may uncommonly lead to osteoporosis.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to cyproterone, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing.
swelling of the face, lips, tongue,throat or other parts of the body
rash, itching or hives on the skin
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 30°C. Protect it from light and moisture.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine 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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
What APO-Cyproterone 100 mg looks like
White to off-white, capsule-shaped tablet with ‘100’ engraved on one face, and a break line on the other face.
APO-Cyproterone 100 mg tablets are presented in blister packs containing 50 tablets.
* Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 100 mg of cyproterone(as cyproteroneacetate) as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Number
APO-Cyproterone 100 mg tablets:
AUST R 101535.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was last updated in:
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