Prospect: information for the user

Abiraterone Stada 500 mg film-coated tablets EFG

abiraterone acetate

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed only for you, and you must 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, pharmacist or nurse even if they do not appear in this prospect. See section 4.

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

2.What you need to know before starting to take Abiraterone Stada

3.How to take Abiraterone Stada

4.Possible adverse effects

5.Storage of Abiraterone Stada

6.Contents of the package and additional information

Abiraterona Stada 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. Abiraterona causes the body to stop producing testosterone, thereby delaying the growth of prostate cancer.

When abiraterona 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 levels (androgen deprivation therapy).

When taking this medication, your doctor will also prescribe another medication called prednisone or prednisolone, to reduce the risk 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 Stada

-if you are allergic to abiraterona or any of the other components of this medication (listed in section 6).

-if you are a woman, especially if you are pregnant. Abiraterona should only be used in male patients.

varones.

-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 gained weight rapidly

-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 problems, including heart rhythm problems (arrhythmia), or are being treated with medications for these conditions.

Inform your doctor if you have yellow 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 liver failure) may occur, which can be fatal.

You may experience a decrease in the number of red blood cells in your blood, reduced libido, and cases of muscle weakness and/or muscle pain.

Abiraterona should not be administered in combination with Ra-223 due to a possible increase in the 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 do not have any 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 abiraterona, they should immediately go to the hospital and bring the leaflet with them to show to the emergency doctor.

Other medications and Abiraterona Stada

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 range of medications, including heart medications, tranquilizers, some diabetes medications, herbal medicines (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 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), moxifloxacine (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

Abiraterona Stada 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 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 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 Stada contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 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 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 Taken with Food”).

-Swallow the tablets whole with water.

-Do not break the tablets.

-Abiraterone is administered 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, you may need 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.

You may also be prescribed other medications while taking abiraterone and prednisone or prednisolone.

If you take more Abiraterone Stada 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 Abiraterone Stada

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

-If you forget to take abiraterone or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you interrupt the treatment with Abiraterone Stada

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

Stop taking abiraterone 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 failure).

Unknown(the frequency 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 medication may cause bone density loss in men receiving treatment for prostate cancer. Abiraterone 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 not listed in this prospectus. 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 medication.

-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 on the blister pack after CAD. The expiration date is the last day of the month indicated.

-This medication does not require special storage conditions.

-Do not dispose of medications through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition of Abiraterona Stada

-The active ingredient is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.

-The other components are:

Tablet core: Sodium croscarmellose, sodium lauryl sulfate, Povidone (E1201), Microcrystalline cellulose (E460), Lactose monohydrate, Anhydrous colloidal silica (E551), Magnesium stearate (E470b) (see section 2. “Abiraterona Stada contains lactose and sodium”).

Coating:Polyvinyl alcohol (E1203), Titanium dioxide (E171), Macrogol (E1521), Talc (E553b), Iron oxide red (E172), Iron oxide black (E172).

Appearance of the product and content of the container

-Abiraterona Stada 500 mg tablets are coated, purple, oval-shaped tablets, engraved with “500” on one face.

-Tablets are presented in aluminum-OPA/Alu/PVC or aluminum-PVC/PE/PVDC blisters containing10, 14, 56, 60 or 112coated tablets or perforated single-dose blisters of aluminum-OPA/Alu/PVC or aluminum-PVC/PE/PVDC containing10x1, 14x1, 56x1, 60x1 or 112x1coated tablets.

Only some container sizes may be commercially available.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Remedica Ltd

Aharnon Street, Limassol Industrial Estate,

3056 Limassol

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Last review date of this leaflet:August 2024

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