Abirateron Zentiva

Leaflet attached to the packaging: patient information

Abirateron Zentiva, 500 mg, coated tablets

abiraterone acetate

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Abirateron Zentiva is a medicine that contains abiraterone acetate. It is used in adult men for the treatment of prostate cancer that has spread to other parts of the body. Abirateron Zentiva works by stopping the production of testosterone in the body; this can slow down the growth of prostate cancer.
In cases where Abirateron Zentiva is recommended for the treatment of early-stage disease, when hormonal therapy is still effective, it is used in combination with a therapy that lowers testosterone levels (androgen suppression therapy).
During treatment with this medicine, the doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention, or low potassium levels in the blood.

2. Important information before taking Abirateron Zentiva

When not to take 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 damage;
• in combination with the medicine Ra-223 (used to treat prostate cancer).

Do not take this medicine if any of the above situations apply to the patient. In case of doubts, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with this medicine, discuss it with your doctor or pharmacist:

• if the patient has liver problems;
• if the patient has high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of heart rhythm disorders);
• if the patient has had other heart or blood vessel diseases;
• if the patient has an irregular or rapid heart rhythm;
• 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 taken a medicine called ketoconazole in the past to treat prostate cancer;
• the need to take this medicine with prednisone or prednisolone;
• the possibility of side effects related to bones;
• if the patient has high blood sugar levels.

Tell your doctor if you have any heart or blood vessel disorders, including heart rhythm disorders (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 symptoms of liver function disorders. Rarely, acute liver failure may occur, which can be life-threatening.
There may be a decrease in the number of red blood cells, decreased libido, muscle weakness, and/or muscle pain.
Abirateron Zentiva should not be given in combination with Ra-223 due to the possible increased risk of bone fractures or death.
If the patient plans to take Ra-223 after treatment with Abirateron Zentiva and prednisone or prednisolone, they must wait 5 days before starting Ra-223 treatment.
In case of doubts about any of the above situations, consult a doctor or pharmacist before taking this medicine.

Blood tests

Abirateron Zentiva may affect liver function, and the patient may not have any symptoms. During treatment with this medicine, the doctor will periodically order blood tests to check the effect of the medicine on the liver.

Children and adolescents

This medicine is not used in children and adolescents. If Abirateron Zentiva is accidentally swallowed by a child, you should immediately go to the hospital, taking the patient information leaflet with you to show it to the doctor in the emergency room.

Abirateron Zentiva and other medicines

Before taking any medicine, consult a doctor or pharmacist.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is important because Abirateron Zentiva may enhance the effect of many medicines, including heart medicines, sedatives, certain antidiabetic medicines, herbal medicines (e.g., St. John's wort), and others. Your doctor may change the doses of these medicines. Other medicines may also increase or decrease the effect of Abirateron Zentiva. This may result in side effects or inadequate effect of Abirateron Zentiva.
Androgen suppression may increase the risk of heart rhythm disorders. Tell your doctor if you are taking medicines:

• used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol);
• that may increase the risk of heart rhythm disorders [e.g., methadone (pain reliever and used to treat addiction), moxifloxacin (antibiotic), antipsychotic medicines (used to treat severe mental disorders)].

Tell your doctor about taking any of the above medicines.

Taking Abirateron Zentiva with food

The medicine should not be taken with food (see section 3 "How to take Abirateron Zentiva").
Taking Abirateron Zentiva with food may cause side effects.

Pregnancy and breastfeeding

Abirateron Zentiva is not used in women.
Women who are pregnant or may be pregnant should wear protective gloves when handling or administering 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 may become pregnant, they should use a condom or other effective contraceptive method.
If the patient has sexual intercourse with a pregnant woman, they should use a condom to protect the unborn child.

Driving and using machines

It is unlikely that this medicine will affect the ability to drive or use tools and machines.

Abirateron Zentiva contains lactose and sodium

If the doctor has informed the patient that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.
This medicine contains 24 mg of sodium (the main component of common salt) in each dose consisting of two 500 mg tablets. This corresponds to 1% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Abirateron Zentiva

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

How much medicine to take

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

Taking this medicine

The medicine should be taken orally.
Abirateron Zentiva should not be taken with food. Taking Abirateron Zentiva with food may cause side effects.
Abirateron Zentiva should be taken as a single dose once a day on an empty stomach. Abirateron Zentiva should be taken at least 2 hours after a meal and no meals should be eaten for at least 1 hour after taking Abirateron Zentiva (see section 2 "Taking Abirateron Zentiva with food").
The tablets should be swallowed whole, with a glass of water.
Do not crush the tablets.
Abirateron Zentiva is taken with a medicine called prednisone or prednisolone. Prednisone or prednisolone should be taken as directed by the doctor.
Prednisone or prednisolone should be taken every day while taking Abirateron Zentiva.
The amount of prednisone or prednisolone used may be changed in life-threatening situations. The doctor will inform the patient if it is necessary to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without consulting a doctor.
The doctor may also prescribe other medicines to the patient taking Abirateron Zentiva and prednisone or prednisolone.

Taking more Abirateron Zentiva than prescribed

If the patient takes more medicine than they should, they should immediately contact their doctor or go to the hospital.

Missing a dose of Abirateron Zentiva

If the patient forgets to take Abirateron Zentiva, prednisone, or prednisolone, they should take the usual dose the next day.
If the patient forgets to take Abirateron Zentiva, prednisone, or prednisolone for more than one day, they should immediately contact their doctor.

Stopping treatment with Abirateron Zentiva

Do not stop taking Abirateron Zentiva or prednisone or prednisolone without consulting a doctor.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Stop taking Abirateron Zentiva and immediately contact a doctor if the patient notices any of the following symptoms:

• Muscle weakness, muscle tremors (tremors), or heart palpitations. These may be symptoms 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
• high liver enzyme levels
• high blood pressure
• urinary tract infections
• diarrhea.

Common(may affect up to 1 in 10 people):

• high lipid levels in the blood
• 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 disorders (related to electrolyte imbalance)
• heart rhythm disorders (arrhythmia)
• muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1000 people):

• lung inflammation (also called 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 itching rash.

Bone loss may occur in men treated for prostate cancer. Abirateron Zentiva in combination with prednisone or prednisolone may increase bone loss.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Abirateron Zentiva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and HDPE bottle or on the blister after: "EXP". The expiry date refers to the last day of the month.
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 that are no longer needed. This 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: lactose monohydrate, 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, iron oxide red (E 172), and iron oxide black (E 172).

What Abirateron Zentiva looks like and contents of the pack

Abirateron Zentiva, 500 mg, is available in the form of oval, purple, coated tablets, approximately 19 mm long and 11 mm wide, with "A7TN" embossed on one side and "500" on the other.
The carton contains a blister pack with 56 or 60 coated tablets.
The carton contains a single-dose blister pack with 56 x 1 or 60 x 1 coated tablets.
The carton contains one bottle with 60 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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
Netherlands

This medicinal product is authorized 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
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 further information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
tel: +48 22 375 92 00
[logo of the marketing authorization holder]
Date of last revision of the leaflet:November 2024