Brand name Zytiga

Form tablets

Active substance / Dosage

ABIRATERONE ACETATE

Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription

ATC code

L02BX03

Registration number 041427

Manufacturer JANSSEN-CILAG INTERNATIONAL N.V.

Table of Contents

Package leaflet: Information for the user
ZYTIGA 250 mg tablets
1. What ZYTIGA is and what it is used for
2. What you need to know before taking ZYTIGA
3. How to take ZYTIGA
4. Possible side effects
5. How to store ZYTIGA
6. Package contents and other information
Package leaflet: Information for the user
ZYTIGA 500 mg film-coated tablets
1. What ZYTIGA is and what it is used for
2. What you need to know before taking ZYTIGA
3. How to take ZYTIGA
4. Possible side effects
5. How to store ZYTIGA
6. Package contents and other information

Package leaflet: Information for the user

ZYTIGA 250 mg tablets

abiraterone acetate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet:

What ZYTIGA is and what it is used for
What you need to know before taking ZYTIGA
How to take ZYTIGA
Possible side effects
How to store ZYTIGA
Contents of the pack and other information

1. What ZYTIGA is and what it is used for

ZYTIGA contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men whose cancer has spread to other parts of the body. ZYTIGA stops the body from producing testosterone; this may slow down the growth of prostate cancer.
When ZYTIGA is prescribed at the early stage of the disease that still responds to hormone therapy, it is used in combination with a treatment that lowers testosterone levels (androgen deprivation therapy).
When taking this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine helps reduce the risk of high blood pressure, fluid retention (too much water in the body), or low levels in the blood of a chemical known as potassium.

2. What you need to know before taking ZYTIGA

Do not take ZYTIGA

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

Do not take this medicine if any of these conditions apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

if you have liver problems
if you have been diagnosed with high blood pressure, heart failure, or low blood potassium levels (low potassium levels 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 heartbeat
if you have shortness of breath
if you have gained weight rapidly
if you have swelling in your feet, ankles, or legs
if you have previously taken a medicine called ketoconazole for prostate cancer
about the need to take this medicine together with prednisone or prednisolone
about possible effects on bones
if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorders, including heart rhythm problems (arrhythmias), or if you are taking medicines for these conditions.

Inform your doctor if you develop yellowing of the skin or eyes, dark-colored urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, a liver function problem (called acute liver failure) may occur, which can lead to death.

Possible side effects include reduction in red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain.

ZYTIGA must not be given in combination with Ra-223 due to a possible increased risk of fractures or death.

If you are considering taking Ra-223 after treatment with ZYTIGA and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

ZYTIGA may affect the liver and may not cause symptoms. While taking this medicine, your doctor will periodically perform blood tests to monitor for any effects of ZYTIGA on the liver.

Children and adolescents

This medicine is not indicated for use in children and adolescents. If ZYTIGA is accidentally ingested by a child or adolescent, go to hospital immediately and bring this leaflet to show the emergency doctor.

Other medicines and ZYTIGA

Talk to your doctor or pharmacist before taking any medicine.

Inform 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 those for the heart, tranquilizers, some diabetes medicines, herbal remedies (e.g. St. John's wort), and others. Your doctor may decide to adjust the dose of these medicines. In addition, some medicines may increase or decrease the effects of ZYTIGA, which could lead to side effects or reduced effectiveness.

Androgen deprivation therapy may increase the risk of heart rhythm problems.

Inform your doctor if you are taking medicines:

used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and treatment of opioid dependence), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Inform 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 "How to take this medicine").
Taking ZYTIGA with food may cause adverse effects.

Pregnancy and breastfeeding

ZYTIGA is not indicated for use in women.
This medicine may harm the unborn baby if taken by pregnant women.
Pregnant women or women who may be pregnant must wear gloves if they need to touch or handle ZYTIGA.
If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.
If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn baby.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or operate machinery.

ZYTIGA contains lactose and sodium

ZYTIGA contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains 27.2 mg of sodium (a main component of table salt) in the daily dose of four tablets. This corresponds to 1.36% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to take ZYTIGA

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose is 1,000 mg (four tablets) once daily.

How to take this medicine

Take this medicine by mouth.
Do not take ZYTIGA with food. Taking ZYTIGA with food may result in higher than intended absorption of the medicine into the body, which may cause side effects.
Take ZYTIGA tablets as a single daily dose on an empty stomach. ZYTIGA should be taken at least two hours after a meal and no food should be consumed for at least one hour after taking ZYTIGA. (See section 2 “ZYTIGA with food”.)
Swallow the tablets whole with a glass of water.
Do not break the tablets.
ZYTIGA is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
You must take prednisone or prednisolone every day while taking ZYTIGA.
The dose of prednisone or prednisolone may need to be adjusted in certain emergency situations. Your doctor will inform you if you need to change the dose of prednisone or prednisolone.
Do not stop taking prednisone or prednisolone unless your doctor tells you to do so.

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 ZYTIGA than you should, contact your doctor or go to hospital immediately.

If you forget to take ZYTIGA

If you forget to take ZYTIGA or prednisone or prednisolone, take your usual dose the next day.
If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, speak to your doctor without delay.

If you stop taking ZYTIGA
Do not stop taking ZYTIGA or prednisone or prednisolone unless your doctor tells you to do so.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking ZYTIGA and contact a doctor immediately:

Muscle weakness, muscle spasms, or a sensation of pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
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 function test values, high blood pressure, urinary tract infection, diarrhoea.
Common (may affect up to 1 in 10 people)
High levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation), heart failure, rapid heartbeat, severe infection 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 salt and water imbalances), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect up to 1 in 1,000 people)
Lung inflammation (also known as allergic alveolitis).
Liver function problems (also known as acute liver failure).
Not known (frequency cannot be estimated from the available data)
Heart attack, changes in the ECG (electrocardiogram) – QT interval prolongation, and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or hives.
Loss of bone tissue may occur in men being treated for prostate cancer. ZYTIGA in combination with prednisone or prednisolone may increase bone tissue loss.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZYTIGA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle label. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZYTIGA contains

The active substance is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.
The other excipients are microcrystalline cellulose, sodium croscarmellose, monohydrate lactose; magnesium stearate, povidone (K29/K32), anhydrous colloidal silica, and sodium lauryl sulfate (see section 2, “ZYTIGA contains lactose and sodium”).

Description of the appearance of ZYTIGA and contents of the pack

ZYTIGA tablets are oval-shaped (15.9 mm long x 9.5 mm wide), white to almost white, with “AA250” engraved on one side.
The tablets are supplied in a plastic bottle with a child-resistant closure. Each bottle contains 120 tablets. Each carton contains one bottle.

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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tel/Tél: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel. +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD.
Tlf: +45 45 94 82 82 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: +49 2137 955 955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Janssen-Cilag Pharma GmbH
Tηλ: +30 210 80 90 000 Tel: +43 1 610 300

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.+48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: +353 1 800 709 122 Tel: +386 1 401 18 00
[email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija United Kingdom (Northern Ireland)
UAB "JOHNSON & JOHNSON" filiāle Latvijā Janssen Sciences Ireland UC
Tel: +371 678 93561 Tel: +44 1 494 567 444
[email protected]

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: Information for the user

ZYTIGA 500 mg film-coated tablets

abiraterone acetate
Please read this entire leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ZYTIGA is and what it is used for
What you need to know before taking ZYTIGA
How to take ZYTIGA
Possible side effects
How to store ZYTIGA
Contents of the pack and other information

1. What ZYTIGA is and what it is used for

ZYTIGA contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops the body from producing testosterone; this may slow down the growth of prostate cancer.
When ZYTIGA is prescribed at the early stage of the disease that still responds to hormone therapy, it is used together with a treatment that lowers testosterone levels (androgen deprivation therapy).
When taking this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine helps reduce the risk of high blood pressure, fluid retention (too much fluid in the body), or low levels in the blood of a chemical known as potassium.

2. What you need to know before taking ZYTIGA

Do not take ZYTIGA

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

if you have liver problems
if you have been diagnosed with high blood pressure, heart failure, or low potassium levels in the blood (low 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 heartbeat
if you have shortness of breath
if you have gained weight rapidly
if you have swelling in your feet, ankles, or legs
if you have previously taken a medicine called ketoconazole for prostate cancer
about the need to take this medicine together with prednisone or prednisolone
about possible effects on bones
if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorders, including heart rhythm problems (arrhythmia), or if you are taking medicines for these conditions.
Inform your doctor if you develop yellowing of the skin or eyes, dark-colored urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, impaired liver function (called acute liver failure) may occur, which can be fatal.
Possible side effects include decreased red blood cells, reduced sexual desire (libido), muscle weakness and/or muscle pain.
ZYTIGA must not be administered in combination with Ra-223 due to a possible increased risk of fractures or death.
If you are considering taking Ra-223 after treatment with ZYTIGA and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.
If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

ZYTIGA may affect the liver and may not cause noticeable symptoms. While taking this medicine, your doctor will periodically perform blood tests to monitor for any effects of ZYTIGA on the liver.

Children and adolescents

This medicine is not indicated for use in children and adolescents. If ZYTIGA is accidentally ingested by a child or adolescent, go to hospital immediately and bring the package leaflet to show the emergency doctor.

Other medicines and ZYTIGA

Talk to your doctor or pharmacist before taking any medicine.
Inform 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 medications, tranquilizers, certain diabetes medications, herbal remedies (e.g., St. John’s wort), and others. Your doctor may decide to adjust the dose of these medicines. In addition, some medicines may increase or decrease the effects of ZYTIGA, which could lead to side effects or reduce the effectiveness of ZYTIGA.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking medicines:

used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, sotalol);
known to increase the risk of heart rhythm problems [e.g., methadone (used to relieve pain and treat opioid addiction), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

ZYTIGA and food

This medicine must not be taken with food (see section “How to take this medicine”).
Taking ZYTIGA with food may cause adverse effects.

Pregnancy and breastfeeding

ZYTIGA is not indicated for use in women.

This medicine may harm an unborn baby if taken during pregnancy.
If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.
If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn baby.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or operate tools or machinery.

ZYTIGA contains lactose and sodium

ZYTIGA contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.
This medicine contains 27 mg of sodium (a main component of table salt) in the daily dose of two tablets. This corresponds to 1.35% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to take ZYTIGA

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How much to take
The recommended dose is 1,000 mg (two tablets) once daily.

How to take this medicine

Take this medicine by mouth.
Do not take ZYTIGA with food. Taking ZYTIGA with food may result in higher than intended absorption of the medicine into the body, which may cause side effects.
Take ZYTIGA tablets as a single daily dose on an empty stomach. ZYTIGA should be taken at least two hours after a meal and no food should be consumed for at least one hour after taking ZYTIGA. (See section 2 “ZYTIGA with food”).
Swallow the tablets whole with a glass of water.
Do not break the tablets.
ZYTIGA is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
You must take prednisone or prednisolone every day while you are taking ZYTIGA.
The dose of prednisone or prednisolone may need to be adjusted in certain emergency situations. Your doctor will inform you if you need to change the dose of prednisone or prednisolone. 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 ZYTIGA than you should, contact your doctor or go to a hospital immediately.

If you forget to take ZYTIGA

If you forget to take ZYTIGA or prednisone or prednisolone, take your usual dose the next day.
If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, speak to your doctor without delay.

If you stop taking ZYTIGA
Do not stop taking ZYTIGA or prednisone or prednisolone unless your doctor tells you to.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the side effects listed below, stop taking ZYTIGA and contact a doctor immediately:

Muscle weakness, muscle spasms, or a sensation of pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
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 function test values, high blood pressure, urinary tract infection, diarrhoea.
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, rapid heartbeat, severe infection 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 salt and water imbalances), 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 function problems (also called acute liver failure).
Not known (frequency cannot be estimated from the available data)
Heart attack, changes in ECG (electrocardiogram) – QT interval prolongation, and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or hives.
Loss of bone tissue may occur in men being treated for prostate cancer. ZYTIGA in combination with prednisone or prednisolone may increase bone tissue loss.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZYTIGA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack, carton, and blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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); sodium croscarmellose; hypromellose 2910 (15 mPa.S); monohydrate lactose; magnesium stearate; anhydrous colloidal silica; and sodium lauryl sulfate (see section 2 “ZYTIGA contains lactose and sodium”). The coating contains black iron oxide (E172); red iron oxide (E172); macrogol 3350; polyvinyl alcohol; talc; and titanium dioxide.

Description of the appearance of ZYTIGA and contents of the pack

ZYTIGA tablets are film-coated, oval in shape (20 mm in length x 10 mm in width), purple in colour, with “AA” engraved on one side and “500” on the other side. Each 28-day pack contains 56 film-coated tablets in 4 cardboard boxes, each containing 14 film-coated tablets. Each 30-day pack contains 60 film-coated tablets in 5 cardboard boxes, each containing 12 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 medicinal product, please contact the local representative of the Marketing Authorization Holder: