ABIRATERONA 250 mg Tablets

2. What you need to know before you take Abiraterone Accord

Do not take Abiraterone Accord

• 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 you are pregnant. Abiraterone Accord should only be taken by male patients.

• if you have severe liver disease.
• in combination with Ra-223 (which is used for the treatment of prostate cancer).

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before you start taking this medicine:

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

Tell your doctor if you have been told you have any heart or blood vessel disorder, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these disorders.

Tell your doctor if you have yellowing of the skin or eyes, dark urine, or severe nausea or vomiting, as these can be signs or symptoms of liver problems. Rarely, liver failure (called acute hepatic failure) can occur, which can be life-threatening.

A decrease in the number of red blood cells in your blood, reduced sexual desire and cases of muscle weakness and/or muscle pain may occur.

Abiraterone Accord should not be taken in combination with Ra-223 due to a possible increased risk of bone fractures or death.

If you plan to take Ra-223 after treatment with Abiraterone Accord and prednisone or prednisolone, you should wait 5 days before starting treatment with Ra-223.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

This medicine may affect your liver even if you have no symptoms. While you are taking this medicine, your doctor will regularly perform blood tests to check for any effects on your liver.

Children and adolescents

This medicine should not be used in children or adolescents. If a child or adolescent accidentally ingests Abiraterone Accord, they should go to the hospital immediately and bring this leaflet with them to show to the emergency doctor.

Other medicines and Abiraterone Accord

Consult your doctor or pharmacist before taking any other medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because Abiraterone Accord can increase the effects of a number of medicines including heart medicines, sedatives, some diabetes medicines, herbal medicines (e.g. St John's Wort) and others. Your doctor may consider changing the dose of these medicines. Also, some medicines may increase or decrease the effects of Abiraterone Accord. This can lead to side effects or Abiraterone Accord not working as well as it should.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Tell your doctor if you are being treated with medicines

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

Consult your doctor if you are taking any of the medicines listed above.

Abiraterone Accord with food

• This medicine should not be taken with food (see section 3, “How to take this medicine”).
• Taking Abiraterone Accord with food may cause side effects.

Pregnancy and breast-feeding

Abiraterone Accord is not indicated in women.

• This medicine may harm your unborn baby if you take it when you are pregnant.
• Pregnant women or women who think they may be pregnant should wear gloves if they need to touch or handle this medicine.
• If you have sex with a woman who can become pregnant, you should use a condom and another effective method of birth control.
• If you have sex with a pregnant woman, you should use a condom to protect the baby.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use tools or machines.

Abiraterone Accord contains lactose and sodium

• This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
• This medicine contains less than 23 mg of sodium (1 mmol) in a daily dose of four tablets; this is essentially “sodium-free”.

3. How to take Abiraterone Accord

Follow exactly the instructions of your doctor. If you are not sure, consult your doctor or pharmacist.

How much to take

The recommended dose is 1,000 mg (four tablets) once a day.

How to take this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Accord with food.
• Take Abiraterone Accord at least one hour before or at least two hours after taking any food (see section 2, “Abiraterone Accord with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone Accord is given together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor tells you.
• You will need to take prednisone or prednisolone every day while you are taking Abiraterone Accord.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. 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.

You may also be given other medicines while you are taking Abiraterone Accord and prednisone or prednisolone.

If you take more Abiraterone Accord than you should

If you take more than you should, consult your doctor or go to the hospital immediately.

If you forget to take Abiraterone Accord

• If you forget to take Abiraterone Accord or prednisone or prednisolone, take your normal dose the next day.
• If you forget to take Abiraterone Accord or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you stop taking Abiraterone Accord

Do not stop taking Abiraterone Accord or prednisone or prednisolone unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Abiraterone Accord and see a doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions or a fast or irregular heart beat (palpitations).

These may be signs of low potassium levels in your blood.

Other side effects are:

Very common(may affect more than 1 in 10 people):

Fluid retention in your legs or feet, low potassium levels in your blood, increased liver tests, high blood pressure, urinary tract infection, diarrhea.

Common(may affect up to 1 in 10 people):

High levels of fats in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, fast heart beat, severe infections (sepsis), bone fractures, indigestion, blood in your urine, skin rash.

Uncommon(may affect up to 1 in 100 people):

Problems with your adrenal glands (related to problems with salt and water), 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).

Liver failure (called acute hepatic failure).

Not known(frequency cannot be estimated from the available data):

Heart attack, changes in the electrocardiogram (ECG) (prolonged QT), and severe allergic reactions with difficulty swallowing or breathing, face, lips, tongue or throat swelling, or itchy rash.

Bone thinning (loss of bone density) may occur in men taking Abiraterone Accord for prostate cancer. Abiraterone Accord in combination with prednisone or prednisolone may increase this loss of bone density.

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Accord

• 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 on the label of the bottle. The expiry date refers to the last day of that month.
• No special storage conditions are required.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Abiraterone Accord contains

• The active substance is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.

The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone (E1201), sodium lauryl sulfate, colloidal anhydrous silica and magnesium stearate (E572) (see section 2, “Abiraterone Accord contains lactose and sodium”).

Appearance and packaging

• Abiraterone Accord tablets are white or almost white, oval (16 mm long x 9.5 mm wide), engraved with “ATN” on one side and “250” on the other.
• The tablets are packed in a HDPE bottle with a child-resistant polypropylene cap. Each bottle contains 120 tablets. Each carton contains one bottle.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6a Planta,

Barcelona, 08039

Spain

Manufacturer

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

Wessling Hungary Kft

Anonymus u. 6, Budapest,

1045, Hungary

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,

08040 Barcelona, Spain

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice,

Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.