Abiraterone Kern Pharma 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Abiraterone Kern Pharma 500 mg film-coated tablets EFG

abiraterone acetate

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Contents of the package leaflet

1. What Abiraterone Kern Pharma is and what it is used for
2. What you need to know before taking Abiraterone Kern Pharma
3. How to take Abiraterone Kern Pharma
4. Possible side effects
5. How to store Abiraterone Kern Pharma
6. Contents of the pack and other information

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

Abiraterone Kern Pharma contains a medicine called abiraterone acetate. It is used for the treatment of prostate cancer in adult men when the disease has spread to other parts of the body. This medicine causes your body to stop producing testosterone; thus, it can slow the growth of prostate cancer.

When this medicine is prescribed at earlier stages of the disease and there is still response to hormonal treatment, it is used in combination 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 possibility of experiencing high blood pressure, fluid retention (accumulation of excess fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before starting 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 intended for use only 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 apply to you. If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low blood potassium levels (low blood potassium 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 previously taken a medicine called ketoconazole for prostate cancer
• regarding the need to take this medicine with prednisone or prednisolone
• regarding possible adverse effects on your bones
• if you have high blood sugar levels.

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

Inform your doctor if you develop 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 function failure (called acute liver failure) may occur, which can lead to death.

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

This medicine must 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 medicine and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

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

Blood tests

This medicine may affect your liver even if you do not have any symptoms. While taking this medicine, your doctor will perform periodic blood tests to monitor for any effects on your liver.

Children and adolescents

This medicine must not be used in children or adolescents. If a child or adolescent accidentally ingests this medicine, seek immediate medical attention and bring the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Kern Pharma

Consult your doctor or pharmacist before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because this medicine may increase the effects of a number of medicines, including those for heart conditions, tranquilizers, certain diabetes medicines, herbal medicines (e.g., St. John’s wort), and others. Your doctor may consider adjusting the dose of these medicines. In addition, some medicines may increase or decrease the effects of abiraterone, which could lead to adverse effects or reduce the effectiveness of this medicine.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking any of the following medicines:

• used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, 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 must not be taken with food (see section 3, “How to take this medicine”).
• Taking this medicine with food may cause adverse effects.

Pregnancy and breastfeeding

This medicine is not intended for use in women.

• This medicine may be harmful to the fetus if taken by a pregnant woman.
• If you have sexual intercourse with a woman of childbearing potential, you must use a condom and another effective method of contraception.
• If you have sexual intercourse 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 operate tools or machinery.

Abiraterone Kern Pharma contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Abiraterone Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take

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

How to take Abiraterone Kern Pharma

• Take this medicine by mouth.
• Do not take this medicine with food. Taking abiraterone with food may cause your body to absorb more medicine than needed, which could lead to side effects.
• Take this medicine as a single daily dose on 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 Kern Pharma with food”).
• Swallow the tablets whole with water.
• Do not split the tablets.
• This medicine is administered together with a medicine 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 you are taking this medicine.
• If you have a medical emergency, the dose of prednisone or prednisolone you are taking may need to be adjusted. Your doctor will advise you if any change in dose is necessary. Do not stop taking prednisone or prednisolone unless instructed by your doctor.

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, consult your doctor or go to the hospital immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Abiraterone Kern Pharma

• If you forget to take this medicine or prednisone or prednisolone, take the usual dose the next day.
• If you forget to take this medicine or prednisone or prednisolone for more than one day, consult 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 about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Stop taking this medicine and contact your doctor immediately if you experience any of the following effects:

• Muscle weakness, muscle cramps or increased heart rate (palpitations). These may be signs of low potassium levels in your blood.

Other adverse effects are:

Very common (may affect more than 1 in 10 people):

Fluid retention in the legs or feet, decreased blood potassium levels, increased liver function test results, high blood pressure, urinary tract infection, diarrhoea.

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, serious infections called sepsis, bone fractures, indigestion, blood in the urine, skin rash.

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

Adrenal gland problems (related to salt and water imbalance), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.

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

Lung inflammation (also known as allergic alveolitis). Liver function failure (also known as acute liver failure).

Frequency not known (cannot be estimated from available data):

Heart attack, changes in electrocardiogram-ECG (QT prolongation), and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.

Bone density loss may occur in men receiving treatment for prostate cancer. This medicine, when used in combination with prednisone or prednisolone, may increase this bone density loss.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es . By reporting adverse reactions, 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 stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents 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 components are: monohydrate lactose, sodium croscarmellose, 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 contents of the pack

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

Marketing Authorization 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 latest review of this leaflet: June 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/