Product Information for the User

Abiraterone Krka 500 mg Film-Coated Tablets

Abiraterone Acetate

Read this entire leaflet carefully before you start taking Abiraterone Krka, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

Abiraterona Krka contains a medicine called abiraterone acetate. It is used for the treatment of prostate cancer in adult men whose cancer has spread to other parts of the body. Abiraterona Krka makes your body stop producing testosterone; this way it can delay the growth of prostate cancer.

When Abiraterona Krka is prescribed in the initial stages of the disease and there is still a response to hormone treatment, it is used together with a treatment to reduce testosterone (androgen deprivation treatment).

When you take Abiraterona Krka, your doctor will also prescribe another medicine called prednisone or prednisolone, to reduce the possibility of suffering an increase in blood pressure, accumulating too much fluid in your body (fluid retention) or decreasing the levels of a chemical called potassium in your blood.

Do not take Abiraterona Krka

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if you are pregnant. Abiraterona Krka should only be used in male patients.
• if you have a serious liver disease.
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Abiraterona Krka:

• if you have liver problems
• if you have been told you have high blood pressure or heart failure or low levels of potassium in the blood (low levels of potassium in the blood may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have a fast or irregular heartbeat
• if you have difficulty breathing
• if you have rapidly gained weight
• if you have swelling in your feet, ankles, or legs
• if you have taken in the past a medicine known as ketoconazole for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about possible side effects on your bones
• if you have high levels of sugar in the blood.

Inform your doctor if you have been told you have any heart or blood vessel disorder, including heart rhythm problems (arrhythmia), or are being treated with medicines for these disorders.

Inform your doctor if you have yellowing of the skin or eyes, dark urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, liver failure (called acute liver failure) may occur, which can be fatal.

You may experience a decrease in the number of red blood cells in the blood, reduced libido, and cases of muscle weakness and/or muscle pain.

Abiraterona Krka should not be administered in combination with Ra-223 due to a possible increased risk of bone fracture or death.

If you plan to take Ra-223 after treatment with Abiraterona Krka and prednisone/prednisolone, you should wait 5 days before starting the treatment with Ra-223.

If you are unsure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterona Krka may affect your liver even if you have no symptoms. While taking this medicine, your doctor will make periodic blood tests to monitor any effect on your liver.

Children and adolescents

This medicine should not be used in children or adolescents. If a child or adolescent accidentally ingests Abiraterona Krka, they should immediately go to the hospital and bring the package insert with them to show to the emergency doctor.

Other medicines and Abiraterona Krka

Consult your doctor or pharmacist before taking any other medicine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is important because Abiraterona Krka may increase the effects of a number of medicines including heart medicines, tranquilizers, some diabetes medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medicines. Additionally, some medicines may increase or decrease the effects of Abiraterona Krka. This may lead to side effects or Abiraterona Krka may not work as well as it should.

The androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are being treated with medicines

• used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol);
• that increase the risk of heart rhythm problems [e.g., methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Consult with your doctor if you are taking any of the medicines listed above.

Abiraterona Krka with food

• This medicine should not be taken with food (see section 3, “How to take Abiraterona Krka”).
• Taking Abiraterona Krka with food may cause side effects.

Pregnancy and breastfeeding

Abiraterona Krka is not indicated in women.

• This medicine may be harmful to the fetus if a pregnant woman takes it.
• Women who are pregnant or may be pregnant should wear gloves when handling or touching Abiraterona Krka.
• If you have sexual intercourse with a fertile woman, you should use a condom and another effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, you should use a condom to protect the fetus.

Driving and operating machines

This medicine is unlikely to affect your ability to drive and use machinery.

Abiraterona Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per two tablets; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is 1,000 mg (two tablets) once a day.

How to take Abiraterona Krka

• Take Abiraterona Krka orally.
• Do not take Abiraterona Krka with food.Taking Abiraterona Krka with food may cause the body to absorb more medication than necessary, which may lead to side effects.
• Take the Abiraterona Krka tablets as a single dose once a day with an empty stomach. Abiraterona Krka should be taken at least two hours after eating and no food should be consumed at least one hour after taking Abiraterona Krka (see section 2, “Abiraterona Krka with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterona Krka is administered along with a medication called prednisone or prednisolone.
• Take prednisone or prednisolone exactly as instructed by your doctor.
• You will need to take prednisone or prednisolone every day while taking Abiraterona Krka.
• If you have a medical emergency, you may need to adjust the amount of prednisone or prednisolone you take. Your doctor will let you know if you need to modify the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

Your doctor may also prescribe other medications while you are taking Abiraterona Krka and prednisone or prednisolone.

If you take more Abiraterona Krka than you should

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

If you forget to take Abiraterona Krka

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

If you interrupt treatment with Abiraterona Krka

Do not stop taking Abiraterona Krka or prednisone or prednisolone unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Abiraterona Krka and seek medical attention immediately if you experience any of the following side effects:

• Muscle weakness, muscle cramps, or rapid heartbeat (palpitations). They may be signs of low potassium levels in your blood.

Other side effects are:

Very common(may affect more than 1 in 10 people):

• Fluid retention in the legs or feet,
• Decreased potassium levels in the blood,
• Elevations in liver function tests,
• High blood pressure,
• Urinary tract infection,
• Diarrhea.

Common(may affect up to 1 in 10 people):

• High levels of fats in the blood,
• Chest pain,
• Irregular heartbeat (atrial fibrillation),
• Heart failure,
• Tachycardia,
• Severe infections called sepsis,
• Bone fractures,
• Indigestion,
• Blood in the urine,
• Skin rash.

Uncommon(may affect up to 1 in 100 people):

• Problems with the adrenal glands (related to issues with salt and water),
• Abnormal heart rhythm (arrhythmia),
• Muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000 people):

• Irritation in the lungs (also known as allergic alveolitis),
• Failure of liver function (also known as acute liver failure).

Unknown(the frequency cannot be estimated from the available data):

• Heart attack, changes in the electrocardiogram-ECG (prolongation of QT),
• Severe allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue, or throat, or itchy rash.

This medicine may cause bone density loss in men receiving treatment for prostate cancer. Abiraterona Krka in combination with prednisone or prednisolone may increase this bone density loss.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. In this way, you will help protect the environment.

Abiraterone Krka Composition

• The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are:

Core of the tablet : lactose monohydrate, hypromellose (E464), sodium lauryl sulfate, sodium croscarmellose (E468), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate (E470b).

Covering macrogol, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).

See section 2: “Abiraterone Krka contains lactose and sodium”.

Appearance of the product and contents of the pack

Film-coated tablets (tablets) of violet-grey to violet, oval, biconvex, approximately 20 mm in length x 10 mm in width.

Abiraterone Krka is available in packs containing:

• 56 or 60 film-coated tablets in blisters,
• 56 film-coated tablets in blisters, calendar blister.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

KRKA-FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .