Abiraterone 500 mg Film-Coated Tablets

• 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.

1. What Abiraterone is and what it is used for
2. What you need to know before you take Abiraterone
3. How to take Abiraterone
4. Possible side effects
5. How to store Abiraterone
6. Contents of the pack and other information

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6)
• if you are a woman, especially if pregnant. This medicine is for use in male patients only
• if you have severe liver damage
• in combination with Ra-223 (which is used to treat prostate cancer).

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:

• if you have liver problems
• if you have been told you have high blood pressure or heart failure or low blood potassium (low blood potassium may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have an irregular or rapid heart rate
• if you have shortness of breath
• if you have gained weight rapidly
• if you have swelling in the feet, ankles, or legs
• if you have taken a medicine known as ketoconazole in the past for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about possible effects on your bones
• if you have high blood sugar.

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 this medicine 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.

This medicine 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 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. 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

• used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

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 this medicine with food may cause side effects.

Abiraterone 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 Abiraterone.

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.

This medicine is not likely to affect your being able to drive and use any tools or machines.

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 24 mg of sodium (main component of cooking/table salt) in each dose of two 500 mg tablets. This is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult.

The recommended dose is 1,000 mg (two tablets of 500 mg) once a day.

Take this medicine by mouth.

Do not take Abiraterone with food. Taking Abiraterone with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.

Take Abiraterone tablets as a single dose once daily on an empty stomach. Abiraterone must be taken at least two hours after eating and food must not be eaten for at least one hour after taking Abiraterone (see section 2, “Abiraterone with food”).

Swallow the tablets whole with water.

Do not break the tablets.

Abiraterone is taken with a medicine called prednisone or prednisolone. Take the prednisone or prednisolone exactly as your doctor has told you.

You need to take prednisone or prednisolone every day while you are taking this medicine.

The amount of prednisone or prednisolone you take may need to change if you have a medical emergency. Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

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.

If you forget to take Abiraterone or prednisone or prednisolone, take your usual dose the following day.

If you forget to take this medicine or prednisone or prednisolone for more than one day, talk to your doctor without delay.

Do not stop taking this medicine or prednisone or prednisolone unless your doctor tells you to.

• muscle weakness, muscle twitches or a pounding heart beat (palpitations). These may be signs that the level of potassium in your blood is low

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)
• 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 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 to provide more information on the safety of this medicine.

Abiraterone Tablets

• The active substance is abiraterone acetate.
• Each film-coated tablet contains 500 mg abiraterone acetate.
• The other ingredients are lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hypromellose, sodium laurilsulfate, silica, colloidal anhydrous and magnesium stearate (tablet core), polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide red (E 172) and iron oxide black (E 172) (tablet coating).

Abiraterone Tablets

Abiraterone 500 mg are oval-shaped purple film-coated tablets, approximately 19 mm long by 11 mm wide and debossed with “A7TN” on one side and “500” on the other side.

Each blister pack contains 56, 56x1, 60 or 60x1 film-coated tablets.

Each bottle pack contains one bottle with 60 film-coated tablets.

Not all pack sizes may be marketed

or