Abiraterone stada

Patient Information Leaflet

Abiraterone STADA, 250 mg, film-coated tablets
Abiraterone STADA, 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. 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 personally. Do not share it with others. It may harm them, even if their symptoms are the same as yours.
• 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 STADA is and what it is 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 Abiraterone STADA is and what it is used for

Abiraterone STADA is a medicine containing abiraterone acetate. It is used in adult
men for the treatment of metastatic prostate cancer (cancer of the prostate gland that has spread to other parts of the body). Abiraterone
STADA inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abiraterone STADA is used at an early stage of hormone-sensitive disease, it is given in combination with androgen-deprivation therapy (therapy that lowers testosterone levels).
While taking 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 blood potassium levels.

2. Important information before using Abiraterone STADA

When not to use Abiraterone STADA

• 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 STADA is intended for use in men only;
• 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 to the patient. In case of
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 problems;
• if the patient has high blood pressure, heart failure, or low blood potassium levels (low blood potassium may increase the risk of heart rhythm disturbances);
• 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 need to take this medicine together with prednisone or prednisolone;
• the possibility of bone-related adverse effects;
• if the patient has high blood sugar levels.

Tell your doctor if the patient has any heart or blood vessel disorders, including heart rhythm
problems (arrhythmia), or if the patient 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 signs of liver problems. Rarely, liver dysfunction (known as acute liver
failure) may occur, which can lead to death.
A decrease in red blood cell count, reduced libido, muscle weakness and/or muscle pain may occur.
Abiraterone STADA 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 STADA and
prednisone/prednisolone, a 5-day interval should be observed before starting Ra-223 treatment.
If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist
before using this medicine.
Blood tests
Abiraterone STADA 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 STADA is
accidentally swallowed by a child, seek immediate medical attention at a hospital. Bring the patient
leaflet along to show the emergency room doctor.
Abiraterone STADA and other medicines
Before taking any medicine, consult a doctor or pharmacist. Inform your doctor or pharmacist about
all medicines the patient is currently taking or has recently taken, as well as any medicines the
patient plans to take. This is important because Abiraterone STADA may enhance the effects of
many medicines, including heart medications, sedatives, certain antidiabetic drugs, herbal remedies
(e.g. St. John’s wort), and others. The doctor may need to adjust the doses of these medicines.
Likewise, other medicines may increase or decrease the effect of Abiraterone STADA, which may
lead to adverse effects or reduced efficacy of Abiraterone STADA.
Androgen suppression may increase the risk of heart rhythm disturbances. 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, sotalol);
• medicines that may increase the risk of heart rhythm disturbances [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe mental disorders)].

Inform your doctor if the patient is taking any of the above-mentioned medicines.
Taking Abiraterone STADA with food

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

Pregnancy and breastfeeding
Abiraterone STADA is not intended for use in women.

• This medicine may harm the unborn child if taken by a pregnant woman.
• 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 will affect the ability to drive, use tools, or operate machinery.
Abiraterone STADA contains lactose and sodium.

• If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using this medicine.
• The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Abiraterone STADA

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 (four 250 mg tablets or two 500 mg tablets) once daily.
Taking this medicine

• Take this medicine by mouth.
• 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 necessary, which may lead to adverse effects.
• Take Abiraterone STADA as a single daily dose on an empty stomach. Abiraterone STADA should be taken at least two hours after eating and no food should be consumed for at least one 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 together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as prescribed by your doctor.
• You must take prednisone or prednisolone every day during treatment with Abiraterone STADA.
• The amount of prednisone or prednisolone taken may be adjusted if urgently needed.

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 STADA and prednisone or prednisolone.
Taking more Abiraterone STADA than recommended
If you take more medicine than you should, contact your doctor immediately or go to hospital.
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, contact your doctor immediately.

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

4. Possible adverse reactions

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

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse. Adverse reactions 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
Phone: +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 authorization holder. By reporting adverse reactions, additional information on the safety of this medicine can be collected.

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 stated on the blister pack and the outer carton after: EXP. The expiry date refers to the last day of the stated month.
• No special storage instructions apply.
• Medicines should not be disposed of via the sewage system 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 packaging and other information

What Abiraterone STADA contains

• The active substance is abiraterone acetate. Each 250 mg film-coated tablet contains 250 mg of abiraterone. Each 500 mg film-coated tablet contains 500 mg of abiraterone.
• The other ingredients are:
  Tablet core: sodium croscarmellose, 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").
  Film coating Opadry II 85F200051 Purple: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.
  For 500 mg tablets only additionally: iron oxide red (E 172), iron oxide black (E 172).

What Abiraterone STADA looks like and contents of the pack

• Abiraterone STADA 250 mg are white or almost white, oval film-coated tablets with "250" embossed on one side.
• Abiraterone STADA 500 mg are purple, oval film-coated tablets with "500" embossed on one side.

The tablets are supplied in:
250 mg:

• Blisters made of Aluminium/OPA/Aluminium/PVC or Aluminium/PVC/PE/PVDC containing 120 film-coated tablets in a cardboard box.

500 mg:

• Blisters made of Aluminium/OPA/Aluminium/PVC or Aluminium/PVC/PE/PVDC containing 60 film-coated tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 Wien
Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Abirateron CF 250 mg, filmomhulde tabletten
Abirateron CF 500 mg, filmomhulde tabletten
Austria: Abirateron STADA 500 mg Filmtabletten
Abirateron EG 250 mg filmomhulde tabletten
Belgium: Abirateron EG 500 mg filmomhulde tabletten
Czech Republic: Abirateron STADA
Germany: Abirateron AL 500 mg Filmtabletten
Greece: Abiraterone/STADA επικαλυμμένα με λεπτό υμένιο δισκία, 500 mg
Spain: Abiraterona stada 500 mg comprimidos recubiertos con película EFG
Finland: Abiraterone STADA 500 mg kalvopäällysteinen tabletti
France: ABIRATERONE EG 500mg, comprimé pelliculé
Croatia: Abirateron Stada 500 mg filmom obložene tablete
Hungary: Abirateron STADA 500 mg filmtabletta
Ireland: Abiraterone Clonmel 500 mg film-coated tablets
Iceland: Abiraterone STADA 500 mg filmuhúðaðar töflur
Italy: ABIRATERONE EG
Luxembourg: Abirateron EG 250 mg comprimés pelliculés
Abirateron EG 500 mg comprimés pelliculés
Denmark, Norway: Abiraterone STADA
Poland: Abiraterone STADA
Portugal: Abiraterona STADA
Romania: Abirateronă STADA 250 mg comprimate filmate
Abirateronă STADA 500 mg comprimate filmate
Slovakia: Abirateron STADA 250 mg filmom obalené tablety
Abirateron STADA 500 mg filmom obalené tablety