Abiraterone Tarbis 250 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Abiraterone Tarbis 250 mg film-coated tablets EFG

abiraterone acetate

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Abiraterone Tarbis is and what it is used for
2. What you need to know before taking Abiraterone Tarbis
3. How to take Abiraterone Tarbis
4. Possible side effects
5. How to store Abiraterone Tarbis
6. Contents of the pack and other information

1. What Abiraterona Tarbis is and what it is used for

Abiraterona contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men in whom the cancer has spread to other parts of the body. Abiraterone causes your body to stop producing testosterone; thus, it can slow down the growth of prostate cancer.

When Abiraterona is prescribed at earlier stages of the disease and there is still response to hormonal treatment, it is used in combination with a therapy 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 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 starting to take Abiraterone Tarbis

Do not take Abiraterone Tarbis

• 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 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 apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you have liver problems;
• if you have been diagnosed with high blood pressure, heart failure, or low potassium levels in the blood (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, darkened urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, liver function failure (called acute hepatic failure) may occur, which can lead to death.

A decrease in red blood cells, reduced sex drive, and cases of muscle weakness and/or muscle pain may occur.

Abiraterone 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 and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

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

Blood tests

Abiraterone 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 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, seek immediate medical attention at a hospital and bring the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Tarbis

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 may increase the effects of a number of medicines, including those for heart conditions, tranquilizers, 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. This could lead to adverse effects or reduced effectiveness of abiraterone.

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)].

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

Abiraterone Tarbis with food

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

Pregnancy and breastfeeding

Abiraterone 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 suspect they may be pregnant must wear gloves if they need to handle abiraterone.
• 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 machinery.

Abiraterone Tarbis contains lactose

Abiraterone contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Abiraterone Tarbis contains sodium

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

3. How to take Abiraterone Tarbis

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 (four 250 mg tablets) once daily.

How to take this medicine

• Take this medicine by mouth.
• Do not take this medicine with food. Taking abiraterone with food may cause your body to absorb more medication than needed, which may lead to side effects.
• Take abiraterone tablets as a single daily dose on an empty stomach. Abiraterone should be taken at least two hours after eating, and no food should be consumed for at least one hour after taking abiraterone. (See section 2, “Abiraterone Tarbis with food”). Swallow the tablets whole with water.
• Do not split the tablets.
• Abiraterone 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.
• 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 in your prednisone or prednisolone dose is necessary. Do not stop taking prednisone or prednisolone unless instructed by your doctor.

Your doctor may also prescribe other medicines while you are taking abiraterone and prednisone or prednisolone.

If you take more Abiraterone 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Abiraterone Tarbis

• If you forget to take abiraterone or prednisone or prednisolone, take your 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 stop taking Abiraterone Tarbis

Do not stop taking abiraterone or prednisone or prednisolone unless instructed by your doctor.

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

4. Possible adverse effects

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

Stop taking Abiraterone Tarbis and contact your doctor immediately if you experience any of the following symptoms:

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

Other adverse effects include:

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

Fluid retention in the legs or feet, decreased blood potassium levels, elevations in liver function tests, 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):

Problems with the adrenal glands (related to disturbances in salt and water balance), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.

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

Lung inflammation (also known as allergic alveolitis).

Liver function failure (also known as acute liver failure).

Frequency not known (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 in combination with prednisone or prednisolone may increase this bone density loss.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Tarbis

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

Do not use this medicine after the expiry date stated on the carton and on the blister or bottle. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Tarbis

The active substance is abiraterone acetate.

Each film-coated tablet contains 250 mg of abiraterone acetate.

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

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

Appearance of the product and contents of the pack

White, oval-shaped, film-coated tablets, engraved with "H" on one side and "A1" on the other, free from physical defects. (Dimensions: 14.60 mm x 8.60 mm).

Al-Al blister pack containing 120 film-coated tablets in a blister with unit-dose perforations of 120 x 1 film-coated tablets.

HDPE bottle:

120 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Abirateron Amarox 250 mg Filmtabletten

Netherlands: Abirateron Amarox 250 mg filmomhulde tabletten

Spain: Abiraterona Tarbis 250 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: December 2022

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