ABIRATERONE SANDOZ 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Abiraterone Sandoz 1,000 mg film-coated tablets

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 further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Abiraterone Sandoz and what is it used for
2. What you need to know before you take Abiraterone Sandoz
3. How to take Abiraterone Sandoz
4. Possible side effects

5 Storage of Abiraterone Sandoz

1. Contents of the pack and other information

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

Abiraterone Sandoz 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 and also to treat prostate cancer in adult men that has not spread to other parts of the body. Abiraterone works by stopping your body from making testosterone; this can slow down the growth of prostate cancer.

When abiraterone is prescribed in the early stages of the disease and there is still response to hormonal treatment, it is used together with 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 you experiencing high blood pressure, accumulating too much water in your body (fluid retention), or low levels of a chemical called potassium in your blood.

2. What you need to know before you take Abiraterone Sandoz

Do not takeAbiraterone Sandoz

• 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 should only be used in male patients,
• if you have severe liver disease,
• in combination with Ra-223 (which is used for the treatment of prostate cancer).

Do not take this medicine if any of the above applies 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 you start 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 rhythm,
• 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 life-threatening.

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

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

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone 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 effect on your liver.

Children and adolescents

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

Other medicines and Abiraterone Sandoz

Talk to your doctor or pharmacist before taking any other medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because abiraterone can increase the effects of a number of medicines, including medicines for the heart, sedatives, some medicines for diabetes, herbal medicines (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medicines. Also, some medicines may increase or decrease the effects of abiraterone. This can lead to side effects or abiraterone 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 Sandoz with food

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

Pregnancy and breastfeeding

ABIRATERONE 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 method of contraception.
• 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 Sandoz contains lactose and sodium

• 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 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Abiraterone Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much to take

The recommended dose is 1,000 mg (one tablet) once a day.

How to take this medicine

• Take this medicine by mouth.
• Do not take abiraterone with food.
• Take abiraterone at least one hour before or at least two hours after eating any food(see section 2, “Taking Abiraterone Sandoz with food”).
• Swallow the tablets whole with water. The tablet can be divided into equal doses.
• Abiraterone is given together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor has told you.
• You will need to take prednisone or prednisolone every day while you are taking abiraterone.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. Your doctor will tell you if it is necessary 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 abiraterone and prednisone or prednisolone.

If you take more Abiraterone Sandoz 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, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Abiraterone Sandoz

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

If you stop taking Abiraterone Sandoz

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

If you have any further questions on the use of this product, 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 abiraterone and talk to your doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions, or rapid heartbeat (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 heartbeat (atrial fibrillation), heart failure, fast heartbeat, 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 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 (also called acute hepatic failure).

Frequency not known(frequency 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. Abiraterone 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Sandoz

• 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 Sandoz

• The active substance is abiraterone acetate. Each film-coated tablet contains 1,000 mg of abiraterone acetate.
• The other ingredients are:

Tablet: croscarmellose sodium (E468), sodium lauryl sulfate, povidone (E1201), microcrystalline cellulose (E460), lactose monohydrate, colloidal anhydrous silica (E551), magnesium stearate (E470b), (see section 2. “Abiraterone Sandoz contains lactose and sodium”).

Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).

Appearance and packaging

• Abiraterone Sandoz are white to off-white, oval, film-coated tablets with a score line on one side and a smooth surface on the other side, with dimensions of 23.1 mm x 11.1 mm.

The tablets are packaged in:

• Aluminum-OPA/Alu/PVC blisters containing 28, 30, 56, multiple packs of 60 (2 packs of 30), 84 (3 packs of 28), and 90 (3 packs of 30) film-coated tablets.
• Perforated unit dose aluminum-OPA/Alu/PVC blisters containing 28x1, 30x1, 56x1, multiple packs of 60x1 (2 packs of 30x1), 84x1 (3 packs of 28x1), and 90x1 (3 packs of 30x1) film-coated tablets.
• High-density polyethylene (HDPE) bottle with a polypropylene (PP) screw cap with a child-resistant closure.
• High-density polyethylene (HDPE) bottle of 30 tablets, with an oxygen absorber, closed with a polypropylene (PP) screw cap with a child-resistant closure. Do not swallow the desiccant.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

or

Remedica LTD

Aharnon Street,

Limassol Industrial Estate,

3056 Limassol

Cyprus

Date of last revision of this leaflet: July 2024.

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