ABIRATERONE TRONYL 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abiraterona Tronyl 500 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 Abiraterona Tronyl and what is it used for
2. What you need to know before you take Abiraterona Tronyl
3. How to take Abiraterona Tronyl
4. Possible side effects
   1. Storage of Abiraterona Tronyl

1. Contents of the pack and further information

1. What is Abiraterona Tronyl and what is it used for

Abiraterona Tronyl 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 acetate makes your body stop producing testosterone; this can slow down the growth of prostate cancer.

When abiraterone acetate is prescribed in the early stages of the disease and there is still a response to hormonal treatment, it is used together with 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, or low potassium levels in your blood.

2. What you need to know before you take Abiraterona Tronyl

Do not take Abiraterona Tronyl

• 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 acetate 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 unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take abiraterone acetate:

• 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 the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have a fast or irregular heart rate
• 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 (called acute hepatic failure) may occur, which can be life-threatening.

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

Abiraterone acetate should not be taken 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 acetate and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment.

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

Blood tests

Abiraterone acetate may affect your liver even if you have no 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 acetate, they should go to the hospital immediately and bring this leaflet with them to show the emergency doctor.

Other medicines and Abiraterona Tronyl

Consult your doctor or pharmacist before using 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 acetate may 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. Additionally, some medicines may increase or decrease the effects of Abiraterona Tronyl. This may lead to side effects or Abiraterona Tronyl 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);
• 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.

Abiraterona Tronyl with food

• This medicine should not be taken with food (see section 3, "How to take this medicine").
• Taking abiraterone acetate with food may cause side effects.

Pregnancy and breastfeeding

Abiraterone acetate 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 must use a condom and another effective contraceptive method.
• If you have sex 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 use tools or machines.

Abiraterona Tronyl contains lactose and sodium

• If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
• This medicine contains 23.6 mg of sodium (a major component of cooking/table salt) in a daily dose of two tablets. This is equivalent to 1.18% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterona Tronyl

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 1000 mg (two 500 mg tablets) once a day.

How to take this medicine

• Take this medicine by mouth.
• Do not take abiraterone acetate with food.Taking abiraterone acetate with food may cause your body to absorb more medicine than necessary, which can cause side effects.
• Take the abiraterone acetate tablets as a single dose once a day on an empty stomach. Abiraterone acetate should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking Abiraterona Tronyl (see section 2, "Abiraterona Tronyl with food").
• Swallow the tablets whole with water.
• Do not split the tablets.
• Abiraterone acetate is given together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor tells you.
• You will need to take prednisone or prednisolone every day while you are taking abiraterone acetate.
• 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.

It is also possible that your doctor will prescribe other medicines while you are taking abiraterone acetate and prednisone or prednisolone.

If you take more Abiraterona Tronyl than you should

If you take more than you should, consult your doctor or go to the hospital immediately.

If you forget to take Abiraterona Tronyl

• If you forget to take abiraterone acetate or prednisone or prednisolone, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.
• If you forget to take abiraterone acetate or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you stop taking Abiraterona Tronyl

Do not stop taking abiraterone acetate 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 Abiraterona Tronyl and contact your doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions, or rapid heartbeat (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
• increases in 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 heartbeat (atrial fibrillation)
• heart failure
• rapid heartbeat
• severe 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 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)

Not known(frequency cannot be estimated from the available data)

• heart attack
• changes in the electrocardiogram (ECG) (prolongation QT)
• 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 acetate 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 or pharmacist. 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: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterona Tronyl

This medicine does not require any special storage conditions.

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 shown.

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 further information

Composition of Abiraterona Tronyl

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are:Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, hypromellose, type 2910 6cP, colloidal anhydrous silica, and magnesium stearate

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172), black iron oxide (E172).

Appearance and packaging

Abiraterona Tronyl tablets are purple, oval, biconvex, film-coated (21.1 mm in length x 9.6 mm in width)

Abiraterona Tronyl is available in packs of 56 or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua, Portugal

Phone: +351 231 920 250

Fax: +351 231 921 055

Email: basi@basi.pt

Local representative

LAPHYSAN, S.A.U.

Anabel Segura 11, Edificio A, Planta 4, Puerta D,

28108 Alcobendas - Madrid

Spain

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua, Portugal

This medicine is authorised in the Member States of the European Economic Area under the following names:

Portugal:

Abiraterona Tronyl 500 mg film-coated tablets

Spain:

Abiraterona Tronyl 500 mg film-coated tablets

Date of last revision of this leaflet: 04/2024