Abiraterone Tecnigen

Package leaflet: Information for the user

ABIRATERONE TECNIGEN 500 mg tablets

abiraterone acetate
Generic medicine
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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

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

ABIRATERONE TECNIGEN 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 TECNIGEN stops the body from producing testosterone; this may slow down the growth of prostate cancer.
When ABIRATERONE TECNIGEN is prescribed in the early stage of the disease, which still responds to hormone therapy, it is used in combination 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 this medicine

Do not take ABIRATERONE TECNIGEN

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

Do not take this medicine if any of these conditions apply to you. If you are in doubt, 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 blood potassium levels (low 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 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 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 be fatal.

Possible side effects include reduction in red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain.

ABIRATERONE TECNIGEN must not be given 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 TECNIGEN 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 TECNIGEN may affect the liver and may not cause any symptoms.

While taking this medicine, your doctor will periodically perform blood tests to monitor for any effects of ABIRATERONE TECNIGEN on the liver.

Children and adolescents

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

Other medicines and ABIRATERONE TECNIGEN

Talk to 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 TECNIGEN may increase the effects of certain medicines, including heart medications, 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 TECNIGEN. This could lead to unwanted side effects or ABIRATERONE TECNIGEN 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 disorders (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 TECNIGEN with food

• This medicine must not be taken with food (see section 3. How to take ABIRATERONE TECNIGEN).
• Taking ABIRATERONE TECNIGEN with food may cause unwanted effects.

Pregnancy and breastfeeding

ABIRATERONE TECNIGEN is not indicated for use in women.

• This medicine may harm the unborn baby if taken during pregnancy.
• If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective method of contraception.
• 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 machinery.

ABIRATERONE TECNIGEN contains lactose and sodium

• ABIRATERONE TECNIGEN contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
• This medicine contains 23.6 mg of sodium (a main component of table salt) in the daily dose of two tablets. This corresponds to 1.18% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to take ABIRATERONE TECNIGEN

Take this medicine exactly as your doctor has told you. 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.
Taking this medicine

• Take this medicine by mouth.

• Do not take ABIRATERONE TECNIGEN with food. Taking Abiraterone TECNIGEN with food may lead to increased absorption of the medicine by the body, which could cause side effects.

• Take Abiraterone TECNIGEN as a single daily dose on an empty stomach. Abiraterone TECNIGEN must be taken at least two hours after eating, and you must not eat for at least one hour after taking Abiraterone TECNIGEN (see section 2 “ABIRATERONE TECNIGEN with food”).

• Swallow the tablets whole with a glass of water.

• Do not break the tablets.

• ABIRATERONE TECNIGEN 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 TECNIGEN.

• Your 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 do so.

Your doctor may also prescribe other medicines while you are taking ABIRATERONE
TECNIGEN and prednisone or prednisolone.
If you take more ABIRATERONE TECNIGEN than you should
If you take more ABIRATERONE TECNIGEN than prescribed, contact your doctor or go to hospital immediately.
If you forget to take ABIRATERONE TECNIGEN

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

If you stop taking ABIRATERONE TECNIGEN
Do not stop taking ABIRATERONE TECNIGEN or prednisone or prednisolone unless your doctor tells you to do so.
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 TECNIGEN 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)
Elevated levels of fats in the blood, chest pain, irregular heart rhythm (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 itchy skin rash.
Loss of bone tissue may occur in men treated for prostate cancer.
ABIRATERONE TECNIGEN 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 the website
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 TECNIGEN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer carton and blister pack. 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 TECNIGEN contains

• The active substance is abiraterone acetate. Each tablet contains 500 mg of abiraterone acetate.
• The other ingredients are microcrystalline cellulose (silicified); microcrystalline cellulose; lactose monohydrate; sodium croscarmellose; hypromellose E15; sodium lauryl sulfate; colloidal anhydrous silica; and magnesium stearate (see section 2, “Abiraterone TECNIGEN contains lactose and sodium”).
• The tablet coating contains polyvinyl alcohol; polyethylene glycol; talc; titanium dioxide; black iron oxide (E172); red iron oxide (E172).

Description of the appearance of ABIRATERONE TECNIGEN and package contents

• The film-coated tablets of Abiraterone TECNIGEN are pink, elliptical, biconvex, film-coated tablets.
• The film-coated tablets of Abiraterone TECNIGEN are packed in PVC/PE/PVdC-Alu blisters in packs of 56 and 60 film-coated tablets.
• Not all pack sizes may be marketed.

Marketing Authorization Holder
TECNIGEN – Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande, nº 2, Abrunheira
2710-228 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 Member States of the European Economic Area under the following names:
Italy – Abiraterone Tecnigen.
Portugal – Abiraterona Tecnigen.
Spain – Abiraterona Tecnigen.
Hungary – Abiraterone TECNIGEN 500 mg tabletta.