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: PL 31750/0198.
Abiraterone 500 mg film-coated tablets
Abiraterone 500 mg film-coated tablets
1. What Abiraterone Tablets are and what they are used for
2. What you need to know before you take Abiraterone Tablets
3. How to take Abiraterone Tablets
4. Possible side effects
5. How to store Abiraterone Tablets
6. Contents of the pack and other information
Abiraterone Tablets contain 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 acetate stops your body from making testosterone; this can slow the growth of prostate cancer.
When abiraterone acetate 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 acetate 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 acetate 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 acetate 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 this medicine 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 this medicine 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 acetate. This may lead to side effects or to Abiraterone acetate 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 acetate is not for use in women.
Women who are pregnant or who may be pregnant should wear gloves if they need to touch or handle this medicine.
This medicine is not likely to affect your being able to drive and use any tools or machines.
Abiraterone Tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 27 mg of sodium (main component of cooking/table salt) in each dose of two tablets. This is equivalent to 1.35% of the recommended maximum daily dietary intake of sodium for an adult.
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 Tablets 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 Tablets 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.
These may be signs that the level of potassium in your blood is low.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Bone loss may occur in men treated for prostate cancer. Abiraterone acetate 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 the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Stor By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, and the blister after ‘EXP’. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 to protect the environment.
Purple, oval-shaped, biconvex film-coated tablets (20 mm long by 10 mm wide), debossed with “S500” on one side and plain on the other side.
Abiraterone Tablets are available in blister packs.
Pack size: outer carton containing 56 film-coated tablets.
This leaflet was last revised in 02/2022