Prospecto: information for the user

Abiraterona Qilu500mg coated tablets EFG

abiraterona acetate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

Content of the prospect

1. What isAbiraterona Qiluand for what it is used
2. What you need to know before starting to takeAbiraterona Qilu
3. How to takeAbiraterona Qilu
4. Possible adverse effects
5. Storage ofAbiraterona Qilu
6. Contents of the package and additional information

Abiraterona Qilucontains a medication called abiraterone acetate. It is used for the treatment of prostate cancer in adult men whose cancer has spread to other parts of the body.Abirateronacauses your body to stop producing testosterone; in this way, it can delay the growth of prostate cancer.

Whenabirateronais prescribed in the early stages of disease and there is still a response to hormonal treatment, it is used in combination with a treatment to reduce testosterone levels (androgen deprivation treatment).

When you take this medication, your doctor will also prescribe another medication called prednisone or prednisolone, to reduce the possibility of experiencing an increase in blood pressure, accumulating too much fluid in your body (fluid retention) or decreasing the levels of a chemical called potassium in your blood.

Do not takeAbiraterona Qilu

• if you are allergic to abiraterone acetate or any of the other ingredients in this medicine (listed in section6).
• if you are a woman, especially if you are pregnant.Abirateronashould only be used in male patients.
• if you have a serious liver disease.
• when combined with Ra-223 (used to treat 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 to takethis 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 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 taken in the past a medicine called 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.

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

Inform 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 liver failure) may occur, which can be fatal.

You may experience a decrease in the number of red blood cells in your blood, reduced sex drive, and cases of muscle weakness and/or muscle pain.

Abirateronashould not be administered in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.

If you plan to take Ra-223 after treatment withabirateronaand prednisone/prednisolone, you should wait 5 days before starting the treatment with Ra-223.

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

Blood tests

Abirateronamay affect your liver even if you have no symptoms. While you are taking this medicine, your doctor will make periodic blood tests to monitor any effect on your liver.

Children and adolescents

This medicine should not be used in children or adolescents. If a child or adolescent accidentally ingestsabirateronathey should immediately go to the hospital and bring the leaflet with them to show to the emergency doctor.

Other medicines andAbiraterona Qilu

Consult your doctor or pharmacist before taking any other medicine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is important becauseabirateronamay increase the effects of a range of 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 may increase or decrease the effects ofabiraterona. This may lead to side effects orabirateronanot working as well as it should.

The androgen deprivation therapy may increase the risk of heart rhythm problems. Inform 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 with your doctor if you are taking any of the medicines listed above.

Abiraterona Qiluwith food

• Do not take this medicine with food (see section3, “How to take this medicine”).
• Takingabirateronawith food may cause side effects.

Pregnancy and breastfeeding

This medicine is not indicated in women.

• This medicine may be harmful to the fetus if a pregnant woman takes it.
• If you have sex with a fertile woman, you should use a condom and another effective contraceptive method.
• If you have sex with a pregnant woman, you should use a condom toprotect the fetus.

Driving and operating machinery

This medicine has no or negligible influence on your ability to drive and use machines.

Abiraterona Qilucontains lactose and sodium

• This medicine contains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.
• This medicine contains less than 1mmol of sodium (23mg) per dose of two tablets; this is, essentially“sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

How to take this medication

• Take this medication orally.

-Do not take this medication with food.

• Takethis medicationat least one hour before or at least two hours after taking any food(see section 2, «Abiraterone Qiluwith food»).
• Swallow the tablets whole with water.
• Do not break the tablets.
• This medication is administered with a medication 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 taking this medication.
• 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 modify the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

Your doctor may also prescribe other medications while you are taking this medication 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeAbiraterone Qilu

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

If you interrupt the treatment withAbiraterone Qilu

Do not stop takingthis medicationor prednisone or prednisolone unless your doctor tells you to.

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

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

Stop takingabirateroneand seek medical attention immediately if you experience any of the following side effects:

• Muscle weakness, muscle cramps, 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 10people):

• Fluid retention in the legs or feet
• Decreased potassium levels in the blood
• Elevations in liver function tests
• High blood pressure
• Urinary tract infection
• Diarrhea.

Common(may affect up to 1 in 10people):

• High levels of fats in the blood
• Chest pain
• Irregular heartbeat (atrial fibrillation)
• Heart failure
• Tachycardia
• Severe infections called sepsis
• Bone fractures
• Indigestion,
• Blood in the urine
• Skin rash

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

• Problems with the adrenal glands (related to issues with salt and water)
• Abnormal heart rhythm (arrhythmia)
• Muscle weakness and/or muscle pain

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

• Irritation in the lungs (also known as allergic alveolitis)
• Failure of liver function (also known as acute liver failure)

Unknown(the frequency cannot be estimated from available data):

• Heart attack
• Changes in the electrocardiogram-ECG (prolongation of QT)
• Severe allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue, or throat, or itchy rash

This medicine may cause bone density loss in men receiving treatment for prostate cancer.Abirateronein combination with prednisone or prednisolone may increase this bone density loss.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, on the cardboard carton, and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAbiraterona Qilu

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

500 mg of abiraterone acetate.

• The other components are Lactose monohydrate, Hypromellose(E464),Croscarmellose sodium(E468),Laurilsulfate of sodium(E487),Microcrystalline cellulose(E460),Magnesium stearate(E572),Silica colloidal anhydrous (silicon dioxide)(E551). (see section 2.«Abiraterona Qilu contains lactose and sodium»). The film coating containsPoly(vinyl alcohol)(E1203),Titanium dioxide(E171),Macrogol(E1521),Talc(E533b),Iron oxide red (E172), Iron oxide black (E172).

Appearance of the product and contents of the package

• The Abiraterona Qilu tablets are oval-shaped, film-coated tablets with a light brown color (20.1mm in length x 10.1mm in width), engraved with “125”on one side.
• Each box contains 56 or 56 x1film-coated tablets in 4blister packs

with 14film-coated tablets each.

• Each box contains 60 x1 film-coated tablets in 5 blister packs with

12 film-coated tablets each.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Qilu Pharma Spain S.L.

Paseo de la Castellana 40,

floor 8, 28046 - Madrid

Spain

Responsible for manufacturing

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

Phone: +34 93 342 7890

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: April 2022

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/