Product Information for the User

Abiraterone Kern Pharma500mg Film-Coated TabletsEFG

Abiraterone Acetate

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 product information. See section 4.

Abiraterona Kern Pharma contains a medicine 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. This medicine makes your body stop producing testosterone; in this way it can slow down the growth of prostate cancer.

When this medicine is prescribed in the early stages of the disease and there is still a response to hormone treatment, it is used together with a treatment to reduce testosterone (androgen deprivation treatment).

When you take this medicine, your doctor will prescribe another medicine called prednisone or prednisolone, to reduce the possibility of suffering 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 take Abiraterona Kern Pharma

• if you are allergic to abiraterone acetate or any of the other components of this medication (listed in section 6).
• if you are a woman, especially if you are pregnant. This medication 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 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 heart rhythm
• 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 withprednisone orprednisolone
• 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 problems, including heart rhythm problems (arrhythmia), or are being treated with medications 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, 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 medication 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 this medication and prednisone/prednisolone, you should wait 5 days before starting 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

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

Children and adolescents

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

Other medications and Abiraterona Kern Pharma

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 this medication 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 abiraterone. This may lead to adverse effects or this medication may not work as well as it should.

The androgen deprivation treatment 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), moxifloxacino (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

Taking Abiraterona Kern Pharma with food

• This medication should not be taken with food (see section 3, “How to take this medication”).
• Taking this medication with food may cause adverse effects.

Pregnancy and breastfeeding

This medication is not indicated in women.

• This medication 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 medication will affect your ability to drive and use tools or machines.

Abiraterona Kern Pharma contains lactose and sodium

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

This medication contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”.

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 tablets) once a day.

How to take Abiraterona Kern Pharma

• Take this medication orally.
• Do not take this medication with food.Taking abiraterone with food may cause the body to absorb more medication than necessary, which may lead to side effects.
• Take this medication as 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 at least one hour after taking abiraterone (see section 2, “Abiraterone Kern Pharma 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 need 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 inform 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.

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

If you take more Abiraterona Kern Pharma 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 Kern Pharma

• 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 Kern Pharma

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 may cause side effects, although not everyone will experience them.

Stop taking this medicine and 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 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):

Pulmonary irritation (also known as allergic alveolitis). Failure of liver function (also known as acute liver insufficiency).

Frequency not known(cannot be estimated from 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 medicine in combination with prednisone or prednisolone may increase this bone density loss.

Reporting 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 to 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 blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Abiraterona Kern Pharma

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are: lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate (see section 2. “Abiraterona Kern Pharma contains lactose and sodium”), microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate. The film coating contains iron oxide black (E172), iron oxide red (E172), macrogol, polyvinyl alcohol, talc, and titanium dioxide.

Appearance of the product and content of the container

• The tablets are purple, oval-shaped (20 mm in length by 10 mm in width), with a biconvex bisected edge, film-coated, with “A” engraved on one face and “500” on the other face.
• Each 30-day box contains 60 film-coated tablets.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

Bluepharma - Indústria Farmacêutica, S.A.

S. Martinho do Bispo

3045-016 Coimbra

Portugal

or

Bluepharma - Indústria Farmacêutica, S.A.

Eiras, Rua Adriano Lucas

3020-430 Coimbra

Portugal

Last review date of this leaflet: June 2024

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