Abiraterone Zentiva

Package leaflet: Information for the user

Abiraterone Zentiva 500 mg film-coated tablets

Generic medicine
Please read 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Abiraterone Zentiva contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men whose cancer has spread to other parts of the body.
This medicine stops the body from producing testosterone, which may slow down the growth of prostate cancer.
When Abiraterone Zentiva is prescribed at 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 taking this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine helps reduce the risk of high blood pressure, fluid retention (too much fluid in the body), or low levels in the blood of a chemical known as potassium.

2. What you need to know before taking Abiraterone Zentiva

Do not take Abiraterone Zentiva

• 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. Abiraterone Zentiva is intended for use in men only.
• if you have severe liver damage.
• in combination with Ra-223 (used to treat prostate cancer).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told you have 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 have shortness of breath
• 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 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 taking 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 Zentiva must not be given in combination with Ra-223 due to a possible increased risk of fractures or death.

If you are considering treatment with Ra-223 after treatment with Abiraterone Zentiva and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

Abiraterone Zentiva may affect the liver and may not cause any symptoms. While taking this medicine, your doctor will periodically perform blood tests to check for any effects on the liver.

Children and adolescents

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

Other medicines and Abiraterone Zentiva

Ask 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 Zentiva may increase the effects of certain medicines, including heart medications, tranquilizers, herbal remedies (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 Zentiva. This could lead to side effects or may reduce the effectiveness of this medicine.

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, sotalol);
• known to increase the risk of heart rhythm problems [e.g., methadone (used to relieve pain and treat 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 Zentiva with food

• This medicine must not be taken with food (see section 3 “How to take this medicine”).
• Taking Abiraterone Zentiva with food may cause unwanted side effects.

Pregnancy and breastfeeding

Abiraterone Zentiva is not indicated for use in women.

• This medicine may harm an 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 Zentiva.
• 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 operate tools or machinery.

Abiraterone Zentiva contains lactose and sodium

• This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take Abiraterone Zentiva

Take this medicine exactly as prescribed by your doctor. 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 Zentiva with food. Taking Abiraterone Zentiva with food may lead to higher than intended absorption of the medicine into the body, which could cause side effects.
• Take the Abiraterone Zentiva tablets as a single daily dose on an empty stomach. Abiraterone Zentiva must be taken at least two hours after food and no food should be ingested for at least one hour after taking Abiraterone Zentiva (see section 2 “Abiraterone Zentiva with food”).
• Swallow the tablets whole with a glass of water.
• Do not break the tablets.
• Abiraterone Zentiva is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as instructed by your doctor.
• You must take prednisone or prednisolone every day while taking Abiraterone Zentiva.
• The dose of prednisone or prednisolone may need to be adjusted in certain emergency situations. Your doctor will inform you if you need to change your 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 Zentiva and prednisone or prednisolone.

If you take more Abiraterone Zentiva than you should
If you take more Abiraterone Zentiva than prescribed, contact your doctor or go to hospital immediately.

If you forget to take Abiraterone Zentiva

• If you forget to take Abiraterone Zentiva or prednisone or prednisolone, take your usual dose the next day.
• If you forget to take Abiraterone Zentiva or prednisone or prednisolone for more than one day, speak to your doctor without delay.

If you stop taking Abiraterone Zentiva
Do not stop taking Abiraterone Zentiva 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 everybody gets them.
If you notice any of the side effects listed below, stop taking Abiraterone Zentiva and contact a doctor immediately:

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

Other side effects include:
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 heart rate
• 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 problems)
• abnormal 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)
• liver function problems (also called 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, or hives.

Loss of bone tissue may occur in men treated for prostate cancer. Abiraterone Zentiva 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Abiraterone Zentiva

• 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 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 Zentiva contains

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other excipients are:
  Tablet core: monohydrate lactose; microcrystalline cellulose; sodium croscarmellose; sodium lauryl sulfate; hypromellose; magnesium stearate; anhydrous colloidal silica.
  Tablet coating: polyvinyl alcohol; macrogol; talc; titanium dioxide; iron oxide red; iron oxide black.

Description of the appearance of Abiraterone Zentiva and contents of the pack
Abiraterone Zentiva tablets are film-coated, brown-purple in colour, oval-shaped (20 mm x 10 mm).
The film-coated tablets of Abiraterone Zentiva are packed in PVC/PVDC/Aluminum blisters.
Each pack contains 56, 60, 112 or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia, S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturer
DELPHARM LILLE SAS – LYS LEZ LANNOY
Parc d´Activités Roubaix-Est, 22 rue de Toufflers CS 50070
ZIP Code 59452
France
ZENTIVA, k.s.
U kabelovny 130, Dolní Měcholupy, Praha 10,
102 37 Czech Republic
Prestige Promotion Verkaufsforderung & Werbeservice GmbH
Borsigstrasse 2, Alzenau, Bavaria, 63755
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Czech Republic, Denmark, Estonia, France, Italy, Latvia, Lithuania, Norway, Slovakia and Sweden: Abiraterone Zentiva
Netherlands, Germany: Abirateron Zentiva
Portugal: Abiraterona Zentiva