Abiraterone Fresenius Kabi

Package Leaflet: Information for the Patient

Abiraterone Fresenius Kabi, 250 mg, Tablets

Abiraterone Acetate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Abiraterone Fresenius Kabi and what is it used for

Abiraterone Fresenius Kabi 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. Abiraterone Fresenius Kabi works by stopping the production of testosterone in the body; this can slow down the growth of prostate cancer.
When Abiraterone Fresenius Kabi is used at an early stage of the disease that responds to hormonal 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 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 Abiraterone Fresenius Kabi

When not to take Abiraterone Fresenius Kabi

• in women, especially during pregnancy. Abiraterone Fresenius Kabi is only used in men;
• in combination with the medicine Ra-223 (used to treat prostate cancer).

Do not take this medicine if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• the need to take this medicine with prednisolone;
• the possibility of side effects related to bones;

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 signs 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 sex drive, muscle weakness, and (or) muscle pain.
Abiraterone Fresenius Kabi should 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 Fresenius Kabi and 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 Fresenius Kabi 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 the liver.

Children and adolescents

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

Abiraterone Fresenius Kabi 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 Fresenius Kabi 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 Abiraterone Fresenius Kabi. This may result in side effects or inadequate effect of Abiraterone Fresenius Kabi.
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);
• medicines 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 if you are taking any of the above medicines.

Abiraterone Fresenius Kabi with food

This medicine should not be taken with food (see section 3. "How to take Abiraterone Fresenius Kabi").
Taking Abiraterone Fresenius Kabi with food may cause side effects.

Pregnancy and breastfeeding

Abiraterone Fresenius Kabi is not used in women.
Pregnant or potentially pregnant women should use protective gloves when handling this medicine.
The medicine may harm the unborn child if taken by a pregnant woman.
If you have sexual intercourse with a woman who may become pregnant, you should use a condom and another effective method of contraception.
If you have sexual intercourse 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 and machines.

Abiraterone Fresenius Kabi contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose of four 250 mg tablets, which means it is essentially "sodium-free".

3. How to take Abiraterone Fresenius Kabi

This medicine should always be taken exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much to take

The recommended dose is 1,000 mg (four 250 mg tablets) once a day.

How to take this medicine

Oral use.
Abiraterone Fresenius Kabi should not be taken with food. Taking Abiraterone Fresenius Kabi with food may cause side effects.
Abiraterone Fresenius Kabi tablets should be taken as a single dose once a day on an empty stomach. Abiraterone Fresenius Kabi should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking Abiraterone Fresenius Kabi (see section 2. "Taking Abiraterone Fresenius Kabi with food").
The tablets should be swallowed whole with water.
Do not crush the tablets.
Abiraterone Fresenius Kabi is taken with a medicine called prednisolone. You should take prednisolone as your doctor has told you.
You should take prednisolone every day while taking Abiraterone Fresenius Kabi.
The amount of prednisolone you take may need to be changed in case of an emergency. Your doctor will tell you if you need to change the dose of prednisolone. Do not stop taking prednisolone without consulting your doctor.
Your doctor may also prescribe other medicines for you to take with Abiraterone Fresenius Kabi and prednisolone.

If you take more Abiraterone Fresenius Kabi than you should

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

If you forget to take Abiraterone Fresenius Kabi

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

If you stop taking Abiraterone Fresenius Kabi

Do not stop taking Abiraterone Fresenius Kabi or prednisolone without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Abiraterone Fresenius Kabi and contact your doctor immediately if you experience any of the following:

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

Other side effects:

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, heart rhythm disorders (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 disorders (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 (QT interval prolongation);
• 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 Fresenius Kabi in combination with prednisolone may enhance this effect.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abiraterone Fresenius Kabi

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 bottle after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions 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. This will help protect the environment.

6. Contents of the pack and other information

What Abiraterone Fresenius Kabi contains

• The active substance is abiraterone acetate.
• Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose type 102, sodium croscarmellose, povidone K29/32, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.

What Abiraterone Fresenius Kabi looks like and contents of the pack

White to off-white, oval tablets, approximately 16 mm in length and 9.5 mm in width, with "ATN" engraved on one side and "250" on the other side.
Pack size: bottle containing 120 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Aleje Jerozolimskie 134
02-305 Warsaw

Manufacturer

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

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

Date of last revision of the leaflet:20.11.2024