Package leaflet: Information for the user

Abiraterone Sandoz, 1000 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 in combination with androgen-deprivation 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 exclusively in men;
if the patient has severe liver impairment;
in combination with Ra-223 (used in the treatment of prostate cancer).

Do not take this medicine 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 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 developing heart rhythm disorders);
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's body weight has increased rapidly;
if the patient has swelling of the feet, ankles or legs;
if the patient has previously taken the medicine ketoconazole for the treatment of prostate cancer;
the need to take 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 disorders (arrhythmia), or is taking medicines for these conditions.
Tell your doctor if the patient develops yellowing of the skin or eyes, dark-coloured urine,
severe nausea or vomiting, which may be signs of liver problems. Rarely,
liver dysfunction (known as acute liver failure) may occur, which could
lead to death.
Reduction in red blood cells, decreased libido, muscle weakness and (or) muscle pain may occur.
Abiraterone Sandoz must not be administered 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 intended for use in children and adolescents. If abiraterone is accidentally swallowed
by a child or adolescent, immediate medical attention is required; bring the patient leaflet
to the emergency department to show to the 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 medicines, 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.
This may result in adverse effects or reduced effectiveness of abiraterone.
Androgen suppression may increase the risk of heart rhythm disorders. Tell your doctor
if the patient is taking medicines:

used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
that may increase the risk of heart rhythm disorders [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe mental 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 contraceptive method 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 operating machinery
It is unlikely that this medicine affects the ability to drive, use tools or operate machinery.
Abiraterone Sandoz contains lactose and sodium

Abiraterone Sandoz contains lactose (a type of sugar). If the patient has previously been diagnosed with 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 prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
How much medicine to take
The recommended dose is 1000 mg (one tablet) taken once daily.
Taking this medicine

Take orally.
Abiraterone Sandoz must not be taken 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 at least two hours after eating, and you should not eat for at least one hour after taking Abiraterone Sandoz (see section 2, "Taking Abiraterone Sandoz with food").
Swallow the tablets with water. The tablets may be divided into equal doses.
Abiraterone Sandoz is taken together with a medicine called prednisone or prednisolone. You must take prednisone or prednisolone exactly as directed by your doctor.
You must take prednisone or prednisolone every day during treatment with Abiraterone Sandoz.
The amount of prednisone or prednisolone taken may need to be adjusted in certain situations. Your doctor will inform you if a dose adjustment is necessary.
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 prescribed
If you take more medicine than you should, contact your doctor immediately or go to the nearest hospital.
Missed 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 treatment with Abiraterone Sandoz
Do not stop taking Abiraterone Sandoz or prednisone or prednisolone without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Abiraterone Sandoz must be discontinued and the patient should immediately contact a
doctor if any of the following symptoms occur:

Muscle weakness, muscle tremors, or rapid heartbeat (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, elevated liver function test results, high blood pressure, urinary tract infections, diarrhoea.
Common (may affect less than 1 in 10 people):
High blood lipid (fat) levels, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heart rate, 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), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect less than 1 in 1,000 people):
Lung irritation (also known as allergic alveolitis). 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 swallowing or breathing, facial, lip, tongue or throat swelling, or itchy rash.
Loss of bone mass may occur in men treated for prostate cancer. Abiraterone Sandoz in combination with prednisone and prednisolone may worsen this effect.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Abiraterone Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and bottle label following EXP. The expiry date refers to the last day of the indicated month.
There are no special storage conditions required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This 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 1000 mg of abiraterone acetate.
The other ingredients are: sodium croscarmellose, sodium lauryl sulphate, povidone K30, microcrystalline cellulose type 102, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (see section 2, "Abiraterone Sandoz contains lactose and sodium").
Coating – Opadry II 85F18422 White: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Abiraterone Sandoz looks like and contents of the pack

Abiraterone Sandoz tablets are white or almost white, oval, film-coated tablets with a breakline on one side and smooth on the other, measuring 23.1 mm x 11.1 mm.
The film-coated tablets are packed in:
Aluminium/OPA/Aluminium/PVC blisters containing 30 film-coated tablets in a cardboard box,
single-dose perforated blisters made of Aluminium/OPA/Aluminium/PVC containing 30x1 film-coated tablet 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 farmacevtska družba d.d.
Verovškova ulica 57
1526, Ljubljana
Slovenia
This product is authorised for sale in the European Economic Area (EEA) and in the United Kingdom (Northern Ireland) under the following names:
Netherlands Abirateron Sandoz 1000 mg, filmomhulde tabletten
Austria Abirateron Sandoz 1000 mg – Filmtabletten
Czech Republic Abiraterone Sandoz
Germany Abirateron HEXAL 1000 mg Filmtabletten
Denmark Abirateron Sandoz
Estonia Abiraterone Sandoz
Spain Abiraterona 1.000 mg comprimidos recubiertos con película
Finland Abirateron Sandoz 1000 mg kalvopäällysteinen tabletti
France ABIRATERONE SANDOZ 1000 mg, comprimé pelliculé
Greece Abiraterone/Sandoz επικαλυμμένα με λεπτό υμένιο δισκία 1000 mg
Croatia Abirateron Sandoz 1000 mg filmom obložene tablete
Hungary Abiraterone Sandoz 1000 mg filmtabletta
Italy Abiraterone Sandoz GmbH
Lithuania Abiraterone Sandoz 1000 mg plėvele dengtos tabletės
Latvia Abiraterone Sandoz 1000 mg apvalkotās tabletes
Norway Abirateron Sandoz
Poland Abiraterone Sandoz
Portugal Abiraterona Sandoz
Sweden Abirateron Sandoz
Slovakia Abiraterón Sandoz 1000 mg filmom obalené tablety
United Kingdom Abiraterone Sandoz 1000 mg film-coated tablets
For more detailed information about this medicine, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
(logo of the marketing authorisation holder)