Abiraterone eugia

Package leaflet: Information for the user

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

• Keep this leaflet as you may need to read it again.
• If you have any further questions, 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, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Abiraterone Eugia 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 Eugia works by inhibiting the production of testosterone in the body; this may slow down the progression of prostate cancer.
When Abiraterone Eugia is used at an early stage of hormone-sensitive disease, it is administered together with androgen-deprivation therapy (hormonal therapy that reduces testosterone levels).
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 blood potassium levels.

2. Important information before taking Abiraterone Eugia

When not to take Abiraterone Eugia

• if the patient is allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• in women, especially during pregnancy. Abiraterone Eugia 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).

Do not take this medicine 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 disease
• if the patient has hypertension, heart failure or low blood potassium levels (low blood potassium may increase the risk of cardiac arrhythmia)
• if the patient has other heart or blood vessel disorders
• 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.

Inform the doctor if the patient has any heart or blood vessel disorders, including
heart rhythm disorders (arrhythmia), or is taking medicines for these conditions.
Inform the 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, reduced libido, muscle weakness and/or muscle pain may occur.
Abiraterone Eugia must not be administered in combination with radium-223 (Ra-223) due to the possible increased risk of bone fractures or death.
If the patient intends to receive radium-223 (Ra-223) after treatment with Abiraterone Eugia
and prednisone/prednisolone, a 5-day interval should be observed before starting radium-223 therapy.
If in doubt whether any of the above situations apply, consult a doctor or pharmacist before using this medicine.
Blood tests
Abiraterone Eugia may affect liver function, and the patient may not experience any symptoms. During treatment, the doctor will periodically order blood tests to monitor the medicine’s effect on the liver.
Children and adolescents
This medicine is not intended for use in children and adolescents. If Abiraterone Eugia is accidentally swallowed by a child, seek immediate medical attention at a hospital, bringing this patient leaflet to show to the emergency room doctor.
Abiraterone Eugia and other medicines
Before taking any medicine, consult a doctor or pharmacist.
Inform the 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 Eugia may enhance the effects of many medicines, including cardiac medications, sedatives, certain antidiabetic drugs, herbal remedies (e.g. St. John’s wort) and others. The doctor may adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone Eugia, potentially leading to adverse reactions or reduced efficacy.
Androgen suppression may increase the risk of cardiac arrhythmia. Inform the doctor if the patient is taking any of the following medicines:

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

Inform the doctor if the patient is taking any of the medicines listed above.
Abiraterone Eugia and food

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

Pregnancy and breastfeeding
Abiraterone Eugia 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 must be used together with another effective method of contraception.
• If the patient has sexual intercourse with a pregnant woman, a condom must be used to protect the unborn child.

Driving and operating machinery
This medicine has no influence on the ability to drive or operate tools and machines.
Abiraterone Eugia contains lactose and sodium

• Abiraterone Eugia contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

This medicine contains 26.18 mg of sodium (the main component of table salt) in the daily dose of two tablets. This corresponds to 1.31% of the maximum recommended daily sodium intake in the adult diet.

3. How to take Abiraterone Eugia

This medicine should always be taken 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 tablets) once daily.
Taking this medicine

• This medicine should be taken orally.
• Abiraterone Eugia must not be taken with food. Taking Abiraterone Eugia with food may result in more medicine being absorbed by the body than necessary, which could cause adverse effects.
• Abiraterone Eugia tablets should be taken as a single daily dose on an empty stomach. Abiraterone Eugia should be taken at least two hours after eating, and food should not be consumed for at least one hour after taking Abiraterone Eugia (see section 2, "Abiraterone Eugia with food").
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone Eugia is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as prescribed by your doctor.
• Prednisone or prednisolone should be taken every day during treatment with Abiraterone Eugia.
• The dose of prednisone or prednisolone may need to be adjusted in certain situations. Your doctor will inform you if a change in the dose of prednisone or prednisolone is required. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines to you while you are taking Abiraterone Eugia and prednisone or prednisolone.
Taking more Abiraterone Eugia than prescribed
If you take more Abiraterone Eugia than prescribed, contact your doctor immediately or go to a hospital.
Missing a dose of Abiraterone Eugia

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

Stopping Abiraterone Eugia treatment
Do not stop taking Abiraterone Eugia or prednisone or prednisolone unless your doctor advises you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Abiraterone Eugia and contact your doctor immediately if you notice any of the following symptoms:

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

Other adverse reactions include:
Very common (may affect more than 1 in 10 people):
Swelling of the legs or feet, low blood potassium levels, increased liver function test results, high blood pressure, urinary tract infections, diarrhoea.
Common (may affect up to 1 in 10 people):
High blood lipid levels, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat, severe infections known as sepsis, bone fractures, indigestion, blood in the urine, rash.
Uncommon (may affect up to 1 in 100 people):
Adrenal gland dysfunction (related to disturbances in water and electrolyte balance), 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 interstitial pneumonitis).
Liver failure (also known as acute liver failure).
Frequency not known (cannot be estimated from the available data):
Heart attack, changes in ECG (prolongation of the QT interval), and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
In men treated for prostate cancer, loss of bone mass may occur. Abiraterone Eugia in combination with prednisone or prednisolone may worsen loss of bone mass.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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, tel.: +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 Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Abiraterone Eugia

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box, bottle, or blister pack following: EXP. The expiry date refers to the last day of the specified month.
• There are no special storage instructions for this medicine.
• Medicines must 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 pack and other information

What Abiraterone Eugia contains
The active substance is abiraterone acetate. Each coated tablet contains 500 mg of abiraterone acetate.
Other ingredients: monohydrate lactose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, microcrystalline cellulose silicon dioxide, anhydrous colloidal silicon dioxide, magnesium stearate (see section 2, "Abiraterone Eugia contains lactose and sodium").
The tablet coating contains:
Opadry purple: polyvinyl alcohol – partially hydrolysed, titanium dioxide, macrogol/PEG, talc, iron oxide red, iron oxide black.

What Abiraterone Eugia looks like and contents of the pack
Abiraterone Eugia 500 mg coated tablets are purple, oval, film-coated tablets, embossed with the code "A500" on one side and smooth on the other.
Abiraterone Eugia 500 mg coated tablets are available in blisters.
Pack sizes:
Blister packs: 56, 60 and 120 film-coated tablets.
Perforated single-dose blisters: 56 x 1, 60 x 1, 120 x 1 film-coated tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Eugia Pharma (Malta) Limited
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus N 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: ABIRATERONE EUGIA 500 mg, comprimé pelliculé
Germany: Abirateron PUREN 250 mg Filmtabletten
Abirateron PUREN 500 mg Filmtabletten
Italy: Abiraterone Eugia
Spain: Abiraterona Eugia 500 mg comprimidos recubiertos con película EFG
Belgium: Abiraterone Eugia 500 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Luxembourg: Abiraterone Eugia 500 mg comprimés pelliculés/Filmtabletten
Poland: Abiraterone Eugia
Portugal: Abiraterona Eugia