ABIRATERONE TECNIGEN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abiraterone Tecnigen 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 Tecnigen and what is it used for
2. What you need to know before you take Abiraterone Tecnigen
3. How to take Abiraterone Tecnigen
4. Possible side effects

5 Conservation of Abiraterone Tecnigen

1. Contents of the pack and further information

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

Abiraterone Tecnigen 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 makes your body stop producing testosterone; this can delay the growth of prostate cancer.

When abiraterone is prescribed in the early stages of the disease and there is still a response to hormonal treatment, it is used together 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 high blood pressure, fluid retention, or low potassium levels in your blood.

2. What you need to know before you take Abiraterone Tecnigen

Do not take Abiraterone Tecnigen

• 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 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 unsure, 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 the blood (low potassium levels in the blood can increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have a fast or irregular heart rate
• 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 may 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 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 and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment.

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

Blood tests

Abiraterone may affect your liver even if you have no symptoms. While you are taking this medicine, your doctor will perform regular 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, they should go to the hospital immediately and bring this leaflet with them to show the emergency doctor.

Other medicines and Abiraterone Tecnigen

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 can increase the effects of certain 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, which can lead to side effects or reduced efficacy.

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 above medicines.

Abiraterone with food

This medicine should not be taken with food (see section 3, "How to take this medicine").

Taking Abiraterone with food can cause side effects.

Pregnancy and breastfeeding

Abiraterone is not indicated in women.

• This medicine may harm the fetus if taken by a pregnant woman.
• If you have sex with a woman of childbearing age, you must use a condom and another effective contraceptive method.
• If you have sex 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 use tools or machines.

Abiraterone contains lactose and sodium

Abiraterone contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains 23.6 mg of sodium (a major component of table salt/cooking salt) in each dose of two tablets. This is equivalent to 1.18% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterone Tecnigen

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, 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 medicine

• Take this medicine orally.
• Do not take abiraterone with food. Taking abiraterone with food can cause your body to absorb more medicine than necessary, leading to side effects.
• Take the abiraterone tablets as a single dose once a day on an empty stomach. Abiraterone should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking abiraterone (see section 2, "Abiraterone Tecnigen with food").
• Swallow the tablets whole with water.
• Do not break 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, it may be necessary 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.

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

If you take more Abiraterone Tecnigen 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Abiraterone Tecnigen

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 Tecnigen

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

• Muscle weakness, muscle contractions, or rapid heartbeat (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 heartbeat (atrial fibrillation), heart failure, fast heartbeat, 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 salt and water problems), 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).

Frequency not known(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 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 or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Abiraterone Tecnigen

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 label, blister, and carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

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

6. Contents of the pack and further information

Composition of Abiraterone Tecnigen

The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.

The other ingredients are: tablet core: microcrystalline cellulose (silicified), microcrystalline cellulose, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, and sodium lauryl sulfate (see section 2, "Abiraterone Tecnigen contains lactose and sodium"). film coating: iron oxide black (E172), iron oxide red (E172), macrogol, polyvinyl alcohol, talc, and titanium dioxide.

Appearance and packaging

Abiraterone Tecnigen tablets are pink, elliptical, and biconvex.

Abiraterone Tecnigen tablets are packaged in PVC/PE/PVDC-ALU blisters with 56 or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Farmoz Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, nº 2, Abrunheira

2710-228 Sintra (Portugal)

Manufacturer

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos (Portugal)

Local representative of the marketing authorisation holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Date of last revision of this leaflet:July 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).