Abiraterone Teva 500 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Abiraterone Teva

3. How to take Abiraterone Teva

4. Possible side effects

5. How to store Abiraterone Teva

6. Contents of the pack and other information

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

Abiraterone Teva contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men when the disease has spread to other parts of the body. Abiraterone acetate causes your body to stop producing testosterone; this can help slow down the growth of prostate cancer.

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

When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone, to reduce the risk of developing high blood pressure, fluid retention (accumulation of excess fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before taking Abiraterone Teva

Do not take Abiraterone Teva

• if you are allergic to abiraterone acetate or to any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if you are pregnant. Abiraterone acetate is intended for use only 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 apply to you. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• if you have liver problems

• if you have been diagnosed with high blood pressure, heart failure, or low blood potassium levels (low potassium levels 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 gained weight rapidly

• if you have swelling in your feet, ankles, or legs

• if you have previously taken a medicine called ketoconazole for prostate cancer

• regarding the need to take this medicine with prednisone or prednisolone

• about possible adverse effects on your bones

• if you have high blood sugar levels.

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

Inform your doctor if you develop 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 function failure (called acute liver failure) may occur, which can lead to death.

A decrease in red blood cell count, reduced sexual desire, and cases of muscle weakness and/or muscle pain may occur.

Abiraterone acetate must 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 must wait 5 days before starting treatment with Ra-223.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone acetate may affect your liver even if you do not have any symptoms. While you are taking this medicine, your doctor will perform periodic blood tests to monitor 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 acetate, seek immediate medical attention at a hospital and bring this leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Teva

Talk to your doctor or pharmacist before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because abiraterone acetate may increase the effects of several medicines, including medicines for the heart, sedatives, certain diabetes medicines, herbal medicines (e.g., St. John’s wort), and others. Your doctor may consider adjusting the dose of these medicines. In addition, some medicines may increase or decrease the effects of abiraterone acetate. This could lead to adverse effects or reduced effectiveness of abiraterone acetate.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking 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 serious mental illnesses)].

Talk to your doctor if you are taking any of the medicines listed above.

Abiraterone Teva with food

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

Pregnancy and breastfeeding

Abiraterone acetate is not indicated for use in women.

• This medicine may be harmful to the fetus if taken by a pregnant woman.

• Pregnant women or women who may be pregnant must wear gloves if they need to handle abiraterone acetate.

• If you have sexual intercourse with a woman of childbearing age, 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 using machines

It is unlikely that this medicine will affect your ability to drive or operate tools or machines.

Abiraterone Teva contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, 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.

3. How to take Abiraterone Teva

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

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

How to take this medicine

• Take this medicine by mouth.

• Do not take Abiraterone Teva with food. Taking abiraterone acetate with food may increase the amount of medicine absorbed by the body beyond the intended level, which could lead to adverse effects.

• Take abiraterone acetate as a single daily dose on an empty stomach. Abiraterone acetate should be taken at least one hour before or at least two hours after eating any food (see section 2, “Abiraterone Teva with food”).

• Swallow the tablets whole with water.

• Do not split the tablets.

• Abiraterone acetate is administered together with a medicine 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 you are taking abiraterone acetate.

• If you have a medical emergency, the dose of prednisone or prednisolone you are taking may need to be adjusted. Your doctor will advise you if any change to your prednisone or prednisolone dose is necessary. 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 usual dose the next day.
• If you forget to take abiraterone acetate or prednisone or prednisolone for more than one day, contact 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 about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Stop taking Abiraterone Teva and contact your doctor immediately if you experience any of the following side effects:

• Muscle weakness, muscle twitching, or increased heart rate (palpitations). These may be signs of low potassium levels in your blood.

Other adverse effects are:

Very common (may affect more than 1 in 10 people):

• Fluid retention in the legs or feet, low blood potassium levels, increased liver function test results, high blood pressure, urinary tract infection, diarrhoea.

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, serious 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 salt and water imbalances), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.

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

• Lung irritation (also known as allergic alveolitis).
• Liver function failure (also called acute liver failure).

Not known (frequency cannot be estimated from available data):

• Heart attack, changes in electrocardiogram-ECG (QT prolongation), and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, 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 adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the carton, the cardboard box, and the blister pack. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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, equivalent to 446.3 mg of abiraterone.
• The other components are: monohydrate lactose, sodium lauryl sulfate, sodium croscarmellose, microcrystalline cellulose, povidone, magnesium stearate, and colloidal anhydrous 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 contents of the pack

Abiraterone Teva are yellow, oblong, film-coated tablets, marked with "A436" on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva B.V.

Swensweg 5

2031GA Haarlem, Netherlands

The 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.

Anabel Segura, 11, Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid

Spain

Date of the most recent review 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/)