Abiraterone aristo

Package leaflet: Information for the patient

Abirateron Aristo, 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, 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, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Abirateron Aristo is and what it is used for

Abirateron Aristo 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). Abirateron Aristo inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abirateron Aristo is used at an early stage of the disease that responds to hormonal therapy, it is given in combination 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 likelihood of developing high blood pressure, fluid retention (fluid buildup), or low blood potassium levels.

2. Important information before using Abirateron Aristo

When not to use Abirateron Aristo:

• if the patient is allergic to abiraterone or any of the other ingredients of this medicine (listed in section 6);
• in women, especially during pregnancy. Abirateron Aristo 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. In case of
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 problems;
• 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 disturbances);
• if the patient has other heart or blood vessel diseases;
• if the patient has irregular or rapid heartbeat;
• if the patient has shortness of breath;
• if the patient has gained weight rapidly;
• if the patient has swelling of the feet, ankles, or legs;
• if the patient has previously taken a medicine called ketoconazole for the treatment of prostate cancer;
• if the patient needs to take this medicine with prednisone or prednisolone;
• if there is a risk of bone-related adverse effects;
• if the patient has high blood sugar levels.

Inform the doctor if the patient has any heart or blood vessel disorders, including heart
rhythm disturbances (arrhythmia), or is taking medicines for these conditions.
Inform the doctor if the patient develops yellowing of the skin or eyes, dark urine, or severe
nausea or vomiting, which may be signs of liver problems. Rarely, acute liver failure may
occur, which can be fatal.
Decreased red blood cell count, reduced libido, muscle weakness, and/or muscle pain may occur.
Abirateron Aristo must not be used in combination with Ra-223 due to a possible increased
risk of bone fractures or death.
Before starting planned Ra-223 therapy, the patient must wait 5 days after the last dose of
Abirateron Aristo and prednisone/prednisolone.
If in doubt whether any of the above situations apply, consult a doctor or pharmacist before
using this medicine.
Blood tests
Abirateron Aristo may affect liver function, and the patient may not experience any symptoms.
During treatment, the doctor 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 Abirateron Aristo is
accidentally swallowed by a child, seek immediate medical attention at a hospital, bringing
the patient leaflet to show the emergency room doctor.
Abirateron Aristo and other medicines
Before taking any medicine, consult a doctor or pharmacist.
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as
any medicines the patient plans to take. This is important because Abirateron Aristo 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 Abirateron Aristo, potentially leading to adverse effects or reduced efficacy.
Androgen suppression may increase the risk of heart rhythm disturbances. Inform the doctor
if the patient is taking any of the following medicines:

• those used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• those that may increase the risk of heart rhythm disturbances [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe psychiatric disorders)].

Inform the doctor if the patient is taking any of the medicines listed above.
Taking Abirateron Aristo with food
This medicine must not be taken with food (see section 3, "How to take Abirateron Aristo").
Taking Abirateron Aristo with food may lead to adverse effects.
Pregnancy and breastfeeding
Abirateron Aristo is not used in women. This medicine may harm an unborn child if taken by a
pregnant woman.
If the patient has sexual intercourse with a woman who could become pregnant, a condom or
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.
Abirateron Aristo, 500 mg, tablets
Women who are pregnant or may be pregnant should wear protective gloves when handling or
coming into contact with Abirateron Aristo.
Driving and operating machinery
It is unlikely that this medicine affects the ability to drive or operate tools and machinery.
Abirateron Aristo contains lactose and sodium

• Abirateron Aristo contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• The medicine also contains 23 mg of sodium (the main component of table salt) per dose unit consisting of two 500 mg tablets. This corresponds to 1.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Abirateron Aristo

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 1000 mg (two tablets) taken once daily.

How to take the medicine

• Take orally.
• Abirateron Aristo must not be taken with food. Abirateron Aristo should be taken at least one hour before or at least two hours after eating (see section 2, "Taking Abirateron Aristo with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Abirateron Aristo is taken together with a medicine called prednisone or prednisolone. Prednisone or prednisolone should be taken exactly as prescribed by your doctor.
• Prednisone or prednisolone should be taken every day during treatment with Abirateron Aristo.
• The dose of prednisone or prednisolone may be adjusted if necessary. Your doctor will inform you if any changes to the dose of prednisone or prednisolone are required. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines to you while you are taking Abirateron Aristo and prednisone or prednisolone.

Taking more Abirateron Aristo than prescribed

If you take more Abirateron Aristo than you should, contact your doctor immediately or go to hospital.

Missing a dose of Abirateron Aristo

If you forget to take Abirateron Aristo, prednisone, or prednisolone, take your usual dose the next day.

If you forget to take Abirateron Aristo, prednisone, or prednisolone for more than one day, contact your doctor immediately.

Stopping treatment with Abirateron Aristo

Do not stop taking Abirateron Aristo, prednisone, 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 effects

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

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

Other adverse effects include:
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 called 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 inflammation (also known as allergic alveolitis). Liver dysfunction (also known as acute liver failure).
Frequency not known (cannot be estimated from available data):
Heart attack, changes in ECG (prolongation of QT interval), and severe allergic reactions causing difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Bone mass loss may occur in men treated for prostate cancer. Abirateron Aristo in combination with prednisone and prednisolone may worsen this effect.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Abirateron Aristo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the mentioned month.
• There are no special storage temperature requirements for this medicine.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Abirateron Aristo contains

• The active substance is abiraterone acetate. Each coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: microcrystalline cellulose type 102, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose 2910, colloidal anhydrous silica, and sodium lauryl sulfate (see section 2 "Abirateron Aristo contains lactose and sodium"). The tablet coating contains black iron oxide (E 172), red iron oxide (E 172), polyethylene glycol-grafted polyvinyl alcohol copolymer, talc, and titanium dioxide (E 171).

What Abirateron Aristo looks like and contents of the pack

• Abirateron Aristo 500 mg are oval, biconvex, film-coated tablets in a violet colour, marked with the imprint "500" on one side and smooth on the other.
• The tablets are supplied in PVC/PVDC/aluminium blister packs contained in cardboard boxes containing 60, 60 x 1, or 112 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Tel: +48 22 855 40 93
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15,
Münster, 48159
Germany
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Abirateron Aristo 500 mg Filmtabletten
Czech Republic Abirateron Aristo
Denmark Abitateron Aristo
Spain Abiraterona Aristo 500 mg comprimidos recubiertos con película EFG
Ireland Abiraterone Aristo 500 mg film-coated tablets
Germany Abirateron Aristo 500 mg Filmtabletten
Norway Abirateron Aristo
Poland Abitateron Aristo
Portugal Abiraterona Aristo 500 mg comprimidos revestidos por película
Slovakia Abiraterone Aristo
Sweden Abirateron Aristo
United Kingdom Abiraterone 500 mg film-coated tablets
Italy Abiraterone Aristo 500 mg compresse rivestite con film