Abiraterone Ariti

Package Leaflet: Information for the Patient

Abiraterone Ariti, 500 mg, Film-Coated Tablets

Abiraterone Acetate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Abiraterone Ariti is a medicine that contains abiraterone acetate. It is used in adult men for the treatment of prostate cancer that has spread to other parts of the body. Abiraterone Ariti works by stopping the production of testosterone in the body; this can slow down the growth of prostate cancer.

When Abiraterone Ariti is used at an early stage of the disease that responds to hormonal therapy, it is given together with a therapy that lowers testosterone levels (androgen suppression 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 buildup in the body (fluid retention), or low potassium levels in the blood.

2. Important information before taking Abiraterone Ariti

When not to take Abiraterone Ariti:

• in women, especially during pregnancy. Abiraterone Ariti is for use in men only;
• in combination with the medicine Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with this medicine, discuss with your doctor or pharmacist:

• the need to take this medicine with prednisone or prednisolone;
• the possibility of side effects related to bones;

Tell your doctor if you have any heart or blood vessel disorders, including abnormal heart rhythms (arrhythmia), or if you are taking medicines 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 disorders. Rarely, acute liver failure may occur, which can be life-threatening.

There may be a decrease in the number of red blood cells, decreased sex drive, muscle weakness, and (or) muscle pain.

Abiraterone Ariti should not be taken in combination with Ra-223 due to the possible increased risk of bone fractures or death.

If you plan to take Ra-223 after treatment with Abiraterone Ariti and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone Ariti may affect liver function, and you may not have any symptoms.

During treatment with this medicine, your doctor will periodically order blood tests to check the effect of the medicine on the liver.

Children and adolescents

This medicine is not used in children and adolescents.

If Abiraterone Ariti is accidentally swallowed by a child, you should immediately go to the hospital, taking the patient information leaflet with you to show it to the doctor on duty.

Abiraterone Ariti and other medicines

Before taking any medicine, consult your doctor or pharmacist.

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

This is important because Abiraterone Ariti may enhance the effect of many medicines, including heart medicines, sedatives, certain antidiabetic medicines, herbal medicines (e.g., St. John's Wort), and others.

Your doctor may change the doses of these medicines.

Also, other medicines may increase or decrease the effect of Abiraterone Ariti.

This can result in side effects or inadequate effect of Abiraterone Ariti.

Androgen suppression may increase the risk of abnormal heart rhythms.

Tell your doctor if you are taking medicines:

• used to treat abnormal heart rhythms (e.g., quinidine, procainamide, amiodarone, and sotalol);
• that may increase the risk of abnormal heart rhythms [e.g., methadone (pain reliever and used for addiction treatment), moxifloxacin (antibiotic), antipsychotic medicines (used for severe mental disorders)].

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

Taking Abiraterone Ariti with food

• Do not take this medicine with food (see section 3, "How to take Abiraterone Ariti").
• Taking Abiraterone Ariti with food may cause side effects.

Pregnancy and breastfeeding

Abiraterone Ariti is not used in women.

• The medicine may harm an unborn child if taken by a pregnant woman.
• Women who are pregnant or may become pregnant should use protective gloves when handling Abiraterone Ariti.
• If you have sexual intercourse with a woman who may become pregnant, you should use a condom or other effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, you should use a condom to protect the unborn child.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use tools and machines.

Abiraterone Ariti contains lactose

Abiraterone Ariti contains lactose (a type of sugar).

If you have been diagnosed with intolerance to some sugars, you should consult your 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 common salt) per tablet.

This is equivalent to 0.6% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Abiraterone Ariti

Always take this medicine exactly as your doctor has told you.

If you are unsure, consult your doctor or pharmacist.

How much to take

The recommended dose is 1000 mg (two 500 mg tablets) taken once a day.

How to take the medicine

• Take this medicine orally.
• Do not take Abiraterone Ariti with food.
• Take Abiraterone Ariti at least 1 hour before eating or at least 2 hours after eating(see section 2, "Taking Abiraterone Ariti with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Abiraterone Ariti is taken with a medicine called prednisone or prednisolone.
• Take prednisone or prednisolone as directed by your doctor.
• Take prednisone or prednisolone every day while taking Abiraterone Ariti.
• The amount of prednisone or prednisolone used may be changed if necessary.

Your doctor will inform you if you need to change the dose of prednisone or prednisolone you are taking.

Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines for you to take with Abiraterone Ariti and prednisone or prednisolone.

If you take more Abiraterone Ariti than you should

If you take more Abiraterone Ariti than you should, contact your doctor or go to the hospital immediately.

If you forget to take 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 treatment with Abiraterone Ariti

Do not stop taking Abiraterone Ariti or prednisone or prednisolone without consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Abiraterone Ariti and contact your doctor immediately if you notice any of the following:

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

Other side effects:

Very common(may affect more than 1 in 10 people):
Swelling of the feet or ankles, low potassium levels in the blood, increased liver function test values, high blood pressure, urinary tract infections, diarrhea.
Common(may affect up to 1 in 10 people):
High lipid levels in the blood, chest pain, abnormal heart rhythms (atrial fibrillation), heart failure, rapid heart rate, severe infection - sepsis, bone fractures, indigestion, blood in the urine, rash.
Uncommon(may affect up to 1 in 100 people):
Adrenal gland disorders (related to electrolyte imbalance), abnormal heart rhythm (arrhythmia), muscle weakness and (or) muscle pain.
Rare(may affect up to 1 in 1,000 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 (QT interval prolongation), and severe allergic reactions, causing difficulty swallowing or breathing, facial, lip, tongue, or throat swelling, or itchy rash.
There may be a loss of bone mass in men treated for prostate cancer. Abiraterone Ariti in combination with prednisone and prednisolone may enhance this effect.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
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.

By reporting side effects, you can help 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 which is stated on the carton and blister after EXP.
• The expiry date refers to the last day of that month.
• 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.
• This will help protect the environment.

6. Contents of the pack and other information

What Abiraterone Ariti contains

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

Other ingredients are: lactose monohydrate, croscarmellose sodium, hypromellose 2910 (15 mPas), sodium lauryl sulfate, microcrystalline cellulose, silicon dioxide, 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 film-coated tablet (21 mm in length), with "500" engraved on one side.

Abiraterone Ariti 500 mg is available in blisters containing 56, 60, or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

ARITI SA
52 Tatoiou Avenue
Acharnai, 13677 Attiki
Greece

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
To obtain more detailed information on this medicine, please consult the marketing authorization holder:
ARITI SA
52 Tatoiou Avenue
Acharnai, 13677 Attiki
Greece
Date of last revision of the leaflet: