ABIRATERONE FARMOZ 250 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Abiraterona Farmoz 250 mg tablets EFG

abiraterone acetate

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 symptoms are the same as yours.
• If you experience 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 Farmoz and what is it used for
2. What you need to know before you take Abiraterona Farmoz
3. How to take Abiraterona Farmoz
4. Possible side effects
5. Storage of Abiraterona Farmoz
6. Contents of the pack and other information

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

This medicine contains 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, which helps to slow down the growth of prostate cancer.

When abiraterone is prescribed in the early stages of the disease and there is still a response to hormonal treatment, it is used together with a treatment to reduce 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 Abiraterona Farmoz

Do not take Abiraterona Farmoz

• 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 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 told you have high blood pressure or heart failure or low potassium levels in your blood (low potassium levels in your blood can 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 rhythm
• 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 ketoconazole in the past 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 disorders, 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 can be signs or symptoms of liver problems. Rarely, acute liver failure (called acute hepatic insufficiency) can occur, which can be life-threatening.

A decrease in the number of red blood cells, 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 fractures or death.

If you plan to take Ra-223 after treatment with this medicine 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

This medicine may affect your liver, even if you have no symptoms. While you are taking this medicine, your doctor will perform regular blood tests to check for any effects on your liver.

Children and adolescents

This medicine should not be used in children or adolescents. If a child or adolescent accidentally ingests this medicine, they should go to the hospital immediately and bring this leaflet to show the emergency doctor.

Other medicines and Abiraterona Farmoz

Consult your doctor or pharmacist before taking any other medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because abiraterone can 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 can increase or decrease the effects of abiraterone, which can lead to side effects or reduced effectiveness of this medicine.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Tell your doctor if you are being treated with medicines for heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or 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 above medicines.

Abiraterona Farmoz with food

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

Pregnancy and breastfeeding

Abiraterona is not indicated in women.

Pregnant women or women who think they may be pregnant should wear gloves if they need to touch or handle this medicine.

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.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use tools or machines.

Abiraterona Farmoz 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 less than 41 mg of sodium (1 mmol) per dose of four tablets. This is equivalent to 2% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterona Farmoz

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

How much to take

The recommended dose is 1,000 mg (four 250 mg tablets) once a day.

How to take this medicine

• Take this medicine orally.
• Do not take abiraterone with food.

• Abiraterona Farmoz should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking Abiraterona Farmoz(see section 2, "Abiraterona Farmoz with food").
• Swallow the tablets whole with water.
• Do not break the tablets.
• This medicine 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 this medicine.
• If you have a medical emergency, your doctor 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.

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

If you take more Abiraterona Farmoz than you should

If you take more than you should, talk to 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, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Abiraterona Farmoz

• If you forget to take this medicine or prednisone or prednisolone, take your usual dose the next day.
• If you forget to take this medicine or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you stop taking Abiraterona Farmoz

Do not stop taking this medicine 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 abiraterone and see your doctor immediately if you get any of the following:

• Muscle weakness, muscle contractions, or rapid heartbeat (palpitations). These can 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 heartbeat (atrial fibrillation), heart failure, rapid heartbeat, severe infections (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 problems), 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 insufficiency)

Frequency not known(frequency cannot be estimated from the available data): Heart attack, changes in the electrocardiogram (ECG) (QT prolongation), 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. This medicine 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterona Farmoz

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 HDPE bottle after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abiraterona Farmoz

• The active substance is abiraterone acetate.
• Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, anhydrous colloidal silica, and sodium lauryl sulfate. (See section 2, Abiraterona Farmoz contains lactose and sodium).

Appearance and packaging of the product

Abiraterona Farmoz 250 mg tablets are white or almost white, oval-shaped tablets.

The tablets are packed in a child-resistant plastic bottle. Each pack contains a bottle of 120 tablets.

Marketing authorisation holder and manufacturer

Farmoz - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, nº 2, Abrunheira

2710-089 Sintra

Portugal

Manufacturer

Tecnimede - Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of last revision of this leaflet:February 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es/