Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- 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
- 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 any type of cancer (except for cancer of the prostate gland)
- If you have ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your doctor if you are in doubt
- If you have wasting diseases (diseases involving an unintended loss of weight or muscle) except for prostate cancer that cannot be operated on
- If you have blood clots (thrombosis or embolism)
- If you are allergicto 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 before taking Cyprostat
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 Cyprostat has very rarely been linked to the development of benign (non-malignant) liver tumoursand 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
- blood clotshave been reported in patients taking this medicine which may also be linked to the reason you are taking Cyprostat. 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 Cyprostat. (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.
- shortness of breathhas been reported in patients taking this medicine at high doses (300 mg daily),
- Cyprostat 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
- Your doctor will check the function of your adrenal glands, as they may become suppressed during treatment with Cyprostat. 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 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:
- 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)
- medicines such as ketoconazole, itraconazole, clotrimazole for the treatment of fungal conditions
- medicines such as ritonavir used to treat HIV infections
- cholesterol-lowering drugs such as statins. Cyprostat 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 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.
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