Abiraterone Normon 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Abiraterone Normon 500 mg film-coated tablets EFG

abiraterone acetate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Leaflet contents

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

1. What Abiraterone Normon is and what it is used for

Abiraterone Normon contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men whose cancer has spread to other parts of the body.

Abiraterone causes your body to stop producing testosterone; in this way, it can slow down the growth of prostate cancer.

When abiraterone is prescribed at the early 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 risk of developing high blood pressure, fluid retention (accumulation of fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before taking Abiraterone Normon

Do not take Abiraterone Normon

• 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. Abiraterone 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 applies to you. If you are unsure, 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 levels of potassium in your blood (low blood potassium levels 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, darkened 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 cell count, reduced sexual desire (libido), and cases of muscle weakness and/or muscle pain may occur.

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

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

Blood tests

Abiraterone may affect your liver, even if you do not have any symptoms. While you are taking this medicine, your doctor will perform periodic blood tests to monitor 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 abiraterone, go to the hospital immediately and bring the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Normon

Talk to 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 medicine. This is important because abiraterone may increase the effects of several medicines, including medicines for the heart, tranquilizers, some diabetes medicines, herbal remedies (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. This could lead to adverse effects or reduced effectiveness of abiraterone.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking 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 serious mental illnesses)].

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

Abiraterone Normon with food

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

Pregnancy and breastfeeding

Abiraterone is not indicated 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 age, 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 use of machines

It is unlikely that this medicine will affect your ability to drive or operate tools or machinery.

Abiraterone Normon contains lactose and sodium

Abiraterone Normon contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 24 mg of sodium (a main component of table/cooking salt) per two-tablet dose. This corresponds to 1.2% of the maximum daily recommended sodium intake for an adult.

3. How to take Abiraterone Normon

Follow exactly your doctor's instructions on how to take 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 this medicine

• Take this medicine by mouth.
• Do not take abiraterone with food. Taking Abiraterone Normon with food may cause your body to absorb more medicine than needed, which could lead to side effects.
• Take the Abiraterone Normon tablets as a single dose once daily on an empty stomach. Abiraterone Normon should be taken at least two hours after eating, and no food should be consumed for at least one hour after taking Abiraterone Normon (see section 2, “Abiraterone Normon with food”).
• Swallow the tablets whole with water.
• Do not split the tablets.
• Abiraterone is administered together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• You will need to take prednisone or prednisolone every day while you are taking abiraterone.
• If you have a medical emergency, the dose of prednisone or prednisolone you are taking may need to be adjusted. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

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

If you take more Abiraterone Normon 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, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Abiraterone Normon

• If you forget to take abiraterone or prednisone or prednisolone, take your usual dose the next day.
• If you forget to take abiraterone or prednisone or prednisolone for more than one day, contact your doctor immediately.

If you stop taking Abiraterone Normon

Do not stop taking abiraterone or prednisone or prednisolone unless your doctor tells you to.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Stop taking Abiraterona Normon 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 include:

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 imbalances), 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).

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 mineral density loss may occur in men receiving treatment for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase this loss of bone density.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Normon

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 refers to 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 containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Normon

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are silicified microcrystalline cellulose (composed of microcrystalline cellulose and anhydrous colloidal silica), sodium croscarmellose, hypromellose 2910, lactose monohydrate, magnesium stearate, anhydrous colloidal silica and sodium lauryl sulfate (see section 2, “Abiraterone Normon contains lactose and sodium”). The film coating contains black iron oxide (E-172), red iron oxide (E-172), yellow iron oxide (E-172), macrogol 3350, polyvinyl alcohol, talc and titanium dioxide (E-171).

Nature of the product and pack sizes

Abiraterone Normon tablets are red-beige, oval-shaped, film-coated tablets, marked with “500” on one side.

Each 28-day pack contains 56 film-coated tablets.

Each 30-day pack contains 60 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera.

C/ La Vallina s/n - 24008 Villaquilambre - León (SPAIN)

Laboratorios Liconsa, S.A.

Av. Miralcampo, 7 - 19200 Azuqueca de Henares - Guadalajara (SPAIN)

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Abirateron Normon 500 mg Filmomhulde tabletten
Spain: Abiraterona Normon 500 mg comprimidos recubiertos con película EFG
Portugal: Abiraterona Normon

Date of the most recent revision of this leaflet: 11/2024

Detailed 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/).