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: PLGB 53835/0015.
Abiraterone 500 mg film-coated tablets
Abiraterone 500 mg film-coated tablets
1. What Abiraterone 500 mg film-coated tablets are and what it is used for
2. What you need to know before you take Abiraterone 500 mg film-coated tablets
3. How to take Abiraterone 500 mg film-coated tablets
4. Possible side effects
5. How to store Abiraterone 500 mg film-coated tablets
6. Contents of the pack and other information
Abiraterone 500 mg film-coated tablets contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. Abiraterone stops your body from making testosterone; this can slow the growth of prostate cancer.
When abiraterone is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy).
When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Talk to your doctor or pharmacist before taking this medicine:
Tell your doctor if you have been told you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.
Tell your doctor if you have yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death.
Decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.
Abiraterone must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death. If you plan to take Ra-223 following treatment with abiraterone and prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Abiraterone may affect your liver, and you may not have any symptoms. When you are taking this medicine, your doctor will check your blood periodically to look for any effects on your liver.
This medicine is not for use in children and adolescents. If abiraterone is accidentally ingested by a child or adolescent, go to the hospital immediately and take the package leaflet with you to show to the emergency doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because abiraterone may increase the effects of a number of medicines including heart medicines, tranquilisers, some medicines for diabetes, herbal medicines (e.g., St John’s wort) and others. Your doctor may want to change the dose of these medicines. Also some medicines may increase or decrease the effects of abiraterone. This may lead to side effects or to abiraterone not working as well as it should.
Androgen deprivation treatment may increase the risk of heart rhythm problems. Tell your doctor if you are receiving medicine
Tell your doctor if you are taking any of the medicines listed above.
Abiraterone 500 mg film-coated tablets are not for use in women.
This medicine is not likely to affect your being able to drive and use any tools or machines.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1,000 mg (two tablets) once a day.
Your doctor may also prescribe other medicines while you are taking abiraterone and prednisone or prednisolone.
If you take more than you should, talk to your doctor or go to a hospital immediately.
Do not stop taking abiraterone or prednisone or prednisolone unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
Fluid in your legs or feet, low blood potassium, liver function test increases, high blood pressure, urinary tract infection, diarrhoea.
Common (may affect up to 1 in 10 people):
High fat levels in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, rapid heart rate, severe infections called sepsis, bone fractures, indigestion, blood in urine, rash.
Uncommon (may affect up to 1 in 100 people):
Adrenal gland problems (related to salt and water problems), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect up to 1 in 1,000 people):
Lung irritation (also called allergic alveolitis). Failure of the liver to function (also called acute liver failure).
Not known (frequency cannot be estimated from the available data):
Heart attack, changes in ECG - electrocardiogram (QT prolongation), and serious allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue or throat, or an itchy rash.
Bone loss may occur in men treated for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase bone loss.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Each 28 day carton contains 56 film-coated tablets in 4 blisters of 14 film-coated tablets each.
Each 30 day carton contains 60 film-coated tablets in 5 blisters of 12 film-coated tablets each.
This leaflet was last revised in November 2021.