ABIRATERONE KRKA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abiraterone Krka 500 mg Film-Coated Tablets

Abiraterone acetate

Read all of this leaflet carefully before you start taking Abiraterone Krka, 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Abiraterone Krka and what is it used for
2. What you need to know before you take Abiraterone Krka
3. How to take Abiraterone Krka
4. Possible side effects
5. Storage of Abiraterone Krka
6. Contents of the pack and other information

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

Abiraterone Krka contains the active substance abiraterone acetate. It is used for the treatment of prostate cancer in adult men that has spread to other parts of the body. Abiraterone Krka works by stopping your body from making testosterone, which helps to slow down the growth of the prostate cancer.

When Abiraterone Krka is prescribed at the early stages of the disease and when there is still response to hormonal treatment, it is used together with treatment to lower testosterone levels (androgen deprivation therapy).

When you take Abiraterone Krka, your doctor will also prescribe another medicine called prednisone or prednisolone to reduce the risk of high blood pressure, fluid retention, or low potassium levels in your blood.

2. What you need to know before you take Abiraterone Krka

Do not take Abiraterone 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. Abiraterone Krka is for use in male patients only.
• if you have severe 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 not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Abiraterone Krka:

• if you have liver problems
• if you have been told you have high blood pressure, heart failure, or low potassium levels in your blood (low potassium levels in your blood may increase your risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have a fast or irregular heart beat
• if you have difficulty breathing
• if you have gained weight quickly
• if you have swelling in your feet, ankles, or legs
• if you have taken ketoconazole in the past 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 blood sugar levels.

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

Tell your doctor if you have yellowing of the skin or eyes, dark urine, or severe nausea or vomiting, as these can be signs of liver problems. Rarely, liver failure (acute hepatic failure) can occur, which can be life-threatening.

A decrease in red blood cell count, reduced sexual desire (libido), and cases of muscle weakness and/or muscle pain may occur.

Abiraterone Krka must not be taken in combination with Ra-223 due to a possible increased risk of bone fractures or death.

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

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

Blood tests

Abiraterone Krka may affect your liver even if you do not have any symptoms. While you are taking this medicine, your doctor will regularly perform blood tests to check for any effects on your liver.

Children and adolescents

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

Other medicines and Abiraterone Krka

Consult your doctor or pharmacist before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Abiraterone Krka can increase the effects of certain medicines, including heart medicines, sedatives, 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 Abiraterone Krka, which can lead to side effects or reduced effectiveness of Abiraterone Krka.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Tell your doctor if you are being treated with medicines for heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol); or medicines 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 your doctor if you are taking any of the medicines listed above.

Abiraterone Krka with food

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

Pregnancy and breast-feeding

Abiraterone Krka is not indicated in women.

• This medicine may harm the fetus if taken by a pregnant woman.
• Women who are pregnant or may become pregnant must wear gloves if they handle or touch Abiraterone Krka.
• If you have sex with a woman who can become pregnant, you must use a condom and another effective method of birth control.
• If you have sex with a pregnant woman, you must use a condom to protect the fetus.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use tools/machines.

Abiraterone Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Abiraterone Krka

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, 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 Abiraterone Krka

• Take Abiraterone Krka by mouth.
• Do not take Abiraterone Krka with food.Taking Abiraterone Krka with food may cause your body to absorb more medicine than necessary, which can cause side effects.
• Take the Abiraterone Krka tablets as a single dose once a day on an empty stomach. Abiraterone Krka should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking Abiraterone Krka (see section 2, "Abiraterone Krka with food").
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone Krka is given together with a medicine called prednisone or prednisolone.
• Take prednisone or prednisolone exactly as your doctor tells you.
• You will need to take prednisone or prednisolone every day while you are taking Abiraterone Krka.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

It is also possible that your doctor will prescribe other medicines while you are taking Abiraterone Krka and prednisone or prednisolone.

If you take more Abiraterone Krka than you should

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

If you forget to take Abiraterone Krka

• If you forget to take Abiraterone Krka or prednisone or prednisolone, take your normal dose the next day.
• If you forget to take Abiraterone Krka or prednisone or prednisolone for more than one day, talk to your doctor immediately.

If you stop taking Abiraterone Krka

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Abiraterone Krka and contact your doctor immediately if you experience any of the following:

• muscle weakness, muscle contractions, or a fast heart beat (palpitations). These can 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,
• low potassium levels in the blood,
• increases 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 heart beat (atrial fibrillation),
• heart failure,
• fast heart beat (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 problems with salt and water),
• abnormal heart rhythm (arrhythmia),
• muscle weakness and/or muscle pain.

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

• lung inflammation (also called allergic alveolitis),
• liver failure (also called acute hepatic failure).

Not known(frequency cannot be estimated from the available data):

• heart attack, changes in the electrocardiogram (ECG) (prolonged QT),
• severe allergic reactions with difficulty swallowing or breathing, face, lips, tongue, or throat swelling, or itchy rash.

Bone loss (osteoporosis) may occur in men receiving treatment for prostate cancer. Abiraterone Krka in combination with prednisone or prednisolone may increase this bone loss.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Krka

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should 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

Composition of Abiraterone Krka

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

Tablet core: lactose monohydrate, hypromellose (E464), sodium lauryl sulfate, croscarmellose sodium (E468), silicified microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate (E470b).

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

See section 2: "Abiraterone Krka contains lactose and sodium".

Appearance and packaging of the product

Film-coated tablets (tablets) are purple to grey-violet, oval, biconvex, approximately 20 mm long x 10 mm wide.

Abiraterone Krka is available in packs containing:

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

Not all pack sizes may be marketed.

Marketing authorisation 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 further information about this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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