Abiraterone Exeltis

Package Leaflet: Information for the User

Abiraterone Exeltis, 500 mg, film-coated tablets

Abiraterone acetate

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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What is Abiraterone Exeltis and what is it used for
• 2. What you need to know before you take Abiraterone Exeltis
• 3. How to take Abiraterone Exeltis
• 4. Possible side effects
• 5. How to store Abiraterone Exeltis
• 6. Contents of the pack and other information

1. What is Abiraterone Exeltis and what is it used for

Abiraterone Exeltis contains the active substance abiraterone acetate. It is used in adult men to treat prostate cancer that has spread to other parts of the body. Abiraterone Exeltis works by stopping the production of testosterone in the body; this can slow down the growth of prostate cancer.

When Abiraterone Exeltis is used in early stages of hormone-sensitive prostate cancer, it is given together with a treatment that lowers testosterone levels (androgen deprivation therapy).

While taking 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 (oedema), or low potassium levels in the blood.

2. What you need to know before you take Abiraterone Exeltis

When not to take Abiraterone Exeltis

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6);
• in women, especially if pregnant. Abiraterone Exeltis is for use in men only;
• in patients with severe liver damage;
• in combination with a medicine called Ra-223 (used to treat prostate cancer).

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Abiraterone Exeltis.

Warnings and precautions

Before taking Abiraterone Exeltis, talk to your doctor or pharmacist if:

• you have liver problems;
• you have high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of abnormal heart rhythms);
• you have had other heart problems or blood vessel problems in the past;
• you have an irregular or fast heartbeat;
• you have shortness of breath;
• your body weight has increased in a short time;
• you have swelling of your feet, ankles, or legs;
• you have taken a medicine called ketoconazole in the past to treat prostate cancer;
• you need to take this medicine with prednisone or prednisolone;
• the possible effect of treatment on bones;
• you have high blood sugar levels;

Tell your doctor if you have any other heart or blood vessel problems, including abnormal heart rhythms (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 problems. Rarely, acute liver failure can occur, which can be life-threatening.

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

Abiraterone Exeltis must not be taken with a medicine called Ra-223, due to the possible increased risk of bone fractures or death.

If you plan to take Ra-223 after treatment with Abiraterone Exeltis and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Abiraterone Exeltis.

Blood tests

Abiraterone Exeltis may affect your liver and you may not have any symptoms. While taking this medicine, your doctor will regularly prescribe blood tests to check the effect of the medicine on your liver.

Children and adolescents

This medicine is not intended for use in children and adolescents. If Abiraterone Exeltis is accidentally swallowed by a child, you should go to the hospital immediately and take the package leaflet with you to show to the doctor.

Abiraterone Exeltis with 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, and about any medicines you plan to take. This is important because Abiraterone Exeltis may increase the effects of many medicines, including heart medicines, sedatives, some anti-diabetic medicines, herbal medicines (e.g. containing St. John's Wort), and others. Your doctor may change the dose of these medicines. Other medicines may also increase or decrease the effects of Abiraterone Exeltis, which may result in side effects or reduced effectiveness of Abiraterone Exeltis.

Androgen deprivation therapy may increase the risk of abnormal heart rhythms. Tell your doctor if you are taking medicines for:

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

Tell your doctor if you are taking any of the above medicines.

Abiraterone Exeltis with food

• This medicine must not be taken with food (see section 3, "How to take Abiraterone Exeltis").
• Taking Abiraterone Exeltis with food may cause side effects.

Pregnancy and breast-feeding

Abiraterone Exeltis is not for use in women.

• This medicine may harm an 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 or machines.

Abiraterone Exeltis contains lactose and sodium

• Abiraterone Exeltis contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains 24 mg of sodium (a major component of cooking salt) in the daily dose of two tablets. This is equivalent to 1.2% of the maximum recommended daily intake of sodium for adults.

3. How to take Abiraterone Exeltis

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

What dose to take

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

How to take Abiraterone Exeltis

• Take this medicine by mouth.
• Do not take Abiraterone Exeltis with food.Taking Abiraterone Exeltis with food may cause side effects.
• Take the tablets as a single dose once a day on an empty stomach. Take Abiraterone Exeltis at least 2 hours after eating and do not eat for at least 1 hour after taking Abiraterone Exeltis (see section 2, "Abiraterone Exeltis with food").

Swallow the tablets whole with water. Do not crush the tablets.

Take Abiraterone Exeltis with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as directed by your doctor.

Take prednisone or prednisolone every day while taking Abiraterone Exeltis.

The dose of prednisone or prednisolone may need to be changed in case of an emergency. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without talking to your doctor.

Your doctor may also prescribe other medicines for you to take with Abiraterone Exeltis and prednisone or prednisolone.

If you take more Abiraterone Exeltis than you should

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

If you forget to take Abiraterone Exeltis

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

If you stop taking Abiraterone Exeltis

Do not stop taking Abiraterone Exeltis or prednisone, or prednisolone without talking to your doctor.

If you have any further questions on the use of this product, 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 Exeltis and contact your doctor immediately if you notice any of the following:

symptoms:

• Muscle weakness, muscle 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, increased liver enzymes, high blood pressure, urinary tract infections, diarrhea.
Common(may affect up to 1 in 10 people):
High levels of fats in the blood, chest pain, abnormal heart rhythms (atrial fibrillation), heart failure, fast heartbeat, severe infection (sepsis), bone fractures, indigestion, blood in the urine, rash.
Uncommon(may affect up to 1 in 100 people):
Adrenal gland problems (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).
Liver failure (also known as acute liver failure).
Frequency not known(frequency cannot be estimated from the available data):
Heart attack, changes in ECG (QT interval prolongation), and severe allergic reactions with difficulty swallowing or breathing, facial, lip, tongue, or throat swelling, or itchy rash.
Bone loss may occur in men treated for prostate cancer. Abiraterone Exeltis taken with prednisone and prednisolone may increase bone loss.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the https://smz.ezdrowie.gov.plwebsite or to the pharmaceutical company. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abiraterone Exeltis

• 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 blister after EXP. The expiry date refers to the last day of that month.
• No special storage precautions are required.
• 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 Exeltis contains

• The active substance is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate, which corresponds to 446 mg of abiraterone.
• The other ingredients are: croscarmellose sodium; sodium lauryl sulfate; hypromellose 2910; microcrystalline cellulose (silicified); colloidal anhydrous silica; lactose monohydrate; magnesium stearate; (see section 2, "Abiraterone Exeltis contains lactose and sodium"). The tablet coating contains polyvinyl alcohol; titanium dioxide (E 171); macrogol 3350; talc; yellow iron oxide (E 172); red iron oxide (E 172); black iron oxide (E 172).

What Abiraterone Exeltis looks like and contents of the pack

• Abiraterone Exeltis is oval, reddish-brown film-coated tablets with "500" engraved on one side.

The pack sizes are 28 days (56 film-coated tablets) or 30 days (60 film-coated tablets).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw
e-mail: biuro@exeltis.com

Manufacturer

Laboratorios Liconsa, S.A.
Miralcampo 7
19200 Azuqueca de Henares, Guadalajara
Spain
Laboratorios León Farma, S.A.
La Vallina s/n
Navatejera Industrial Estate

• 24193 - Villaquilambre, León Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

France
Abiraterone CRISTERS 500 mg Film-coated tablets
Spain
Abiraterona Exeltis 500 mg Film-coated tablets
Netherlands
Abirateron Leon Farma 500 mg Film-coated tablets
Ireland
Abiraterone Rowa 500 mg Film-coated tablets
Poland
Abiraterone Exeltis
Date of last revision of the leaflet: 18.12.2024