Abiraterone zentiva

Package leaflet: Information for the patient

Abirateron Zentiva, 500 mg, film-coated tablets
abiraterone acetate
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Abirateron Zentiva is and what it is used for
2. Important information before taking Abirateron Zentiva
3. How to take Abirateron Zentiva
4. Possible side effects
5. How to store Abirateron Zentiva
6. Contents of the pack and other information

1. What Abirateron Zentiva is and what it is used for

Abirateron Zentiva is a medicine containing abiraterone acetate. It is used in adult men for the treatment of metastatic prostate cancer, i.e. cancer that has spread to other parts of the body. Abirateron Zentiva inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abirateron Zentiva is prescribed for the treatment of early-stage disease still responsive to hormonal therapy, it is used in combination with androgen-deprivation therapy (ADT).
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 (fluid buildup), or low potassium levels in the blood.

2. Important information before using Abirateron Zentiva

When not to use Abirateron Zentiva:

• 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. Abirateron Zentiva is used only in men;
• if the patient has severe liver impairment;
• in combination with the medicine 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 treatment with 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 may increase the risk of developing heart rhythm disturbances);
• if the patient has 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 a medicine called ketoconazole for the treatment of prostate cancer;
• the necessity of taking this medicine with prednisone or prednisolone;
• the possibility of bone-related side 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 problems (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. Acute liver failure, which may lead to death, is rare but possible.

There may be a decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain.

Abirateron Zentiva must not be given in combination with Ra-223 due to a possible increased risk of bone fractures or death.

If the patient plans to receive Ra-223 after treatment with Abirateron Zentiva and prednisone or prednisolone, a 5-day interval must 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

Abirateron Zentiva may affect liver function, and the patient may not experience any symptoms. During treatment, the doctor will periodically order blood tests to monitor the medicine’s effect on the liver.

Children and adolescents

This medicine is not used in children and adolescents. If Abirateron Zentiva is accidentally swallowed by a child, seek immediate medical attention at a hospital, taking the patient leaflet along to show to the doctor in the emergency department.

Abirateron Zentiva and other medicines

Before taking any medicine, consult a doctor or pharmacist.

Inform 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 Abirateron Zentiva 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 need to adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abirateron Zentiva, which could result in side effects or reduced effectiveness.

Androgen suppression may increase the risk of heart rhythm disturbances. Inform 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 disturbances [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe mental disorders)].

Inform your doctor if the patient is taking any of the medicines listed above.

Taking Abirateron Zentiva with food

This medicine must not be taken with food (see section 3 “How to take Abirateron Zentiva”).

Taking Abirateron Zentiva with food may cause adverse effects.

Pregnancy and breastfeeding

Abirateron Zentiva is not used in women.

Women who are pregnant or may become pregnant should wear protective gloves when handling or coming into contact with Abirateron Zentiva.

The medicine may harm the unborn child if taken by a pregnant woman.

If the patient has sexual intercourse with a woman who could become pregnant, a condom or another 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 operating machinery

It is unlikely that this medicine affects the ability to drive, use tools, or operate machinery.

Abirateron Zentiva contains lactose and sodium

If the doctor has informed the patient of an intolerance to certain sugars, consult the doctor before taking this medicine.

This medicine contains 24 mg of sodium (the main component of table salt) in each dose consisting of two 500 mg tablets. This corresponds to 1% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take Abirateron Zentiva

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

How much medicine to take

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

How to take this medicine

This medicine is for oral use.

Abirateron Zentiva must not be taken with food. Taking Abirateron Zentiva with food may result in more of the medicine being absorbed by the body than necessary, which could lead to adverse effects.

Abirateron Zentiva should be taken as a single daily dose on an empty stomach. Abirateron Zentiva should be taken at least two hours after a meal, and food should not be consumed for at least one hour after taking Abirateron Zentiva (see section 2, "Taking Abirateron Zentiva with food").

Tablets should be swallowed whole with water.

Do not crush the tablets.

Abirateron Zentiva is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.

You must take prednisone or prednisolone every day during treatment with Abirateron Zentiva.

The dose of prednisone or prednisolone may need to be adjusted in cases of sudden health or life-threatening situations. Your doctor will inform you if a dose adjustment of prednisone or prednisolone is necessary. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines while you are taking Abirateron Zentiva and prednisone or prednisolone.

Taking more Abirateron Zentiva than recommended

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

Missing a dose of Abirateron Zentiva

If you forget to take Abirateron Zentiva, prednisone or prednisolone, take your usual dose the next day.

If you forget to take Abirateron Zentiva, prednisone or prednisolone for more than one day, contact your doctor immediately.

Stopping Abirateron Zentiva treatment

Do not stop taking Abirateron Zentiva, prednisone or prednisolone without consulting your doctor.

If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with Abirateron Zentiva should be discontinued and the patient should contact their doctor immediately if any of the following symptoms occur:

• Muscle weakness, muscle twitching (tremors), or rapid heartbeat (palpitations). These may be symptoms of low blood potassium levels.

Other adverse effects 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 up to 1 in 10 people):

• high blood lipid levels
• chest pain, irregular heartbeat (atrial fibrillation), heart failure, rapid heart rate
• severe infections called sepsis
• bone fractures
• indigestion
• blood in the urine
• rash.

Uncommon (may affect up to 1 in 100 people):

• adrenal gland dysfunction (related to disturbances in water and electrolyte balance)
• heart rhythm disorders (arrhythmia)
• muscle weakness and/or muscle pain.

Rare (may affect up to 1 in 1000 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 (electrocardiogram) – QT interval prolongation
• severe allergic reactions with difficulty 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. Abirateron Zentiva in combination with prednisone or prednisolone may increase bone mass loss.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Abirateron Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the HDPE bottle or blister pack and
on the carton after "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via the wastewater system 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 Abirateron Zentiva contains

• The active substance is abiraterone acetate.
• Each coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, red iron oxide (E 172) and black iron oxide (E 172).

What Abirateron Zentiva looks like and contents of the pack
Abirateron Zentiva 500 mg is available as oval, film-coated tablets in violet colour, approximately 19 mm in length and 11 mm in width, with the imprint "A7TN" on one side and "500" on the other side.
The carton contains a blister pack with 56 or 60 film-coated tablets.
The carton contains a unit dose blister with 56 x 1 or 60 x 1 film-coated tablets.
The carton contains one bottle with 60 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Synthon Hispania, S.L.
c/ Castelló 1
08830 Sant Boi de Llobregat
Barcelona
Spain

Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria: Абиратерон Зентива 500 mg филмирани таблетки
Croatia: Abirateron Zentiva 500 mg filmom obložene tablete
The Netherlands: Abiraterone Zentiva 500 mg, filmomhulde tabletten
Iceland: Abiraterone Zentiva
Poland: Abirateron Zentiva
Romania: Abirateronă Zentiva 500 mg comprimate filmate
Hungary: Abirateron Zentiva 500 mg filmtabletta

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: + 48 22 375 92 00
[logo of the Marketing Authorisation Holder]