ZYTIGA 500 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ZYTIGA 500 mg film-coated tablets

abiraterone acetate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack

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

1. What ZYTIGA is and what it is used for

ZYTIGA contains the active substance abiraterone acetate. It is used for the treatment of prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops your body from making testosterone; this can slow down the growth of your prostate cancer.

When ZYTIGA is prescribed in the early stages of the disease and you are still responding to hormone treatment, it is used together with treatment to lower testosterone levels (androgen deprivation therapy).

When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone to reduce the risk of high blood pressure, fluid retention, or low potassium levels in your blood.

2. What you need to know before you take ZYTIGA

Do not take ZYTIGA

• 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. ZYTIGA is for use in male patients only.
• if you have severe liver problems.
• in combination 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 not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with this medicine:

• if you have liver problems.
• if you have been told you have high blood pressure, heart failure, or low potassium levels in your blood (low potassium levels in your blood may 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 rhythm.
• 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 ketoconazole in the past 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 of liver problems. Rarely, liver failure (acute hepatic failure) can occur, which can be life-threatening.

A decrease in red blood cell count, reduced sexual desire, and cases of muscle weakness and/or muscle pain may occur.

ZYTIGA must not be taken with Ra-223 due to a possible increased risk of bone fractures or death.

If you plan to take Ra-223 after treatment with ZYTIGA and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

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

Blood tests

ZYTIGA may affect your liver even if you do not have any 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 must not be used in children or adolescents. If a child or adolescent accidentally takes ZYTIGA, they should go to the hospital immediately and bring this leaflet with them to show the emergency doctor.

Other medicines and ZYTIGA

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 ZYTIGA may increase the effects of certain 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 ZYTIGA. This may lead to side effects or ZYTIGA may not work 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.

ZYTIGA with food

• This medicine must not be taken with food (see section 3, "How to take this medicine").
• Taking ZYTIGA with food may cause side effects.

Pregnancy and breastfeeding

ZYTIGA is not indicated in women.

• This medicine may harm the fetus if taken by a pregnant woman.
• If you have sex with a woman of childbearing age, you must use a condom and another effective method of birth control.
• If you have sex with a pregnant woman, you must use a condom to protect the fetus.

Driving and using machines

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

ZYTIGA contains lactose and sodium

• ZYTIGA contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
• This medicine contains 27 mg of sodium (a major component of cooking/table salt) per dose of two tablets. This is approximately 1.35% of the maximum recommended daily intake of sodium for an adult.

3. How to take ZYTIGA

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, 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 medicine

• Take this medicine by mouth.
• Do not take ZYTIGA with food. Taking Zytiga with food may cause your body to absorb more medicine than necessary, which may cause side effects.
• Take the ZYTIGA tablets as a single dose once a day on an empty stomach. ZYTIGA should be taken at least 2 hours after eating and no food should be eaten for at least 1 hour after taking ZYTIGA (see section 2, "ZYTIGA with food").
• Swallow the tablets whole with water.
• Do not break the tablets.
• ZYTIGA 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 ZYTIGA.
• 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.

Your doctor may also prescribe other medicines 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 your normal 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 stop taking ZYTIGA

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

• Muscle weakness, muscle contractions, or rapid heart rate (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, increased liver enzymes, high blood pressure, urinary tract infection, diarrhea.

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

High levels of fats in the blood, chest pain, irregular heart rhythm (atrial fibrillation), heart failure, fast heart rate, severe infections (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 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 inflammation (also called allergic alveolitis).

Liver failure (also called acute hepatic failure).

Frequency not known(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 density loss may occur in men receiving treatment for prostate cancer. ZYTIGA in combination with prednisone or prednisolone may increase this bone density loss.

Reporting of side effects

If you experience 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 ZYTIGA

• 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, blister, and tablet container. The expiry date is the last day of the month stated.
• 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 protect the environment.

6. Contents of the pack and other information

What ZYTIGA contains

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are microcrystalline cellulose (silicified), croscarmellose sodium, hypromellose 2910 (15 mPa.s), lactose monohydrate, magnesium stearate, colloidal anhydrous 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 and packaging

• ZYTIGA tablets are purple, oval, film-coated (20 mm long by 10 mm wide), with "AA" engraved on one face and "500" on the other face.
• Each 28-day pack contains 56 film-coated tablets in 4 cartons with 14 film-coated tablets each.
• Each 30-day pack contains 60 film-coated tablets in 5 cartons with 12 film-coated tablets each.
• Not all pack sizes may be marketed.

Marketing authorisation holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen-Cilag SpA

Via C. Janssen

Borgo San Michele

I-04100 Latina, Italy

For further information on this medicine, contact the local representative of the marketing authorisation holder:

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/, and on the Spanish Agency of Medicines and Health Products (AEMPS) web site (http://www.aemps.gob.es/).