Abiraterone orion

Package leaflet: information for the patient

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

1. What Abiraterone Orion is and what it is used for
Abiraterone Orion contains an active substance called abiraterone acetate. It is used in adult males for the treatment of metastatic prostate cancer. This medicine inhibits testosterone production in the body; this may slow the progression of prostate cancer.
When this medicine is used in the early stage of hormone-sensitive disease, it is given in combination with androgen-deprivation therapy.
During treatment with 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 accumulation), or low potassium levels in the blood.

2. What you need to know before taking Abiraterone Orion

When not to take Abiraterone Orion

• 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. This medicine is intended for use in men only;
• in patients with severe liver impairment;
• in combination with Ra-223 (used in the treatment of prostate cancer).

Do not take this medicine if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting treatment with Abiraterone Orion, discuss with your doctor or pharmacist:

• 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 disturbances);
• 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;
• the possibility of bone-related side effects;
• if you have high blood sugar levels;
• if you have previously had any other heart or blood vessel diseases, including heart rhythm disorders (arrhythmia), or have been treated with medicines used for these conditions;
• if you have yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver dysfunction. Rarely, acute liver failure may occur, which can lead to death.

A decrease in red blood cell count, reduced sex drive (libido), muscle weakness and (or) muscle pain may occur.
This medicine must not be used in combination with Ra-223 due to the possible increased risk of bone fractures or death.
If you plan to receive Ra-223 after treatment with abiraterone and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment.
If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking this medicine.
Blood tests
This medicine may affect liver function, and you may not experience any symptoms.
During treatment, your 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 this medicine is accidentally swallowed by a child, seek immediate medical attention at a hospital, bringing this patient leaflet to show the emergency room doctor.
Abiraterone Orion and other medicines
Before taking any medicine, consult your doctor or pharmacist.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any you plan to take. This is important because this medicine may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic medicines, herbal remedies (e.g. St. John's wort), and others. Your doctor may adjust the doses of these medicines. Other medicines may also increase or decrease the effect of this medicine, which could result in side effects or reduced effectiveness.
Androgen suppression may increase the risk of heart rhythm disturbances. Inform your doctor if you are 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 medication used in addiction treatment), moxifloxacin (an antibiotic), antipsychotic medicines (used in severe psychiatric disorders)].

Abiraterone Orion and food

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

Pregnancy and breastfeeding
This medicine is not used in women.

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

Driving and using machines
It is unlikely that this medicine will affect your ability to drive, use tools, or operate machinery.
Abiraterone Orion contains lactose
This medicine contains 241 mg of lactose (as monohydrate lactose). If you have previously been diagnosed with an intolerance to certain sugars, you should contact your doctor before taking this medicine.
Other excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Abiraterone Orion

This medicine should always be used exactly as your doctor has told you. If you are unsure, you should contact your doctor or pharmacist.
What dose to use
The recommended dose is 1000 mg (two tablets) once daily.
Taking Abiraterone Orion

• Take this medicine by mouth.
• Do not take this medicine with food. Taking this medicine with food may result in more medicine being absorbed by the body than necessary, which could cause adverse effects.
• The tablets should be taken as a single dose once daily on an empty stomach. The medicine should be taken at least two hours after eating, and you must not eat for at least one hour after taking this medicine (see section 2, "Abiraterone Orion with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• This medicine is taken together with a medicine called prednisone or prednisolone. You must take prednisone or prednisolone exactly as directed by your doctor.
• You must take prednisone or prednisolone every day while taking this medicine.
• The amount of prednisone or prednisolone you take may need to be adjusted in certain circumstances. Your doctor will inform you if any dose adjustment of prednisone or prednisolone is required. Do not stop taking prednisone or

prednisolone without consulting your doctor.
Your doctor may also prescribe other medicines for you while you are taking this medicine and prednisone or prednisolone.
If you take more Abiraterone Orion than you should
If you take more than the recommended dose, contact your doctor immediately or go to the nearest hospital.
If you forget to take Abiraterone Orion

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

Stopping Abiraterone Orion
Do not stop taking this medicine or prednisone or prednisolone without consulting your doctor.
If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The patient must stop taking this medicine immediately and contact a doctor immediately
if any of the following symptoms occur:

• Muscle weakness, muscle tremors (shaking), or heart palpitations. These may be symptoms of low blood potassium levels.

Additional adverse reactions:
Very common (may affect more than 1 in 10 patients):
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 patients):
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 patients):
Adrenal gland dysfunction (related to disturbances in water and electrolyte balance), irregular heartbeat (arrhythmia), muscle weakness and (or) muscle pain.
Rare (may affect up to 1 in 1000 patients):
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):
Myocardial infarction, 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. This medicine, when used in combination with prednisone and prednisolone, may exacerbate this effect.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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 to provide more information on the safety of the medicine.

5. How to store Abiraterone Orion

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, label, and blister. The expiry date refers to the last day of the stated month.
• No special storage conditions apply for this medicine.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Abiraterone Orion contains

• The active substance is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.
• The other ingredients are:
  Tablet core: lactose monohydrate, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.
  Tablet coating Opadry II 85F90093 Purple: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E 172).

What Abiraterone Orion looks like and contents of the pack
Oval, purple film-coated tablets, 19 mm in length and 11 mm in width, embossed with
"A7TN" on one side and "500" on the other side.
Pack sizes:
Blister pack: 56 tablets

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
Synthon Hispania S.L.
Calle De Castelló 1
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

For more detailed information about this medicine, please contact the local representative of the marketing authorisation holder:
Orion Pharma Poland Sp. z o.o.
[email protected]