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 47848/0035.
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 tablets stop your body from making testosterone; this can slow the growth of prostate cancer.
When Abiraterone tablets are 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 tablets 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 tablets and prednisone or 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 tablets 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 tablets are 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 tablets may increase the effects of a number of medicines including heart medicines, tranquilizers, 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 tablets. This may lead to side effects or to Abiraterone tablets not working as well as they 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.
This medicine must not be taken with food (see section 3, “Taking this medicine”).
Taking Abiraterone tablets with food may cause side effects.
Abiraterone tablets are not for use in women. This medicine may cause harm to the unborn child if it is taken by women who are pregnant.
If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method.
If you are having sex with a pregnant woman, use a condom to protect the unborn child.
Women who are pregnant or who may be pregnant should wear gloves if they need to touch or handle Abiraterone tablets.
This medicine is not likely to affect your being able to drive and use any tools or machines.
This medicinal product contains 23.2 mg sodium (main component of cooking/table salt) per dose of four tablets for 250 mg and 23 mg sodium per dose of two tablets for 500 mg. This is equivalent to 1.2% 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.
If you forget to take Abiraterone tablets or prednisone or prednisolone, take your usual dose the following day.
If you forget to take Abiraterone tablets or prednisone or prednisolone for more than one day, talk to your doctor without delay.
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.
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 heartbeat (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 tablets 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 Store. By reporting side effects you can help provide more information on the safety of this medicine.
Not all pack sizes may be marketed.
This leaflet was last revised in January 2022