Active ingredient
- cyproterone acetate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00010/0524.
Cyprostat 100mg
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package leaflet: Information for the user
CYPROSTAT® 100 mg tablet
cyproterone acetate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Cyprostat is and what it is used for
2. What you need to know before you take Cyprostat
3. How to take Cyprostat
4. Possible side effects
5. How to store Cyprostat
6. Contents of the pack and other information
1. What Cyprostat is and what it is used for
What is Cyprostat?
Cyprostat is a medicine containing cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (androgens) and reduces the amount of male sex hormones produced by the body.
What is Cyprostat used for?
Cyprostat is used in men to treat prostate cancer.
This medicine is used:
1. to reduce the possible worsening of the disease which may occur when you start other treatments used for prostate cancer
2. for long term treatment of prostate cancer when surgery or other medicines are not suitable
3. to treat hot flushes which may occur during treatments with other medicines used for prostate cancer or following surgery.
2. What you need to know before you take Cyprostat
Do not take Cyprostat:
or:
Warnings and precautions
Talk to your doctor before taking Cyprostat
Several blood tests or checks may be required while you are taking this medicine:
Other medicines and Cyprostat
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Some medicines may stop Cyprostat from working properly. Also, Cyprostat may change the way other medicines you are taking are broken down in your body.
Tell your doctor if you take any other medicines regularly, especially:
If you are diabetic your doctor may need to alter the dose of medicine required to treat your diabetes. See also section 2 ‘Warnings and precautions’.
Driving and using machines
You may feel tired and weak during treatment. If affected, do not drive, operate machinery or do anything where these symptoms may put either yourself or others at risk.
Important information about some of the ingredients in Cyprostat
Cyprostat contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Cyprostat
Your doctor will decide what dose you will take. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Take the tablets after meals and swallow them whole with a drink of water.
The usual dose range is from 1 tablet once a day (100 mg) up to 1 tablet three times a day (300 mg).
If you take more Cyprostat than you should
As soon as you can, talk to your doctor who will tell you what you need to do. There have been no reports of serious illness from taking too much Cyprostat in a single dose.
If you forget to take Cyprostat
If you forget to take a dose, take it as soon as you remember and take the next dose when it is due. Do not take a double dose to make up for a forgotten dose.
If you stop taking Cyprostat
Do not reduce the dose or stop taking your tablets unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have trouble breathing or swallowing, this may be a sign of a rare allergic reaction - contact your doctor or go to a hospital straight away.
These are the possible side effects of Cyprostat, starting with the more common ones:
Very common may affect more than 1 in 10 people
decreased sex drive
impotence
reduced sperm count
reduced volume of ejaculate
Common may affect up to 1 in 10 people
weight decrease or increase, which can be associated with fluid retention
depressed mood
restlessness
breast swelling sometimes with tenderness
hot flushes, sweating
tiredness
shortness of breath
liver problems, some of them severe or even fatal, have been reported with dosages of 100 mg and above of cyproterone acetate treatment. Your doctor may arrange for you to have regular liver tests during treatment to monitor this and may stop your treatment if necessary
Uncommon may affect up to 1 in 100 people
rash
Rare may affect up to 1 in 1,000 people
allergic reaction (possibly causing a rash, itching or more rarely shortness of breath. If you have trouble breathing or swallowing, contact your doctor or go to a hospital straight away)
tender lumps in the breasts and oozing of milky fluid from the nipples. These effects usually disappear if treatment is stopped or if the dose of Cyprostat is reduced
meningioma, see also section 2 ‘Warnings and precautions’
Very rare may affect up to 1 in 10,000 people
benign (non-malignant) liver tumours, see also section 2 ‘Warnings and precautions’
some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway
Effects of Cyprostat on sperm
After you have been taking this medicine for some months, you may not have any sperm in your ejaculate. You will probably become unable to make anyone pregnant, but note that this does not happen at once. Do not rely on this medicine for contraception at any time. While the overall number of sperm that you produce will be reduced, more of your sperm than usual will be abnormal in shape. Some people think these abnormal sperm might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children.
Other changes that have been reported include:
After stopping treatment
After stopping treatment, the decrease in sex drive, reduction in sperm count and breast swelling will generally go back to normal.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cyprostat
6. Contents of the pack and other information
What Cyprostat contains
What Cyprostat looks like and contents of the pack
Each pack of Cyprostat 100 mg contains 80 tablets as 8 blister strips of 10 tablets.
The tablets are white and oblong with one side scored and embossed with “LA” on both sides of the score. The other side of the tablet is embossed with a regular hexagon.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
or
This leaflet was last revised in May 2020.
Other formats:
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0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference number
Cyprostat 100 mg 00010/0524
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