ABIRATERONE 500 mg Фильм-Coated Таблетки

Содержание инструкции

1. Abiraterone Zentiva 500 mg film-coated tablets
   1. What is Abiraterone Zentiva and what is it used for
   2. What you need to know before you take Abiraterone Zentiva
   3. How to take Abiraterone Zentiva
   4. Possible side effects
   5. How to store Abiraterone Zentiva

Abiraterone Zentiva 500 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Abiraterone Zentiva and what is it used for

Abiraterone Zentiva contains a medicine called abiraterone acetate. It is used for the
treatment of prostate cancer in adult men that has spread to other parts of the body.
This medicine stops the production of testosterone by the body; this may
slow down the growth of prostate cancer.
When Abiraterone Zentiva is prescribed in the early stages of the disease, which still responds
to hormonal therapy, it is used with a treatment that lowers testosterone levels
(androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe you another medicine called
prednisone or prednisolone. This medicine serves to reduce the possibility of having high
blood pressure, too much water in the body (fluid retention), or reduced levels in the blood of
a chemical substance known as potassium.

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

Do not take Abiraterone Zentiva

• 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. The use of Abiraterone Zentiva is only indicated in 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 you fall into any of these conditions. If you have any doubts, ask 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 or heart failure or low potassium levels in your blood (low potassium levels can increase the risk of heart rhythm problems)
• if you have had other problems with your heart or blood vessels
• if you have an irregular or fast heartbeat
• if you are short of breath
• if you have gained weight rapidly
• if you have swelling of your feet, ankles or legs
• if you have taken a medicine called ketoconazole in the past for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about the possible effects on bones
• if you have high levels of sugar in your blood.

Tell your doctor if you have been told you have any heart or blood vessel problems, including
problems with your heart rhythm (arrhythmia) or if you are being treated with medicines for these conditions.
Tell your doctor if you have yellowing of the skin or eyes, dark coloured urine or severe nausea or
vomiting, as these could be signs or symptoms of liver problems. Rarely, a liver problem (called acute liver failure) can
occur, which can lead to death.
Decreases in red blood cells, decreased sexual desire (libido),
muscle weakness and/or muscle pain may occur.
Abiraterone Zentiva should not be given in combination with Ra-223 due to a possible
increased risk of fractures or death.
If you think you are going to take Ra-223 after treatment with Abiraterone Zentiva and
prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223.
If you have any doubts about whether any of the points above apply to you, ask your doctor
or pharmacist before taking this medicine.

Blood monitoring
Abiraterone Zentiva can affect the liver and may not have any symptoms. When you take
this medicine, your doctor will periodically perform blood tests to check for
any effects on the liver.

Children and adolescents
The medicine is not indicated in children and adolescents. If Abiraterone Zentiva is
accidentally swallowed by a child or adolescent, go to hospital immediately and

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 medicine. This is important because Abiraterone Zentiva can increase the effects of
some medicines including medicines for the heart, tranquillisers, herbal medicines (for example
St John's Wort) and others. Your doctor may decide to change the dose of these medicines. Also,
some medicines can increase or decrease the effects of Abiraterone Zentiva. This can lead
to unwanted effects or this medicine may not work as well as it should.
Androgen deprivation therapy can increase the risk of heart rhythm problems.
Tell your doctor if you are taking medicines:

• used to treat heart rhythm problems (for example quinidine, procainamide, amiodarone and sotalol);
• known to increase the risk of heart rhythm problems [for example methadone (used to relieve pain and for the treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

Tell your doctor if you are taking any of the medicines listed above.

Abiraterone Zentiva with food

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

Pregnancy and breastfeeding
The use of Abiraterone Zentiva is not indicated in women.

• This medicine can cause harm to the unborn child if taken by pregnant women.
• Pregnant women or those who may become pregnant mustwear gloves if they need to touch or handle AbirateroneZentiva.
• If you have sexual intercourse with a woman of childbearing potential, you must use acondom and another effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom toprotect the fetus.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive and operate tools or
machinery.

Abiraterone Zentiva contains lactose and sodium

• This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free’.

3. How to take Abiraterone Zentiva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

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

Taking this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Zentiva with food. Taking Abiraterone Zentiva with food may cause greater absorption of the medicine by the body than necessary, and this may cause undesirable effects.
• Take the tablets of Abiraterone Zentiva as a single dose once a day on an empty stomach. Abiraterone Zentiva must be taken at least two hours after a meal and no food should be ingested for at least one hour after taking Abiraterone Zentiva (see paragraph 2 “Abiraterone Zentiva with food”).
• Swallow the tablets whole, with a little water.
• Do not break the tablets.
• Abiraterone Zentiva is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone following exactly the instructions of your doctor.
• You must take prednisone or prednisolone every day while taking Abiraterone Zentiva.
• It may be necessary to change the amount of prednisone or prednisolone in emergency situations. Your doctor will inform you if you need to change the amount of prednisone or prednisolone you are taking. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

Your doctor may also prescribe you other medicines while you take Abiraterone Zentiva and
prednisone or prednisolone. If you take more Abiraterone Zentiva than you should
If you take more Abiraterone Zentiva than you should, 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 the usual dose the next day.
• If you forget to take Abiraterone Zentiva or prednisone or prednisolone for more than one day, talk to your doctor without waiting too long.

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 further questions on 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 everybody gets them.

If you notice any of the following side effects, stop taking Abiraterone Zentiva and contact your doctor immediately:

• muscle weakness, muscle spasms or a feeling of a 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 in the legs or feet
• low levels of potassium in the blood
• increased values in liver function tests
• 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
• fast heartbeat
• serious 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 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 irritation (also called allergic alveolitis)
• problems with liver function (also called acute liver failure)

Not known(frequency cannot be estimated from available data)

• Heart attack
• Changes in the ECG - electrocardiogram (prolongation of the QT interval),
• Serious allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or hives.

Bone loss may occur in men treated for prostate cancer. Abiraterone
Zentiva 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 not listed in this leaflet. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you 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 which is stated on the pack 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 any medicine via water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

What Abiraterone Zentiva contains

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

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

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

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 authorised in the Member States of the European Economic Area with the
following denominations:
Austria, Czech Republic, Denmark, Estonia, France, Italy, Latvia, Lithuania, Norway,
Slovakia and Sweden: Abiraterone Zentiva
Netherlands, Germany: Abirateron Zentiva
Portugal: Abiraterona Zentiva