ABIRATERONE VIVANTA 500 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Abiraterone Vivanta 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, 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Abiraterone Vivanta contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men whose 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 earlier stages of the disease and there is still response to hormonal treatment, it is used in combination with a treatment to lower 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 called potassium in your blood.

2. What you need to know before taking Abiraterone Vivanta

Do not take Abiraterone Vivanta

• 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 apply to you. If you have any doubts, 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 told you have high blood pressure, heart failure, or low levels of potassium in your blood (low blood 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

• about 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 liver failure) may occur, which can lead to death.

A decrease in red blood cells, reduced sex drive, 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 Ra-223 treatment.

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 Vivanta

Talk to your doctor or pharmacist before taking any medicine.

Tell 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, some medicines for diabetes, herbal remedies (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 make abiraterone less effective.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking 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 in drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

Consult your doctor if you are taking any of the medicines listed above.

Taking Abiraterone Vivanta with food

• This medicine must not be taken with food (see section 3, “How to take Abiraterone Vivanta”).
• 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.
• Pregnant women or women who suspect they may be pregnant must wear gloves if they need to handle or touch abiraterone.
• If you have sexual intercourse with a woman of childbearing potential, 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 tools or machinery.

Abiraterone Vivanta contains lactose and sodium

• Abiraterone Vivanta contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
• This medicine contains 27 mg of sodium (a main component of table/cooking salt) per daily dose of 1,000 mg (two 500 mg tablets), equivalent to 1.35% of the maximum recommended daily sodium intake for an adult.

3. How to take Abiraterone Vivanta

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is 1,000 mg (two 500 mg 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 medication than needed, which may lead to side effects.
• Take the 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 Vivanta with food").
• Swallow the tablets whole with water.
• Do not split the tablets.
• Abiraterone is administered 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, the dose of prednisone or prednisolone you are taking may need to be adjusted. Your doctor will advise you if any change in your prednisone or prednisolone dose is required. 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 Vivanta 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 Vivanta

• 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 Vivanta

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 Abiraterone Vivanta and contact your doctor immediately if you experience any of the following symptoms:

• 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, low 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 inflammation (also known as allergic alveolitis).

Liver dysfunction (also called acute liver failure).

Frequency not known (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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Vivanta

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after CAD/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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Abiraterone Vivanta

• The active substance is abiraterone acetate.
• Each film-coated tablet contains 500 mg of abiraterone acetate, equivalent to 446 mg of abiraterone.
• The other components are lactose monohydrate, sodium croscarmellose (E468), hypromellose 2910, 3 mPa.s (E464), sodium lauryl sulfate (E487), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), magnesium stearate (E470b), poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide red (E172), iron oxide black (E172) (see section 2, "Abiraterone Vivanta contains lactose and sodium").

Appearance of the product and contents of the pack

Abiraterone Vivanta 500 mg tablets are purple, oval-shaped, approximately 20 mm long and 10 mm wide, engraved with "MA" on one side and "22" on the other.

Pack sizes:

Blister packs containing 60 film-coated tablets.

Perforated unit dose blisters containing 56x1, 60x1, 112x1 film-coated tablets.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinova 260/1, Cakovice,

19600, Prague 9

Czech Republic

Manufacturer responsible

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola, PLA3000, Malta

or

MSN Labs Europe Limited
KW20A Corradino Park, Paola, PLA3000, Malta

You may request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o. Spanish branch
C/Guzmán el Bueno, 133, edificio Britannia
28003 Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names

Date of the last revision of this leaflet: December 2024

Detailed 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/).