Abiraterone Sandoz

Package Leaflet: Information for the User

Abiraterone Sandoz, 500 mg, film-coated tablets

Abiraterone acetate

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

• Keep this leaflet. 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 signs of illness are the same as yours.
• If you get 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. Important information before taking Abiraterone Sandoz
• 3. How to take Abiraterone Sandoz
• 4. Possible side effects
• 5. How to store Abiraterone Sandoz
• 6. 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 in adult men for the treatment of prostate cancer that has spread to other parts of the body, as well as for the treatment of prostate cancer that has not spread to other parts of the body. Abiraterone Sandoz works by stopping the production of testosterone in the body; this can slow down the growth of prostate cancer.

When Abiraterone Sandoz is used at an early stage of the disease in response to hormone therapy, it is given together with a therapy that reduces testosterone levels (androgen suppression therapy).

During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention (oedema), or low potassium levels in the blood.

2. Important information before taking Abiraterone Sandoz

When not to take Abiraterone Sandoz

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• in women, especially during pregnancy. Abiraterone is only used in men.
• if you have severe liver damage
• 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

Before taking this medicine, discuss with your doctor or pharmacist:

• if you have liver problems;
• if you have high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of abnormal heart rhythms);
• if you have had other heart or blood vessel problems;
• if you have an irregular or rapid heart rhythm;
• if you have shortness of breath;
• if you have gained weight in a short time;
• if you have swelling of your feet, ankles, or legs;
• if you have taken the medicine ketokonazole in the past for the treatment of prostate cancer;
• the need to take this medicine with prednisone or prednisolone;
• the possibility of bone-related side effects;
• if you have high blood sugar levels.

Tell your doctor if you have any heart or blood vessel problems, including abnormal heart rhythms (arrhythmia), or if you are taking medicines for these conditions.

Tell your doctor if you have yellowing of the skin or eyes, dark urine, severe nausea, or vomiting, which may be signs of liver problems. Rarely, liver problems (called acute liver failure) may occur, which can be life-threatening.

Abiraterone Sandoz may cause a decrease in red blood cells, decreased sex drive (libido), muscle weakness, and/or muscle pain.

Abiraterone Sandoz must not be taken in combination with Ra-223 due to the possible increased risk of bone fractures or death.

If you plan to take Ra-223 after treatment with Abiraterone Sandoz and prednisone/prednisolone, you should 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 liver function, and you may not have any symptoms.

During treatment with this medicine, your doctor will periodically order blood tests to check the effect of the medicine on your liver.

Children and adolescents

This medicine is not used in children and adolescents. If abiraterone is accidentally ingested by a child or adolescent, you should immediately go to the hospital, taking this leaflet with you to show to the doctor.

Abiraterone Sandoz and other medicines

Before taking any medicine, consult your doctor or pharmacist.

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is important because abiraterone may increase the effects of many medicines, including heart medicines, sedatives, certain diabetes medicines, herbal medicines (such as St. John's Wort), and others. Your doctor may change the doses of these medicines.

Taking Abiraterone Sandoz with food

• This medicine must not be taken with food (see section 3, "How to take Abiraterone Sandoz").
• Taking Abiraterone Sandoz with food may cause side effects.

Pregnancy and breastfeeding

Abiraterone Sandoz is not used in women.

• The medicine may harm an unborn child if taken by a pregnant woman.
• If you have sex with a woman who may become pregnant, you should use a condom or other effective birth control method.
• If you have sex with a pregnant woman, you should use a condom to protect the unborn child.

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 you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Abiraterone Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you.

How much to take

The recommended dose is 1000 mg (two 500 mg tablets) taken once a day.

How to take it

• Take by mouth.
• Do not take Abiraterone Sandoz with food.
• Take Abiraterone Sandoz at least 1 hour before or at least 2 hours after food(see section 2, "Taking Abiraterone Sandoz with food").
• Swallow the tablets whole with a glass of water.
• Do not crush the tablets.
• Abiraterone Sandoz is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as your doctor has told you.
• Take prednisone or prednisolone every day while taking Abiraterone Sandoz.
• The amount of prednisone or prednisolone you take may need to be changed. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without talking to your doctor.

Your doctor may also prescribe other medicines for you to take while you are taking Abiraterone Sandoz and prednisone or prednisolone.

If you take more Abiraterone Sandoz than you should

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

If you forget to take Abiraterone Sandoz

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

If you stop taking Abiraterone Sandoz

Do not stop taking Abiraterone Sandoz or prednisone or prednisolone without talking to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Abiraterone Sandoz and contact your doctor immediately if you notice any of the following:

• Muscle weakness, trembling (tremors), or heart pounding (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:

Very common(may affect more than 1 in 10 people):
Swelling of the feet or ankles, low potassium levels in the blood, increased liver enzymes, high blood pressure, urinary tract infections, diarrhea.
Common(may affect up to 1 in 10 people):
High levels of lipids (fats) in the blood, chest pain, abnormal heart rhythms (atrial fibrillation), heart failure, rapid heart rate, severe infection - sepsis, bone fractures, indigestion, blood in the urine, rash.
Uncommon(may affect up to 1 in 100 people):
Adrenal gland problems (related to electrolyte 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). Acute liver failure.
Frequency not known(cannot be estimated from the available data):
Heart attack, changes in ECG (prolonged QT interval), and severe allergic reactions, causing difficulty swallowing or breathing, swelling of the face, lips, tongue, or throat, or itchy rash.
Bone loss may occur in men treated for prostate cancer. Abiraterone Sandoz in combination with prednisone and prednisolone may increase this effect.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store 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 refers to the last day of that month.
• There are no special storage conditions for this medicine.
• 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

What Abiraterone Sandoz contains

• The active substance is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: croscarmellose sodium, sodium lauryl sulfate, povidone K30, microcrystalline cellulose type 102, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (see section 2, "Abiraterone Sandoz contains lactose and sodium"). Opadry II 85F200051 Purple: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E172).

What Abiraterone Sandoz looks like and contents of the pack

Abiraterone Sandoz is a purple, oval, film-coated tablet with "500" debossed on one side.

The tablets are packaged in:

• Aluminum/OPA/Aluminum/PVC or Aluminum/PVC/PE/PVDC blisters containing 60 film-coated tablets in a cardboard box.
• Aluminum/OPA/Aluminum/PVC or Aluminum/PVC/PE/PVDC single-dose blisters containing 60x1 film-coated tablets in a cardboard box.

Marketing Authorisation Holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Abirateron Sandoz 500 mg Filmtabletten
Bulgaria
Абиратерон 500 mg филмирани таблетки
Cyprus
Abiraterone PharOS 500 mg film-coated tablets
Czech Republic
Abiraterone Sandoz
Denmark
Abirateron Sandoz
Estonia
Abiraterone Sandoz
Finland
Abiraterone Sandoz 500 mg kalvopäällysteinen tabletti
France
ABIRATERONE SANDOZ 500 mg, comprimé pelliculé
Greece
Abiraterone/Sandoz επικαλυμμένα με λεπτό υμένιο δισκία 500 mg
Croatia
Abirateron Sandoz 500 mg filmom obložene tablete
Hungary
Abiraterone Sandoz 500 mg filmtabletta
Ireland
Abiraterone 500 mg film-coated tablets
Italy
Abiraterone Sandoz
Lithuania
Abiraterone Sandoz 500 mg plėvele dengtos tabletės
Latvia
Abiraterone Sandoz 500 mg apvalkotās tabletes
Netherlands
Abirateron Sandoz 500 mg, filmomhulde tabletten
Norway
Abirateron Sandoz
Poland
Abiraterone Sandoz
Portugal
Abiraterona Sandoz
Sweden
Abirateron Sandoz
Slovakia
Abiraterón Sandoz 500 mg filmom obalené tablety
Northern Ireland
Abiraterone Sandoz 500 mg film-coated tablets

For further information on this medicine, contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
Date of last revision of the leaflet:07/2024
(logo of the Marketing Authorisation Holder)