Package Leaflet: Information for the User

Abiraterona Combix 500 mg Film-Coated Tablets EFG

Abiraterona acetate

Read this leaflet carefully before you start taking this medicine because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Abiraterona Combix is and what it is used for

2. What you need to know before you start taking Abiraterona Combix

3. How to take Abiraterona Combix

4. Possible side effects

5. Storage of Abiraterona Combix

6. Contents of the pack and additional information

Abiraterona Combixcontains a medication called abiraterone acetate. It is used for the treatment of prostate cancer in adult men who have spread to other parts of the body.This medicationcauses your body to stop producing testosterone; in this way, it can delay the growth of prostate cancer.

Whenthis medicationis prescribed in the early stages of the disease and there is still a response to hormone treatment, it is used in combination with a treatment to reduce testosterone (androgen deprivation therapy).

When you take this medication, your doctor will also prescribe another medication called prednisone or prednisolone, to reduce the risk of experiencing 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 Combix

• if you are allergic to abiraterone acetate or any of the other components of this medication (listed in section 6).
• if you are a woman, especially if you are pregnant.This medicationshould 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 medication if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• 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 rapid 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 medication known as ketoconazole for prostate cancer
• about the need to take this medication with prednisone or prednisolone
• about possible adverse effects on your bones
• if you have high blood sugar.

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

Inform your doctor if you have yellow 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 libido, and cases of muscle weakness and/or muscle pain.

This medicationshould 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 withthis medicationand 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 medication.

Blood tests
This medicationmay affect your liver even if you have no symptoms. While taking this medication, your doctor will perform blood tests periodically to monitor any effects on your liver.

Children and adolescents

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

Other medications andAbiraterona Combix

Consult your doctor or pharmacist before taking any medication.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is important becausethis medicationmay increase the effects of a range of medications including heart medications, tranquilizers, some diabetes medications, herbal medications (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medications. Additionally, some medications may increase or decrease the effects ofthis medication. This may lead to adverse effects orthis medicationnot working as well as it should.

The androgen deprivation treatment may increase the risk of heart rhythm problems. Inform your doctor if you are being treated with medications:

• 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 with your doctor if you are taking any of the medications listed above.

Abiraterona Combixwith food

• This medication should not be taken with food (see section 3, “How to take this medication”).
• Takingthis medicationwith food may cause adverse effects.

Pregnancy andbreastfeeding

This medicationis not indicated in women.

• This medication 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 machinery

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

Abiraterona Combixcontains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationas indicated by your doctor.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 takethis medicationwith food.
• Takethis medicationat least one hour before or at least two hours after taking any food(see section 2, “Abiraterona Combixwith food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• This medicationis administered along with a medication called prednisone or prednisolone. Take prednisone or prednisolone exactly as instructed by your doctor.
• You will have to take prednisone or prednisolone every day while takingthis medication.
• 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.

It is also possible that your doctor will prescribe other medications while you are takingthis medicationand prednisone or prednisolone.

If you take moreAbiraterona Combixthan you should

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

If you forgot to takeAbiraterona Combix

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

If you interrupt the treatment withAbiraterona Combix

Do not stop takingthis medicationor prednisone or prednisolone unless your doctor tells you to.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop takingthis medicineand seek medical attention immediately if you experience any of the following side effects:

• Muscle weakness, muscle cramps, or rapid heart rate (palpitations). They 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 fats in the blood, chest pain, irregular heart rhythm (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):
Lung irritation (also known as allergic alveolitis).
Liver function failure (also known as acute hepatic insufficiency).

Unknown(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 medicine may cause bone density loss in men receiving treatment for prostate cancer.This medicinein 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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keepthis medicationout of the sight and reach of children.
• Do not usethis medicationafter the expiration date that appears onthe box, on the cardboard carton, and on the blister pack.The expiration date is the last day of the month indicated.
• No special storage conditions are required.
• Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAbiraterona Combix

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

Appearance of the product and contents of the pack

• The tablets are purple, oval-shaped, with a beveled edge and film-coated, with “A” engraved on one face and “500” on the other face.
• Each box contains 56 film-coated tablets in 4 blisters with 14 film-coated tablets each.
• Each box contains 60 film-coated tablets in 5 blisters with 12 film-coated tablets each.
• Each box contains 112 film-coated tablets in 8 blisters with 14 film-coated tablets each.
• Multiple pack containing 2 boxes, each containing 56 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Bluepharma – Indústria Farmacêutica, S.A.

S. Martinho do Bispo

3045-016 Coimbra

Portugal

or

Bluepharma Industria Farmaceutica S.A.

Eiras, Rua Adriano Lucas,

Coimbra, 3020-430,

Portugal

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:August 2021

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/