Abiraterone Farmoz

Package leaflet: Information for the user

ABIRATERONE FARMOZ 250 mg tablets

abiraterone acetate
Read this entire leaflet carefully before 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 ABIRATERONE FARMOZ is and what it is used for

ABIRATERONE FARMOZ contains a medicine called abiraterone acetate. It is used
for the treatment of prostate cancer in adult men whose cancer has spread to other parts of the body.
ABIRATERONE FARMOZ stops the body's production of testosterone; this
may slow down the growth of prostate cancer.
When ABIRATERONE FARMOZ is prescribed at the early stage of the disease, when the cancer 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. This medicine is used to reduce the risk of high blood pressure,
fluid retention (too much fluid in the body), or low levels in the blood of a chemical substance known as potassium.

2. What you need to know before taking

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 pregnant. The use of ABIRATERONE FARMOZ is intended only for men.
• If you have severe liver damage.
• In combination with Ra-223 (used to treat prostate cancer).

Do not take this medicine if you fall into any of these categories. If you have any doubts, 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 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 together 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.
Reduction 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 are considering taking Ra-223 after treatment with ABIRATERONE FARMOZ 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 FARMOZ may affect the liver and may not cause symptoms. While taking this medicine, your doctor will periodically perform blood tests to check for any effects of ABIRATERONE FARMOZ on the liver.
Children and adolescents
This medicine is not indicated for use in children and adolescents. If ABIRATERONE FARMOZ 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 FARMOZ
Ask your doctor or pharmacist 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 FARMOZ may increase the effects of certain medicines, including those for heart conditions, tranquilizers, certain diabetes medicines, 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 FARMOZ. This could lead to unwanted side effects or ABIRATERONE FARMOZ may not work as intended.
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 treat opioid addiction), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Inform your doctor if you are taking any of the medicines listed above.
ABIRATERONE FARMOZ with food

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

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

• This medicine may cause harm to the fetus if taken by pregnant women.
• Pregnant women or women who may be pregnant must wear gloves if they need to touch or handle ABIRATERONE FARMOZ.
• 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 fetus.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use tools or machinery.
ABIRATERONE FARMOZ contains lactose and sodium

• ABIRATERONE FARMOZ contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
• This medicine contains 27.2 mg of sodium (a main component of table salt) in the daily dose of four tablets. This corresponds to 1.36% of the maximum daily recommended dietary intake for an adult.

3. How to take ABIRATERONE FARMOZ

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
How much to take
The recommended dose is 1,000 mg (four tablets) once daily.
How to take 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 some water.

• Do not break the tablets.

• ABIRATERONE FARMOZ 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 FARMOZ.

• 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 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 your usual dose the next day.
• If you forget to take ABIRATERONE FARMOZ or prednisone or prednisolone for more than one day, speak with your doctor as soon as possible.

If you stop treatment with ABIRATERONE FARMOZ
Do not stop taking ABIRATERONE FARMOZ 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 FARMOZ and contact a doctor immediately:

• muscle weakness, muscle spasms, or 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 retention in 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 heartbeat (atrial fibrillation), heart failure, rapid 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 imbalances), 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, and 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 FARMOZ in combination with prednisone or prednisolone may increase loss of bone tissue.

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 FARMOZ

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label of the cardboard and plastic container. 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 FARMOZ contains

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

Description of the appearance of ABIRATERONE FARMOZ and package contents

• 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 Authorization 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 authorized in the European Economic Area countries under the following names:
Cyprus – Abiraterone Farmoz
Italy – Abiraterone Farmoz.
Portugal – Abiraterona Farmoz.
Spain – Abiraterone Farmoz.
Hungary – Abiraterone Farmoz 250 mg tabletta.