ABIRATERON 500 mg Tablets

Contents of the leaflet

1. What Abirateron SUN is and what it is used for
2. Before you take Abirateron SUN
   1. When not to take Abirateron SUN:
   2. Warnings and precautions
   3. Blood tests
   4. Children and adolescents
   5. Abirateron SUN with other medicines
   6. Taking Abirateron SUN with food
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Abirateron SUN contains lactose and sodium
3. How to take Abirateron SUN
   1. How much to take
   2. How to take
   3. If you take more Abirateron SUN than you should
   4. If you forget to take Abirateron SUN
   5. If you stop taking Abirateron SUN
4. Possible side effects
   1. Stop taking Abirateron SUN and contact your doctor immediately if you notice any of the following:
   2. Other side effects include:
   3. Reporting of side effects
5. How to store Abirateron SUN
6. Contents of the pack and other information
   1. What Abirateron SUN contains
   2. What Abirateron SUN looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom under the following names:
   6. For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

1. What Abirateron SUN is and what it is used for

Abirateron SUN contains the active substance abiraterone acetate. It is used in adult men for the treatment of prostate cancer that has spread to other parts of the body. Abirateron SUN works by stopping the production of testosterone in the body; this can slow down the growth of prostate cancer.

When Abirateron SUN is used at an early stage of the disease in response to hormonal therapy, it is given together with a therapy that reduces testosterone levels (androgen deprivation therapy).

During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention (oedema), or low potassium levels in the blood.

2. Before you take Abirateron SUN

When not to take Abirateron SUN:

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• in women, especially if pregnant. Abirateron SUN is for use in men only.
• if you have severe liver damage.
• in combination with a medicine called 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 Abirateron SUN.

Warnings and precautions

Before taking Abirateron SUN, tell your doctor or pharmacist:

• if you have liver disease
• if you have high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of abnormal heart rhythms)
• if you have had other heart or blood vessel diseases
• if you have irregular or rapid heartbeats
• if you have shortness of breath
• if you have gained weight in a short time
• if you have swelling of the feet, ankles, or legs
• if you have taken ketoconazole in the past for the treatment of prostate cancer
• the need to take this medicine with prednisone or prednisolone
• the possibility of bone-related side effects
• if you have high blood sugar levels.

Tell your doctor if you have any heart or blood vessel diseases, including abnormal heart rhythms (arrhythmia), or if you are taking medicines for these conditions.

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

Abirateron SUN may cause a decrease in red blood cells, decreased sex drive, muscle weakness, and/or muscle pain.

Abirateron SUN must not be taken in combination with Ra-223 due to the possible increased risk of bone fractures or death.

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

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Abirateron SUN.

Blood tests

Abirateron SUN may affect liver function, and you may not have any symptoms. During treatment with this medicine, your doctor will periodically order blood tests to check the effect of the medicine on your liver.

Children and adolescents

This medicine is not used in children and adolescents. If Abirateron SUN is accidentally ingested by a child or adolescent, you should immediately go to the hospital, taking the patient information leaflet with you to show to the doctor.

Abirateron SUN with other medicines

Before taking any medicine, consult your doctor or pharmacist.

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is important because Abirateron SUN may increase the effects of many medicines, including heart medicines, sedatives, certain anti-diabetic medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may need to adjust the doses of these medicines. Other medicines may also increase or decrease the effects of Abirateron SUN, which may result in side effects or reduced efficacy of Abirateron SUN.

Androgen deprivation therapy may increase the risk of abnormal heart rhythms. Tell your doctor if you are taking medicines:

• used to treat abnormal heart rhythms (e.g., quinidine, procainamide, amiodarone, and sotalol);
• that may increase the risk of abnormal heart rhythms [e.g., methadone (pain reliever and used for addiction treatment), moxifloxacin (antibiotic), antipsychotic medicines (used for severe mental disorders)].

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

Taking Abirateron SUN with food

• Do not take this medicine with food (see section 3, "How to take Abirateron SUN").
• Taking Abirateron SUN with food may cause side effects.

Pregnancy and breastfeeding

Abirateron SUN is not used in women.

• The medicine may harm an unborn baby if taken by a pregnant woman.
• If you have sex with a woman who may become pregnant, 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 unborn baby.

Driving and using machines

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

Abirateron SUN contains lactose and sodium

Abirateron SUN contains lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The medicine contains 22 mg of sodium (a major component of cooking salt) per dose of two tablets. This is equivalent to 1.1% of the maximum recommended daily intake of sodium for adults.

3. How to take Abirateron SUN

Always 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 1000 mg (two tablets) taken once a day.

How to take

• Take the medicine by mouth.
• Do not take Abirateron SUN with food. Taking Abirateron SUN with food may cause side effects.
• Take a single dose of tablets once a day on an empty stomach. Take Abirateron SUN at least 1 hour before or at least 2 hours after food (see section 2, "Taking Abirateron SUN with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Take Abirateron SUN with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as directed by your doctor.
• Take prednisone or prednisolone every day while taking Abirateron SUN.

The amount of prednisone or prednisolone you take may need to be changed. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines for you to take while taking Abirateron SUN and prednisone or prednisolone.

If you take more Abirateron SUN than you should

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

If you forget to take Abirateron SUN

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

If you stop taking Abirateron SUN

Do not stop taking Abirateron SUN or prednisone/prednisolone without consulting your doctor.

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 Abirateron SUN and contact your doctor immediately if you notice any of the following:

• muscle weakness
• muscle tremors (tremors)
• heart palpitations (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):

• swelling of the feet or ankles
• low potassium levels in the blood
• high liver enzyme levels
• high blood pressure
• urinary tract infections
• diarrhea.

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

• high lipid levels in the blood
• chest pain
• abnormal heart rhythms (atrial fibrillation)
• heart failure
• rapid heart rate
• severe infection, sepsis
• bone fractures
• indigestion
• blood in the urine
• rash.

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

• adrenal gland problems (related to electrolyte imbalance)
• abnormal heart rhythms (arrhythmia)
• muscle weakness and/or muscle pain.

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

• lung inflammation (also known as allergic alveolitis)
• acute liver failure.

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

• heart attack, changes in ECG (prolonged QT interval)
• severe allergic reactions, causing 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. Abirateron SUN in combination with prednisone and prednisolone may increase this effect.

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 to the national reporting system via the contact details listed below.

5. How to store Abirateron 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 after "EXP". The expiry date refers to the last day of that month.

No special precautions for storage are necessary.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Abirateron SUN contains

• 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, "Abirateron SUN contains lactose and sodium"). Coating: black iron oxide (E 172), red iron oxide (E 172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide (E 171).

What Abirateron SUN looks like and contents of the pack

Oval, biconvex, film-coated tablets are purple in color (approximately 20.03 mm in length and 10.02 mm in width), with "S500" debossed on one side.

Abirateron SUN is available in blister packs.

Pack sizes: cardboard box containing 56, 60, or 120 film-coated tablets and unit dose blisters in packs of 56 x 1, 60 x 1, and 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

Terapia S.A.

Strada Fabricii Nr. 124

400632 Cluj-Napoca

Cluj

Romania

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

Germany

Abirateron SUN 500 mg Filmtabletten

France

ABIRATÉRONE SUN 500 mg, comprimé pelliculé

Italy

Abiraterone SUN

Romania

Abirateronă SUN 500 mg comprimate filmate

Spain

Abiraterona SUN 500 mg comprimidos recubiertos con película

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Ranbaxy (Poland) Sp. z o. o.

ul. Kubickiego 11

02-954 Warszawa

Poland

Tel. +48 22 642 07 75

Date of last revision of the leaflet: 18.11.2022