Label: information for the user

Abiraterona Teva 500 mg film-coated tablets EFG

Abiraterona acetate

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

1. How to take Abiraterona Teva
2. Possible adverse effects

1. Storage of Abiraterona Teva
2. Contents of the pack and additional information

Abiraterona Teva contains a medicine 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 acetate makes your body stop producing testosterone; in this way, it can delay the growth of prostate cancer.

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

When you take this medicine, your doctor will prescribe another medicine called prednisone or prednisolone, to reduce the possibility of suffering 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 Teva

• 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 acetate 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 fast 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 side 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 problems, including heart rhythm problems (arrhythmia), or are being treated with medicines 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 your blood, reduced sex drive, and cases of muscle weakness and/or muscle pain.

Abiraterone acetate 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 abiraterone acetate 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

Abiraterone acetate 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 abiraterone acetate, they should immediately go to the hospital and bring the leaflet with them to show to the emergency doctor.

Other medicines and Abiraterona Teva

Consult your doctor or pharmacist before taking any other 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 abiraterone acetate may increase the effects of a range 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 abiraterone acetate, which may lead to side effects or abiraterone acetate not working as well as it should.

The androgen deprivation therapy 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 Teva 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 acetate is not indicated in women.

• This medicine may be harmful to the fetus if a pregnant woman takes it.
• Pregnant women or those who may be pregnant should wear gloves if they have to touch or handle abiraterona acetate.

• If you have sexual intercourse with a fertile woman, you should use a condom and another effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, you should 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 Teva contains lactose and sodium

This medicine 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.

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

Follow exactly the administration instructions for 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.

How to take this medication

• Take this medication orally.

• Do not take Abiraterone Teva with food. Taking abiraterone acetate with food may cause the body to absorb more of the medication than necessary, which may lead to adverse effects.
• Take abiraterone acetate in a single dose once a day with an empty stomach. Abiraterone acetate should be taken at least one hour before or at least two hours after taking any food(see section 2, “Abiraterone Teva with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.

• Abiraterone acetate 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 acetate.
• If you have a medical emergency, you may need to adjust the amount of prednisone or prednisolone you take. Your doctor will let you know 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 acetate and prednisone or prednisolone.

If you take more Abiraterone Teva than you should

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

If you forget to take Abiraterone Teva

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

If you interrupt treatment with Abiraterone Teva

Do not stop taking abiraterone acetate 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 Teva and seek medical attention 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):

• Irritation in the lungs (also known as allergic alveolitis).
• Failure of liver function (also known as acute liver failure).

Unknown(frequency 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 acetate 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 of 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, on the cardboard case, and on the blister pack. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

Composition of Abiraterona Teva

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate, which is equivalent to 446.3 mg of abiraterone.
• The other components are: lactose monohydrate, sodium lauryl sulfate, sodium croscarmellose, microcrystalline cellulose, povidone, magnesium stearate, and anhydrous colloidal silica. The film coating contains: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), and yellow iron oxide (E172).

Appearance of the product and content of the container

Abiraterona Teva are yellow, oblong-shaped film-coated tablets with "A436" engraved on one face.

Abiraterona Teva is available in containers with a blister pack of 14, 56, 60, and 120 film-coated tablets, and in containers with a perforated single-dose blister pack of 14x1, 56x1, 60x1, and 120x1 film-coated tablets.

Only some sizes of containers may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031GA Haarlem Netherlands

Netherlands

Responsible manufacturer

Balkanpharma Dupnitsa AD,

Samokovsko Shosse 3, 2600

Dupnitsa, Bulgaria

Merckle GmbH,

Graf-Arco-Str. 3, 89079 Ulm

Germany

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80., 31-546 Krakow

Poland

Local representative:

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid

Spain

Last review date of this leaflet: May 2022

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