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Information for Consumers

Revised: 12 June 2015

Consumer Medicine Information

PROCUR

cyproterone acetate 50mg and 100mg tablets

What is in this leaflet

This leaflet answers some common questions about PROCUR 50mg and 100mg tablets.

It does not contain all the information available on this medicine.

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 using PROCUR against the benefits expected it will have for you.

If you have concerns about taking PROCUR 50mg and 100mg tablets, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What PROCUR tablets are used for

PROCUR tablets contain the active ingredient cyproterone acetate

Cyproterone acetate is an antiandrogen. It works by blocking the actions of male sex hormones (androgens). It also reduces the production of male hormones in the testes and inhibits ovarian function in female.

PROCUR is normally used to reduce increased sex drive (hypersexuality) in adult males or to treat inoperable prostate cancer in males or severe signs of androgenization such as excessive hairiness in women.

Your doctor may have prescribed PROCUR tablets for another purpose. Ask your doctor if you have any questions about why PROCUR has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you use PROCUR tablets

When you must not take it

Do not take this medicine if:

A liver function test should be performed before treatment.

Male patients: Your doctor may instruct you to have a sperm count recorded before starting treatment to determine whether you are fertile or infertile. There may be a reduction in the overall number of sperm during treatment but it will gradually recover after you have stopped the treatment.

Female patients: Your doctor may perform a thorough gynaecological examination before starting treatment.

Taking other medicines

Tell your doctor if you are taking any other medicines or if you had an allergic reaction to any medicine that you have taken previously to treat your current condition.

If you are diabetic, your doctor may alter the dose of oral antidiabetics or insulin required to treat your diabetes.

Using PROCUR tablets

How much to take

For Men

For treatment of inoperable prostate cancer:
To eliminate the effect of male sex hormones produced by the adrenal glands, the usual daily dose is:

To reduce the initial increase of male sex hormones in treatment with LH-RH agonists (such as buserelin), the initial dose of PROCUR is100mg tablets twice daily alone for 5-7 days, followed by 100mg twice daily for 3-4 weeks together with an LH-RH agonist.

To eliminate the effect of male sex hormones produced by the adrenal glands in treatment with LH-RH agonists, the usual dose is 100mg once or twice daily.

For Women
For women of childbearing age, the usual dose is 100mg daily from the 1st to the 10th day of the menstrual cycle (=10 days). In addition, your doctor will also prescribe a combined oral contraceptive pill from the 1st to the 21st day of the cycle to provide the necessary contraceptive protection and to stabilise the cycle.

Take the tablets at the same time each day. If more than 12 hours pass from this time, ask your doctor or pharmacist for advice as to how to continue.

After 21 days, there will be a 7-day tablet-free interval during which withdrawal bleeding will occur. If bleeding fails to occur, this may be a sign that you are pregnant. Talk to your doctor immediately.

After there is improvement to your condition, your doctor may lower the dose to 25-50mg daily during the first 10 days of the combined treatment.

In post-menopausal patients or patients who have undergone removal of the womb, PROCUR may be used alone. The usual dose is 25 - 50mg once daily for 21 days followed by a 7-day tablet-free interval.

If you forget to take it

If you miss a dose, just take the next dose when it is due. Do not take extra tablets to make up for missed doses.

Taking your medicine at the same time each day may help you to remember to take it regularly. This is especially important for women of childbearig age as this helps avoid pregnancy. If you have trouble remembering to take your medicine, ask you pharmacist for some hints.

While you are using PROCUR

Things you must do

If you are going to have blood tests, tell your doctor that you are taking PROCUR.

If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking PROCUR tablets.

During treatment with PROCUR, you will need to have blood tests and liver function tests regularly to monitor your health.

Tell your doctor if you develop a skin rash or hives,

Tell your doctor if you become pregnant.

Keep all appointments you and your doctor have scheduled so that your progress can be followed.

Tell your doctor if, for some reason, you have not taken your medicine exactly as prescribed. Otherwise your doctor may think it was not effective and change your treatment unnecessarily.

Things you must not do

Do not stop taking PROCUR or change the dose without consulting your doctor first.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

Be careful when driving, operating machinery or performing jobs that need you to be alert until you are certain that PROCUR does not affect your performance.

PROCUR can lead to tiredness and can impair your ability to concentrate.

Be careful when drinking alcohol. Avoid drinking a lot of alcohol regularly.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PROCUR.

Like other medicines, PROCUR can cause some side effects. If they occur, most of them are likely to be minor and temporary but some may be serious and will need medical attention.

Tell your doctor immediately if you notice any of the following:

These are severe side effects. You may need urgent medical attention.

Following are the more common side effects of PROCUR. They are usually mild.

Tell your doctor if you notice any of the following:

Men: Infertility and breast enlargement may occur during treatment.

Women : Ovulation is inhibited. Discomfort of the breasts may occur.

Sex steroids may promote the growth of certain tumours such as liver tumour. Very rarely, thinning of the bones (osteoporosis) may occur.

The list of side effects mentioned above is not complete. If you should suffer from any of these side effects or any other undesired effect please tell your doctor or pharmacist.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

PROCUR tablets are not known to be addictive

Overdose

Immediately contact either your doctor, Poisons Information Centre (0800 POISON or 0800 764 766) or accident and emergency department at your nearest hospital, if you think that you or anyone else may have taken too much PROCUR tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Take the pack of PROCUR with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Storage

Keep your tablets in the blister strips or bottle until it is time to take them. If you leave the tablets out of the packaging, they may not keep as well.

Keep PROCUR tablets in a cool dry place where the temperature stays below 30°C.

Do not leave or store PROCUR tablets in the bathroom, near a sink or stove, on a windowsill or in a car.

Heat and dampness can destroy some medicines

Keep PROCUR tablets where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

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 which are left over.

Product Description

What PROCUR tablets look like

PROCUR 50mg - White to off-white, round, flat, tablets having a score and embossed 50 on one side and plain on the other.

PROCUR 100mg - White to off-white, capsule shaped tablets having a score on one face and embossed 100 on the other.

Ingredients -

Active ingredient:
cyproterone acetate

Other ingredients (excipients):
Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, lactose.

Supplier

Distributed in New Zealand by:

Douglas Pharmaceuticals Limited
P O Box 45 027
Lincoln
Auckland 0651
New Zealand

This leaflet was prepared on 10 April 2007 based on the approved NZ data sheet for the above products.

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