Package Leaflet: Information for the User

Abiraterone Zentiva500 mg Film-Coated Tablets

abiraterone 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. See section 4.

AbirateronaZentivacontains a medicine called abiraterone acetate. It is used for the treatment of prostate cancer in adult men whose cancer has spread to other parts of the body. Abiraterone makes your body stop producing testosterone; this way it can slow down the growth of prostate cancer.

When abiraterone is prescribed in the early 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 take Abiraterona Zentiva

• 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. Abiraterona 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 the blood, reduced libido, and cases of muscle weakness and/or muscle pain.

Abiraterona 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 abiraterona 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

Abiraterona may affect your liver even if you have no symptoms. While taking this medicine, your doctor will perform 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 abiraterona, they should immediately go to the hospital and bring the leaflet with them to show to the emergency doctor.

Other medicines and Abiraterona Zentiva

Consult your doctor or pharmacist before taking any 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 abiraterona 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 abiraterona. This may lead to side effects or abiraterona 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.

Abiraterona Zentiva with food

This medicine should not be taken with food (see section 3, “How to take this medicine”).

Taking abiraterona 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 should use a condom and another effective contraceptive method.

If you have sexual intercourse with a pregnant woman, you should 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 Zentiva contains lactose and sodium

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

This medicine contains 23 mg of sodium (main component of table salt/for cooking) in a daily dose of two tablets. This is equivalent to 1.2% of the maximum daily sodium intake recommended for an adult.

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

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 abiraterone with food.Taking abiraterone with food may cause the body to absorb more medication than necessary, which may lead to side effects.
• Take the abiraterone tablets as a single dose once a day with an empty stomach. Abiraterone should be taken at least two hours after eating and no food should be consumed at least one hour after taking abiraterone (see section 2, “Abiraterone Zentiva with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone is administered 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 abiraterone.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. Your doctor will inform 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 abiraterone and prednisone or prednisolone.

If you take more Abiraterone Zentiva 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Abiraterone Zentiva

If you forgot to take abiraterone or prednisone or prednisolone, take the usual dose the next day.

If you forgot to take abiraterone or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you interrupt treatment with Abiraterone Zentiva

Do not stop taking abiraterone 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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Muscle weakness, muscle cramps, or rapid heartbeat (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 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).

Unknown frequency(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. 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 leaflet. 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 medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Abiraterone Zentiva

• The active ingredient is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.

• The other components are microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose (type 2910), anhydrous colloidal silica, and sodium lauryl sulfate (see section 2. “Abiraterone Zentiva contains lactose and sodium”).
• Coating: iron oxide black (E172), iron oxide red (E172), graft copolymer of macrogol poly (vinyl alcohol), talc, and titanium dioxide (E171).

Appearance of the product and contents of the container

Abiraterone tablets are purple, oval, biconvex, coated, and engraved with “500” on one face and smooth on the other face.

The tablets are presented in blisters in carton boxes with 56, 60, 60 x 1, or 112 coated tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Zentivak.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10,

Czech Republic

Responsible manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15,

Münster, 48159

Germany

O

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

Last review date of this leaflet:August 2024

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