Abiraterone Krka

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 this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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 for the treatment of adult men with prostate cancer that has spread to other parts of the body.
Abiraterone Krka stops the body from producing testosterone; this may slow down the growth of prostate cancer.
When Abiraterone Krka is prescribed in the early stage of the disease that still responds to hormone therapy, it is used together with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone, to reduce the possibility of developing high blood pressure, too much fluid in the body (fluid retention), or low levels in the blood of a chemical known as potassium.

2. What you need to know before taking Abiraterone Krka

Do not take Abiraterone Krka

• if you are allergic to abiraterone acetate or to any of the other ingredients of this medicine (listed in section 6)
• if you are a woman, especially if pregnant; the use of Abiraterone Krka is intended only for men
• if you have severe liver damage
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Abiraterone Krka:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low potassium levels 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 an irregular or rapid heartbeat
• if you experience shortness of breath
• if you gain 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 effects on bones
• if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorders, 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-colored urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, a liver function problem (called acute liver failure) may occur, which can lead to death.
Possible side effects include reduction in red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain.
Abiraterone Krka must not be administered in combination with Ra-223 due to a possible increased risk of fractures or death.
If you are considering taking Ra-223 after treatment with Abiraterone Krka and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.
If you have any doubts whether any of the points listed above may apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

Abiraterone Krka may affect the liver and may not cause symptoms. While taking this medicine, your doctor will periodically perform blood tests to monitor any potential effects of Abiraterone Krka on your liver.

Children and adolescents

This medicine is not indicated for use in children and adolescents. If Abiraterone Krka is accidentally ingested by a child or adolescent, go immediately to hospital and bring the package leaflet to show the emergency doctor.

Other medicines and Abiraterone Krka

Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Abiraterone Krka may increase the effects of certain medicines, including heart medications, tranquilizers, some diabetes medicines, herbal medicines (e.g. St. John’s wort), and others. Your doctor may decide to adjust the dose of these medicines. In addition, some medicines may increase or decrease the effects of Abiraterone Krka. This could lead to unwanted side effects or Abiraterone Krka may not work as well as it should.

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)
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for treatment of opioid dependence), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Inform 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 “How to take this medicine”).
• Taking Abiraterone Krka with food may cause adverse effects.

Pregnancy and breastfeeding

• The use of Abiraterone Krka is not indicated in women.
• This medicine may cause harm to the unborn baby if taken during pregnancy.
• Pregnant women or women who may be pregnant must wear gloves if they need to touch or handle 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, use a condom to protect the unborn baby.

Driving and using machines

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

Abiraterone Krka contains lactose and sodium

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per two-tablet dose, i.e. essentially ‘sodium-free’.

3. How to take Abiraterone Krka

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
How much to take
The recommended dose is 1,000 mg (two tablets) once daily.
How to take this medicine

• Take this medicine by mouth.

• Do not take Abiraterone Krka with food. Taking Abiraterone Krka with food may cause your body to absorb more of the medicine than intended, which could lead to unwanted side effects.

• Take the Abiraterone Krka tablets as a single daily dose on an empty stomach. Abiraterone Krka should be taken at least two hours after a meal 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 some water.

• Do not crush the tablets.

• Abiraterone Krka is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.

• You must take prednisone or prednisolone every day while you are taking Abiraterone Krka.

• The dose of prednisone or prednisolone may need to be adjusted in emergency situations. Your doctor will inform 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.

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 Abiraterone Krka than you should, contact 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, speak 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 questions about how to use 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.
If you notice any of the side effects listed below, stop taking Abiraterone Krka and contact a doctor immediately:

• muscle weakness, muscle spasms, or sensation of a pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

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

• fluid retention in the legs or feet,
• low potassium levels in the blood,
• increased liver function test values,
• 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 heart rhythm (atrial fibrillation),
• heart failure,
• fast heartbeat,
• severe infection 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 salt and water imbalance),
• abnormal heart rhythm (arrhythmia),
• muscle weakness and/or muscle pain.

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

• lung irritation (also known as allergic alveolitis),
• liver function problems (also known as acute liver failure).

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

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

Loss of bone tissue may occur in men treated for prostate cancer. Abiraterone Krka in combination with prednisone or prednisolone may increase bone tissue loss.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Abiraterone Krka contains

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate, equivalent to 446 mg of abiraterone.
• The other excipients are: tablet core: monohydrate lactose, hypromellose (E 464), sodium lauryl sulfate, sodium croscarmellose (E 468), silicified microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate (E 470b)

coating: macrogol, polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172). See section 2 “Abiraterone Krka contains lactose and sodium”.

Description of the appearance of Abiraterone Krka and the contents of the pack

Film-coated tablets (tablets) from grey-violet to violet, oval, biconvex, with approximate dimensions of 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 blister calendar packs.

Not all 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
KRKA Belgium, SA. UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България Luxembourg/Luxemburg
КРКА България ЕООД KRKA Belgium, SA.
Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika Magyarország
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490

Danmark Malta
KRKA Sverige AB E. J. Busuttil Ltd.
Tlf: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885

Deutschland Nederland
Acurae Pharma GmbH KRKA Belgium, SA.
Tel: + 49 (0) 4721 590910 Tel: + 32 (0) 487 50 73 62 (BE)

Eesti Norge
KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB
Tel: + 372 (0) 6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. KRKA Pharma GmbH, Wien
Τηλ: + 30 210 8009111 Tel: + 43 (0)1 66 24 300

España Polska
KRKA Farmacéutica, S.L. KRKA-POLSKA Sp. z o.o.
Tel: + 34 911 61 03 80 Tel.: + 48 (0)22 573 7500

France Portugal
KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650

Hrvatska România
KRKA - FARMA d.o.o. KRKA Romania S.R.L., Bucharest
Tel: + 385 1 6312 101 Tel: + 4 021 310 66 05

Ireland Slovenija
KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto
Tel: + 353 1 413 3710 Tel: + 386 (0) 1 47 51 100

Ísland Slovenská republika
LYFIS ehf. KRKA Slovensko, s.r.o.
Sími: + 354 534 3500 Tel: + 421 (0) 2 571 04 501

Italia Suomi/Finland
KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy
Tel: + 39 02 3300 8841 Puh/Tel: + 358 20 754 5330

Κύπρος Sverige
KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB
Τηλ: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.