Abiraterone fresenius kabi

Patient Information Leaflet

Abiraterone Fresenius Kabi, 500 mg, film-coated tablets
Abiraterone acetate
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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Abiraterone Fresenius Kabi is and what it is used for
2. What you need to know 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 (cancer of the prostate gland 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 together with androgen-deprivation therapy (testosterone-lowering 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 (fluid buildup),
or low potassium levels in the blood.

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).

Do not use 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 diseases;
• if the patient has high blood pressure, 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 in 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 reactions;
• if the patient has high blood sugar levels.

Tell your doctor if the patient has any heart or blood vessel disorders, including heart rhythm disturbances (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 symptoms of liver dysfunction. Rarely, acute liver failure may occur, which can lead to death.

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

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 to the patient, consult a 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 treating physician will periodically order blood tests to monitor the medicine’s effect 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, bringing this patient leaflet to show to the emergency room doctor.

Abiraterone Fresenius Kabi 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 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 of Abiraterone Fresenius Kabi.

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);
• medicines that may increase the risk of heart rhythm disturbances [e.g. methadone (a painkiller and medication used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe psychiatric disorders)].

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

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.

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 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 your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before using this medicine.

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

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 (two 500 mg tablets) once daily.
How to take this medicine
Oral administration.
Do not take Abiraterone Fresenius Kabi 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").
Swallow the tablets whole with water.
Do not crush the tablets.
Abiraterone Fresenius Kabi is used together with a medicine called prednisolone. Take prednisolone exactly as prescribed by your doctor.
You must take prednisolone every day while taking Abiraterone Fresenius Kabi.
The dose of prednisolone may need to be adjusted in certain circumstances. Your doctor will inform you if any changes to your prednisolone dose are 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 recommended
If you take more Abiraterone Fresenius Kabi than you should, contact your doctor immediately or go to a 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 they do not occur in everyone.
You must stop taking Abiraterone Fresenius Kabi and contact your doctor immediately if you experience any of the following symptoms:

• muscle weakness, muscle twitching (tremors), or rapid heartbeat (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 urine;
• rash.

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

• adrenal gland disorders (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 irritation (also known as allergic alveolitis);
• acute liver failure.

Frequency not known (cannot be estimated from the available data):

• myocardial infarction, 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 treated for prostate cancer.
Abiraterone Fresenius Kabi in combination with prednisone may worsen this effect.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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
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 marketing authorisation holder.
Reporting adverse reactions helps 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 stated on the carton, bottle, or blister pack after: "EXP". The expiry date refers to the last day of the stated month.
No special storage precautions apply.
Medicines should not be disposed of via wastewater 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 Abiraterone Fresenius Kabi 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 (E171), macrogol 3350, talc, red iron oxide (E172), black iron oxide (E172).

What Abiraterone Fresenius Kabi looks like and contents of the pack
Purple, oval coated tablets approximately 19 mm in length and 11 mm in width, with the imprint
“A7TN” on one side and “500” on the other side.
Pack sizes:

• Blister packs containing 56 or 60 coated tablets, in a cardboard box;
• Single-dose blister packs containing 56x1 or 60x1 coated tablets, in a cardboard box;
• Bottle containing 60 coated 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
Poland

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

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