ABIRATERONE QILU 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abiraterone Qilu500mg 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 Qilu and what is it used for
2. What you need to know before you take Abiraterone Qilu
3. How to take Abiraterone Qilu
4. Possible side effects
5. Storage of Abiraterone Qilu
6. Contents of the pack and other information

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

Abiraterone Qilu 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 slow down 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 levels of a chemical called potassium in your blood.

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

Do not takeAbiraterone Qilu

• 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 levels of potassium in the blood (low levels of potassium 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 a medicine called ketoconazole in the past 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) can 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 given 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 do not have any symptoms. While you are taking this medicine, your doctor will perform regular blood tests to check for any effects on your liver.

Children and adolescents

This medicine should not be used in children and 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 andAbiraterone Qilu

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, 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 can increase or decrease the effects of abiraterone. This can lead to side effects or abiraterone not working 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 for heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol); or medicines 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 Qiluwith food

• Do not take this medicine with food (see section 3, "How to take this medicine").
• Taking abiraterone with food can cause side effects.

Pregnancy and breastfeeding

This medicine 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 method of birth control.
• If you have sex with a pregnant woman, you must use a condom to protect the fetus.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or minimal.

Abiraterone Qilucontains lactose and sodium

• This medicine 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 less than 1 mmol of sodium (23 mg) per dose of two tablets; this is essentially "sodium-free".

3. How to take Abiraterone Qilu

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

How to take this medicine

• Take this medicine orally.

- Taking Abiraterone Qilu with food may cause your body to absorb more medicine than necessary and this can cause side effects.

- (See section 2, "

• Swallow the tablets whole with water.
• Do not break the tablets.
• This medicine is given together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as told by your doctor.
• You will need to take prednisone or prednisolone every day while you are taking this medicine.
• 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 amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

It is also possible that your doctor will prescribe other medicines while you are taking this medicine and prednisone or prednisolone.

If you take moreAbiraterone Qiluthan 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 takeAbiraterone Qilu

• If you forget to take this medicine or prednisone or prednisolone, take your normal dose the next day.
• If you forget to take this medicine or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you stop takingAbiraterone Qilu

Do not stop taking this medicine 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 takingabirateroneand contact your doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions, or rapid heartbeat (palpitations).

These can be signs of low levels of potassium 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 levels of potassium in the blood
• increases in 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):

• Problems with the adrenal glands (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 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Qilu

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 after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition ofAbiraterone Qilu

• The active substance is abiraterone acetate. Each film-coated tablet contains

500 mg of abiraterone acetate.

• The other ingredients are Lactose monohydrate, Hypromellose (E464), Croscarmellose sodium (E468), Sodium lauryl sulfate (E487), Microcrystalline cellulose (E460), Magnesium stearate (E572), Silica, colloidal anhydrous (Silicon dioxide) (E551). (See section 2, "Abiraterone Qilu contains lactose and sodium"). The film coating contains Poly(vinyl alcohol) (E1203), Titanium dioxide (E171), Macrogol (E1521), Talc (E533b), Iron oxide red (E172), Iron oxide black (E172).

Appearance and packaging

• Abiraterone Qilu tablets are oval, film-coated tablets, light purple in color (20.1 mm in length x 10.1 mm in width), engraved with "125" on one side.
• Each carton contains 56 or 56 x 1 film-coated tablets in 4 blisters

with 14 film-coated tablets each.

• Each carton contains 60 x 1 film-coated tablets in 5 blisters with

12 film-coated tablets each.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Qilu Pharma Spain S.L.

Paseo de la Castellana 40,

8th floor, 28046 - Madrid

Spain

Manufacturer

Kymos, S.L.

Ronda de Can Fatjó

7B (Parque Tecnológico del Vallès)

Cerdanyola del Vallès, 08290 Barcelona

Spain

Or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

Alcobendas, 28108 Madrid

Spain

Or

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road,

Portmarnock, Co. Dublin,

Ireland

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 – Barcelona

Spain

Tel.: +34 93 342 7890

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: August 2024

Other sources of information

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