Abiraterone Accord 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Abiraterone Accord 500 mg film-coated tablets EFG

abiraterone acetate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the 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 to treat prostate cancer in adult men when the disease has spread to other parts of the body.

Abiraterone Accord causes your body to stop producing testosterone; in this way, it can slow down the growth of prostate cancer.

When Abiraterone Accord is prescribed at earlier stages of the disease and there is still response to hormonal treatment, it is used in combination with a treatment to reduce testosterone (androgen deprivation therapy).

When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone, to reduce the risk of high blood pressure, fluid retention (build-up of fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before starting to take 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. Abiraterone Accord is intended for use only in male patients.

• if you have severe liver disease.

• 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 are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low potassium levels in your blood (low potassium levels may increase the risk of heart rhythm problems)
• if you have previously had other heart or blood vessel problems
• if you have a fast or irregular heartbeat
• if you have difficulty breathing
• 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
• regarding the need to take this medicine with prednisone or prednisolone
• about possible adverse effects on your 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 being treated with medicines for these conditions.

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

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

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

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

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

Blood tests

This medicine may affect your liver even if you do not have any symptoms. While you are taking this medicine, your doctor will perform periodic blood tests to monitor any effects on your liver.

Children and adolescents

This medicine must not be used in children or adolescents. If a child or adolescent accidentally ingests Abiraterone Accord, seek immediate medical attention and bring the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Accord

Talk to your doctor or pharmacist before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because Abiraterone Accord may increase the effects of a number of medicines, including those for the heart, tranquilizers, certain diabetes medicines, herbal remedies (e.g., St. John’s wort), and others. Your doctor may consider adjusting the dose of these medicines. In addition, some medicines may increase or decrease the effects of Abiraterone Accord. This could lead to adverse effects or reduced effectiveness of Abiraterone Accord.

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);
• that increase the risk of heart rhythm problems [e.g., methadone (used for pain relief and in drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

Consult 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 adverse effects.

Pregnancy and breastfeeding

Abiraterone Accord is not indicated for use in women.

-This medicine may be harmful to the fetus if taken by a pregnant woman.

-Pregnant women or women who may be pregnant should wear gloves if they need to touch or handle 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, 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 operate tools or machinery.

Abiraterone Accord contains lactose and sodium

• This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
• This medicine also contains 24 mg of sodium (a main component of table/cooking salt) in each dose of two tablets. This corresponds to 1.04% of the maximum daily sodium intake for an adult.

3. How to take Abiraterone Accord

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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 Abiraterone Accord with food.
• Take Abiraterone Accord at least one hour before or at least two hours after eating (see section 2, “Abiraterone Accord with food”).
• Swallow the tablets whole with water.
• Do not split the tablets.
• Abiraterone Accord is given together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as instructed by your doctor.
• You will need to take prednisone or prednisolone every day while you are taking Abiraterone Accord.
• If you have a medical emergency, the dose of prednisone or prednisolone you are taking may need to be adjusted. Your doctor will tell you if this is necessary. 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 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, contact your doctor immediately.

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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Abiraterone Accord and contact your doctor immediately if you experience any of the following effects:

• Muscle weakness, muscle twitching or increased heart rate (palpitations).

These may be signs of low potassium levels in your blood.

Other adverse effects are:

Very common (may affect more than 1 in 10 people):

Fluid retention in the legs or feet, decreased blood potassium levels, increases 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 heartbeat (atrial fibrillation), heart failure, tachycardia, serious infections called sepsis, bone fractures, indigestion, blood in the urine, skin rash.

Uncommon (may affect up to 1 in 100 people):

Problems with the adrenal glands (related to 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 failure (also known as acute liver failure).

Not known (frequency cannot be estimated from available data):

Heart attack, changes in electrocardiogram (ECG) (QT prolongation), and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.

Loss of bone density may occur in men receiving treatment for prostate cancer. Abiraterone Accord in combination with prednisone or prednisolone may increase this loss of bone density.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton, the cardboard box, and the blister pack, following EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Accord

• The active substance is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.

The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose, sodium lauryl sulfate, colloidal anhydrous silica and magnesium stearate (E572) (see section 2, “Abiraterone Accord contains lactose and sodium”).

The film coating contains polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide red (E172), iron oxide black (E172).

Nature and contents of the container

• Abiraterone Accord tablets are oval, film-coated, purple in colour, approximately 19 mm in length x 11 mm in width, engraved with “A 7 TN” on one side and “500” on the other.
• The tablets are presented in unit-dose PVC/PVdC-aluminium blisters of 56 x 1 and/or 60 x 1 film-coated tablets in a cardboard carton.

Only certain 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

Wessling Hungary Kft

Anonymus u. 6, Budapest,

1045, Hungary

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

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.