ABIRATERONE ZENTIVA 250 mg TABLETS

Introduction

Package Leaflet: Information for the User

Abiraterone Zentiva 250 mg 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. Storage of 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 there is still response to hormonal treatment, it is used together with treatment to lower 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 high blood pressure, fluid retention, or low potassium levels 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 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 applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with 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 may 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 disorder, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these disorders.

Tell 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, liver failure (acute hepatic failure) may occur, which can be life-threatening.

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

Abiraterone should not be given 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 treatment with Ra-223.

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 do not have any symptoms. While you are taking this medicine, your doctor will regularly perform blood tests to check for 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 go to the hospital immediately and bring this leaflet with them to show the emergency doctor.

Other medicines and Abiraterone Zentiva

Consult your doctor or pharmacist before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because abiraterone may increase the effects of certain medicines, including heart medicines, sedatives, 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 may not work 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 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

Abiraterone is not indicated in women.

This medicine may harm the fetus if taken by a pregnant woman.

If you have sex with a woman of childbearing age, you should use a condom and another effective contraceptive method.

If you have sex with a pregnant woman, you should use a condom to protect the fetus.

Pregnant or potentially pregnant women should wear gloves if they need to touch or handle this medicine.

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

3. How to take Abiraterone Zentiva

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, consult your doctor or pharmacist.

How much to take

The recommended dose is 1,000 mg (four tablets) once a day.

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 necessary, which may 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 no food should be consumed 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 together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as told by your doctor.
• 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, 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, 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 medicine, 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 contact your doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions, or rapid 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 the legs or feet, low potassium levels in the blood, elevated liver function tests, high blood pressure, urinary tract infection, diarrhea.

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

High levels of fats in the blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, fast heart rate, 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 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 density loss may occur in men receiving treatment for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase this bone density loss.

Reporting of side effects

If you experience 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 Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the label of the bottle after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Store in the original package to protect from light.

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 protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Zentiva

• The active substance is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients 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").

Appearance and packaging

Abiraterone tablets are white to off-white, oval, biconvex, uncoated, with "250" engraved on one side and smooth on the other.

The tablets are packaged in a 100 ml high-density polyethylene (HDPE) bottle with a child-resistant cap and a desiccant included (polypropylene, PP). Each bottle contains 120 tablets. Each carton contains one bottle.

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 request 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