ABIRATERONE EXELTIS 500 mg FILM-COATED TABLETS

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

Abiraterone Exeltis 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. This medicine stops 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 you are still responding to hormone treatment, it is used together with a treatment to lower testosterone levels (androgen deprivation treatment).

When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention (water retention), or low potassium levels in your blood.

2. What you need to know before you take Abiraterone Exeltis

Do not take Abiraterone Exeltis

• 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. This medicine is only for use 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 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 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 can be signs of liver problems. Rarely, liver failure (acute hepatic failure) can 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.

This medicine should not be taken 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 abiraterone and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

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 have no symptoms. While you are taking this medicine, your doctor will regularly perform blood tests to check 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, they should go to the hospital immediately and bring this leaflet with them to show to the emergency doctor.

Other medicines and Abiraterone Exeltis

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 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 treatment 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.

Abiraterone Exeltis 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 must use a condom and another effective method of birth control.
• 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.

Abiraterone Exeltis contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains 24 mg of sodium (a major component of cooking/table salt) in each dose of two tablets. This is equivalent to 1.2% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterone Exeltis

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

How much to take

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

Taking this medicine

• Take this medicine by mouth.
• Do not take this medicine with food. Taking Abiraterone Exeltis with food may cause your body to absorb more medicine than necessary, which can cause side effects.
• Take the Abiraterone Exeltis tablets as a single dose once a day on an empty stomach. Abiraterone Exeltis should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking Abiraterone Exeltis (see section 2, “Abiraterone Exeltis 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 your doctor tells you.

• You will need to take prednisone or prednisolone every day while you are taking Abiraterone Exeltis.
• 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.

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

If you take more Abiraterone Exeltis 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, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Abiraterone Exeltis

• 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 Exeltis

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 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 Abiraterone Exeltis and see a doctor immediately if you experience 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 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(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 Exeltis 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 Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Exeltis

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 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 Abiraterone Exeltis

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate, equivalent to 446 mg of abiraterone.
• The other ingredients are microcrystalline cellulose (silicified): composed of microcrystalline cellulose and colloidal anhydrous silica; croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, colloidal silica, and sodium lauryl sulfate (see section 2, “Abiraterone Exeltis contains lactose and sodium”). The film coating contains: black iron oxide (E172); red iron oxide (E172), yellow iron oxide (E172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide (E171).

Appearance and packaging

• Abiraterone Exeltis are film-coated tablets, reddish-brown in color, oval in shape, and engraved with "500" on one side.
• Abiraterone Exeltis is available in blister packs of 56 and 60 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Exeltis Healthcare, S.L.

Avda. de Miralcampo, 7

Polígono Industrial Miralcampo,

19200 Azuqueca de Henares, Guadalajara

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera.

C/ La Vallina s/n

24008 - Villaquilambre, León.

Spain

or

Laboratorios Liconsa, S.A.

Av. Miralcampo, 7,

19200 Azuqueca de Henares, Guadalajara,

Spain

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

Date of last revision of this leaflet: September 2024

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