ABIRATERONE 250 mg Коированная Таблетка

Содержание инструкции

1. ABIRATERONE FARMOZ 250 mg tablets
   1. What is ABIRATERONE FARMOZ and what is it used for
   2. What you need to know before you take
   3. How to take ABIRATERONE FARMOZ
   4. Possible side effects
2. ABIRATERONE FARMOZ in association with prednisone or prednisolone may increase bone tissue loss.
   1. How to store ABIRATERONE FARMOZ
   2. Contents of the pack and other information

ABIRATERONE FARMOZ 250 mg tablets

abiraterone acetate

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

1. What is ABIRATERONE FARMOZ and what is it used for

ABIRATERONE FARMOZ 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.
ABIRATERONE FARMOZ stops the production of testosterone by the body; this
may slow the growth of prostate cancer.
When ABIRATERONE FARMOZ is prescribed in the early stages of the disease, which still responds
to hormone 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 is used 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 FARMOZ Do not take
ABIRATERONE FARMOZ

• 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 you are pregnant. The use of ABIRATERONE FARMOZ 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 heart or blood vessel problems;
• 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 previously taken a medicine called ketoconazole for prostate cancer;
• about the need to take this medicine with prednisone or prednisolone;
• about the possible effects on bones;
• if you have high blood sugar levels.

Tell your doctor if you have been told you have any heart or blood vessel problems, including
heart rhythm problems (arrhythmia) or if you are being treated with medicines for these problems.
Tell your doctor if you have 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 dysfunction (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 FARMOZ must not be administered 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 FARMOZ and
prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223.
If you have any doubts about whether any of the above points apply to you, ask your doctor
or pharmacist before taking this medicine.

Blood monitoring
ABIRATERONE FARMOZ can affect the liver and may not have any symptoms. When
taking this medicine, your doctor will periodically perform blood tests to check
for any effects of ABIRATERONE FARMOZ on the liver.

Children and adolescents
The medicine is not indicated in children and adolescents. If ABIRATERONE FARMOZ is
accidentally ingested by a child or adolescent, go to hospital immediately.

Other medicines and ABIRATERONE FARMOZ
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 FARMOZ can increase
the effects of some medicines including medicines for the heart, sedatives, some medicines for
diabetes, herbal medicines (e.g. St John's wort) and others. The doctor may decide
to change the dose of these medicines. Also, some medicines can increase or decrease the
effects of ABIRATERONE FARMOZ. This can lead to unwanted effects or ABIRATERONE
FARMOZ 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 (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 the treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

ABIRATERONE FARMOZ with food

• This medicine should not be taken with food (see section “How to take this medicine”).
• Taking ABIRATERONE FARMOZ with food can cause unwanted effects.

Pregnancy and breastfeeding
The use of ABIRATERONE FARMOZ is not indicated in women.

• This medicine can cause harm to the fetus if taken by pregnant women.
• Pregnant women or those who may be pregnant should wear glovesif they need to touch or handle ABIRATERONE FARMOZ.
• If you have sexual intercourse with a woman of childbearing potential, you should use a condom andanother effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom toprotect the fetus.

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

ABIRATERONE FARMOZ contains lactose and sodium

• ABIRATERONE FARMOZ contains lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine contains 27.2 mg of sodium (the main component of table salt) in the daily dose of four tablets. This is equivalent to 1.36% of the recommended maximum daily intake with the diet of an adult.

3. How to take ABIRATERONE FARMOZ

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 1000 mg (four tablets) once a day.

Taking this medicine

• Take this medicine by mouth.
• Do not take ABIRATERONE FARMOZ with food.
• Take Abiraterone Farmoz at least one hour before or at least two hours after a meal (see section 2 “ABIRATERONE FARMOZ with food”).
• Swallow the tablets whole, with a little water.
• Do not break the tablets.
• ABIRATERONE FARMOZ 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

FARMOZ.

• 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 take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

The doctor may also prescribe you other medicines while you take ABIRATERONE
FARMOZ and prednisone or prednisolone.

If you take more ABIRATERONE FARMOZ than you should
If you take more ABIRATERONE FARMOZ than you should, contact your doctor or go to hospital
immediately.

If you forget to take ABIRATERONE FARMOZ

• If you forget to take ABIRATERONE FARMOZ or prednisone or prednisolone, take the usual dose the next day.
• If you forget to take ABIRATERONE FARMOZ or prednisone or prednisolone for more than one day, talk to your doctor without waiting too long.

If you stop taking ABIRATERONE FARMOZ
Do not stop taking ABIRATERONE FARMOZ 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 FARMOZ 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, rash.

Uncommon(may affect up to 1 in 100 people)
Problems with the adrenal glands (related to salt and water problems), abnormal heartbeat
(arrhythmia), muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000)
Lung irritation (also called allergic alveolitis). Liver function problems (also
called acute liver failure).

Not known(frequency cannot be estimated based on available data)
Heart attack, changes in the ECG – electrocardiogram (prolongation of the QT interval),
and serious allergic reactions with difficulty swallowing or breathing, swelling of the face, lips,
tongue or throat, or hives.
Bone tissue loss may occur in men treated for prostate cancer.

ABIRATERONE FARMOZ in association with prednisone or prednisolone may increase bone tissue loss.

of bone tissue.

Reporting of adverse reactions
If you experience any side effect, including those not listed in this leaflet, please contact
your doctor or pharmacist. You can also report side effects directly through 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 FARMOZ

• 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 packaging label and the bottle. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not dispose of any medicine in water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ABIRATERONE FARMOZ contains

• The active ingredient is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients are microcrystalline cellulose; sodium croscarmellose; lactose monohydrate; magnesium stearate; povidone; colloidal anhydrous silica; and sodium lauryl sulfate (see section 2, “Abiraterone Farmoz contains lactose and sodium”).

Description of the appearance of ABIRATERONE FARMOZ and contents of the pack

• Abiraterone Farmoz tablets are white to off-white, oval tablets.
• The tablets are supplied in a plastic bottle with a child-resistant closure. Each bottle contains 120 tablets. Each carton contains one bottle.

Marketing Authorisation Holder
Farmoz – Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, nº 2, Abrunheira, 2710-089 Sintra, Portugal.

Manufacturer
Tecnimede – Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria, 2565-187 Dois Portos, Portugal.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Cyprus – Abiraterone Farmoz
Italy – Abiraterone Farmoz.
Portugal – Abiraterona Farmoz.
Spain – Abiraterone Farmoz.
Hungary – Abiraterone Farmoz 250 mg tabletta.