ABIRATERONE KERN PHARMA 500 mg FILM-COATED TABLETS

1. What is Abiraterone Kern Pharma and what is it used for

Abiraterone Kern Pharma 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. This medicine stops your body from making testosterone; this can slow down the growth of your prostate cancer.

When this medicine 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 potassium levels in your blood.

2. What you need to know before you take Abiraterone Kern Pharma

Do not take Abiraterone Kern Pharma

• 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 is only for use 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 not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told you have high blood pressure or heart failure or low potassium levels in your blood (low potassium levels in your 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 beat
• 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 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 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 fatal.

A decrease in the number of red blood cells, reduced sexual desire, and cases of muscle weakness and/or muscle pain may occur.

This medicine should not be taken 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 medicine and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment.

If you are not sure 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 you are taking this medicine, your doctor will do regular blood tests to check for any effects on your liver.

Children and adolescents

This medicine should not be used in children or adolescents. If a child or adolescent accidentally takes this medicine, they should go to the hospital immediately and bring this leaflet to show the emergency doctor.

Other medicines and Abiraterone Kern Pharma

Talk to 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 this medicine can increase the effects of a number of medicines, including heart medicines, sedatives, some diabetes medicines, herbal medicines (e.g. St. John's Wort), and others. Your doctor may consider changing the dose of these medicines. Also, some medicines can increase or decrease the effects of abiraterone. This can lead to side effects or this medicine 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

• 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)].

Talk to your doctor if you are taking any of the medicines listed above.

Taking Abiraterone Kern Pharma with food

• This medicine should not be taken with food (see section 3, “How to take this medicine”).
• Taking this medicine 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 contraceptive method.
• If you have sex with a pregnant woman, you must use a condom to protect the fetus.

Driving and using machines

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

Abiraterone Kern Pharma contains 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 23 mg of sodium (1mmol) per tablet; this is essentially “sodium-free”.

3. How to take Abiraterone Kern Pharma

Follow exactly the instructions of your doctor. If you are not sure, consult your doctor or pharmacist.

How much to take

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

How to take Abiraterone Kern Pharma

• Take this medicine by mouth.
• Do not take this medicine with food.Taking abiraterone with food can cause your body to absorb more medicine than necessary, which can cause side effects.
• Take this medicine as a single dose once a day on an empty stomach. Abiraterone should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking abiraterone (see section 2, “Abiraterone Kern Pharma with food”).
• 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 your doctor tells you.
• 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.

Your doctor may also prescribe other medicines while you are taking this medicine and prednisone or prednisolone.

If you take more Abiraterone Kern Pharma than you should

If you take more than you should, talk to your doctor or go to the hospital immediately.

In case of overdose or accidental ingestion, talk to 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 take Abiraterone Kern Pharma

• 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, talk to your doctor immediately.

If you stop taking Abiraterone Kern Pharma

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 taking this medicine and see a doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions, or rapid heart rate (palpitations). These can 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 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 heart rhythm (atrial fibrillation), heart failure, fast heart rate, severe infections (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).

Frequency not known(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. This medicine 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 Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Kern Pharma

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 and blister 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Kern Pharma

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

Appearance of the product and pack contents

• The tablets are purple, oval-shaped (20 mm long and 10 mm wide), with a biconvex beveled edge, film-coated, with “A” engraved on one side and “500” on the other side.
• Each 30-day pack contains 60 film-coated tablets.

Marketing authorisation holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

• Martinho do Bispo

3045-016 Coimbra

Portugal

or

Bluepharma - Indústria Farmacêutica, S.A.

Eiras, Rua Adriano Lucas

3020-430 Coimbra

Portugal

Date of last revision of this leaflet:June 2024

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/