Abiraterone fresenius kabi

Package leaflet: Information for the patient

Abiraterone Fresenius Kabi, 250 mg, tablets
Abirateroni acetas
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

Abiraterone Fresenius Kabi 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. Abiraterone
Fresenius Kabi inhibits the production of testosterone in the body; this may slow the progression of
prostate cancer.
When Abiraterone Fresenius Kabi is used at an early stage of hormone-sensitive disease, it is administered in combination with androgen-deprivation therapy.
During treatment with this medicine, your doctor will also prescribe another medicine called prednisolone. This is to reduce the risk of developing high blood pressure, fluid retention (fluid accumulation), or low blood potassium levels.

2. Important information before using Abiraterone Fresenius Kabi

When not to use Abiraterone Fresenius Kabi

• if the patient is allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6);
• in women, especially during pregnancy. Abiraterone Fresenius Kabi is intended for use in men only;
• 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 treatment with this medicine, discuss the following with your doctor or pharmacist:

• if the patient has liver diseases;
• if the patient has hypertension, heart failure or low blood potassium levels (low blood potassium levels may increase the risk of 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 ketoconazole for the treatment of prostate cancer;
• the necessity of taking this medicine with prednisolone;
• the possibility of bone-related adverse effects;
• 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 develop yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver dysfunction. Rarely, acute liver failure may occur, which can lead to death.

A decrease in red blood cell count, reduced libido, muscle weakness and/or muscle pain may occur.

Abiraterone Fresenius Kabi 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 use Ra-223 after treatment with Abiraterone Fresenius Kabi and prednisolone, a 5-day interval should be observed before starting Ra-223 therapy.

If in doubt whether any of the above situations apply, consult your doctor or pharmacist before using this medicine.

Blood tests

Abiraterone Fresenius Kabi 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 Fresenius Kabi is accidentally swallowed by a child, seek immediate medical attention at a hospital, taking the patient leaflet along to show the emergency room doctor.

Abiraterone Fresenius Kabi 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 Fresenius Kabi 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 need to adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone Fresenius Kabi, potentially leading to adverse effects or reduced efficacy.

Androgen suppression may increase the risk of heart rhythm disorders. Inform your doctor if the patient is taking:

• medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• medicines 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 psychiatric disorders)].

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

Abiraterone Fresenius Kabi and food

This medicine must not be taken with food (see section 3, "How to take Abiraterone Fresenius Kabi").

Taking Abiraterone Fresenius Kabi with food may cause adverse effects.

Pregnancy and breastfeeding

Abiraterone Fresenius Kabi is not used in women.

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

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

If the patient has sexual intercourse with a woman who may become pregnant, a condom and 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.

Abiraterone Fresenius Kabi contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per dose of four 250 mg tablets, meaning the medicine is considered "sodium-free".

3. How to take Abiraterone Fresenius Kabi

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

How much medicine to take
The recommended dose is 1,000 mg (four 250 mg tablets) once daily.

How to take this medicine
Oral administration.
Abiraterone Fresenius Kabi must not be taken with food. Taking Abiraterone Fresenius Kabi with food may result in more of the medicine being absorbed by the body than intended, which may cause adverse effects.
Abiraterone Fresenius Kabi tablets should be taken as a single daily dose on an empty stomach. Abiraterone Fresenius Kabi should be taken at least two hours after eating, and food should not be consumed for at least one 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 to be used together with a medicine called prednisolone. Prednisolone should be taken as directed by your doctor.
Prednisolone should be taken daily during treatment with Abiraterone Fresenius Kabi.
The amount of prednisolone prescribed may be adjusted if necessary. Your doctor will inform you if a change in prednisolone dose is required. Do not stop taking prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines while you are taking Abiraterone Fresenius Kabi and prednisolone.

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

If you miss a dose of 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.

Stopping Abiraterone Fresenius Kabi treatment
Do not stop taking Abiraterone Fresenius Kabi 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 reactions

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

• muscle weakness, muscle tremors, or heart palpitations. These may be symptoms of low blood potassium levels.

Other adverse reactions:
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, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat;
• severe infection – 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);
• irregular heartbeat (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 (prolongation of QT interval);
• 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 being treated for prostate cancer.
Abiraterone Fresenius Kabi in combination with prednisolone may worsen this effect.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices
and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 to provide more information on the safety of the 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 stated on the carton and bottle after:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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, embossed with
"ATN" 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 Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Manufacturer
Synthon Hispania, S.L.
c/ Castelló, 1
08830 Sant Boi de Llobregat (Barcelona)
Spain

This medicinal product is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: