Abiraterone Zentiva 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Abiraterone Zentiva 500 mg film-coated tablets EFG

abiraterone acetate

Read the entire 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, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Abiraterone Zentiva contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men when the cancer has spread to other parts of the body. Abiraterone stops your body from producing testosterone; this can help slow down the growth of prostate cancer.

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

When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone, to reduce the risk of high blood pressure, fluid retention (build-up of fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before taking Abiraterone Zentiva

Do not take Abiraterone Zentiva

• 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 you are pregnant. Abiraterone should only be used in male patients.
• 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 apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low levels of potassium 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 a fast or irregular heartbeat
• if you have difficulty breathing
• 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
• regarding the need to take this medicine with prednisone or prednisolone
• about possible adverse effects on your bones
• if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorder, 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 urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, liver function failure (called acute hepatic failure) may occur, which can lead to death.

A decrease in red blood cells, reduced sexual desire, and cases of muscle weakness and/or muscle pain may occur.

Abiraterone must 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 must wait 5 days before starting treatment with Ra-223.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone may affect your liver even if you do not have any symptoms. While you are taking this medicine, your doctor will perform periodic blood tests to monitor 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 ingests abiraterone, seek immediate medical attention at a hospital and bring the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Zentiva

Talk to your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because abiraterone may increase the effects of a number of medicines, including medicines for the heart, tranquilizers, certain diabetes medicines, herbal medicines (e.g., St. John’s wort), and others. Your doctor may consider adjusting the dose of these medicines. In addition, some medicines may increase or decrease the effects of abiraterone. This could lead to adverse effects or reduce abiraterone’s effectiveness.

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);
• 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 serious mental illnesses)].

Discuss with 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 may cause adverse effects.

Pregnancy and breastfeeding

Abiraterone is not indicated for use in women.

This medicine may be harmful to the fetus if taken by a pregnant woman.

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, you must use a condom to protect the fetus.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or operate machinery.

Abiraterone Zentiva contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him or her before taking this medicine.

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

3. How to take Abiraterone Zentiva

Follow exactly your doctor's instructions on how to take this medicine. 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 with food. Taking abiraterone with food may cause your body to absorb more medicine than needed, which can lead to side effects.
• Take abiraterone tablets as a single daily dose on an empty stomach. Abiraterone should be taken at least two hours after eating, and no food should be consumed for at least one hour after taking abiraterone (see section 2, “Abiraterone Zentiva with food”).
• Swallow the tablets whole with water.
• Do not split the tablets.
• Abiraterone is given together with a medicine 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 you are taking abiraterone.
• If you have a medical emergency, your dose of prednisone or prednisolone may need to be adjusted. Your doctor will tell you if your dose of prednisone or prednisolone needs to be changed. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

Your doctor may also prescribe 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, consult your doctor or go to the hospital immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Abiraterone Zentiva

If you forget to take abiraterone or prednisone or prednisolone, take your usual 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 instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking this medicine and contact your doctor immediately if you experience any of the following effects:

• Muscle weakness, muscle cramps, or increased heart rate (palpitations).

These may be signs of low potassium levels in your blood.

Other adverse effects include:

Very common (may affect more than 1 in 10 people):

Fluid retention in the legs or feet, decreased blood potassium levels, increased liver function test results, high blood pressure, urinary tract infection, diarrhoea.

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, serious infections called sepsis, bone fractures, indigestion, blood in the urine, skin rash.

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

Adrenal gland problems (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 failure (also called acute liver failure).

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

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

Loss of bone density may occur in men receiving treatment for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase this loss of bone density.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Zentiva

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help 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 components 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), poly(ethylene glycol) graft copolymer of poly(vinyl alcohol), talc, and titanium dioxide (E171).

Appearance of the product and contents of the container

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

The tablets are supplied in blisters packed in cardboard boxes containing 56, 60, 60 x 1, or 112 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva k.s.,

U kabelovny 130,

Dolní Měcholupy,

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

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Building 3, Floor 1

28224 Pozuelo de Alarcón, Madrid

Spain

Date of the most recent review of this leaflet: August 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es