Abiraterone Accord

Italy
Brand name Abiraterone Accord
Form tablets
Active substance / Dosage
ABIRATERONE
Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription
ATC code
L02BX03
Registration number 049479
Manufacturer ACCORD HEALTHCARE, S.L.U.
Abiraterone Accord tablets

Table of Contents

Patient Information Leaflet: Information for the User

Abiraterone Accord 250 mg Tablets

abiraterone acetate
Read 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 you, because it could be harmful.
  • If you experience any side effects, including 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 taking 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 Abiraterone Accord is 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 whose cancer has spread to other parts of the body.
Abiraterone Accord stops the body from producing testosterone; this may slow down the growth of prostate cancer.
When Abiraterone Accord 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 water in the body), or low 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 pregnant. The use of Abiraterone Accord is intended only for 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 the above apply to you. If you have any doubts, 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 levels may increase the risk of heart rhythm problems)
  • if you have had other heart or blood vessel problems
  • if you have 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 disorder, including heart rhythm problems (arrhythmia), or if you are being treated with 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 decreased red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain.
Abiraterone Accord 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 Abiraterone Accord and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.
If you have any doubts whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.
Blood monitoring
This medicine may affect your liver, and you may not experience 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 intended for use in children and adolescents. If Abiraterone Accord 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 Abiraterone Accord
Ask 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 Abiraterone Accord may increase the effects of certain medicines, including medicines for the heart, tranquilizers, some medicines for diabetes, 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 Abiraterone Accord. This could lead to unwanted side effects or Abiraterone Accord may not work as effectively.
Androgen deprivation therapy may increase the risk of heart rhythm problems.
Inform 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 treatment of opioid addiction), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Inform your doctor if you are taking any of the medicines listed above.
Abiraterone Accord with food

  • This medicine must not be taken with food (see section 3 “How to take this medicine”).
  • Taking Abiraterone Accord with food may cause unwanted effects.

Pregnancy and breastfeeding
The use of Abiraterone Accord is not indicated 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 this medicine.
  • 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.
Abiraterone Accord contains lactose and sodium

  • This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
  • This medicine contains less than 1 mmol (23 mg) of sodium in the daily dose of four tablets, i.e. essentially “sodium-free”.

3. How to take Abiraterone Accord

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.
How much to take
The recommended dose is 1000 mg (four tablets) once daily.
How to take 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 some water.

  • Do not break the tablets.

  • Abiraterone Accord is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor has instructed.

  • You must take prednisone or prednisolone every day while you are taking Abiraterone Accord.

  • 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 you are taking.

  • 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 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 your usual dose the next day.

  • If you forget to take Abiraterone Accord or prednisone or prednisolone for more than one day, speak to your doctor without delay.

If you stop treatment with Abiraterone Accord
Do not stop taking Abiraterone Accord or prednisone or prednisolone unless your doctor tells you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the side effects listed below, stop taking Abiraterone Accord 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 irritation (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 ECG (electrocardiogram) (QT interval prolongation), and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Loss of bone tissue may occur in men being treated for prostate cancer. Abiraterone Accord 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 detailed 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 stated on the carton and on the label of the bottle. 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 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 Abiraterone Accord contains

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

Description of the appearance of Abiraterone Accord and contents of the pack

  • Abiraterone Accord tablets are oval-shaped, approximately 16 mm in length x 9.5 mm in width, white to off-white in colour, with "ATN" engraved on one side and "250" on the other.
  • The tablets are supplied in a high-density polyethylene bottle with a polypropylene child-resistant closure. Each bottle contains 120 tablets. Each carton contains one bottle.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6th Floor,
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
The Netherlands
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
For further information on this medicinal product, please 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 / LU / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A.E.
Tel: +30 210 7488 821
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Patient Information Leaflet: Information for the user

Abiraterone Accord 500 mg film-coated tablets

abiraterone acetate
Please read this entire leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 Abiraterone Accord is 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 whose cancer has spread to other parts of the body.
Abiraterone Accord stops the body from producing testosterone; this may slow the growth of prostate cancer.
When Abiraterone Accord is prescribed at the initial stage of the disease, which still responds to hormone therapy, it is used in combination with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine helps reduce the risk of developing high blood pressure, excess fluid in the body (fluid retention), or low 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 pregnant. Abiraterone Accord 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 you fall into any of these categories. If you have any doubts, 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 irregular or rapid heartbeat
  • if you experience shortness of breath
  • if you gain 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 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 disorder, 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 could 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.

Abiraterone Accord 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 Abiraterone Accord and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

If you have any doubts about whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

This medicine may affect the liver, and you may not experience 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 for use in children and adolescents. If Abiraterone Accord 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 Abiraterone Accord

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 Abiraterone Accord may increase the effects of certain medicines, including those for heart conditions, 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 Abiraterone Accord. This could lead to unwanted side effects or Abiraterone Accord may not work as effectively.

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 dependence), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

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

Abiraterone Accord and food

  • This medicine must not be taken with food (see section 3 “How to take this medicine”).
  • Taking Abiraterone Accord with food may cause adverse effects.

Pregnancy and breastfeeding

Abiraterone Accord is not indicated for use in women.

  • This medicine may harm the unborn baby if taken during pregnancy.
  • Pregnant women or women of childbearing potential must wear gloves before touching or handling this medicine.
  • If you have sexual intercourse with a woman of childbearing potential, 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 use tools or machines.

Abiraterone Accord contains lactose and sodium

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

3. How to take Abiraterone Accord

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
How much to take
The recommended dose is 1000 mg (two tablets) once daily.
How to take 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 some water.
  • Do not break the tablets.
  • Abiraterone Accord is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor has instructed.
  • You must take prednisone or prednisolone every day while taking Abiraterone Accord.
  • The dose of prednisone or prednisolone may need to be adjusted in 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 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 your usual dose the next day.
  • If you forget to take Abiraterone Accord or prednisone or prednisolone for more than one day, speak to your doctor without delay.

If you stop taking Abiraterone Accord
Do not stop taking Abiraterone Accord or prednisone or prednisolone unless your doctor tells you to do so.
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 everyone experiences them.
If you notice any of the following side effects, stop taking Abiraterone Accord and contact a doctor immediately:

  • Muscle weakness, muscle spasms, or a pounding sensation in the chest (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)
Elevated blood fat levels, 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 irritation (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 ECG (electrocardiogram) – QT interval prolongation, and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Loss of bone tissue may occur in men treated for prostate cancer. Abiraterone Accord in combination with prednisone or prednisolone may increase bone tissue loss.

Reporting of side effects
If you experience any side effect, 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 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 stated on the carton 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 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 Abiraterone Accord contains

  • The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
  • The other excipients are monohydrate lactose; 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-shaped, approximately 19 mm in length x 11 mm in width, purple in colour, with “A 7 TN” engraved on one side and “500” on the other side.
  • Unit-dose divisible blisters in PVC/PVdC-aluminium packs containing 56 x 1, 60 x 1 and 112 x 1 film-coated tablets in a cardboard box.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6th Floor,
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
The Netherlands
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
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A.E.
Tel: +30 210 7488 821
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu