Abiraterone Aristo

PACKAGE LEAFLET

Information for the patient
Abiraterone Aristo 250 mg tablets
Abiraterone Aristo 500 mg film-coated tablets
Abiraterone acetate
Equivalent medicinal product
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Abiraterone Aristo contains a medicine called abiraterone acetate. It is used for the
treatment of prostate cancer in adult men whose cancer has spread to other parts of the body.
Abiraterone Aristo stops the body from producing testosterone; this may slow down the
growth of prostate cancer.
When Abiraterone Aristo is prescribed at the early stage of the disease, which still responds to
hormonal therapy, it is used together with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe another medicine called
prednisone or prednisolone. This medicine helps reduce the risk of high blood pressure, fluid retention (excess fluid in the body), or low levels in the blood of a chemical substance known as potassium.

2. What you should know before taking Abiraterone Aristo

Do not take Abiraterone Aristo

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if pregnant. Abiraterone Aristo is intended for use only in men.
• if you have severe liver damage.
• in combination with Ra-223 (used to treat prostate cancer).

Do not take this medicine if you fall into any of these categories. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told you have high blood pressure, heart failure, or low potassium levels in your blood (low potassium levels may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have an irregular or rapid heartbeat
• if you have shortness of breath
• if you have gained weight rapidly
• if you have swelling in your feet, ankles, or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• about the need to take this medicine together with prednisone or prednisolone
• about possible effects on bones
• if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorders, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these conditions.
Inform your doctor if you develop yellowing of the skin or eyes, dark-coloured urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. Rarely, liver function problems (called acute liver failure) may occur, which can lead to death.
Possible side effects include decreased red blood cells, reduced sexual desire (libido), muscle weakness and/or muscle pain.
Abiraterone Aristo must not be administered in combination with Ra-223 due to a possible increased risk of fractures or death.
If you are considering taking Ra-223 after treatment with Abiraterone Aristo and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.
If you have any doubts about whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

Abiraterone Aristo may affect the liver and may not cause any symptoms. While taking this medicine, your doctor will periodically perform blood tests to monitor for any effects of Abiraterone Aristo on the liver.

Children and adolescents

This medicine is not indicated for use in children and adolescents. If Abiraterone Aristo is accidentally ingested by a child or adolescent, go to hospital immediately and bring the package leaflet to show the emergency doctor.

Other medicines and Abiraterone Aristo

Ask your doctor or pharmacist before taking any medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Abiraterone Aristo may increase the effects of certain medicines, including heart medications, tranquilizers, some diabetes medicines, herbal remedies (e.g. St. John’s wort), and others. Your doctor may decide to adjust the dose of these medicines. In addition, some medicines may increase or decrease the effects of Abiraterone Aristo. This could lead to unwanted side effects or Abiraterone Aristo may not work as effectively as it should.
Androgen deprivation therapy may increase the risk of heart rhythm problems.
Inform your doctor if you are taking medicines:

• used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for treatment of opioid dependence), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

Abiraterone Aristo with food

This medicine must not be taken with food (see section “How to take this medicine”).
Taking Abiraterone Aristo with food may cause unwanted effects.

Pregnancy and breastfeeding

Abiraterone Aristo is not indicated for use in women.
This medicine may harm the unborn baby if taken during pregnancy.
If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.
If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn baby.
Abiraterone Aristo 250 mg tablets
Pregnant women or women who may be pregnant must wear gloves if they need to touch or handle Abiraterone Aristo.

Driving and using machines

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

Abiraterone Aristo contains lactose and sodium

• Abiraterone Aristo contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
• This medicine contains 23.2 mg of sodium (a key component of table salt) per 4-tablet dose of 250 mg tablets and 23 mg of sodium per 2-tablet dose of 500 mg tablets. This corresponds to 1.2% of the maximum daily dietary intake recommended for an adult.

3. How to take Abiraterone Aristo

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

250 mg tablets
The recommended dose is 1000 mg (4 tablets) once daily.

500 mg film-coated tablets
The recommended dose is 1000 mg (2 tablets) once daily.

How to take this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Aristo with food. Taking Abiraterone Aristo with food may increase the absorption of the medicine beyond the required level, which could lead to adverse effects.
• Take the Abiraterone Aristo tablets as a single daily dose on an empty stomach. Abiraterone Aristo must be taken at least two hours after eating, and no food should be consumed for at least one hour after taking Abiraterone Aristo (see section 2 “Abiraterone Aristo with food”).
• Swallow the tablets whole with a glass of water.
• Do not break the tablets.
• Abiraterone Aristo is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• You must take prednisone or prednisolone every day while you are taking Abiraterone Aristo.
• The dose of prednisone or prednisolone may need to be adjusted in certain emergency situations. Your doctor will inform you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone unless your doctor tells you to do so.

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

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

If you forget to take Abiraterone Aristo
If you forget to take Abiraterone Aristo or prednisone or prednisolone, take your usual dose the next day.
If you forget to take Abiraterone Aristo or prednisone or prednisolone for more than one day, speak to your doctor promptly.

If you stop taking Abiraterone Aristo
Do not stop taking Abiraterone Aristo or prednisone or prednisolone unless your doctor tells you to do so.

If you have any questions about how to use 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.
If you notice any of the side effects listed below, stop taking Abiraterone Aristo and contact a doctor immediately:

• muscle weakness, muscle spasms, or a pounding sensation in the chest (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
Very common (may affect more than 1 in 10 people):
Fluid retention in the legs or feet, low potassium levels in the blood, increased liver function test values, high blood pressure, urinary tract infection, diarrhoea.
Common (may affect up to 1 in 10 people):
High levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation), heart failure, rapid heartbeat, serious infection called sepsis, bone fractures, indigestion, blood in the urine, skin rash.
Uncommon (may affect up to 1 in 100 people):
Problems with the adrenal glands (related to salt and water imbalances), abnormal heart rhythm (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 function problems (also known as acute liver failure).
Not known (frequency cannot be estimated from the available data):
Heart attack, changes in ECG (electrocardiogram) – QT interval prolongation, and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or hives.
Loss of bone tissue may occur in men being treated for prostate cancer. Abiraterone Aristo in combination with prednisone or prednisolone may increase the loss of bone tissue.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abiraterone Aristo

Keep this medicine out of the sight and reach of children.
250 mg tablets
Do not use this medicine after the expiry date which is stated on the carton and bottle after
Exp. The expiry date refers to the last day of that month.
500 mg film-coated tablets
Do not use this medicine after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.
250 mg tablets
This medicine does not require any special storage conditions or temperature.
Store in the original packaging to protect the medicine from light.
500 mg film-coated tablets
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Aristo contains
250 mg tablets

• The active substance is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.
• The other components are microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose (type 2910), colloidal anhydrous silica, and sodium lauryl sulfate (see section 2 “Abiraterone Aristo contains lactose and sodium”).

500 mg film-coated tablets

• The active substance is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.
• The other components are microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose (type 2910), colloidal anhydrous silica, and sodium lauryl sulfate (see section 2 “Abiraterone Aristo contains lactose and sodium”). The film coating contains black iron oxide (E172), red iron oxide (E172), macrogol poly(vinyl alcohol) grafted copolymer, talc, titanium dioxide (E171).

Description of the appearance of Abiraterone Aristo and package contents

• Abiraterone Aristo 250 mg tablets are white to off-white, oval, biconvex, uncoated tablets, imprinted with "250" on one side and smooth on the other. The tablets are supplied in a 100 ml HDPE bottle with a child-resistant polypropylene (PP) closure and integrated desiccant. Each bottle contains 120 tablets. Each carton contains one bottle.
• Abiraterone Aristo 500 mg film-coated tablets are purple, oval, biconvex film-coated tablets (19 mm long and 11 mm wide), imprinted with "500" on one side and smooth on the other. The film-coated tablets are packaged in blisters within cardboard boxes containing 56, 60, or 112 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
Sales License Holder:
Aristo Pharma Italy S.r.l.
[email protected]
This medicinal product is authorized in the Member States of the European Economic Area under the following names: