Cyproterone Acetate 50mg tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about Procur tablets. 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 Procur tablets against the benefits the medicine is expected to 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.
Procur is the brand name for tablets containing 50 mg of the antiandrogenic substance, cyproterone acetate as the active ingredient.
As well as its active ingredient, Procur contains lactose, cellulose-microcrystalline, croscarmellose sodium, povidone and magnesium stearate.
What is Procur used for and how does it work?
Procur is an antiandrogenic hormone medication which has several different uses. 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.
Cancer of the prostate gland generally requires androgenic hormones to grow. Procur 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.
Procur tablets are also used to reduce the male sex drive in certain cases.
It is used in the treatment of women who have a problem with facial or chest hair, are balding or have severe acne.
Procur is only available on a doctor’s prescription.
There is no evidence that Procur tablets are addictive
Before you take Procur
Procur can rarely cause severe damage to your liver, resulting in jaundice and hepatitis. Your doctor should perform a blood test to check your liver before starting you on Procur and again if liver disease is suspected. Yellowing of the skin/eyes, abdominal pain or swelling and darkening of the urine should be all reported immediately to your doctor.
As with other sex steroids, benign and malignant liver changes have been reported in isolated cases. In very rare cases, liver tumours may lead to life-threatening bleeding. Tell your doctor if you have upper abdominal complaints. Procur has been observed to attach itself to the genetic material in animal and human liver cells. However an increase in liver cancers has not been seen in humans.
Female patients should be aware that the long term effects of Procur tablets on fertility are not known. A thorough gynaecological examination should be carried out by a doctor before starting treatment.
Pregnant women must not take Procr therefore pregnancy must be excluded at the time therapy is commenced in women of child-bearing age. Appropriate contraception should be commenced before starting Procur to prevent pregnancy and control the menstrual cycle. You should discuss this with your doctor before taking Procur.
Procur tablets 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. Male patients may need to have a sperm count.
Before you start to take Procur tablets
Tell your doctor if:
- You are pregnant or breastfeeding
- You suffer from or have a history of jaundice or persistent itching during pregnancy
- You have a history of herpes of pregnancy
Procur tablets should not be taken during pregnancy as it may lead to the development of female characteristics in male babies.
- You are allergic to any other medicines or other substances such as foods, dyes or preservatives or any of the ingredients in the tablet.
- You have in the past suffered from blood clots in the leg, stroke or heart attack.
- You have sickle-cell anaemia.
- You have severe diabetes that has damaged your blood vessels.
- You have suffered from any disease or tumour of your liver.
- You have suffered from severe chronic depression.
- You have Dubin-Johnson syndrome or Rotor syndrome.
If you are not sure whether you should be taking Procur tablets, talk to your doctor.
Do not take Procur tablets if:
- The expiry date on the pack has passed. If you take this medicine after the date has passed it may have no effect at all, or worse, an entirely unexpected effect.
- The packaging is torn or shows signs of tampering or the tablets do not look quite right.
Do not give Procur tablets to children.
Taking other medicines
If you are taking other medicines you must tell your doctor. This includes medicine that you can buy without a prescription from a pharmacy, supermarket or a health food shop. Some medicines are affected by others. Your doctor or pharmacist will be able to tell you what you should do when you have to take other medicines while you are on Procur.
How to take Procur tablets
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.
The dosage of Procur will be determined by your doctor.
Swallow the prescribed dose with a glass of water after a meal.
If you forget to take it
If it is almost time to take your next dose, skip the dose that you have missed and take your next dose when you are meant to. Otherwise take it as soon as you remember, then go back to taking your tablets as usual.
Do not double a dose to make up for a dose that you have missed.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to the casualty department at your nearest hospital, if you think that you or anyone else may have taken too many Procur tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers of these places/services handy.
While you are taking Procur tablets
Things you must do
If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking Procur tablets.
You may be required to have regular tests for liver, blood or other body functions.
Female patients who are taking the combined Procur/ethinyloesradiol treatment who have a family history of breast cancer should have regular breast examinations.
Things you must not do
Do not give Procur tablets to anyone else, even if they have the same condition as you.
Do not use Procur tablets to treat any other medical complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Procur tablets affect you. Procur may cause drowsiness and loss of concentration in some people.
Female patients should not smoke whilst taking combined Procur/ethinyloesradiol treatment. Use of any oral contraceptives may be associated with an increased risk of heart attack and stroke.
Female patients should be aware that the contraceptive action of the combined treatment of Procur and ethinyloestradiol may be reduced by diarrhoea or vomiting shortly after taking a tablet. In these cases, an additional form of contraception such as a condom or diaphragm should be used for the remainder of the cycle.
In women taking combined Procur/ethinyloesradiol treatment, if light bleeding or spotting occurs during the 3 weeks in which the tablets are being taken, do not stop taking your tablets. However if unusual bleeding continues or if bleeding is heavy, consult your doctor immediately.
If you are taking Procur tablets to reduce your sex drive, alcohol may stop Procur from working as well as it should.
Check with your doctor or pharmacist as soon as possible if you have any problems while you are taking Procur tablets, even if you do not think that the problems are connected with the medicine or are not listed in this leaflet.
Like all medicines, Procur tablets can cause side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
Infertility and impotence are expected effects of Procur and cannot generally be avoided. The most common side effect that may occur is tiredness and loss of concentration which may affect your ability to drive or operate machinery. Procur may occasionally result in gynaecomastia (swelling of the breast area which is sometimes also associated with tenderness or sensitivity of the breast area to touch), changes in body weight, diminished libido, nausea, allergy, headache, depressive moods, shortness of breath and blood clotting (which may lead to a clot on the lungs, stroke or heart attack).
This is not a complete list of all possible side effects.
Tell your doctor if you notice any other effects while using Procur tablets.
After Using Procur tablets
Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep as well.
Keep Procur tablets in a cool dry place where the temperature stays below 30°C.
Do not store Procur tablets or any other medicine in the bathroom or near a sink.
Do not leave Procur tablets in the car or on window sills. Heat and dampness can destroy some medicines.
Keep Procur tablets where children can not reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Tell your doctor if you stop taking the tablets or the tablets have passed their expiry date. Ask your pharmacist what to do with any tablets left over.
Procur are white round tablets engraved 50 with a break line on one side, plain on the other side.
Procur is presented in bottles containing either 20 tablets or 50 tablets.
Australian Registration Number:
Procur 50 mg tablet bottle AUST R 101531
Ascent Pharma Pty Ltd
151-153 Clarendon street
VIC 3205, Australia.
Date of leaflet preparation: May 2010
Published by MIMS November 2010