ABIRATERONE TEVA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abiraterone Teva 500 mg film-coated tablets EFG

Abiraterone acetate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get 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 Abiraterone Teva and what is it used for
2. What you need to know before you take Abiraterone Teva

1. How to take Abiraterone Teva
2. Possible side effects

1. Storage of Abiraterone Teva
2. Contents of the pack and other information

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

Abiraterone Teva 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. Abiraterone acetate works by stopping your body from making testosterone; this can slow down the growth of your prostate cancer.

When abiraterone acetate is prescribed in the early stages of the disease and there is still response to hormonal treatment, it is used together with treatment to lower 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 Abiraterone Teva

Do not take Abiraterone 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 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 may increase your risk of heart rhythm problems)

• if you have had other heart or blood vessel problems
• if you have a fast or irregular heart beat

• 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 or symptoms of liver problems. Rarely, liver failure (called acute hepatic failure) may 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 acetate should not be taken 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 treatment with Ra-223.

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 acetate 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 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 go to the hospital immediately and bring this leaflet with them to show the emergency doctor.

Other medicines and Abiraterone Teva

Consult your doctor or pharmacist before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because abiraterone acetate may increase the effects of a number of 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 acetate. This may lead to side effects or abiraterone acetate may not work as well as it should.

Androgen deprivation therapy 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 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

Abiraterone acetate is not indicated in women.

• This medicine may harm the fetus if taken by a pregnant woman.
• Pregnant or potentially pregnant women should wear gloves if they have to touch or handle abiraterone acetate.

• 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.

Abiraterone Teva 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 less than 23 mg of sodium (1 mmol) per dose; this is essentially sodium-free.

3. How to take Abiraterone Teva

Follow exactly the instructions of your doctor. If you are not sure, consult your doctor or pharmacist.

How much to take

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

How to take this medicine

• Take this medicine by mouth.

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

• Abiraterone acetate 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 acetate.
• 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 dose of prednisone or prednisolone. 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 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 your normal 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 stop taking Abiraterone Teva

Do not stop taking abiraterone acetate 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 Teva and contact your doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions, or rapid heart beat (palpitations). These 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 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 heart beat (atrial fibrillation), heart failure, rapid heart beat, severe infections called sepsis, bone fractures, indigestion, blood in the urine, skin rash.

Uncommon(may affect up to 1 in 100 people):

• Adrenal gland problems (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 (called acute hepatic failure).

Not known(frequency 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 acetate 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Teva

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, blister, and tablet packaging. The expiry date is the last day of the month stated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. If you are not sure what to do with unused medicines, ask your pharmacist for advice. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Teva

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate, which is equivalent to 446.3 mg of abiraterone.
• The other ingredients are: lactose monohydrate, sodium lauryl sulfate, croscarmellose sodium, 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 and packaging

Abiraterone Teva are yellow, oblong, film-coated tablets with “A436” engraved on one side.

Abiraterone Teva is available in blister packs of 14, 56, 60, and 120 film-coated tablets and in unit dose blister packs of 14x1, 56x1, 60x1, and 120x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva B.V.

Swensweg 5

2031GA Haarlem Netherlands

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

Date of last revision of this leaflet: May 2022

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/)