Abiraterone Sun

Package leaflet: Information for the user

Abiraterone SUN 500 mg film-coated tablets

abiraterone acetate
Equivalent medicine
Read all of this leaflet carefully before you start 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 their symptoms are the same as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Abiraterone SUN contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men whose cancer has spread to other parts of the body. Abiraterone SUN stops the body from producing testosterone; this may slow down the growth of prostate cancer.
When Abiraterone SUN is prescribed in the early 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 is used to reduce the risk of high blood pressure, fluid retention (too much fluid in the body), or low levels in the blood of a chemical known as potassium.

2. What you need to know before taking Abiraterone SUN

Do not take Abiraterone SUN

• 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 SUN 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 any of these conditions apply to you. If in doubt, 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 an 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
• if you need to take this medicine with prednisone or prednisolone and have concerns 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 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, dark-colored urine, or severe nausea or
vomiting, as these may be signs or symptoms of liver problems. Rarely, impaired liver function (called acute liver failure) may occur, which can be fatal.
Possible side effects include reduced red blood cells, decreased sexual desire (libido),
muscle weakness and/or muscle pain.
Abiraterone SUN 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 SUN and prednisone/prednisolone,
you must wait 5 days before starting Ra-223 treatment.
If you are unsure whether any of the points listed above apply to you, consult your doctor
or pharmacist before taking this medicine.
Blood monitoring
Abiraterone SUN may affect the liver and may not cause symptoms. While taking this
medicine, your doctor will periodically perform blood tests to monitor for any effects
of Abiraterone SUN on the liver.
Children and adolescents
This medicine is not indicated for use in children and adolescents. If Abiraterone SUN is accidentally
ingested by a child or adolescent, go to hospital immediately and bring the package leaflet to show the
emergency room doctor.
Other medicines and Abiraterone SUN
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 SUN may increase the effects of
certain medicines, including those for the heart, 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 SUN. This could lead to side effects or Abiraterone SUN may not
work as effectively as it should.
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, and sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for treatment of opioid dependence), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

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

Pregnancy and breastfeeding
Abiraterone SUN is not indicated for use in women.

• This medicine may harm the unborn baby if taken during pregnancy.
• 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 use tools or
machinery.
Abiraterone SUN contains lactose and sodium
Abiraterone SUN contains lactose (a type of sugar). If your doctor has informed you that you have an
intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains 22 mg of sodium (a main component of table salt) per dose equivalent to two tablets. This corresponds to 1.1% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to take Abiraterone SUN

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
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 SUN with food. Taking Abiraterone SUN with food may increase the absorption of the medicine beyond what is necessary, which could lead to unwanted side effects.
• Take the Abiraterone SUN tablets as a single daily dose on an empty stomach. Abiraterone SUN should be taken at least two hours after a meal, and no food should be consumed for at least one hour after taking Abiraterone SUN. (See section 2 “Abiraterone SUN with food”).
• Swallow the tablets whole with a glass of water.
• Do not break the tablets.
• Abiraterone SUN is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• You must take prednisone or prednisolone every day while you are taking Abiraterone SUN.
• 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 SUN and prednisone or prednisolone.
If you take more Abiraterone SUN than you should
If you take more Abiraterone SUN than you should, contact your doctor or go to a hospital immediately.
If you forget to take Abiraterone SUN

• If you forget to take Abiraterone SUN or prednisone or prednisolone, take your usual dose the next day.
• If you forget to take Abiraterone SUN or prednisone or prednisolone for more than one day, speak with your doctor as soon as possible.

If you stop taking Abiraterone SUN
Do not stop taking Abiraterone SUN or prednisone or prednisolone unless your doctor tells you to do so.
If you have any questions 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 everybody gets them.
If you notice any of the side effects listed below, stop taking Abiraterone SUN and contact a doctor immediately:

• muscle weakness
• muscle spasms
• 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)

• elevated 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
• 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)
• severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or hives.

Loss of bone tissue may occur in men being treated for prostate cancer. Abiraterone SUN in combination with prednisone or prednisolone may increase loss of bone tissue.
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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Abiraterone SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the 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 medicines 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 SUN contains

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

Description of the appearance of Abiraterone SUN and package contents
Abiraterone SUN tablets are film-coated, purple in colour, oval-shaped, biconvex (20.03 mm in length x 10.02 mm in width), with 'S500' engraved on one side.
Abiraterone SUN is available in blisters.
Pack sizes: outer carton containing 56, 60 or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharma France
31 Rue des Poissonniers
92200 Neuilly-sur-Seine
France

Local representative:
Sun Pharma Italia S.r.l. – Viale Giulio Richard, 3 – 20143 Milano, Italy

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judeţul Cluj
Romania

This medicinal product is authorized in the EEA Member States under the following names
Germany: Abirateron SUN
France: Abiratérone SUN
Italy: Abiraterone SUN
Poland: Abirateron SUN
Romania: Abiraterona SUN
Spain: Abiraterona SUN
The Netherlands: Abirateron SUN

This patient information leaflet was last approved in: