Package Insert: Information for the Patient

Abiraterone Cipla 500 mg Film-Coated Tablets

Abiraterone acetate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others 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 package insert. See section 4.

This medication contains abiraterone acetate. It is used for the treatment of prostate cancer in adult men who have spread to other parts of the body. This medication makes your body stop producing testosterone; in this way it can delay the growth of prostate cancer.

When this medication is prescribed in the initial stages of disease and there is still a response to hormonal treatment, it is used along with a treatment to reduce testosterone (androgen deprivation therapy).

When you take this medication, your doctor will prescribe another medication called prednisone or prednisolone, to decrease the possibility of suffering an increase in blood pressure, that you accumulate too much water in your body (fluid retention) or that you decrease the levels of a chemical called potassium in your blood.

Do not take Abiraterona Cipla

• 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. This medicine should only be used in male patients.
• if you have a serious 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 to take 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 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 rapidly gained weight
• if you have swelling in the 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 levels of sugar in the blood.

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 the blood, reduced sex drive, and cases of muscle weakness and/or muscle pain.

This medicine should 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 with this medicine and 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

This medicine may affect your liver even if you have no symptoms. While taking this medicine, your doctor will make blood tests periodically 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 ingests this medicine, they should immediately go to the hospital and bring the leaflet with them to show to the emergency doctor.

Other medicines and Abiraterona Cipla

Consult your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is important because this medicine may 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 of this medicine, which may lead to side effects or this medicine not 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), moxifloxacine (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

Abiraterona Cipla with food

• This medicine should not be taken with food (see section 3, “How to take this medicine”).
• The taking of this medicine with 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 sexual intercourse with a fertile woman, 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 operating machines

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

Abiraterona Cipla contains 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 him before taking this medicine
• This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free.”

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, 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 medication

• Take this medication orally.
• Do not take this medication with food.
• Take this medication at least one hour before or at least two hours after taking any food(see section 2, “Abiraterona Cipla with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• This medication is administered along with a medication called prednisone or prednisolone. Take prednisone or prednisolone exactly as instructed by your doctor.
• You will have to take prednisone or prednisolone every day while taking this medication.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. Your doctor will indicate 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.

You may also be prescribed other medications while taking this medication and prednisone or prednisolone.

If you take more Abiraterona Cipla 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Abiraterona Cipla

• 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 treatment with Abiraterona Cipla

Do not stop taking this medication or prednisone or prednisolone unless your doctor tells you to. If you have any other doubts 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 taking Abiraterona Cipla and seek medical attention immediately if you experience any of the following side effects:

• Muscle weakness, muscle cramps, or rapid heartbeat (palpitations). They 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 test results, high blood pressure, urinary tract infections, 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, tachycardia, 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 issues 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 known as allergic alveolitis).
Liver function failure (also known as acute liver failure).

Unknown(the frequency cannot be estimated from the available data):
Heart attack, changes in the electrocardiogram-ECG (prolongation of QT), and 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.This medicinein 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 tothrough 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 and blister pack. 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 packaging and unusedmedications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Abiraterona Cipla 500 mg tablets

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, laurilsulfate sodium (see section 2, “Abiraterona Cipla contains lactose and sodium”). The film coating contains ferrous oxide NF/iron oxide black, iron oxide red (E172), macrogol/PEG, partially hydrolyzed polyvinyl alcohol, talc, and titanium dioxide (E171).

Appearance of the product and contents of the package

• The tablets are purple, oval-shaped, with a biconvex bisected edge, film-coated, marked with “A” on one face and “500” on the other face. Dimensions: 7.00 mm- 8.00 mm in thickness; 20.1 ± 0.2 mm in length; 10.1 ± 0.2 mm in width.
• The tablets may be packaged in transparent PVC/PE/PVdC blisters with a hard aluminum foil backing coated with heat-sealed lacquer or in single-dose perforated blisters containing 56 and 60 film-coated tablets.
• Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder and manufacturer:

Cipla Europe NV

De Keyserlei 58-60, Box 19,

2018, Antwerp

Belgium

Local representative:

Cipla Europe NV subsidiary in Spain

C/Guzmán el Bueno, 133

Edif Britannia- 28003- Madrid, Spain

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

Last review date of this leaflet:June 2022

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