<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<PB n=1>
<CB n=1>
<DIV type=0>

<HEAD weight="bold" >
Patient Information Leaflet Leaflet not to be removed
</HEAD>


<BLOCK>

<EMPH weight="bold">
Cyprostat Please read this leaflet carefully before you start your treatment A guide to using Cyprostat 100 mg tablets
</EMPH>

</BLOCK>


<BLOCK>
This leaflet gives you some information about Cyprostat 100 mg. Additional information is available from your doctor or pharmacist.
</BLOCK>


<BLOCK>
Cyprostat 100 mg contains cyproterone acetate. This substance is an antiandrogen. That is, it blocks the actions of male sex hormones (androgens). It also reduces the amount of male sex hormones produced by the body.
</BLOCK>


<BLOCK>
The reason why you can only obtain this medicine on prescription is that it may only be used under careful medical supervision.
</BLOCK>


<BLOCK>
Please tell your doctor if you have any doubts or worries about using this medicine, either before you start or while you are using it.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
The name of your medicine is:
</EMPH>
 Cyprostat 100 mg (cyproterone acetate)
</BLOCK>

<DIV type=1>

<HEAD weight="bold" >
What does your medicine contain?
</HEAD>


<BLOCK>
Each pack contains 84 tablets, each containing 100 mg cyproterone acetate.
</BLOCK>


<BLOCK>
Each tablet also contains the inactive ingredients:
</BLOCK>

<DIV type=2>

<HEAD>
maize starch povidone aerosil (E551) magnesium stearate (E 572) lactose
</HEAD>


<BLOCK>
Cyprostat 100 mg is an antiandrogen therapy. That is, it blocks the actions of male sex hormones (androgens).
</BLOCK>

<CB n=2>

</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
The product licence is held by
</HEAD>


<BLOCK>
Schering Health Care Ltd.,
</BLOCK>

<DIV type=2>

<HEAD>
The Brow Burgess Hill West Sussex RH15 9NE
</HEAD>


</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Product licence number: 0053/0133 Cyprostat 100 mg is manufactured by Schering AG Berlin, Germany Uses
</HEAD>


<BLOCK>
As R blocks the actions of male sex hormones and reduces the amount of male sex hormones produced by the body, cyproterone acetate can be used to treat cancer of the prostate gland which may be dependent on male hormones.
</BLOCK>


<BLOCK>
The medicine is used:
</BLOCK>


<LIST type="ordered">

<ITEM>

<BLOCK>
to reduce the possible worsening of the disease which may occur in the early stages of other treatments used for prostate cancer.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
in long term treatment when surgery or other medicines are not suitable.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
to treat hot flushes which may arise during treatments with other medicines used for prostate cancer or following surgery.
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
Reasons for not using Cyprostat 100 mg
</HEAD>


<BLOCK>
There are no conditions that absolutely rule out its use.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What you should know before taking Cyprostat 100 mg tablets
</HEAD>


<BLOCK>
In patients with a history of blood clots (thrombosis or embolism) there is a possibility that new clots may occur. In extremely rare cases, blood clots have been reported in patients taking this medicine. However, these have not been definitely linked to cyproterone acetate.
</BLOCK>


<BLOCK>
H you have abnormalities of the red blood cells (sickle cell anaemia) or severe diabetes affecting the blood vessels, treatment with this medicine may lead to a worsening of these conditions.
</BLOCK>

<CB n=1>

<BLOCK>
Some patients with severe depression may notice a worsening of this condition whilst taking this medicine.
</BLOCK>


<BLOCK>
Tiredness and weakness can occur, especially during the first few weeks of treatment. You should not drive or operate machinery under these conditions.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What you should know if you take other drugs
</HEAD>


<BLOCK>
If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How to take your medicine
</HEAD>


<BLOCK>
Read the instructions on the label carefully and take the tablets as instructed. Your doctor will decide how much you need to take. The tablets should be taken after meals and swallowed whole with a drink of water. Do not reduce the dose or interrupt the treatment unless your doctor tells you to.
</BLOCK>


<BLOCK>
The normal dose taken is as follows:
</BLOCK>


<LIST type="ordered">

<ITEM>

<BLOCK>
When used to reduce the possible worsening of the disease which may occur in the early stages of other treatments used for prostate cancer the daily dosage is usually 300 mg (one tablet three times a day) which may be reduced by your doctor to 200 mg (one tablet twice a day).
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
In long-term treatment, the daily dosage is usually 200-300 mg (one tablet two or three times a day).
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
To treat hot flushes the daily dosage is usually 100 mg (one tablet a day).
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
What to do if you miss a dose
</HEAD>


<BLOCK>
If you have forgotten to take your medicine, do not make up for R by taking extra tablets. When you remember, take the next prescribed dose and continue with the treatment. If you are concerned, consult your doctor or pharmacist.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Overdosage
</HEAD>


<BLOCK>
There have been no reports of serious ill-effects from overdosage. You should consult your doctor who will be able to advise you what action, if any, is necessary.
</BLOCK>

<PB n=2>
<CB n=2>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Side-effects
</HEAD>


<BLOCK>
Discomfort or even enlargement of the breasts occurs in some patients and, in rare cases, there may be tender lumps in the breasts and oozing of milky fluid from the nipples.
</BLOCK>


<BLOCK>
Cyproterone acetate can increase the sugar in your blood, and if you are diabetic your doctor will check this regularly.
</BLOCK>


<BLOCK>
When you have been taking this medicine for some months, you will probably become unable to make anyone pregnant, but note that this does not happen at once, and you should not rely on this medicine for contraception at any time. While the overall number of sperms that you produce will be reduced, more of your sperms than usual will be abnormal in shape. Some people think these abnormal sperms might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children.
</BLOCK>


<BLOCK>
Some patients taking this medicine have noticed breathlessness.
</BLOCK>


<BLOCK>
Disturbances of liver function, some of them severe, have been reported with high-dosed cyproterone acetate treatment. Your doctor may arrange for you to have regular liver tests during treatment.
</BLOCK>


<BLOCK>
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 in the abdomen. Tell your doctor if you have any new &quot;stomach" discomfort or pain that does not soon clear up.
</BLOCK>


<BLOCK>
Effects on the blood (anaemia) and adrenal glands have also been reported rarely during long-term treatment with cyproterone acetate. Your doctor may arrange for you to have regular blood tests during treatment.
</BLOCK>


<BLOCK>
If you take this medicine for a long time, you may notice a change in your weight The skin and hair become less greasy. Other effects which may occur include temporary patchy loss of body <CB n=1> hair, a reduction in hair growth on the body, an increased growth of hair on the head, lightening of hair colour and a female type of pubic hair growth.
</BLOCK>


<BLOCK>
Thinning of the bones (osteoporosis) has been reported very rarely.
</BLOCK>


<BLOCK>
You may feel tired, weak or listless, especially during the first few weeks of treatment.
</BLOCK>


<BLOCK>
You should ask your doctor about any change in health or general sense of well-being that you notice while taking Cyprostat 100 mg.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Expiry date:
</EMPH>
 The expiry date is printed on the pack. Do not use after this date.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Storage:
</EMPH>
 Keep your medicine out of the reach of children.
</BLOCK>


<BLOCK>
Date of last revision of this leaflet: 18 January 1996
</BLOCK>


<BLOCK>
Cyprostat is a registered trademark of Schering AG.
</BLOCK>

</DIV>

</DIV>

</DOCUMENT>
