Abiraterone Krka 500 mg film-coated tablets EFG

Package leaflet: Information for the user

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, 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Abiraterone Krka contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men when the disease has spread to other parts of the body. Abiraterone Krka causes your body to stop producing testosterone; in this way it can slow down the growth of prostate cancer.

When Abiraterone Krka is prescribed at an early stage of the disease and there is still response to hormonal treatment, it is used in combination with a treatment to reduce testosterone (androgen deprivation therapy).

When you take Abiraterone Krka, your doctor will also prescribe another medicine called prednisone or prednisolone, to reduce the risk of developing high blood pressure, fluid retention (accumulation of excess fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before starting to 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 must only be used in male patients.
• 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 apply to you. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Abiraterone Krka:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low levels of potassium in the blood (low potassium levels 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 gained weight rapidly
• if you have swelling in your feet, ankles, or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about possible adverse effects on your bones
• if you have high blood sugar levels.

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

Inform your doctor if you develop 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 function may fail (called acute liver failure), which may lead to death.

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

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

If you are unsure whether any of the above apply 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 periodically perform blood tests to monitor 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, go immediately to the hospital and bring the package leaflet with you to show to the emergency doctor.

Other medicines and Abiraterone Krka

Talk to your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because Abiraterone Krka may increase the effects of a number of medicines, including medicines for the heart, tranquilizers, certain diabetes medicines, herbal medicines (e.g., St. John’s wort), and others. Your doctor may consider adjusting the dose of these medicines. In addition, some medicines may increase or decrease the effects of Abiraterone Krka. This may lead to adverse effects or cause Abiraterone Krka to be less effective.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking 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)].

Talk to 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 adverse effects.

Pregnancy and breastfeeding

Abiraterone Krka is not indicated for use in women.

• This medicine may be harmful to the fetus if taken by a pregnant woman.
• Women who are pregnant or who may be pregnant must wear gloves when handling or touching Abiraterone Krka.
• If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.
• If you have sexual intercourse 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 or machines.

Abiraterone Krka contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Abiraterone Krka

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

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

How to take Abiraterone Krka

• Take Abiraterone Krka orally.
• Do not take Abiraterone Krka with food. Taking Abiraterone Krka with food may cause the body to absorb more medication than intended, which could lead to side effects.
• Take the Abiraterone Krka tablets as a single dose once daily on an empty stomach. Abiraterone Krka should be taken at least two hours after eating and no food should be consumed for at least one hour after taking Abiraterone Krka (see section 2, “Abiraterone Krka with food”).
• Swallow the tablets whole with water.
• Do not split the tablets.
• Abiraterone Krka is administered together with a medicine 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 you are taking Abiraterone Krka.
• If you have a medical emergency, your dose of prednisone or prednisolone may need to be adjusted. Your doctor will advise you if any change in your prednisone or prednisolone dose is necessary. Do not stop taking prednisone or prednisolone unless instructed by your doctor.

Your doctor may also 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, consult your doctor or go to hospital immediately.

If you forget to take Abiraterone Krka

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

If you stop taking Abiraterone Krka

Do not stop taking Abiraterone Krka or prednisone or prednisolone unless instructed by your doctor.

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

4. Possible side effects

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

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

• muscle weakness, muscle cramps, or increased heart rate (palpitations). These may be signs of low potassium levels in your blood.

Other side effects include:

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

• fluid retention in the legs or feet,
• decreased potassium levels in the blood,
• elevated liver function test results,
• high blood pressure,
• urinary tract infection,
• diarrhoea.

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,
• serious infections called sepsis,
• bone fractures,
• indigestion,
• blood in the urine,
• skin rash.

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

• adrenal gland problems (related to salt and water imbalances),
• 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 alveolitis),
• liver dysfunction (also called acute liver failure).

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

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

Loss of bone density may occur in men receiving treatment for prostate cancer. Abiraterone Krka in combination with prednisone or prednisolone may increase this loss of bone density.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included 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 stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

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 and packaging you no longer need. This 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 components are:

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

Coating: 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”.

Nature and contents of the container

Film-coated tablets (tablets) grey-violet to 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 calendar blister packs.

Only certain 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

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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