Prospect: information for the user

Abiraterona Accord 500 mg film-coated tablets EFG

abiraterone acetate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

1.What is Abiraterona Accord and for what it is used

2.What you need to know before starting to take Abiraterona Accord

3.How to take Abiraterona Accord

4.Possible adverse effects

5.Storage of Abiraterona Accord

6.Contents of the package and additional information

Abiraterona Accord contains a medication called abiraterone acetate. It is used for the treatment of prostate cancer in adult men whose cancer has spread to other parts of the body.

Abiraterona Accord causes your body to stop producing testosterone; in this way, it can delay the growth of prostate cancer.

When Abiraterona Accord is prescribed in the early stages of the disease and there is still a response to hormonal treatment, it is used in combination with a treatment to reduce testosterone (androgen deprivation therapy).

When you take this medication, your doctor will also prescribe another medication called prednisone or prednisolone, to reduce the possibility of experiencing an increase in blood pressure, accumulating too much fluid in your body (fluid retention) or decreasing the levels of a chemical called potassium in your blood.

Do not take Abiraterona Accord

-if you are allergic to abiraterone acetate or any of the other components of this medicine (listed in section 6).

• if you are a woman, especially if you are pregnant. Abiraterona Accord should only be used in male patients.

-if you have a serious liver disease.

-when combined with Ra-223 (used for the treatment of prostate cancer).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

-if you have liver problems

-if you have been told that you have high blood pressure or heart failure or low levels of potassium in the blood (low levels of potassium in the blood may increase the risk of heart rhythm problems)

-if you have had other heart or blood vessel problems

-if you have a rapid or irregular heartbeat

-if you have difficulty breathing

-if you have gained weight rapidly

-if you have swelling in your feet, ankles, or legs

-if you have taken in the past a medicine called 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 levels of sugar in the blood.

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

Inform your doctor if you have yellowing of the skin or eyes, dark urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, acute liver failure may occur, which can be fatal.

You may experience a decrease in the number of red blood cells in the blood, reduced libido, and cases of muscle weakness and/or muscle pain.

Abiraterona Accord should not be administered 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 after treatment with Abiraterona Accord and prednisone/prednisolone, you should wait 5 days before starting the treatment with Ra-223.

If you are unsure 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 make periodic blood tests to monitor any effect on your liver.

Children and adolescents

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

Other medicines and Abiraterona Accord

Consult your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is important because Abiraterona Accord may increase the effects of a range of medicines including heart medicines, tranquilizers, some diabetes medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medicines. Additionally, some medicines may increase or decrease the effects of Abiraterona Accord, which may lead to side effects or Abiraterona Accord not working as well as it should.

The androgen deprivation treatment may increase the risk of heart rhythm problems. Inform 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), moxifloxacine (an antibiotic), antipsychotics (used for severe mental illnesses)).

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

Abiraterona Accord with food

-This medicine should not be taken with food (see section 3, “How to take this medicine”).

-Taking Abiraterona Accord with food may cause side effects.

Pregnancy and breastfeeding

Abiraterona Accord is not indicated in women.

-This medicine may be harmful to the fetus if a pregnant woman takes it.

-Pregnant women or those who may be pregnant should wear gloves if they need to touch or handle this medicine.

-If you have sex with a fertile woman, you should use a condom and another effective contraceptive method.

-If you have sex with a pregnant woman, you should use a condom to protect the fetus.

Driving and operating machinery

This medicine is unlikely to affect your ability to drive and use tools or machines.

Abiraterona Accord contains lactose and sodium

-This medicine contains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

-This medicine also contains 24 mg of sodium (main component of table salt/for cooking) in each dose of two tablets. This is equivalent to 1.04% of the maximum daily sodium intake for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

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

How to take this medication

-Take this medication orally.

-Do not take Abiraterona Accord with food.

-Take Abiraterona Accord at least one hour before or at least two hours after taking any food (see section 2, “Abiraterona Accord with food”).

-Swallow the tablets whole with water.

-Do not break the tablets.

-Abiraterona Accord is administered with a medication called prednisone or prednisolone. Take prednisone or prednisolone exactly as instructed by your doctor.

-You will need to take prednisone or prednisolone every day while taking Abiraterona Accord.

-If you have a medical emergency, you may need to adjust the amount of prednisone or prednisolone you take. Your doctor will let you know if you need to modify 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 prescribed other medications while taking Abiraterona Accord and prednisone or prednisolone.

Sif you take more Abiraterona 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 Abiraterona Accord

-If you forget to take Abiraterona Accord or prednisone or prednisolone, take the usual dose the next day.

-If you forget to take Abiraterona Accord or prednisone or prednisolone for more than one day, consult your doctor immediately.

if you interrupt treatment with Abiraterona Accord

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Abiraterona Accord and seek medical attention immediately if you experience any of the following side effects:

-Muscle weakness, muscle cramps, or rapid heartbeat (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 the legs or feet, low potassium levels in the blood, elevated liver function test results, high blood pressure, urinary tract infections, diarrhea.

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

High levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation), heart failure, tachycardia, severe infections called sepsis, bone fractures, indigestion, blood in the urine, skin rash.

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

Problems with the adrenal glands (related to issues with salt and water), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000 people):

Pulmonary irritation (also known as allergic alveolitis).

Liver function failure (also known as acute liver failure).

Unknown(the frequency cannot be estimated from available data):

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

This medicine may cause bone density loss in men receiving treatment for prostate cancer. Abiraterona Accord in combination with prednisone or prednisolone may increase this bone density loss.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

-Keep this medication out of the sight and reach of children.

-Do not use this medication after the expiration date that appears on the box, on the carton packaging, and on the blister pack, after CAD. The expiration date is the last day of the month indicated.

-No special storage conditions are required.

-Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. This will help protect the environment.

Composition of Abiraterona Accord

-The active ingredient is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.

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

The film coating contains polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553 b), red iron oxide (E 172), and black iron oxide (E 172).

Appearance of the product and contents of the pack

-Abiraterona Accord tablets are oval-shaped, film-coated, purple-colored, approximately 19 mm in length x 11 mm in width, and engraved with “A 7 TN” on one face and “500” on the other.

-Tablets are presented in perforated PVC/PVdC-aluminum blisters of 56 x 1 and/or 60 x 1 tablets, film-coated, in a cardboard carton.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6aPlanta,

Barcelona, 08039

Spain

Responsible for manufacturing

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

Last date of revision of this leaflet:

Other sources of information

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