Prospecto:Information for the Patient

Abiraterone Sandoz 500 mg Film-Coated Tablets

abiraterone acetate

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor,pharmacistor nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist or nurse,evenif they do not appear in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Abiraterone Sandoz

3.How to take Abiraterone Sandoz

4.Possible adverse effects

5Storage of Abiraterone Sandoz

6.Contents of the package and additional information

Abiraterona Sandoz contains a medicine called abiraterone acetate. It is used for the treatment of prostate cancer in adult men who have spread to other parts of the body and also for treating prostate cancer in adult men who have not spread to other parts of the body. Abiraterone makes your body stop producing testosterone; in this way it can delay the growth of prostate cancer.

When abiraterone is prescribed in the initial stages of the disease and there is still a response to hormone treatment, it is used together with a treatment to reduce testosterone (androgen deprivation treatment).

When you take this medicine, your doctor will prescribe another medicine called prednisone or prednisolone, to reduce the possibility of suffering an increase in blood pressure, accumulating too much fluid in your body (fluid retention) or decreasing the levels of a chemical called potassium in your blood.

Do not takeAbiraterona Sandoz

• 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 a serious 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 unsure, 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 levels of potassium in the blood (low levels of potassium in the 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 heartbeat,
• if you have difficulty breathing,
• if you have rapidly gained weight,
• 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 levels of sugar in the blood.

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

Inform 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, acute liver failure may occur, which can be fatal.

You may experience a decrease in the number of red blood cells in your blood, reduced sex drive, and cases of muscle weakness and/or muscle pain.

Abiraterone should not be administered 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 the treatment with Ra-223.

If you are unsure 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 have no symptoms. While taking this medicine, your doctor will make blood tests periodically to monitor any effect on your liver.

Children and adolescents

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

Other medicines and Abiraterona Sandoz

Consult your doctor or pharmacist before taking any other medicine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is important because abiraterone may increase the effects of a range of medicines including heart medicines, tranquilizers, 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 not working as well as it should.

The androgen deprivation therapy may increase the risk of heart rhythm problems. Inform 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), moxifloxacine (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

TakingAbiraterona Sandoz 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

ABIRATERONA is not indicated in women.

• This medicine may be harmful to the fetus if a pregnant woman takes it.
• If you have sexual intercourse with a fertile woman, 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 operating machines

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

Abiraterona Sandoz contains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, 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 medication

• Take this medication orally.
• Do not take abiraterona with food.
• Take abiraterona at least one hour before or at least two hours after taking any food (see section 2, “Taking Abiraterona Sandoz with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterona is administered along with a medication 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 taking abiraterona.
• 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 modify 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 medications while you are taking abiraterona and prednisone or prednisolone.

If you take more Abiraterona Sandoz 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 medication and the amount ingested.

If you forget to take Abiraterona Sandoz

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

If you interrupt treatment with Abiraterona Sandoz

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking abiraterone and seek medical attention immediately if you experience any of the following side effects:

• Muscle weakness, muscle cramps, or rapid 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, elevated liver function test results, high blood pressure, urinary tract infections, diarrhea.

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

High levels of fat in the blood, chest pain, irregular heartbeat (atrial fibrillation), heart failure, tachycardia, 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 issues with salt and water), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.

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

Pulmonary irritation (also known as allergic alveolitis).

Failure of liver function (also known as acute liver failure).

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

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keepthis medicationout of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the carton box and on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.
• This medication does not require special conditions for conservation.
• Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Abiraterona Sandoz

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are:

Tablet: croscarmellose sodium, lauryl sulfate sodium, povidone (E1201), microcrystalline cellulose (E460), lactose monohydrate, anhydrous colloidal silica (E551), magnesium stearate (E470b) and (see section 2. “Abiraterona Sandoz contains lactose and sodium”).

Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the container

• Abiraterona Sandoz are purple, oval-shaped, film-coated tablets, marked with the number “500” on one face.

The tablets are packaged:

• Aluminum blisters with OPA/Alu/PVC or aluminum-PVC/PE/PVDC that contain 56, 60, 84, 112 film-coated tablets.Perforated single-dose blisters of aluminum-OPA/Alu/PVC or aluminum-PVC/PE/PVDC that contain 56x1, 60x1, 84x1, 112x1 film-coated tablets.
• High-density polyethylene (HDPE) bottles of 60 tablets, with an oxygen-absorbing deposit, closed with a polypropylene (PP) screw cap with a child-resistant closure.

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Lek Pharmaceuticals d.d.)

Verovškova ulica 57,

1526 Ljubljana

Slovenia

or

Remedica LTD

Aharnon Street,

Limassol Industrial Estate,

3056 Limassol

Cyprus

Last review date of thisleaflet: July 2024.

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/