Label: Information for the User

ZYTIGA 500 mg Film-Coated Tablets

Abiraterone Acetate

Read this label carefully before you start taking this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

ZYTIGA contains a medicine 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. ZYTIGA causes your body to stop producing testosterone; this can slow down the growth of prostate cancer.

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

When you take this medicine, your doctor will also prescribe another medicine 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 ZYTIGA

• if you are allergic to abiraterone acetate or any of the other ingredients of this medication (listed in section 6).
• if you are a woman, especially if you are pregnant. ZYTIGA should only be used in male patients.
• if you have a serious liver disease.
• in combination with Ra-223 (used for the treatment of prostate cancer).

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

Warnings and precautions

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

• if you have liver problems
• if you have been told 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 fast or irregular heart rhythm
• if you have difficulty breathing
• if you have rapidly gained weight
• if you have swelling in your feet, ankles, or legs
• if you have taken in the past a medication known as ketoconazole for prostate cancer
• about the need to take this medication with prednisone or prednisolone
• about possible adverse effects on your bones
• if you have high levels of sugar in the blood.

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

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.

ZYTIGA should not be administered in combination with Ra-223 due to a possible increased risk of bone fracture or death.

If you plan to take Ra-223 after treatment with ZYTIGA 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 medication.

Blood tests

ZYTIGA may affect your liver even if you have no symptoms. While taking this medication, your doctor will perform blood tests periodically to monitor any effects on your liver.

Children and adolescents

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

Other medications and ZYTIGA

Consult your doctor or pharmacist before taking any medication.

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

The androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are being treated with medications

• 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 with your doctor if you are taking any of the medications listed above.

ZYTIGA with food

• This medication should not be taken with food (see section 3, “How to take this medication”).
• Taking ZYTIGA with food may cause adverse effects.

Pregnancy and breastfeeding

ZYTIGA is not indicated in women.

• This medication may be harmful to the fetus if a pregnant woman takes it.
• If you have sexual intercourse with a fertile woman, you must use a condom and another effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, you must use a condom to protect the fetus.

Driving and operating machinery

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

ZYTIGA contains lactose and sodium

• ZYTIGA contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.
• This medication contains 27 mg of sodium (main component of table salt/for cooking) in each dose of two tablets. This is equivalent to 1.35% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 ZYTIGA with food. Taking Zytiga with food may cause the body to absorb more medication than necessary, which may lead to side effects.
• Take the ZYTIGA tablets as a single dose once a day with an empty stomach. ZYTIGA should be taken at least two hours after eating and no food should be consumed at least one hour after taking ZYTIGA. (see section 2, “ZYTIGA with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• ZYTIGA 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 ZYTIGA.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. Your doctor will inform you 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.

Your doctor may also prescribe other medications while you are taking ZYTIGA and prednisone or prednisolone.

If you take more ZYTIGA than you should

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

If you forget to take ZYTIGA

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

If you interrupt treatment with ZYTIGA

Do not stop taking ZYTIGA 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 ZYTIGA and see your doctor immediately if you experience any of the following side effects:

• Muscle weakness, muscle cramps, or rapid heartbeat (palpitations).

They 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).

Failure of liver function (also known as acute hepatic insufficiency).

Unknown 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. ZYTIGA 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 the national reporting system included in Appendix V. By reporting side effects, you can contribute to providing more information about 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. 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 containers and medication that you no longer need. This will help protect the environment.

Composition of ZYTIGA

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are microcrystalline cellulose (silicified), sodium croscarmellose, hypromellose 2910 (15 mPa.s), lactose monohydrate, magnesium stearate, anhydrous colloidal silica, and sodium lauryl sulfate (see section 2. “ZYTIGA contains lactose and sodium”). The film coating contains iron oxide black (E172), iron oxide red (E172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide.

Appearance of the product and contents of the pack

• ZYTIGA tablets are purple, oval-shaped, film-coated (20 mm in length by 10 mm in width), with “AA” engraved on one face and “500” on the other face.
• Each 28-day pack contains 56 film-coated tablets in 4 cardboard cartons with 14 film-coated tablets in each.
• Each 30-day pack contains 60 film-coated tablets in 5 cardboard cartons with 12 film-coated tablets in each.
• Only some pack sizes may be marketed.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Janssen-Cilag SpA

Via C. Janssen

Borgo San Michele

I-04100 Latina, Italy

For further information about this medicinal product, please contact the local representative of the marketing authorization holder.:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/,and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).