Patient leaflet - Cyproterone Acetate 50 mg tablets
1. What Cyproterone Tablets are and what they are used for What is Cyproterone Tablets
Cyproterone tablets are a medicine containing cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (andogens) and reduces the amount of male sex hormones produced by the body.
What is Cyproterone Tablets used for?
Cyproterone tablets are 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 Cyproterone Tablets
Do not take Cyproterone Tablets:
- If you have liver diseases (including previous or existing liver tumours (unless these are due to secondary cancers caused by prostate cancer), Dubin-Johnson Syndrome or Rotor Syndrome)
- if you have ever been diagnosed with meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your physician if you are in doubt.
- if you have any type of cancer (except for cancer of the prostate cancer)
if you have wasting disease (diseases involving an unintended loss of weight or muscle)
except for prostate cancer that cannot be operated on.
if you have a blood clots (thrombosis or embolism)
or:
if you are allergic to cyproterone acetate or any of the other ingredients of this medicine
(listed in section 6)
- If you are under 18 years old or if your testes or bones are not yet fully formed.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Cyproterone Tablets
Several blood tests or checks may be required while you are taking this medicine:
liver problems, some of them severe or even fatal, have been reported with cyproterone acetate treatment. Your doctor may arrange for you to have regular liver tests before and during treatment to monitor this and may stop your treatment if necessary. See also section
4.
- using medicines such as Cyproterone Tablets has very rarely been linked to the development of benign (non-malignant) liver tumours and with 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 straight away
- Use of cyproterone acetate has been linked to the development of a generally benign brain tumour (meningioma). The risk increases especially when you use it for longer duration (several years) or for a shorter duration with high doses (25 mg per day and above). If you are diagnosed with meningioma, your doctor will stop your treatment with cyproterone acetate (see section ‘Do not take Cyproterone Tablets’). If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your doctor straightaway.
blood clots have been reported in patients taking this medicine which may also be linked to the reason you are taking Cyproterone Tablets. Tell your doctor if any of the following apply to you, as you may be at an increased risk of getting a blood clot. If you have:
- a history of blood clots, strokes or heart attacks
- abnormal red blood cells (sickle–cell anaemia)
- severe diabetes that affects your blood circulation
if you suffer from severe depression, this may get worse whilst you are taking
Cyproterone Tablets. (See your doctor if you are affected by this)
- effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine. See also section 4.
- Cyproterone Tablets can alter the sugar levels in your blood. If you are diabetic, check your blood sugar levels regularly. Your doctor may alter the dose of medicine used to treat your diabetes.
- shortness of breath has been reported in patients taking this medicine at high doses (300mg daily)
- Your doctor will check the function of your adrenal glands, as they may become suppressed during treatment with Cyproterone Tablets. Symptoms may include tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles, abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea.
Other medicines and Cyproterone Tablets
Tell your doctor if you are taking, have recently taken or might take any other medications.
Some medicines may stop Cyproterone Tablets from working properly. Also Cyproterone Tablets 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:
- medicines such as Ketroconazole, intraconazole, clotimazole for the treatment of fungal conditions
- medicines such as Ritonavir used to treat HIV infections
- medicines such as Rifampicin for the treatment of tuberculosis
- medicines such as Phenytoin used to treat epilepsy or other illnesses.
- products containing the herbal remedy commonly known as St. John's wort (Hypericum perforatum)
- cholesterol-lowering drugs such as Statins. Cyproterone Tablets may make the side effects of statins worse, for example the breakdown of muscle.
- medicines such as glitazones used to treat diabetes.
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 Cyproterone Tablets
Cyproterone Tablets 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 Cyproterone Tablets
Your doctor will decide what dose you will take. Always take Cyproterone Tablets exactly as your doctor has told you. You should 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 (50 mg) up to 2 tablets three times a day (300 mg).
If you take more Cyproterone Tablets 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 Cyproterone Tablets in a single dose.
If you forget to take Cyproterone Tablets:
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 Cyproterone Tablets
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 Cyproterone Tablets, 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 Cyproterone Tablets 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 Cyproterone Tablets on sperm
After you have been taking this medicine for some months, you may not have any sperm in your ejaculate. You will probably be 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:
- blood clots have been reported in patients taking this medicine but they have not definitely been linked to Cyproterone Tablets. See also section 2 ‘Warnings and precautions’
- the occurrence of meningiomas (a generally benign tumour of the tissue layer between the brain and the skull) has been reported in association with longer term use (years) of Cyproterone Tablets at doses of 25 mg per day and above
- dry skin and improvement in acne
- temporary patchy loss of body hair, a reduction in hair growth on the body, an increased growth of hair on the head, lightening of hair colour, a female type of pubic hair growth
- effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine. Your doctor may arrange for you to have regular blood tests during treatment to monitor this
- thinning of the bones (osteoporosis)
- tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles (often muscle weakness), abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea (suppressed adrenal glands).
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, pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.
Website: http://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 CYPROTERONE TABLETS Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package or container.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice they are discoloured (they should be white).
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Cyproterone Tablets contain
The active substance in the Cyproterone Tablets is cyproterone acetate. Each tablet contains 50 mg or 100 mg of cyproterone acetate
The other ingredients are lactose, maize starch, povidone, colloidal silicon dioxide and magnesium stearate.
What Cyproterone Tablets look like and contents of the pack
Cyproterone acetate 50mg tablets are round white tablets marked CPA, breakline and 50 on one face and CP on the reverse.
Cyproterone acetate 100mg tablets are round white tablets marked CPA, breakline and 100 on one face and CP on the reverse.
Cyproterone acetate 50mg tablets are available in blister packs of PVC film and aluminium foil containing 14, 56 or 168 tablets.
Cyproterone acetate 100mg tablets are available in blister packs of PVC film and aluminium foil containing 21, 84 and 252 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Austin McNeil Ltd., 772 Fulham Road, London, SW6 5SJ, United Kingdom.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.