Label: Information for the User

Abiraterone Tarbis 500 mg Film-Coated Tablets

abiraterone acetate

Read this label carefully before you start taking this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult 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 even if they are not listed in this label. See section 4.

Abiraterona 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. Abiraterona causes the body to stop producing testosterone, thereby slowing the growth of prostate cancer.

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

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

Do not take Abiraterona Tarbis

• if you are allergic to abiraterona acetate or any of the other ingredients of this medicine (listed in section 6).
• 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 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 this medicine:

• if you have liver problems,
• if you have been told 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 heartbeat,
• 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 medicine known as 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 levels of sugar in the blood.

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

Inform 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 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 increase in the 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 medicine.

Blood tests

Abiraterona may affect your liver even if you have no symptoms. While taking this medicine, your doctor will make periodic blood tests to monitor 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 abiraterona, they should immediately go to the hospital and bring the leaflet with them to show to the emergency doctor.

Other medicines and Abiraterona Tarbis

Consult your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is important because abiraterona may increase the effects of a series of medicines including heart medicines, tranquilizers, 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 abiraterona. This 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 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), moxifloxacine (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

Abiraterona Tarbis with food

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

Pregnancy and breastfeeding

Abiraterona is not indicated in women.

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

Abiraterona Tarbis contains lactose

Abiraterona 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 medicine.

Abiraterona Tarbis contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; this is, essentially “sodium-free”.

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 500mg tablets) once a day.

How to take this medication

• Take this medication orally.
• Do not take this medication with food. Taking abiraterone with food may cause the body to absorb more medication than necessary and this may cause side effects.
• Take abiraterone tablets as a single dose once a day with an empty stomach. Abiraterone should be taken at least two hours after eating and no food should be consumed at least one hour after taking abiraterone. (see section 2, “Abiraterone Tarbis 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 have 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 indicate 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.

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

If you take more Abiraterona Tarbis 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 forgot to take Abiraterona Tarbis

• If you forgot to take abiraterone or prednisone or prednisolone, take the usual dose the next day.
• If you forgot to take abiraterone or prednisone or prednisolone for more than a day, consult your doctor immediately.

If you interrupt the treatment with Abiraterona Tarbis

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

If you have any other doubts 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 Tarbis 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 insufficiency).

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: 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 or bottle. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

HDPE bottle (after opening): Use within 60 days.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Abiraterona Tarbis

The active ingredient is abiraterone acetate.

Each film-coated tablet contains 500 mg of abiraterone acetate.

Tablet core :lactose monohydrate, croscarmellose sodium, hypromellose 2910 (E464), lauryl sulfate of sodium, microcrystalline cellulose silicified (anhydrous colloidal silica and microcrystalline cellulose), anhydrous colloidal silica, magnesium stearate

Coating material:partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide(E171), macrogol(E1521)and talc(E553b)

Appearance of the product and content of the container

White film-coated tablets, oval in shape, engraved with "H" on one face and "A65" on the other face, free of physical defects. (Dimensions: 19.90 mm X 10.00 mm).

Aluminum blister pack containing 56 and 60 film-coated tablets in a single-dose perforated blister pack of 56 x 1 and/or 60 x 1 film-coated tablets.

HDPE bottle:

60 film-coated tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany:Abirateron Amarox 500 mg Filmtabletten

Netherlands:Abirateron Amarox 500 mg filmomhulde tabletten

Spain:Abiraterona Tarbis 500 mg film-coated tablets EFG

Last review date of this leaflet: December 2022

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/