Abiraterone Tronyl 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Leaflet contents

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

2. What you need to know before taking Abiraterone Tronyl

3. How to take Abiraterone Tronyl

4. Possible side effects

5. How to store Abiraterone Tronyl

6. Contents of the pack and other information

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

Abiraterone Tronyl 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 acetate causes your body to stop producing testosterone, which can help slow down the growth of prostate cancer.

When abiraterone acetate is prescribed at the early stages of the disease and there is still response to hormonal 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 developing high blood pressure, fluid retention (accumulation of excess fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before starting to take Abiraterone Tronyl

Do not take Abiraterone Tronyl

• 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 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 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 abiraterone acetate:

• 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 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 sexual desire (libido), and cases of muscle weakness and/or muscle pain may occur.

Abiraterone acetate 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 acetate and prednisone/prednisolone, you should 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 acetate 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 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 acetate, go immediately to the hospital and bring the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Tronyl

Talk to your doctor or pharmacist before using 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 acetate may increase the effects of a number of medicines, including medicines for the heart, tranquilizers, some medicines for diabetes, 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 Tronyl. This could lead to adverse effects or make Abiraterone Tronyl 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 as part of 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.

Abiraterone Tronyl with food

• This medicine must not be taken with food (see section 3, “How to take this medicine”).
• Taking abiraterone acetate with food may cause adverse effects.

Pregnancy and breastfeeding

Abiraterone acetate 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 tools or machinery.

Abiraterone Tronyl contains lactose and sodium

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

3. How to take Abiraterone Tronyl

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

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 acetate with food. Taking abiraterone acetate with food may cause your body to absorb more medicine than needed, which may lead to adverse effects.
• Take the abiraterone acetate tablets as a single daily dose on an empty stomach. Abiraterone acetate should be taken at least two hours after eating, and no food should be consumed for at least one hour after taking abiraterone acetate (see section 2, “Abiraterone Tronyl with food”).
• Swallow the tablets whole with water.
• Do not split the tablets.
• Abiraterone acetate 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 acetate.
• 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 the dose of prednisone or prednisolone is required. Do not stop taking prednisone or prednisolone unless instructed by your doctor.

Your doctor may also prescribe other medicines while you are taking abiraterone acetate and prednisone or prednisolone.

If you take more Abiraterone Tronyl than you should

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

If you forget to take Abiraterone 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 the missed dose.
• If you forget to take abiraterone acetate or prednisone or prednisolone for more than one day, contact your doctor immediately.

If you stop taking Abiraterone Tronyl

Do not stop taking abiraterone acetate or prednisone or prednisolone unless instructed to do so 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 may cause adverse effects, although not everyone gets them.

Stop taking Abiraterone Tronyl 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
• 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
• 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 called allergic alveolitis)
• Liver dysfunction (also called acute liver failure)

Not known (frequency cannot be estimated from available data)

• Heart attack
• Changes in electrocardiogram (ECG) (QT prolongation)
• Severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, 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 adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Tronyl

This medicine does not require special storage conditions.

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 EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Abiraterona Tronyl

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

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E 172).

Appearance of the product and contents of the container

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

Abiraterona Tronyl is available in packages containing 56 or 60 film-coated tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua, Portugal

Tel.: +351 231 920 250

Fax: +351 231 921 055

E-mail: [email protected]

Local Representative

LAPHYSAN, S.A.U.

Anabel Segura 11, Edificio A, 4th Floor, Door D,

28108 Alcobendas - Madrid

Spain

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

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

3450-232 Mortágua, Portugal

This medicinal product is authorized 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 the most recent revision of this leaflet: 04/2024