ABIRAL

Package leaflet: Information for the patient

Abiral, 500 mg, film-coated tablets
Abiraterone acetate
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Abiral is and what it is used for

Abiral is a medicine containing abiraterone acetate. It is used in adult men for the treatment of metastatic prostate cancer. Abiral inhibits the production of testosterone in the body; this may slow down the progression of prostate cancer.
When Abiral is used at an early stage of hormone-sensitive disease, it is administered together with androgen-deprivation therapy.
During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the likelihood of developing high blood pressure, fluid retention (fluid accumulation), or low blood potassium levels.

2. Important information before taking Abiral

When not to take Abiral

• if the patient is allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6)
• in women, particularly during pregnancy. Abiral 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. If in doubt,
consult a doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting Abiral, discuss 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 has experienced a rapid weight gain
• if the patient has swelling of the feet, ankles, or legs
• if the patient has previously taken the medicine ketoconazole for prostate cancer
• the need to take this medicine with prednisone or prednisolone
• the possibility of bone-related adverse effects
• if the patient has high blood sugar levels.

Inform your doctor if the patient has any heart or blood vessel disorders,
including heart rhythm disturbances (arrhythmia), or is taking medicines for these conditions.
Inform 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 failure (called acute liver failure) may occur, which can lead to death.
A decrease in red blood cell count, reduced sex drive, muscle weakness and/or muscle pain may occur.
Abiral must not be given in combination with Ra-223 due to a possible increased risk of bone fractures or death.
If the patient plans to receive Ra-223 after treatment with Abiral 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 taking this medicine.
Blood tests
Abiral 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 Abiral is accidentally swallowed by a child, seek immediate medical attention at a hospital, bringing along the patient leaflet to show the emergency room doctor.
Abiral with other medicines
Before taking any medicine, consult a doctor or pharmacist.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take. This is important because Abiral may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic medicines, 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 Abiral, potentially leading to adverse effects or reduced efficacy of Abiral.
Androgen suppression may increase the risk of heart rhythm disturbances. Inform your doctor if the patient is taking:

• 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 psychiatric disorders)].

Inform your doctor if the patient is taking any of the above medicines.
Taking Abiral with food
This medicine must not be taken with food (see section 3 "How to take Abiral").
Taking Abiral with food may cause adverse effects.
Pregnancy, breastfeeding and fertility
Abiral is not used in women. This medicine may harm an 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 or operate tools or machinery.
Abiral contains lactose and sodium
Abiral 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 23 mg of sodium (the main component of table salt) in the daily dose consisting of two 500 mg tablets. This corresponds to 1.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Abiral

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.
Administration of the medicine

• This medicine should be taken orally.
• Abiral must not be taken with food.
• Taking Abiral with food may result in more of the medicine being absorbed by the body than necessary, which could lead to unwanted side effects.
• Abiral should be taken as a single daily dose on an empty stomach. Abiral should be taken at least two hours after a meal, and food should not be consumed for at least one hour after taking Abiral (see section 2, "Taking Abiral with food").
• Tablets should be swallowed whole with water.
• Do not crush the tablets.
• Abiral is taken together with a medicine containing prednisone or prednisolone. Prednisone or prednisolone should be taken according to your doctor's instructions.
• Prednisone or prednisolone should be taken daily during treatment with Abiral.
• The dose of prednisone or prednisolone may be adjusted if necessary. 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 patients taking Abiral together with prednisone or
prednisolone.
Taking more Abiral than recommended

If you take more Abiral than you should, contact your doctor immediately or go to the nearest hospital.
If you miss a dose of Abiral

If you forget to take Abiral or prednisone or prednisolone, take your usual dose the next day.
If you forget to take Abiral or prednisone or prednisolone for more than one day, contact your doctor immediately.
Stopping Abiral treatment

Do not stop taking Abiral 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 experiences them.
You must stop taking Abiral and contact your doctor immediately if the patient notices any of the following symptoms:

• Muscle weakness, muscle tremors, or rapid heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other 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, fast 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),
abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Rare (may occur in up to 1 in 1,000 patients):
Lung irritation (also known as allergic alveolitis), acute liver failure.
Frequency not known (cannot be estimated from available data):
Myocardial infarction (heart attack), 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.
In men treated for prostate cancer, loss of bone mass may occur.
Abiral, when used in combination with prednisone or prednisolone, may worsen this effect.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Abiral

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton or blister pack after "EXP:". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Abiral contains

• The active substance is abiraterone acetate. Each coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: microcrystalline cellulose type 102, sodium croscarmellose, monohydrate lactose, magnesium stearate, hypromellose (type 2910), colloidal anhydrous silica, sodium lauryl sulphate (see section 2 "Abiral contains lactose and sodium"). The tablet coating contains: black iron oxide (E 172), red iron oxide (E 172), polyethylene glycol-grafted polyvinylalcohol copolymer, talc, and titanium dioxide (E 171).

What Abiral looks like and contents of the pack
Abiral is an oval, biconvex, coated tablet, violet in colour, with the imprint "500" on one side and the other side smooth.
Blister packs made of PVC/PVDC/Aluminium are packed in cardboard boxes containing 56 or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel: +48 12 262 32 36
e-mail: [email protected]