Abiraterone exeltis

Package leaflet: Information for the user

Abiraterone Exeltis, 500 mg, film-coated tablets
Abirateroni acetas
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 you only. Do not pass it on to others. It may harm other people, even if their symptoms 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 leaflet

1. What Abiraterone Exeltis is and what it is used for
2. What you need to know before taking 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 Abiraterone Exeltis is and what it is used for
Abiraterone Exeltis contains an active substance called abiraterone acetate. It is used in adult males for the treatment of metastatic prostate cancer (cancer of the prostate gland that has spread to other parts of the body). Abiraterone Exeltis reduces the production of testosterone in the body; this may slow down the progression of prostate cancer.
When Abiraterone Exeltis is used in the early stage of hormone-sensitive disease, it is given together with treatment that reduces 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 (fluid build-up), or low potassium levels in the blood.

2. What you need to know before taking Abiraterone Exeltis

Do not 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 during pregnancy. Abiraterone Exeltis is only used in men;
• in patients with severe liver impairment;
• in combination with the medicine Ra-223 (used in the treatment of prostate cancer).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Abiraterone Exeltis:

• if you have liver disease;
• if you have high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels may increase the risk of heart rhythm problems);
• if you have previously had other heart or blood vessel diseases;
• if you have irregular or rapid heartbeat;
• if you have shortness of breath;
• if your body weight has increased rapidly;
• if you have swelling of the feet, ankles, or legs;
• if you have previously taken the medicine ketoconazole for the treatment of prostate cancer;
• the need to take this medicine with prednisone or prednisolone;
• possible effects of treatment on bones;
• if you have high blood sugar levels.

Tell your doctor if you have any other heart or blood vessel diseases, including heart rhythm disorders (arrhythmia), or if you are being treated with medicines used 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, severe liver problems may occur, which can lead to death.
A decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.
Abiraterone Exeltis must not be used in combination with Ra-223 due to a possible increased risk of bone fractures or death.
If you plan to receive 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 whether any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Blood tests
Abiraterone Exeltis may affect liver function, and you may not have any symptoms. While taking this medicine, your doctor will periodically order blood tests to monitor 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, go to hospital immediately and take this leaflet with you to show the doctor in the emergency department.

Abiraterone Exeltis with other medicines
Talk to your doctor or pharmacist before taking any other medicine.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This is important because Abiraterone Exeltis may increase the effects of many medicines, including heart medicines, sedatives, certain antidiabetic medicines, herbal medicines (e.g. those containing St. John’s wort), and others. Your doctor may need to adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone Exeltis, which could lead to side effects or reduced effectiveness of Abiraterone Exeltis.
Androgen deprivation 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, 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 mental disorders)].

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

Abiraterone Exeltis with food and drink

• Do not take this medicine with food (see section 3, “How to take Abiraterone Exeltis”).
• Taking Abiraterone Exeltis with food may increase the risk of side effects.

Pregnancy and breast-feeding
Abiraterone Exeltis is not used in women.

• This medicine may harm an unborn baby if taken by a pregnant woman.
• If you have sexual intercourse with a woman who could become pregnant, you must use a condom together with another effective method of contraception.
• If you have sexual intercourse with a pregnant woman, you must use a condom to protect the unborn baby.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use 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, talk to your doctor before taking this medicine.
• This medicine contains 24 mg of sodium (the main component of table salt) in two tablets, which is the recommended daily dose. This corresponds to 1.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Abiraterone Exeltis

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
What dose should be used
The recommended dose is 1000 mg (two tablets) once daily.
Taking Abiraterone Exeltis

• Take this medicine by mouth.

• Abiraterone Exeltis must not be taken with food. Taking Abiraterone Exeltis with food may result in more medicine being absorbed by the body than necessary, which could lead to unwanted side effects.

• Abiraterone Exeltis tablets should be taken as a single dose once daily on an empty stomach. Abiraterone Exeltis should be taken at least two hours after a meal, and no food should be consumed for at least one hour after taking Abiraterone Exeltis (see section 2, "Abiraterone Exeltis with food").

• Swallow the tablets whole with water.

• Do not crush the tablets.

• Abiraterone Exeltis is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.

• Prednisone or prednisolone should be taken every day during treatment with Abiraterone Exeltis.

• The dose of prednisone or prednisolone may need to be adjusted in certain situations. Your doctor will inform you if any change in the dose of prednisone or prednisolone is required. Do not stop taking prednisone or prednisolone without first consulting your doctor.

Your doctor may also prescribe other medicines for you while you are taking Abiraterone Exeltis and prednisone or prednisolone.
Taking more Abiraterone Exeltis than recommended
If you take more Abiraterone Exeltis than you should, contact your doctor or go to hospital immediately.
Missing a dose of 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.

Stopping Abiraterone Exeltis
Do not stop taking Abiraterone Exeltis or prednisone or prednisolone without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You must stop taking Abiraterone Exeltis immediately and contact your doctor immediately
if you notice any of the following symptoms:

• Muscle weakness, muscle twitching, or rapid heartbeat (palpitations). These may be symptoms of low potassium levels in the blood.

Other side effects:
Very common (may occur in more than 1 in 10 people):
Swelling of the legs or feet, low potassium levels in the blood, increased liver function test results, high blood pressure, urinary tract infections, diarrhoea.
Common (may occur in less than 1 in 10 people):
High levels of fats in the blood, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat, severe infection called sepsis, bone fractures, indigestion, blood in urine, rash.
Uncommon (may occur in less than 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 occur in less than 1 in 1,000 people):
Lung irritation (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 (prolongation of QT interval), and severe allergic reactions with difficulty 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 Exeltis used concomitantly with prednisone and prednisolone may exacerbate loss of bone mass.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects 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 181 C, 02-222 Warsaw, phone: +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 helps to provide more information on the safety of the 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 stated on the carton and blister. The expiry date refers to the last day of the month indicated.
• 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. 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, equivalent to 446 mg of abiraterone.
• The other ingredients are: sodium croscarmellose; sodium lauryl sulphate; hypromellose 2910; microcrystalline cellulose (silicated); 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 an oval, red-beige film-coated tablet with the imprint “500” on one side.

• Each 28-day pack contains 56 film-coated tablets. Each 30-day pack contains 60 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: [email protected]
Manufacturer
Laboratorios Liconsa, S.A.
Av. Miralcampo 7
19200 Azuqueca de Henares, Guadalajara
Spain
Laboratorios León Farma, S.A.
C/ La Vallina s/n
Pol. Ind. Navatejera
24193 - Villaquilambre, León
Spain
This medicinal product is authorised in the European Economic Area under the following names:
France Abiraterone CRISTERS 500 mg Film-coated tablet
Spain Abiraterone Exeltis 500 mg film-coated tablets
Netherlands Abiraterone Leon Farma 500 mg Film-coated tablets
Ireland Abiraterone Rowa 500 mg Film-coated tablets
Poland Abiraterone Exeltis