Abiraterone ariti

Package leaflet: Information for the patient

Abiraterone Ariti, 500 mg, film-coated tablets
Abiraterone acetate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Abiraterone Ariti is and what it is used for
2. Important information before taking Abiraterone Ariti
3. How to take Abiraterone Ariti
4. Possible side effects
5. How to store Abiraterone Ariti
6. Contents of the pack and other information

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

Abiraterone Ariti is a medicine containing abiraterone acetate. It is used in adult men for the treatment of metastatic prostate cancer. Abiraterone Ariti inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abiraterone Ariti is used at an early stage of hormone-sensitive disease, it is administered 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 risk of high blood pressure, fluid retention (fluid buildup), or low potassium levels in the blood.

2. Important information before using Abiraterone Ariti

When not to use Abiraterone Ariti:

• 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. Abiraterone Ariti is used exclusively in men;
• 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 the following with your doctor or pharmacist:

• if the patient has liver diseases;
• if the patient has hypertension, heart failure or low blood potassium levels (low potassium levels may increase the risk of cardiac arrhythmia);
• 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's body weight has increased rapidly;
• if the patient has swelling of the feet, ankles or legs;
• if the patient has previously taken ketoconazole for the treatment of prostate cancer;
• the necessity of taking this medicine with prednisone or prednisolone;
• the possibility of bone-related adverse reactions;
• if the patient has high blood sugar levels.

Tell your doctor if the patient has any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or is taking medicines for these conditions.

Tell your doctor if the patient develops yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be symptoms of liver dysfunction. Acute liver failure, which may lead to death, is rare but possible.

Decreased red blood cell count, decreased libido, muscle weakness and/or muscle pain may occur.

Abiraterone Ariti must not be given in combination with Ra-223 due to a possible increased risk of bone fractures or death.

If the patient intends to receive Ra-223 after treatment with Abiraterone Ariti and prednisone/prednisolone, a 5-day interval should be observed before starting Ra-223 therapy.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before using this medicine.

Blood tests

Abiraterone Ariti 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 Abiraterone Ariti is accidentally swallowed by a child, seek immediate medical attention and bring the patient leaflet to show the doctor in the emergency department.

Abiraterone Ariti and other medicines

Before taking any medicine, consult a doctor or pharmacist.

Tell your 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 Abiraterone Ariti may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic medicines, herbal medicines (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 Abiraterone Ariti, which may result in adverse reactions or reduced efficacy.

Androgen suppression may increase the risk of cardiac arrhythmia. Inform your doctor if the patient is taking any of the following medicines:

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

Inform your doctor if the patient is taking any of the medicines listed above.

Taking Abiraterone Ariti with food

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

Pregnancy and breastfeeding

Abiraterone Ariti is not used in women.

• This medicine may harm the unborn child if taken by a pregnant woman.
• Women who are pregnant or may be pregnant should wear protective gloves when handling or coming into contact with Abiraterone Ariti.
• 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.

Driving and operating machinery

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

Abiraterone Ariti contains lactose

Abiraterone Ariti contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Abiraterone Ariti contains sodium

Abiraterone Ariti 500 mg film-coated tablets contain 11.76 mg of sodium (the main component of table salt) in each tablet. This corresponds to 0.6% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take Abiraterone Ariti

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 500 mg tablets) taken once daily.
Taking the medicine

• This medicine should be taken orally.
• Abiraterone Ariti must not be taken with food.
• Abiraterone Ariti should be taken at least one hour before eating or at least two hours after eating (see section 2, "Taking Abiraterone Ariti with food").
• Tablets should be swallowed whole with water.
• Do not crush the tablets.
• Abiraterone Ariti 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 Ariti.
• The amount of prednisone or prednisolone taken may be adjusted if necessary.

Your doctor will inform you if there is a need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without consulting your doctor.
Your doctor may also prescribe other medicines for you while you are taking Abiraterone Ariti and prednisone or prednisolone.
Taking more Abiraterone Ariti than prescribed
If you take more medicine than you should, contact your doctor immediately or go to hospital.
Missing a dose of Abiraterone Ariti

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

Stopping Abiraterone Ariti treatment
Do not stop taking Abiraterone Ariti or 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 side effects

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

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

Other side effects reported:
Very common (may occur in more than 1 in 10 people):
Swelling of the legs or feet, low blood potassium levels, increased liver function test parameters, high blood pressure, urinary tract infections, diarrhoea.
Common (may occur in up to 1 in 10 people):
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 occur in up to 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 up to 1 in 1000 people):
Lung inflammation (also known as allergic alveolitis).
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 causing 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 Ariti in combination with prednisone or prednisolone may worsen this effect.

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

5. How to store Abiraterone Ariti

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer carton and blister pack after EXP.
• The expiry date refers to the last day of the stated month.
• No special storage conditions are required 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 Ariti contains

• The active substance is abiraterone acetate. Each coated tablet contains 500 mg of abiraterone acetate.

The other ingredients are: monohydrate lactose, sodium croscarmellose, hypromellose 2910 (15 mPas),
sodium lauryl sulfate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate,
polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc (see section 2, "Abiraterone Ariti contains lactose and sodium").

What Abiraterone Ariti looks like and contents of the pack

Abiraterone Ariti 500 mg is a white or almost white, oval, biconvex coated tablet (21 mm in length), with the imprint "500" on one side.

Abiraterone Ariti 500 mg is available in blisters containing 56, 60 or 120 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

ARITI SA
52 Tatoiou Avenue
Acharnai, 13677 Attiki
Greece

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

For further information on this medicinal product, please contact the Marketing Authorisation Holder:
ARITI SA
52 Tatoiou Avenue
Acharnai, 13677 Attiki
Greece