Abiraterone Stada

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Abiraterone STADA, 250 mg, coated tablets

Abiraterone STADA, 500 mg, coated tablets

Abiraterone acetate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

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

When Abiraterone STADA is used at an early stage of the disease that responds to hormonal therapy, it is given together with therapy that reduces 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 retention, or low potassium levels in the blood.

2. Important information before taking Abiraterone STADA

When not to take Abiraterone STADA

• if the patient is allergic to abiraterone or any of the other ingredients of the medicine (listed in section 6);
• in women, especially during pregnancy. Abiraterone STADA is only used in men;
• if the patient has severe liver damage;
• in combination with the medicine Ra-223 (used to treat 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 this medicine, discuss it with your doctor or pharmacist:

• if the patient has liver problems;
• if the patient has high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of heart rhythm disorders);
• if the patient has had other heart or blood vessel diseases;
• if the patient has an irregular or rapid heart rhythm;
• if the patient has shortness of breath;
• if the patient's weight has increased in a short time;
• if the patient has swelling of the feet, ankles, or legs;
• if the patient has taken the medicine ketokonazole in the past to treat prostate cancer;
• the need to take this medicine with prednisone or prednisolone;
• the possibility of bone-related side effects;
• if the patient has high blood sugar levels.

Tell your doctor if you have any heart or blood vessel disorders, including heart rhythm disorders (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 function disorders. Rarely, liver function disorders (called acute liver failure) may occur, which can be life-threatening.

There may be a decrease in red blood cell count, decreased sex drive, muscle weakness, and/or muscle pain.

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

If the patient plans to take Ra-223 after treatment with Abiraterone STADA and prednisone/prednisolone, they should wait 5 days before starting Ra-223 treatment.

If in doubt whether any of the above situations apply to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone STADA may affect liver function, and the patient 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 STADA is accidentally ingested by a child, you should immediately go to the hospital, taking this leaflet with you to show it to the doctor.

Abiraterone STADA 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 medicines you plan to take. This is important because Abiraterone STADA may enhance the effect of many medicines, including heart medicines, sedatives, some antidiabetic medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may change the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone STADA. This may result in side effects or inadequate effect of Abiraterone STADA.

Androgen suppression may increase the risk of heart rhythm disorders. Tell your doctor if you are taking medicines:

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

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

Taking Abiraterone STADA with food

• The medicine should not be taken with food (see section 3, "How to take Abiraterone STADA").
• Taking Abiraterone STADA with food may cause side effects.

Pregnancy and breastfeeding

Abiraterone STADA is not used in women.

• The medicine may harm an unborn baby if taken by a pregnant woman.
• If you have sex with a woman who may become pregnant, you should use a condom or other effective birth control method.
• If you have sex with a pregnant woman, you should use a condom to protect the unborn baby.

Driving and using machines

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

Abiraterone STADA contains lactose and sodium.

• If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.
• The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Abiraterone STADA

This medicine should always be taken exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How much to take

The recommended dose is 1000 mg (four 250 mg tablets or two 500 mg tablets) once a day.

How to take the medicine

• The medicine should be taken orally.
• Do not take Abiraterone STADA with food.Taking Abiraterone STADA with food may cause more of the medicine to be absorbed by the body than is necessary, which may cause side effects.
• Take Abiraterone STADA as a single dose once a day on an empty stomach. Take Abiraterone STADA at least 2 hours after eating and do not eat for at least 1 hour after taking Abiraterone STADA(see section 2, "Taking Abiraterone STADA with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Abiraterone STADA is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as your doctor has told you.
• Take prednisone or prednisolone every day while taking Abiraterone STADA.
• The amount of prednisone or prednisolone taken may be changed if necessary.

Your doctor will tell you if you 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 to take with Abiraterone STADA and prednisone or prednisolone.

Taking more Abiraterone STADA than prescribed

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

Missing a dose of Abiraterone STADA

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

Stopping Abiraterone STADA treatment

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

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

4. Possible side effects

Like all medicines, Abiraterone STADA can cause side effects, although not everybody gets them.

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

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

Other known 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 results, high blood pressure, urinary tract infections, diarrhea.
Common(may affect up to 1 in 10 people):
High lipid levels in the blood, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heart rate, severe infection - sepsis, bone fractures, nausea, blood in the urine, rash.
Uncommon(may affect up to 1 in 100 people):
Adrenal gland disorders (related to electrolyte imbalance), irregular heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Rare(may affect 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 (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 STADA in combination with prednisone and prednisolone may enhance this effect.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 STADA

• 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 blister and carton 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 STADA contains

• The active substance is abiraterone acetate. Each 250 mg coated tablet contains 250 mg of abiraterone. Each 500 mg coated tablet contains 500 mg of abiraterone.
• The other ingredients are: Core: croscarmellose sodium, sodium lauryl sulfate, povidone K30, microcrystalline cellulose type 102, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (see section 2, "Abiraterone STADA contains lactose and sodium"). Opadry II 85F200051 Purple coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, only for 500 mg additionally:red iron oxide (E 172), black iron oxide (E 172)

What Abiraterone STADA looks like and contents of the pack

• Abiraterone STADA 250 mg is a white or almost white, oval, coated tablet with "250" embossed on one side.
• Abiraterone STADA 500 mg is a purple, oval, coated tablet with "500" embossed on one side.

The tablets are available in:

• blister packs of 120 tablets (250 mg) or 60 tablets (500 mg) in a carton.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer:

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands

Abiraterone CF 250 mg, film-coated tablets

Abiraterone CF 500 mg, film-coated tablets

Austria

Abiraterone STADA 500 mg, film-coated tablets

Belgium

Abiraterone EG 250 mg, film-coated tablets

Abiraterone EG 500 mg, film-coated tablets

Czech Republic

Abiraterone STADA

Germany

Abiraterone AL 500 mg, film-coated tablets

Greece

Abiraterone/STADA, film-coated tablets, 500 mg

Spain

Abiraterone stada 500 mg, film-coated tablets EFG

Finland

Abiraterone STADA 500 mg, film-coated tablets

France

ABIRATERONE EG 500mg, film-coated tablets

Croatia

Abiraterone Stada 500 mg, film-coated tablets

Hungary

Abiraterone STADA 500 mg, film-coated tablets

Ireland

Abiraterone Clonmel 500 mg, film-coated tablets

Iceland

Abiraterone STADA 500 mg, film-coated tablets

Italy

ABIRATERONE EG

Luxembourg

Abiraterone EG 250 mg, film-coated tablets

Abiraterone EG 500 mg, film-coated tablets

Denmark, Norway, Poland

Abiraterone STADA

Portugal

Abiraterone STADA

Romania

Abiraterone STADA 250 mg, film-coated tablets

Abiraterone STADA 500 mg, film-coated tablets

Slovakia

Abiraterone STADA 250 mg, film-coated tablets

Abiraterone STADA 500 mg, film-coated tablets

Date of last revision of the leaflet: 08/2024