ABIRATERONE SUN 500 mg FILM-COATED TABLETS

2. What you need to know before you take Abiraterona SUN

Do not take Abiraterona SUN

• 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 should only be used 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 applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 in your blood may increase the risk of heart rhythm problems),
• if you have had other heart or blood vessel problems,
• if you have a fast or irregular heart rhythm,
• if you have difficulty breathing,
• if you have gained weight quickly,
• if you have swelling in your feet, ankles, or legs,
• if you have taken in the past a medicine known as ketoconazole for prostate cancer,
• about the need to take this medicine with prednisone or prednisolone,
• about possible side effects on your bones,
• if you have high blood sugar levels.

Tell your doctor if you have been told you have any heart or blood vessel disorder, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these disorders.

Tell your doctor if you have yellowing of the skin or eyes, dark urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, liver failure (called acute hepatic failure) may occur, which can be life-threatening.

A decrease in the number of red blood cells in your blood, reduced sexual desire (libido), and cases of muscle weakness and/or muscle pain may occur.

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

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

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

Blood tests

Abiraterone may affect your liver even if you do not have any symptoms. While taking this medicine, your doctor will perform regular blood tests to check for any effect on your liver.

Children and adolescents

This medicine should not be used in children or adolescents. If a child or adolescent accidentally takes abiraterone, they should go to the hospital immediately and bring this leaflet to show the emergency doctor.

Other medicines and abiraterone

Consult your doctor or pharmacist before taking any other medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because abiraterone may increase the effects of a number of medicines, including heart medicines, sedatives, some diabetes medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medicines. Additionally, some medicines may increase or decrease the effects of abiraterone. This may lead to side effects or abiraterone may not work as well as it should.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Tell your doctor if you are being treated with medicines

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

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

Abiraterone with food

• This medicine should not be taken with food (see section 3, “How to take this medicine”).
• Taking abiraterone with food may cause side effects.

Pregnancy and breastfeeding

Abiraterone is not indicated in women.

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

Driving and using machines

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

Abiraterona SUN contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine also contains 22 mg of sodium (the main component of table salt/cooking salt) in each daily dose of 2 tablets. This is equivalent to 1.1% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterona SUN

Follow exactly the instructions of administration of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

How much to take

The recommended dose is 1,000 mg (two tablets) once a day.

How to take this medicine

• Take this medicine by mouth.
• Do not take abiraterone with food. Taking abiraterone with food may cause your body to absorb more medicine than necessary, which may cause side effects.
• Take the abiraterone tablets as a single dose once a day on an empty stomach. Abiraterone should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking abiraterone (see section 2, “Abiraterone with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone is given together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor tells you.
• You will need to take prednisone or prednisolone every day while you are taking abiraterone.
• If you have a medical emergency, you may need to adjust the amount of prednisone or prednisolone you take. Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

Your doctor may also prescribe other medicines while you are taking abiraterone and prednisone or prednisolone.

If you take more Abiraterona SUN than you should

If you take more than you should, consult your doctor or go to the hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Abiraterona SUN

• If you forget to take abiraterone or prednisone or prednisolone, take your usual dose the next day.
• If you forget to take abiraterone or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you stop taking Abiraterona SUN

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking abiraterone and consult your doctor immediately if you experience any of the following:

• Muscle weakness,
• muscle contractions,
• fast heart rate (palpitations).

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

Other side effects are:

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

• fluid retention in the legs or feet,
• low potassium levels in the blood,
• increases in liver function tests,
• high blood pressure,
• urinary tract infection,
• diarrhea.

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

• high levels of fats in the blood,
• chest pain,
• irregular heart rhythm (atrial fibrillation),
• heart failure,
• fast heart rate,
• severe infections 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 problems with salt and water),
• abnormal heart rhythm (arrhythmia),
• muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000 people):

• lung irritation (also called allergic alveolitis),
• liver failure (also called acute hepatic failure).

Frequency not known(cannot be estimated from the available data):

• heart attack, changes in the electrocardiogram (ECG) (prolonged QT),
• severe allergic reactions with difficulty swallowing or breathing, face, lips, tongue, or throat swelling, or itchy rash.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterona SUN

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 and blister label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abiraterona SUN

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, and sodium lauryl sulfate (see section 2, “Abiraterona SUN contains lactose and sodium”). The tablet coating contains black iron oxide (E172), red iron oxide (E172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide (E171).

Appearance and packaging

Film-coated tablets are purple, oval, biconvex (20.03 mm long and 10.02 mm wide), and engraved with “S500” on one side.

Abiraterona SUN is available in blisters.

Package sizes: boxes with PVC/PE/PVdC/Al blisters of 56, 60, or 120 film-coated tablets and boxes with PVC/PE/PVdC/Al unit-dose blisters of 56 x 1, 60 x 1, or 120 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Or

Terapia S.A.

124 Fabricii Street

400632, Cluj-Napoca

Romania

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

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Phone: +34 93 342 78 90

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Abirateron SUN 500 mg Filmtabletten

France: Abiratérone SUN 500 mg comprimé pelliculé

Italy: Abiraterone SUN

Poland: Abirateron SUN

Romania: Abirateronă SUN 500 mg comprimate filmate

Spain: Abiraterona SUN 500mg comprimidos recubiertos con película EFG

Date of last revision of this leaflet: July 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).