InfoCons Consumer Protection informs you – Abiraterone Krka – Package Leaflet

Before anything else

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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 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 that has spread to other parts of the body. Abiraterone Krka stops your body from making testosterone; this can slow the growth of prostate cancer.

When Abiraterone Krka is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy).

When you take this medicine your doctor will also prescribe anot her medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium 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 pregnant. Abiraterone Krka is for us e in male patients only.
• if you have severe liver damage.
• in combination with Ra -223 (which is used to treat prostate cancer).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to 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 told you have high blood pressure or heart failure or low blood potassium (low blood potassium 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 heart rate.
• if you have shortness of breath.

33- if you have gained weight rapidly.

• if you have swelling in the feet, ankles, o r legs.
• if you have taken a medicine known as ketoconazole in the past for prostate cancer.
• about the need to take this medicine with prednisone or prednisolone.
• about possible effects on your bones.
• if you have high blood sugar.

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

Tell your doctor if you have yellowing of the skin or eyes, darkening of the urine, or sev ere nausea or vomiting, as these could be signs or symptoms of liver problems. Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death.

Decrease in red blood cells, reduced sex drive (libido), muscle weakne ss and/or muscle pain may occur.

Abiraterone Krka must not be given in combination with Ra -223 due to a possible increase in the risk of bone fracture or death.

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

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

Blood m onitoring Abiraterone Krka may affect your liver, and you may not have any symptoms. When you are taking this medicine, your doctor will check your blood periodically to look for any effects on your liver.

Children and adolescents

This medicine is not for use in children and adole scents. If Abiraterone Krka is accidentally ingested by a child or adolescent, go to the hospital immediately and take the package leaflet with you to show to the emergency doctor.

Other medicines and Abiraterone Krka

Ask your doctor or pharmacist for adv ice 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 may incr ease the effects of a number of medicines including heart medicines , tranquilisers, some medicines for diabetes, herbal medicines (e.g., St John’s wort) and others. Your doctor may want to change the dose of these medicines. Also, some medicines may increase or decrease the effects of Abiraterone Krka . This may lead to si de effects or to Abiraterone Krka not working as well as it should.

Androgen deprivation treatment may increase the risk of heart rhythm problems. Tell your doctor if you are receiving medicine

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

Tell 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, “Taking this medicine”).
• Taking Abiraterone Krka with food may cause side effects.

34Pregnancy and breast -feeding Abiraterone Krka is not for use in women.

• This medicine may cause harm to th e unborn child if it is taken by women who are pregnant.
• Wom en who are pregnant or who may be pregnant should wear gloves if they need to touch or handle Abiraterone Krka.
• If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method.
• If you are having sex with a pregnant woman, use a condom to protect the unborn child.

Driving and using machines

This medicine is not likely to affect your being able to drive and use any tools or machines.

Abiraterone Krka contains lactose and sodium

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor befor e taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose of two tablets, that is to say essentially ‘sodium -free’.

💊 3. How to take Abiraterone Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to take The recommended dose is 1 000mg (two tablets) once a day.

Taking this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Krka with food. Taking Abiraterone K rka with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
• Take Abiraterone Krka tablets as a single dose once daily on an empty stomach . Abiraterone Krka must be taken at least two hours after e ating and food must not be eaten for at least one hour after taking Abiraterone Krka (see section 2, “ Abiraterone Krka withfood”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone Krka is taken with a medicine called prednisone or prednisolone. Take the prednisone or prednisolone exactly as your doctor has told you.
• You need to take prednisone or prednisolone every day while you are taking Abiraterone Krka .
• The amount of prednisone or prednisolone you take may need to change if y ou have a medical emergency. Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells youto.

Your doctor may also prescribe other medicines w hile 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 a 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 following day.
• If you forget to take Abiraterone Krka or prednisone or prednisolone for more than one day, talk 35to your doctor without delay.

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 medicine, ask your doctor or pharmacist.

❗ 4. Possible side effects

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

Stop taking Abiraterone Krka and see a doctor immediately if you notice any of the following:

• muscle weakness, muscle twitches or a pounding heart beat (palpitations). These may b e signs that the level of potassium in your blood is low.

Other side effects include

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

• fluid in your legs or feet,
• low blood potassium,
• liver function test increases,
• high blood pressure,
• urinary tract infection,
• diarrhoea.

Common (may affect up to 1 in 10 people)

• high fat levels in your blood,
• chest pain,
• irregular heart beat (atrial fibrillation),
• heart failure,
• rapid heart rate,
• sever e infections called sepsis,
• bone fractures,
• indigestion,
• blood in urine,
• rash.

Uncommon (may affect up to 1 in 100 people)

• adrenal gland problems (related to salt and water problems),
• abnor mal heart rhythm (arrhythmia),
• muscle weakness and/or muscle pain.

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

• lung irritation (also called allergic alveolitis),
• failure of the liver to function (also called acute liver failure).

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

• heart attack, changes in ECG -electrocardiogram (QT prolongation)
• serious allergic r eactions with difficulty swallowing or breathing, swollen face, lips, tongue or throat, or an itchy rash.

Bone loss may occur in men treated for prostate cancer. Abiraterone Krka in combination with prednisone or prednisolone may increase bone loss.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 36not 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. How to store Abiraterone Krka

Keep this medi cine out of the sight and reach of children.

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

This medicine does not require any special storage conditi ons.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Abiraterone Krka contains

• The active substance is abiraterone acetate. Each film -coated tablet contains 500 mg abiraterone acetate equiva lent to 446 mg of abiraterone.
• The other ingredients are:

Tablet core: lactose monohydrate, hypromellose (E 464), sodium laurilsulfate, croscarmellose sodium (E 468), silicified microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate (E 470b).

Film-coating: macrogol, poly(vinyl alcohol), talc (E 553b), titanium dioxide (E 171), red iron oxide (E 172), blac k iron oxide (E 172).

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

What Abiraterone Krka looks like and contents of the pack

Grey violet to violet, oval, biconvex, film -coated tablets (tablets), with dimensions approximately of 20mm long x10mm wide.

Abiraterone Krka is available in boxes containing:

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šma rješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz -Lohm ann-Straße 5, 27472 Cuxhaven, Germany KRKA -FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien KRKA Belgium, SA.

Tél/Tel: + 32 (0) 487 50 73 62Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27 40 България Luxembourg/Luxemburg 37КРКА България ЕООД Teл.: + 359 (02) 962 34 50KRKA Belgium, SA.

Tél/Tel: + 32 (0) 487 50 73 62 (BE) Česká republika KRKA ČR, s.r.o.

Tel: + 420 (0) 221 115 150Magyarország KRKA Magyarország Kereskedelmi Kft.

Tel.: + 36 (1) 355 8490 Danmark KRKA Sverige AB Tlf.: + 46 (0) 8 643 67 66 (SE)Malta E. J. Busuttil Ltd.

Tel: + 356 21 445 885 Deutschland 123 Acurae Pharma GmbH Tel: + 49 (0) 4721 590910Nederland KRKA Belgium, SA.

Tel: + 32 (0) 487 50 73 62 (BE) Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658Norge KRKA Sverige AB Tlf: + 46 (0) 8 643 67 66 (SE) Ελλάδα ΒΙΑΝΕΞ Α.Ε.

Τηλ: + 30 210 8009111Österreich KRKA Pharma GmbH, Wien Tel:+ 43 (0)1 66 24 300 España KRKA Farm acéutica, S.L.

Tel: + 34 911 61 03 80Polska KRKA -POLSKA Sp. z o.o.

Tel.: + 48 (0)22 573 7500 France KRKA France Eurl Tél: + 33 (0)1 57 40 82 25Portugal KRKA Farmacêutica, Sociedade Unipessoal Lda.

Tel: + 351 (0)21 46 43 650 Hrvatska KRKA -FARMA d.o.o.

Tel: + 385 1 6312 101România KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05 Ireland KRKA Pharma Dublin, Ltd.

Tel: + 353 1 413 3710Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100 Ísland LYFIS ehf.

Sími: + 354 534 3500Slovenská republika KRKA Slovensko , s.r.o.

Tel: + 421 (0) 2 571 04 501 Italia KRKA Farmaceutici Milano S.r.l.

Tel: + 39 02 3300 8841Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5330 Κύπρος KI.PA. (PHARMACAL) LIMITED Τηλ: + 357 24 651 882Sverige KRKA Sverige AB Tel: + 46 (0) 8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 10

This leaflet was last revised in

38Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Abiraterone Krka (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/21/1553).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.