Package leaflet: Information for the user

Abiraterone Sandoz, 500 mg, film-coated tablets
Abirateroni acetas
Please 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 personally. 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, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Abiraterone Sandoz is and what it is used for
What you need to know before taking Abiraterone Sandoz
How to take Abiraterone Sandoz
Possible side effects
How to store Abiraterone Sandoz
Contents of the pack and other information

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

Abiraterone Sandoz is a medicine containing abiraterone acetate. It is used in adult men for the treatment of metastatic prostate cancer, as well as in adult men for the treatment of non-metastatic prostate cancer.
Abiraterone Sandoz inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abiraterone Sandoz is used at an early stage of hormone-sensitive disease, it is given together with 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 likelihood of developing high blood pressure, fluid retention (fluid buildup), or low potassium levels in the blood.

2. Important information before using Abiraterone Sandoz

When not to use Abiraterone Sandoz

if the patient is allergic to abiraterone or any of the other ingredients of this medicine (listed in section 6);
in women, especially during pregnancy. Abiraterone is used only in men;
if the patient has severe liver impairment;
in combination with Ra-223 (used in the treatment of prostate cancer).

This medicine should not be used if any of the above situations apply to the patient. If in
doubt, consult a doctor or pharmacist before using this medicine.
Warnings and precautions
Before starting to take this medicine, discuss the following with your doctor or pharmacist:

if the patient has liver problems;
if the patient has high blood pressure, heart failure, or low blood potassium levels (low blood potassium levels may increase the risk of heart rhythm disturbances);
if the patient has had other heart or blood vessel diseases;
if the patient has irregular or rapid heartbeat;
if the patient has shortness of breath;
if the patient has experienced rapid weight gain;
if the patient has swelling of the feet, ankles, or legs;
if the patient has previously taken ketoconazole for the treatment of prostate cancer;
the necessity of taking this medicine with prednisone or prednisolone;
the possibility of bone-related adverse effects;
if the patient has high blood sugar levels.

Tell your doctor if the patient has any heart or blood vessel disorders, including heart rhythm disturbances (arrhythmia), or is taking medicines for these conditions.
Tell your doctor if the patient develops yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver problems. Rarely, liver dysfunction (referred to as acute liver failure) may occur, which could lead to death.
A decrease in red blood cell count, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.
Abiraterone Sandoz must not be given in combination with Ra-223 due to the possible increased risk of bone fractures or death.
If the patient intends to receive Ra-223 after treatment with Abiraterone Sandoz and prednisone/prednisolone, a 5-day interval should be observed before starting Ra-223 treatment.
If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before using this medicine.
Blood tests
Abiraterone may affect liver function, and the patient may not experience any symptoms.
During treatment, the doctor will periodically order blood tests to monitor the effect of the medicine on the liver.
Children and adolescents
This medicine is not used in children and adolescents. If abiraterone is accidentally swallowed by a child or adolescent, seek immediate medical attention at a hospital, bringing along the patient leaflet to show the emergency room doctor.
Abiraterone Sandoz and other medicines
Before taking any medicine, consult a doctor or pharmacist.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is important because abiraterone may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic drugs, herbal remedies (e.g. St. John’s wort), and others. The doctor may adjust the doses of these medicines. Other medicines may also increase or decrease the effect of abiraterone, which could lead to adverse effects or reduced effectiveness of abiraterone.
Androgen suppression may increase the risk of heart rhythm disturbances. Tell your doctor if the patient is taking any of the following medicines:

used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
that may increase the risk of heart rhythm disturbances [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe psychiatric disorders)].

Tell your doctor if the patient is taking any of the medicines listed above.
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 adverse effects.

Pregnancy and breastfeeding
Abiraterone Sandoz is not used in women.

This medicine may harm the unborn child if taken by a pregnant woman.
Women who are pregnant or may become pregnant should wear protective gloves when handling or coming into contact with Abiraterone Sandoz.
If the patient has sexual intercourse with a woman who may become pregnant, a condom or other effective method of contraception must be used.
If the patient has sexual intercourse with a pregnant woman, a condom must be used to protect the unborn child.

Driving and using machines
It is unlikely that this medicine affects the ability to drive, use tools, or operate machinery.
Abiraterone Sandoz contains lactose and sodium

If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Abiraterone Sandoz

This medicine should always be taken exactly as your doctor or pharmacist has advised.
If in doubt, consult your doctor or pharmacist.
How much medicine to take

The recommended dose is 1000 mg (two 500 mg tablets) taken once daily.
Taking this medicine

Take orally.
Do not take Abiraterone Sandoz with food. Taking Abiraterone Sandoz with food may result in more of the medicine being absorbed than intended, which could lead to adverse effects.
Abiraterone Sandoz should be taken as a single daily dose on an empty stomach. Take Abiraterone Sandoz at least two hours after eating and do not eat for at least one hour after taking Abiraterone Sandoz (see section 2, "Taking Abiraterone Sandoz with food").
Swallow the tablets whole with water.
Do not crush the tablets.
Abiraterone Sandoz is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
Take prednisone or prednisolone every day during treatment with Abiraterone Sandoz.
The dose of prednisone or prednisolone may be adjusted if necessary. Your doctor will inform you if a change in the dose of prednisone or prednisolone is required. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines while you are taking Abiraterone Sandoz and prednisone or prednisolone.
Taking more Abiraterone Sandoz than recommended

If you take more Abiraterone Sandoz than you should, contact your doctor immediately or go to hospital.
Missing a dose of Abiraterone Sandoz

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

Stopping Abiraterone Sandoz treatment

Do not stop taking Abiraterone Sandoz, prednisone or prednisolone without consulting your doctor.
If you have any further questions about how to use this medicine, ask your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must stop taking Abiraterone Sandoz and contact your doctor immediately if you notice any of the following symptoms:

Muscle weakness, muscle tremors (shaking), or heart palpitations. These may be symptoms of low blood potassium levels.

Other adverse reactions include:
Very common (may affect more than 1 in 10 people):
Swelling of the legs or feet, low blood potassium levels, increased liver function test results, high blood pressure, urinary tract infections, diarrhoea.
Common (may affect less than 1 in 10 people):
High levels of lipids (fats) in the blood, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat, severe infection – sepsis, bone fractures, indigestion, blood in urine, rash.
Uncommon (may affect less than 1 in 100 people):
Adrenal gland dysfunction (related to disturbances in water and electrolyte balance), irregular heartbeat (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect less than 1 in 1,000 people):
Lung irritation (also known as allergic interstitial pneumonia). Acute liver failure.
Frequency not known (cannot be estimated from available data):
Myocardial infarction (heart attack), changes in ECG (prolonged QT interval), and severe allergic reactions causing difficulty in swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.

Loss of bone mass may occur in men treated for prostate cancer. Abiraterone Sandoz in combination with prednisone or prednisolone may worsen this effect.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

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 stated on the cardboard box and on the bottle label after EXP. The expiry date refers to the last day of the stated month.
There are no special requirements for the storage conditions of this medicine.
Medicines must 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: sodium croscarmellose, sodium lauryl sulfate, povidone K30, microcrystalline cellulose type 102, monohydrate lactose, colloidal anhydrous silica, magnesium stearate (see section 2 "Abiraterone Sandoz contains lactose and sodium"). Coating Opadry II 85F200051 Purple: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, red iron oxide (E 172), black iron oxide (E 172).

What Abiraterone Sandoz looks like and contents of the pack
Abiraterone Sandoz is a purple, oval film-coated tablet with the imprint "500" on one side.
The tablets are packed in:

Blister packs made of Aluminium/OPA/Aluminium/PVC or Aluminium/PVC/PE/PVDC containing 60 film-coated tablets in a cardboard box.
Perforated single-dose blisters made of Aluminium/OPA/Aluminium/PVC or Aluminium/PVC/PE/PVDC 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 (EEA) and in the United Kingdom (Northern Ireland) under the following names:
Austria Abirateron Sandoz 500 mg – Filmtabletten
Bulgaria Абиратерон 250 mg филмирани таблетки
Абиратерон 500 mg филмирани таблетки
Cyprus Abiraterone PharOS 250 mg film-coated tablets
Abiraterone PharOS 500 mg film-coated tablets
Czech Republic Abiraterone Sandoz
Germany Abirateron HEXAL 250 mg Filmtabletten
Abirateron HEXAL 500 mg Filmtabletten
Denmark Abirateron Sandoz
Estonia Abiraterone Sandoz
Spain Abiraterona 500 mg comprimidos recubiertos con película EFG
Finland Abirateron Sandoz 500 mg kalvopäällysteinen tabletti
France ABIRATERONE SANDOZ 500 mg, comprimé pelliculé
Greece Abiraterone/Sandoz επικαλυμμένα με λεπτό υμένιο δισκία 250 mg
Abiraterone/Sandoz επικαλυμμένα με λεπτό υμένιο δισκία 500 mg
Croatia Abirateron Sandoz 250 mg filmom obložene tablete
Abirateron Sandoz 500 mg filmom obložene tablete
Hungary Abiraterone Sandoz 500 mg filmtabletta
Ireland Abiraterone 250 mg film-coated tablets
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 250 mg, filmomhulde tabletten
Abirateron Sandoz 500 mg, filmomhulde tabletten
Norway Abirateron Sandoz
Poland Abiraterone Sandoz
Portugal Abiraterona Sandoz
Sweden Abirateron Sandoz
Slovakia Abiraterón Sandoz 250 mg filmom obalené tablety
Abiraterón Sandoz 500 mg filmom obalené tablety
Northern Ireland Abiraterone Sandoz 500 mg film-coated tablets
For more detailed information about this medicine, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
(logo of the marketing authorisation holder)