Prospecto:Information for the User

Abiraterona Dr. Reddys 500 mg Film-Coated Tablets

Abiraterone Acetate

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Abiraterona Dr. Reddys and how is it used

2.What you need to knowbeforestarting totake Abiraterona Dr. Reddys

3.How to take Abiraterona Dr. Reddys

4.Possible adverse effects

5Storage of Abiraterona Dr. Reddys

6.Contents of the package and additional information

Abiraterona Dr. Reddys contains 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. Abiraterone causes the body to stop producing testosterone, thereby delaying the growth of prostate cancer.

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

When taking 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 the body (fluid retention) or decreasing the levels of a chemical called potassium in the blood.

Do not take Abiraterona Dr. Reddys:

• if you are allergic to abiraterone acetate or any of the other ingredients of this medication (listed in section 6).
• if you are a woman, especially if you are pregnant. Abiraterona should be used only 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 medication if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have liver problems
• if you have been told that 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 rapid or irregular heartbeat
• if you have difficulty breathing
• if you have rapidly gained weight
• if you have swelling in your feet, ankles, or legs
• if you have taken in the past a medication known as ketoconazole for prostate cancer
• about the need to take this medication with prednisone or prednisolone
• about possible adverse effects on your bones
• if you have high levels of sugar in the blood.

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

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 hepatic 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.

Abiraterona 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 abiraterona 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 medication.

Blood tests

Abiraterona may affect your liver even if you have no symptoms. While taking this medication, your doctor will perform blood tests periodically to monitor any effect on your liver.

Children and adolescents

This medication should not be used in children or adolescents. If a child or adolescent accidentally ingests abiraterona, they should immediately go to the hospital and bring the package insert with them to show to the emergency doctor.

Other medications and Abiraterona Dr. Reddys

Consult your doctor or pharmacist before taking any medication.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is important because abiraterona may increase the effects of a series of medications including heart medications, tranquilizers, some diabetes medications, herbal medications (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medications. Additionally, some medications may increase or decrease the effects of abiraterona, which may lead to adverse effects or abiraterona 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 medications

• 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 medications listed above.

Abiraterona Dr. Reddys with food

This medication should not be taken with food (see section 3, “How to take this medication”).

Taking abiraterona with food may cause adverse effects.

Pregnancy and breastfeeding

Abiraterona Dr. Reddys is not indicated in women.

Pregnant women or those who may be pregnant should wear gloves if they need to touch or handle Abiraterona Dr. Reddys.

This medication may be harmful to the fetus if a pregnant woman takes it.

If you have sexual intercourse with a fertile woman, you should use a condom and another effective contraceptive method.

If you have sexual intercourse with a pregnant woman, you should use a condom to protect the fetus.

Driving and operating machines

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

Abiraterona Dr. Reddys contains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains 24 mg of sodium (main component of table salt) in each dose of two 500 mg tablets. This is equivalent to 1% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of 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 500 mg tablets) once a day.

How to take this medication

Take this medication orally.

Do not take abiraterone with food.

Taking abiraterone with food may cause the body to absorb more medication than necessary, which may lead to side effects.

Take abiraterone tablets in a single dose once a day with 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 with food”).

Swallow the tablets whole with water.

Do not break the tablets.

Abiraterone is administered along 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 abiraterone.

If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. Your doctor will let you know 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 abiraterone and prednisone or prednisolone.

If you take more Abiraterone Dr. Reddys 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 forgot to take Abiraterone Dr. Reddys

If you forgot to take abiraterone or prednisone or prednisolone, take the usual dose the next day.

If you forgot to take abiraterone or prednisone or prednisolone for more than a day, consult your doctor immediately.

If you interrupt treatment with Abiraterone Dr. Reddys

Do not stop taking abiraterone or 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 taking Abiraterone Dr. Reddy's 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
• 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 10 people):

• High levels of fat in the blood
• Chest pain, irregular heartbeat (atrial fibrillation), heart failure, tachycardia
• Severe infections called sepsis
• Fractures of the bone
• 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):

• 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 the 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 a loss of bone density in men receiving treatment for prostate cancer. Abiraterone Dr. Reddy's in combination with prednisone or prednisolone may increase this loss of bone density.

Reporting of side effects

If you experience any type of side effect, consult your doctor, hospital pharmacist, or nurse, 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: https://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/or HDPE bottle and/or 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 containers and medications you no longer need at the SIGRE collection point at the 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 of Abiraterone Dr. Reddys

• The active ingredient is abiraterone acetate.
• Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, anhydrous colloidal silica, and magnesium stearate (core of the tablet); polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide red (E 172), and iron oxide black (E 172) (tablet coating).

Appearance of the product and contents of the package

Abiraterone Dr. Reddys 500 mg are oval-shaped, purple, film-coated tablets, approximately 19 mm in length by 11 mm in width, engraved with “A7TN” on one side and “500” on the other side.

Each blister pack contains 14, 56, 56x1, 60, 60x1, or 112 film-coated tablets.

Each bottle contains 60 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08039 Barcelona (Spain)

Phone: 93.355.49.16

Fax: 93.355.49.61

Responsible manufacturer

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

545 CM Nijmegen

Netherlands

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

Last review date of thisleaflet:March 2024

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/)