Prospecto: Information for the User

Abiraterone Normon 500mg Film-Coated Tablets

abiraterone acetate

Read this leaflet carefully before you start to take 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist, eveniftheyare not listed in this leaflet. See section 4.

Abiraterona Normon contains a medication called abiraterone acetate. It is used for the treatment of prostate cancer in adult men whose cancer has spread to other parts of the body.

Abiraterone causes your body to stop producing testosterone; in this way, it can delay the growth of prostate cancer.

When abiraterone is prescribed in the early stages of disease and there is still a response to hormone treatment, it is used in combination with a treatment to reduce testosterone (androgen deprivation therapy).

When you take this medication, your doctor will prescribe another medication called prednisone or prednisolone, to reduce the possibility of experiencing an increase in blood pressure, accumulating too much fluid in your body (fluid retention) or decreasing the levels of a chemical called potassium in your blood.

Do not take Abiraterona Normon

• If you are allergic to abiraterone acetate or any of the other components of this medication (listed in section6).
• If you are a woman, especially if you are pregnant. Abiraterona should only be used in male patients.
• If you have a serious liver disease.
• In combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medication if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have liver problems.
• If you have been told that you have high blood pressure or heart failure or low levels of potassium in the blood (low levels of potassium in the blood may increase the risk of heart rhythm problems).
• If you have had other heart or blood vessel problems.
• If you have a rapid or irregular heart rhythm.
• If you have difficulty breathing.
• If you have rapidly gained weight.
• If you have swelling in your feet, ankles, or legs.
• If you have taken in the past a medication known as ketoconazole for prostate cancer.
• About the need to take this medication with prednisone or prednisolone.
• About possible adverse effects on your bones.
• If you have high levels of sugar in the blood.

Inform your doctor if you have been told that you have any heart or blood vessel problems, including heart rhythm problems (arrhythmia), or are being treated with medications for these conditions.

Inform your doctor if you have yellow skin or eyes, dark urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, acute liver failure may occur, which can be fatal.

You may experience a decrease in the number of red blood cells in the blood, reduced libido, and cases of muscle weakness and/or muscle pain.

Abiraterona should 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 abiraterona and prednisone/prednisolone, you should wait 5 days before starting the treatment with Ra-223.

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

Blood tests

Abiraterona may affect your liver, even if you have no symptoms. While taking this medication, your doctor will perform blood tests periodically to monitor any effects on your liver.

Children and adolescents

This medication should not be used in children or adolescents. If a child or adolescent accidentally ingests abiraterona, they should immediately go to the hospital and bring the package insert with them to show to the emergency doctor.

Other medications and Abiraterona Normon

Consult your doctor or pharmacist before taking any medication.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is important because abiraterona may increase the effects of a series of medications, including heart medications, tranquilizers, some diabetes medications, herbal medications (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medications. Additionally, some medications may increase or decrease the effects of abiraterona, which may lead to adverse effects or abiraterona not working as well as it should.

The androgen deprivation treatment may increase the risk of heart rhythm problems. Inform your doctor if you are being treated with medications:

• 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), moxifloxacine (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

Abiraterona Normon with food

• This medication should not be taken with food (see section 3, “How to take this medication”).
• Taking abiraterona with food may cause adverse effects.

Pregnancy and breastfeeding

Abiraterona is not indicated in women.

• This medication may be harmful to the fetus if a pregnant woman takes it.

If you have sexual intercourse with a fertile woman, 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 operating machines

This medication is unlikely to affect your ability to drive and use tools or machines.

Abiraterona Normon contains lactose and sodium

Abiraterona Normon contains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

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

Take this medication

• Take this medication orally.
• Do not take abiraterone with food.Taking Abiraterone Normon with food may cause the body to absorb more medication than necessary, which may lead to side effects.
• Take Abiraterone Normon tablets as a single dose once a day with an empty stomach. Abiraterone Normon should be taken at least two hours after eating and no food should be consumed at least one hour after taking Abiraterone Normon(see section2, “Abiraterone Normon with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone is administered along with a medication 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 taking abiraterone.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. Your doctor will inform you if you need to modify 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 medications while you are taking abiraterone and prednisone or prednisolone.

If you take more Abiraterone Normon 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Abiraterone Normon

• If you forget to take abiraterone or prednisone or prednisolone, take the 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 interrupt treatment with Abiraterone Normon

Do not stop taking abiraterone or prednisone or prednisolone unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Abiraterona Normon and see your doctor immediately if you experience any of the following side effects:

• Muscle weakness, muscle cramps, or rapid heartbeat (palpitations). They 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, elevated liver function test results, high blood pressure, urinary tract infections, 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, 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 issues with salt and water), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000 people):

Pulmonary irritation (also known as allergic alveolitis).

Failure of liver function (also known as acute liver failure).

Frequency not known(cannot be estimated from available data):

Heart attack, changes in the electrocardiogram-ECG (prolongation of QT), and severe allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue, or throat, or itchy rash.

This medicine may cause a loss of bone density in men receiving treatment for prostate cancer. Abiraterona in combination with prednisone or prednisolone may increase this loss of bone density.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and themedicines that you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. In this way, you will help protect the environment.

Composition of Abiraterona Normon

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are siliconized microcrystalline cellulose (composed of microcrystalline cellulose and anhydrous colloidal silica), sodium croscarmellose, hypromellose 2910, lactose monohydrate, magnesium stearate, anhydrous colloidal silica, and sodium lauryl sulfate (see section 2. “Abiraterona Normon contains lactose and sodium”). The film coating contains iron oxide black (E-172), iron oxide red (E-172), iron oxide yellow (E-172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Abiraterona Normon tablets are red-beige, oval-shaped, film-coated, with “500” engraved on one side.

Each 28-day pack contains 56 film-coated tablets.

Each 30-day pack contains 60 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Responsible for manufacturing

Leon Farma Laboratories, S.A.

Navatejera Industrial Estate.

C/ La Vallina s/n - 24008 Villaquilambre - Leon (SPAIN)

Liconsa Laboratories, S.A.

Av. Miralcampo, 7 - 19200 Azuqueca de Henares - Guadalajara (SPAIN)

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

This medicine is authorized in the member states of the European Economic Area with the following names

NetherlandsAbirateron Normon 500 mg Filmomhulde tabletten

SpainAbiraterona Normon 500 mg comprimidos recubiertos con película EFG

PortugalAbiraterona Normon

Last review date of this leaflet: 11/2024

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