Abiraterone aristo

Package leaflet: Information for the patient

Abirateron Aristo, 250 mg, 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 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Abirateron Aristo is and what it is used for
2. Important information 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 hormone-sensitive disease, 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 risk of developing high blood pressure, fluid retention (fluid build-up), 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).

This medicine should not be used if any of the above situations apply. 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 problems;
• the patient has high blood pressure, heart failure, or low blood potassium levels (low potassium levels may increase the risk of heart rhythm disturbances);
• the patient has had other heart or blood vessel diseases;
• the patient has irregular or rapid heartbeat;
• the patient has shortness of breath;
• the patient has gained weight suddenly;
• the patient has swelling in the feet, ankles, or legs;
• the patient has previously taken a medicine called ketoconazole for prostate cancer;
• the patient needs to take this medicine with prednisone or prednisolone;
• there is a risk of bone-related adverse effects;
• 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, or severe nausea or vomiting, as these 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 cell count, reduced libido, muscle weakness, and/or muscle pain.

Abirateron Aristo must not be given 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 end of treatment with 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 effect of the medicine 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, taking the patient leaflet along to show the emergency room doctor.

Abirateron Aristo 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 Abirateron Aristo may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic medicines, 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, which could lead to adverse effects or reduced efficacy.

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

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

Women who are pregnant or may become pregnant should wear protective gloves when handling or using Abirateron Aristo.

Driving and using machines

It is unlikely that this medicine affects the ability to drive, use tools, or operate machinery.

Abirateron Aristo contains lactose and sodium

• Abirateron Aristo contains lactose (a type of sugar). If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• The medicine also contains 23.2 mg of sodium (the main component of table salt) in each dose unit consisting of four 250 mg tablets. This corresponds to 1.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to use 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 (four 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 food (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 directed 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 change in the dose of prednisone or prednisolone is required. Do not stop taking prednisone or prednisolone without consulting your doctor.

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

Taking more Abirateron Aristo than prescribed

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

If you forget to take 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 Abirateron Aristo

Do not stop taking Abirateron Aristo, 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 everybody will get them.
You must stop taking Abirateron Aristo and contact your doctor immediately
if you experience any of the following symptoms:

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

Other side 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 irritation (also known as allergic alveolitis). Liver dysfunction (also known as acute liver failure).
Frequency not known (cannot be estimated from the 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.
Loss of bone mass may occur in men being treated for prostate cancer. Abirateron Aristo in combination with prednisone and prednisolone may worsen this effect.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also 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, tel.: 22 49-21-301, fax: 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 provide more information on the safety of this medicine.

5. How to store Abirateron Aristo

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer carton and bottle label after EXP. The expiry date refers to the last day of the specified month.
• There are no special requirements for storage.
• Store in the original packaging to protect from light.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Abirateron Aristo contains

• The active substance is abiraterone acetate. Each tablet contains 250 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").

What Abirateron Aristo looks like and contents of the pack

• Abirateron Aristo 250 mg are oval, biconvex, uncoated tablets, white to off-white in colour, embossed with "250" on one side and smooth on the other.
• The tablets are supplied in HDPE bottles with a 100 ml capacity, fitted with a child-resistant PP closure and containing a desiccant. Each bottle contains 120 tablets. Each pack contains one bottle.

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 European Economic Area countries under the following names:
Austria Abirateron Aristo 250 mg Tabletten
Czech Republic Abirateron Aristo
Denmark Abitateron Aristo
Spain Abiraterona Aristo 250 mg comprimidos EFG
Ireland Abitaterone Aristo 250 mg tablets
Germany Abirateron Aristo 250 mg Tabletten
Norway Abirateron Aristo
Poland Abirateron Aristo
Portugal Abiraterona Aristo 250 mg comprimidos
Slovakia Abiraterone Aristo
Sweden Abirateron Aristo
United Kingdom Abitaterone Aristo 250 mg tablets
Italy Abiraterone Aristo 250 mg compresse