Abiraterone pharmascience

Patient Information Leaflet

Abiraterone Pharmascience, 500 mg, film-coated tablets
Abirateroni acetas
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please 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.

Table of contents

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

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

Abiraterone Pharmascience is a medicine containing the active substance 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 Pharmascience works by inhibiting the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abiraterone Pharmascience is used at an early stage of hormone-sensitive disease, it is given in combination with androgen-deprivation therapy (treatment 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 using Abiraterone Pharmascience

When not to use Abiraterone Pharmascience

• if the patient is allergic to abiraterone or any of the other ingredients of this medicine (listed in section 6),
• in women, particularly during pregnancy. Abiraterone Pharmascience 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 use 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 to take this medicine, discuss the following with your doctor or pharmacist:

• if the patient has liver function disorders,
• if the patient has hypertension, heart failure, or low blood potassium levels (low blood potassium levels may increase the risk of cardiac arrhythmia),
• 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,
• if this medicine needs to be taken with prednisone or prednisolone,
• if bone-related adverse reactions may occur,
• if the patient has high blood sugar levels.

Tell your doctor if the patient has any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or 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 symptoms of liver function disorders. Rarely, liver function disorders (referred to as acute liver failure) may occur, which can lead to death.
A decrease in red blood cell count, decreased libido, muscle weakness, and/or muscle pain may occur.
Abiraterone Pharmascience must not be administered in combination with Ra-223 due to a possible increased risk of bone fractures or death. If the patient needs to receive Ra-223 after treatment with Abiraterone Pharmascience and prednisone/prednisolone, a 5-day interval should be observed before starting Ra-223 therapy.
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 Pharmascience may affect liver function, and the patient may not experience any symptoms. During treatment with this medicine, the treating physician will periodically order blood tests to monitor its effects on the liver.
Children and adolescents
This medicine is not intended for use in children and adolescents. If Abiraterone Pharmascience is accidentally swallowed by a child or adolescent, seek immediate medical attention at a hospital, bringing the patient leaflet along to show to the emergency room doctor.
Abiraterone Pharmascience 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 Pharmascience 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 Pharmascience, potentially leading to adverse reactions or reduced efficacy of this medicine.
Androgen suppression may increase the risk of cardiac arrhythmia. 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 cardiac arrhythmia [e.g. methadone (a painkiller and medication used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe psychiatric disorders)].

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

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

Pregnancy, breastfeeding, and fertility
Abiraterone Pharmascience 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 affects the ability to drive vehicles, use tools, or operate machinery.
Abiraterone Pharmascience contains lactose and sodium

• Abiraterone Pharmascience contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• This medicine contains less than 1 mmol of sodium (23 mg) in two tablets, which constitute the daily dose; therefore, the medicine is considered "sodium-free."

3. How to take Abiraterone Pharmascience

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 (two tablets) taken once daily.

How to take the medicine

• Take this medicine by mouth.
• Do not take Abiraterone Pharmascience with food. Taking Abiraterone Pharmascience with food may result in more medicine being absorbed by the body than necessary, which could lead to adverse effects.
• Abiraterone Pharmascience tablets should be taken as a single dose once daily on an empty stomach. Abiraterone Pharmascience should be taken at least two hours after eating, and food should not be consumed for at least one hour after taking this medicine (see section 2, "Taking Abiraterone Pharmascience with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Abiraterone Pharmascience is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• Take prednisone or prednisolone every day during treatment with Abiraterone Pharmascience.
• The amount of prednisone or prednisolone taken may be adjusted in case of a medical emergency. Your doctor will inform you if a change in the dose of prednisone or prednisolone is necessary. 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 Pharmascience and prednisone or prednisolone.

Taking more than the recommended dose of Abiraterone Pharmascience

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

Missing a dose of Abiraterone Pharmascience

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

Stopping Abiraterone Pharmascience treatment

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

If you have any further questions about how to use 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.
The patient should stop taking Abiraterone Pharmascience and immediately contact a doctor
if any of the following symptoms occur:

• Muscle weakness, muscle twitching (tremors), or 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 values, high blood pressure, urinary tract infection, 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 infection - sepsis, bone fractures, indigestion, blood in urine, rash.
Uncommon (may affect up to 1 in 100 people):
Adrenal gland dysfunction (related to disturbances in water and electrolyte balance), irregular heartbeat (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect up to 1 in 1000 people):
Lung inflammation (also known as allergic alveolitis). Liver failure (also known as acute liver failure).
Frequency not known (cannot be estimated from available data):
Myocardial infarction, changes in ECG (QT interval prolongation), and severe allergic reactions causing difficulty in swallowing or breathing, facial swelling, swelling of lips, tongue or throat, or itchy rash.
Loss of bone mass may occur in men treated for prostate cancer.
Treatment with Abiraterone Pharmascience in combination with prednisone and prednisolone may worsen this effect.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Abiraterone Pharmascience

• 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, the cardboard wallet pack, and the blister. The expiry date refers to the last day of the stated month.
• No special storage precautions are required for this medicine.
• Medicines must not be disposed of via wastewater 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 the medicine Abiraterone Pharmascience contains

• The active substance is abiraterone acetate. Each coated tablet contains 500 mg of abiraterone acetate. The other ingredients are: monohydrate lactose, sodium croscarmellose, hypromellose 2910 (15 mPas), sodium lauryl sulphate (see section 2 "Abiraterone Pharmascience contains lactose and sodium"), microcrystalline cellulose (siliconized), colloidal anhydrous silica, and magnesium stearate. The tablet coating contains iron oxide black (E 172), iron oxide red (E 172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide (E 171).

What Abiraterone Pharmascience looks like and contents of the pack
Abiraterone Pharmascience is a purple, oval, biconvex coated tablet with bevelled edges,
imprinted with the code "A" on one side and "500" on the other side.
Each cardboard box contains 60 coated tablets in 5 blisters made of PVC/PE/PVDC/Aluminium foil,
with 12 coated tablets in each blister.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Pharmascience International Limited
Lampousas 1
1095 Nicosia
Cyprus
Importer
Bluepharma Indústria Farmacêutica, S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal
Bluepharma Indústria Farmacêutica S.A.
Eiras, Rua Adriano Lucas
3020-430 Coimbra
Portugal
For further information about this medicine, please contact the representative of the Marketing Authorisation Holder: PDG Cetus Pharma Sp. z o.o., Sokratesa 11B, 01-909 Warsaw, tel.: +48 606 383 970, e-mail: [email protected]
This medicine is authorised in the European Economic Area countries under the following names:
Hungary Abiraterone Pharmascience 500 mg filmtabletta
Bulgaria Aбиратерон Фармасайънс 500 mg филмирани таблетки
Croatia Abiraterone Pharmascience 500 mg filmom obložene tablete
Cyprus Abiraterone Pharmascience 500 mg επικαλυμμένα με λεπτό υμένιο δισκία
Poland Abiraterone Pharmascience
Slovenia Abirateron Pharmascience 500 mg filmsko obložene tablete