ABIRATERONE ZENTIVA 500 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

AbirateroneZentiva500 mg film-coated tablets EFG

abiraterone acetate

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

When abiraterone is prescribed in the early stages of the disease and you are still responding to hormone treatment, it is used together with treatment to lower your testosterone levels (androgen deprivation therapy).

When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone to reduce the risk of you getting high blood pressure, retaining too much water in your body (fluid retention), or having low levels of a chemical called potassium in your blood.

2. What you need to know before you take Abiraterone Zentiva

Do not take Abiraterone 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. Abiraterone is for use in male patients only.
• if you have severe 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 not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine:

• if you have liver problems
• if you have been told you have high blood pressure or heart failure or low potassium levels in your blood (low potassium levels in your blood can increase your risk of heart rhythm problems) if you have had other heart or blood vessel problems
• if you have a fast or irregular heart beat
• if you have difficulty breathing
• if you have gained weight quickly
• 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 blood sugar levels.

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

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

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

Abiraterone must not be taken 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 must wait 5 days before starting Ra-223 treatment.

If you are not sure 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 you are taking this medicine, your doctor will do regular blood tests to check for any effects on your liver.

Children and adolescents

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

Other medicines and Abiraterone Zentiva

Consult your doctor or pharmacist before taking any other medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because abiraterone can increase the effects of a number of medicines including medicines for the heart, sedatives, some medicines for diabetes, herbal medicines (e.g. St John's Wort) and others. Your doctor may consider changing the dose of these medicines. Also, some medicines may increase or decrease the effects of abiraterone. This can lead to side effects or abiraterone not working as well as it should.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Tell your doctor if you are being treated with:

• medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol);
• medicines 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 your doctor if you are taking any of the medicines listed above.

Abiraterone Zentiva with food

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

Taking abiraterone with food can cause side effects.

Pregnancy and breast-feeding

Abiraterone is not indicated in women.

This medicine may harm your unborn baby if you take it while you are pregnant.

If you have sex with a woman who can become pregnant, you must use a condom and another effective method of birth control.

If you have sex with a pregnant woman, you must use a condom to protect the baby.

Driving and using machines

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

Abiraterone Zentiva contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Abiraterone Zentiva

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 1,000 mg (two tablets) once a day.

How to take this medicine

• Take this medicine by mouth.
• Do not take abiraterone with food.Taking abiraterone with food can cause your body to absorb more medicine than necessary and this can cause side effects.
• Take the abiraterone tablets as a single dose once a day on an empty stomach. Abiraterone should be taken at least 2 hours after eating and you should not eat for at least 1 hour after taking abiraterone (see section 2, “Abiraterone Zentiva with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone is given with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor has told you.
• You will need to take prednisone or prednisolone every day while you are taking abiraterone.
• 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 change the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

You may also be prescribed other medicines 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, talk to 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Abiraterone Zentiva

If you forget to take abiraterone or prednisone or prednisolone, take your normal dose the next day.

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

If you stop taking Abiraterone Zentiva

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

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 this medicine and see your doctor immediately if you get any of the following:

• Muscle weakness, muscle contractions or fast heart beat (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 your legs or feet, low potassium levels in your blood, increased liver tests, high blood pressure, urinary tract infection, diarrhea.

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

High levels of fats in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, fast heart beat, severe infections called sepsis, bone fractures, indigestion, blood in your urine, skin rash.

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

Problems with your adrenal glands (related to problems 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 called allergic alveolitis).

Liver failure (also called acute hepatic failure).

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

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

Bone thinning (loss of bone density) may occur in men who are treated for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase this bone thinning.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Abiraterone Zentiva

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 is the last day of the month stated.

This medicine does not require any special storage conditions.

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 to protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Zentiva

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

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

Appearance and packaging

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

The tablets are available in blisters in cartons of 56, 60, 60 x 1 or 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Zentiva k.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10,

Czech Republic

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15,

Münster, 48159

Germany

or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

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

28224 Pozuelo de Alarcón, Madrid

Spain

Date of last revision of this leaflet:August 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es