ABIRATERONE 250 mg Tabletka

Treść ulotki

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

Abiraterone Accord 250 mg tablets

abiraterone acetate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Abiraterone Accord contains a medicine called abiraterone acetate. It is used for the
treatment of prostate cancer in adult men that has spread to other parts of the body.
Abiraterone Accord stops the production of testosterone by the body; this may slow down the
growth of prostate cancer.
When Abiraterone Accord is prescribed in the early stages of the disease, which still responds to
hormonal therapy, it is used with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe you another medicine called
prednisone or prednisolone. This medicine is used to reduce the possibility of having high blood
pressure, too much water in the body (fluid retention) or reduced levels in the blood of
a chemical substance known as potassium.

2. What you need to know before taking Abiraterone Accord

Do not take Abiraterone Accord

• 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 you are pregnant. The use of Abiraterone Accord is indicated only in men
• if you have severe liver damage
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if you fall into any of these conditions. If you have doubts, ask 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 told you have high blood pressure or heart failure or low potassium levels in your blood (low potassium levels can increase the risk of heart rhythm problems)
• if you have had other problems with your heart or blood vessels
• if you have an irregular or fast heartbeat
• if you are short of breath
• if you have gained weight rapidly
• if you have swelling in your feet, ankles or legs
• if you have taken a medicine called ketoconazole in the past for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about the possible effects on bones
• if you have high blood sugar levels.

Tell your doctor if you have been told you have any heart or blood vessel problems,
including heart rhythm problems (arrhythmia) or if you are being treated with medicines for these problems.
Tell your doctor if you have yellowing of the skin or eyes, dark urine or severe nausea or
vomiting, as these could be signs or symptoms of liver problems. Rarely, a liver problem (called acute hepatic failure) can occur, which
can lead to death.
Decreases in red blood cells, decreased sexual desire (libido),
muscle weakness and/or muscle pain may occur.
Abiraterone Accord should not be administered in combination with Ra-223 due to a possible
increased risk of fractures or death.
If you think you are going to take Ra-223 after treatment with Abiraterone Accord and prednisone/prednisolone,
you should wait 5 days before starting treatment with Ra-223.
If you have doubts about whether any of the points above apply to you, ask your doctor
or pharmacist before taking this medicine.

Blood monitoring
This medicine can affect the liver and you may not have any symptoms. When you take
this medicine, your doctor will periodically perform blood tests to check for any
effects on the liver.

Children and adolescents
This medicine is not indicated in children and adolescents. If Abiraterone Accord is
accidentally swallowed by a child or adolescent, go to hospital immediately and

Other medicines and Abiraterone Accord
Ask your doctor or pharmacist before taking any medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. This is important because Abiraterone Accord can increase the effects
of some medicines including medicines for the heart, tranquillizers, some medicines for diabetes,
medicinal products of herbal origin (for example St John's wort) and others. Your doctor may decide to
change the dose of these medicines. Also, some medicines can increase or decrease the
effects of Abiraterone Accord. This can lead to undesirable effects or Abiraterone Accord
may not work as well as it should.
Androgen deprivation therapy can increase the risk of heart rhythm problems.
Tell your doctor if you are taking medicines:

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

Tell 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 undesirable effects.

Pregnancy and breastfeeding
The use of Abiraterone Accord is not indicated in women.

• This medicine can cause harm to the unborn child if taken by pregnant women.
• Pregnant women or those who may be pregnant should wear glovesif they need to touch or handle this medicine.
• If you have sexual intercourse with a woman of childbearing potential, you should use a condom andanother effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom toprotect the fetus.

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

Abiraterone Accord contains lactose and sodium

• This medicine contains lactose (a type of sugar). If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per daily dose of four tablets, that is to say essentially “sodium-free”.

3. How to take Abiraterone Accord

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

How much to take
The recommended dose is 1000 mg (four tablets) once a day.

Taking 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 a meal(see section 2 “Abiraterone Accord with food”).
• Swallow the tablets whole, with a little water.
• Do not break the tablets.
• Abiraterone Accord is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone following the instructions of your doctor exactly.
• You must take prednisone or prednisolone every day while taking Abiraterone Accord.
• It may be necessary to change the amount of prednisone or prednisolone in emergency cases. Your doctor will inform you if you need to change the amount of prednisone or

prednisolone you are taking. Do not stop taking prednisone or prednisolone unless your
doctor tells you to.
Your doctor may also prescribe 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 Abiraterone Accord than you should, contact 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 the usual dose the next day.
• If you forget to take Abiraterone Accord or prednisone or prednisolone for more than one day, talk to your doctor without waiting too long.

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 doubts about the use of 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 Abiraterone Accord and contact your doctor immediately:

• muscle weakness, muscle spasms or a feeling of a racing 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 in the legs or feet, low potassium levels in the blood, increased values in liver function tests, 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 heartbeats (atrial fibrillation), heart failure, fast heartbeat, serious infection called sepsis, bone fractures, indigestion, blood in urine, 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)
Lung irritation (also called allergic alveolitis).
Liver function problems (also called acute hepatic failure).

Not known(frequency cannot be estimated from the available data)
Heart attack, changes in the ECG – electrocardiogram (prolongation of the QT interval), and serious allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Bone loss may occur in men treated for prostate cancer. Abiraterone Accord in combination with prednisone or prednisolone may increase bone loss.

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 through 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 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 box and on the label of the bottle. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not dispose of any medicine in waste water 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 Abiraterone Accord contains

• The active ingredient is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.
• The other excipients are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone (E1201), sodium lauryl sulfate, anhydrous colloidal silica and magnesium stearate (E572) (see section 2 “Abiraterone Accord contains lactose and sodium”).

Description of the appearance of Abiraterone Accord and package contents

• Abiraterone Accord tablets have an oval shape, are approximately 16 mm in length x 9.5 mm in width, are white to off-white in color, with “ATN” imprinted on one side and “250” on the other.
• The tablets are supplied in a high-density polyethylene bottle with a child-resistant polypropylene closure. Each bottle contains 120 tablets. Each box contains one bottle.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6 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, Barcellona,
08040 Barcellona, 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL
/ NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Pharmaceutical S.A.
Tel: : +30 210 7488 821

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

Abiraterone Accord 500 mg film-coated tablets

abiraterone acetate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Abiraterone Accord contains a medicine called abiraterone acetate. It is used for the
treatment of prostate cancer in adult men that has spread to other parts of the body.
Abiraterone Accord stops the production of testosterone by the body; this may slow down the
growth of prostate cancer.
When Abiraterone Accord is prescribed in the early stages of the disease, which still responds to
hormonal therapy, it is used with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe you another medicine called
prednisone or prednisolone. This medicine serves to reduce the possibility of having high blood
pressure, too much water in the body (fluid retention), or reduced levels in the blood of
a chemical substance known as potassium.

2. What you need to know before taking 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. The use of Abiraterone Accord is only indicated in men
• if you have severe liver damage
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of these conditions apply to you. If you have any doubts, ask 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 told you have high blood pressure or heart failure or low potassium levels in your blood (low potassium levels can increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have an irregular or fast heartbeat
• if you are short of breath
• if you have rapidly gained weight
• if you have swelling of your feet, ankles or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about the possible effects on bones
• if you have high levels of sugar in your blood.

Tell your doctor if you have been told you have any heart or blood vessel problems,
including heart rhythm problems (arrhythmia) or if you are being treated with medicines for these problems.
Tell your doctor if you have yellowing of the skin or eyes, dark-colored urine, or severe nausea or
vomiting, as these could be signs or symptoms of liver problems. Rarely, a liver problem (called acute hepatic failure) can
occur, which can lead to death.
Decreases in red blood cells, decreased sexual desire (libido),
muscle weakness and/or muscle pain may occur.
Abiraterone Accord should not be given in combination with Ra-223 due to a possible
increased risk of fractures or death.
If you think you are going to take Ra-223 after treatment with Abiraterone Accord and prednisone/prednisolone,
you should wait 5 days before starting treatment with Ra-223.
If you have any doubts about whether any of the above points apply to you, ask your doctor
or pharmacist before taking this medicine.

Blood monitoring
This medicine can affect the liver and you may not have any symptoms. While taking
this medicine, your doctor will periodically perform blood tests to check for any
effects on the liver.

Children and adolescents
This medicine is not indicated in children and adolescents. If Abiraterone Accord is
accidentally swallowed by a child or adolescent, go to hospital immediately.

Other medicines and Abiraterone Accord
Ask your doctor or pharmacist before taking any medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. This is important because Abiraterone Accord can increase the effects of
some medicines, including medicines for the heart, sedatives, some medicines for diabetes,
medicinal products of herbal origin (e.g. St John's wort) and others. Your doctor may decide to
change the dose of these medicines. Also, some medicines can increase or decrease the
effects of Abiraterone Accord. This can lead to undesirable effects or Abiraterone Accord
may not work as well as it should.
Androgen deprivation therapy can increase the risk of heart rhythm problems.
Tell your doctor if you are taking medicines:

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

Tell 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 undesirable effects.

Pregnancy and breastfeeding
The use of Abiraterone Accord is not indicated in women.

• This medicine can cause harm to the fetus if taken by a pregnant woman.
• Pregnant women or women of childbearing potential must wear gloves before touching orhandling this medicine.
• If you have sexual intercourse with a woman of childbearing potential, you must use a condom andanother effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom toprotect the fetus.

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

Abiraterone Accordcontains lactose and sodium

• This medicine contains lactose (a type of sugar). If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.
• This medicine contains 24 mg of sodium (the main component of table salt) per daily dose of two tablets. This is equivalent to 1.04% of the recommended maximum daily intake of sodium for an adult.

3. How to take Abiraterone Accord

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How much to take
The recommended dose is 1000 mg (two tablets) once a day.

Taking 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 a meal(see section 2 “Abiraterone Accord with food”).
• Swallow the tablets whole, with a little water.
• Do not break the tablets.
• Abiraterone Accord is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone following exactly the instructions of your doctor.
• You must take prednisone or prednisolone every day while taking Abiraterone Accord.
• It may be necessary to change the amount of prednisone or prednisolone in emergency situations. Your doctor will inform you if you need to change the amount of prednisone or of

prednisolone you are taking. Do not stop taking prednisone or prednisolone unless your
doctor tells you to.
Your doctor may also prescribe 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 Abiraterone Accord than you should, contact your doctor or go to hospital
immediately.

If you forget to take Abiraterone Accord

• If you forget to take Abiraterone Accord or prednisone or prednisolone, take the usual dose the next day.
• If you forget to take Abiraterone Accord or prednisone or prednisolone for more than one day, talk to your doctor without waiting too long.

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 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 Abiraterone Accord and contact your doctor immediately:

• muscle weakness, muscle spasms or a feeling of a racing 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 in the legs or feet, low levels of potassium in the blood, increased values in liver function tests, 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 heartbeats (atrial fibrillation), heart failure, fast heartbeat, severe infection called sepsis, bone fractures, indigestion, blood in your urine, 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 1000 people)
Lung irritation (also called allergic alveolitis).
Liver function problems (also called acute liver failure).

Not known(frequency cannot be estimated from available data)
Heart attack, changes in the ECG – electrocardiogram (prolongation of the QT interval), and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Bone loss may occur in men treated for prostate cancer. Abiraterone Accord in combination with prednisone or prednisolone may increase bone loss.

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 through 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 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 box and blister after “Exp.”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine in waste water 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 Abiraterone Accord Contains

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other excipients are lactose monohydrate; microcrystalline cellulose (E460); sodium croscarmellose (E468); hypromellose; sodium lauryl sulfate; anhydrous colloidal silica and magnesium stearate (E572) (see section 2 “Abiraterone Accord contains lactose and sodium”). The coating contains polyvinyl alcohol; titanium dioxide; macrogol; talc; black iron oxide (E 172) and red iron oxide (E 172).

Description of the Appearance of Abiraterone Accord and Package Contents

• Abiraterone Accord film-coated tablets are oval in shape, approximately 19 mm in length x 11 mm in width, violet in color, with “A 7 TN” imprinted on one side and “500” on the other side.
• Divisible blister packs for unit doses in PVC/PVdC-aluminum containing 56, 60 and 112 film-coated tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6 Planta,
Barcelona, 08039
Spain

Manufacturers
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, Barcellona,
08040 Barcellona, 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
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL
/ NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Pharmaceutical S.A.
Tel: : +30 210 7488 821

Other Sources of Information
More detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu .