Product Information for the Patient

Abiraterone Mylan 500 mg Film-Coated Tablets

Abiraterone Mylan 1.000 mg Film-Coated Tablets

abiraterone acetate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Abiraterona Mylan 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. Abiraterona Mylan makes your body stop producing testosterone; in this way it can delay the growth of prostate cancer.

When Abiraterona Mylan is prescribed in the initial stages of the disease and there is still a response to hormonal treatment, it is used together with a treatment to reduce testosterone (androgen deprivation treatment).

When you take this medicine, your doctor will prescribe another medicine called prednisone or prednisolone, to reduce the possibility of suffering an increase in blood pressure, accumulating too much fluid in your body (fluid retention) or decreasing the levels of a chemical called potassium in your blood.

Do not take Abiraterona Mylan

• 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. Abiraterona Mylan should only be used in male patients.
• if you have a serious liver disease.
• in combination with Ra-223 (used for the treatment of prostate cancer).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have liver problems.
• if you have been told that you have high blood pressure or heart failure or low levels of potassium in the blood (low levels of potassium in the blood may increase the risk of heart rhythm problems).
• if you have had other heart or blood vessel problems.
• if you have a rapid or irregular heartbeat.
• if you have difficulty breathing.
• if you have gained weight rapidly.
• if you have swelling in your feet, ankles, or legs.
• if you have taken in the past a medicine known as ketoconazole for prostate cancer.
• about the need to take this medicine with prednisone or prednisolone.
• about possible side effects on your bones.
• if you have high levels of sugar in the blood.

Inform your doctor if you have been told that you have any heart or blood vessel problems, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.

Inform 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, acute liver failure may occur, which can be fatal.

You may experience a decrease in the number of red blood cells in the blood, reduced libido, and cases of muscle weakness and/or muscle pain.

Abiraterona Mylan should not be administered in combination with Ra-223 due to a possible increased risk of bone fracture or death.

If you plan to take Ra-223 after treatment with Abiraterona Mylan and prednisone/prednisolone, you should wait 5 days before starting the treatment with Ra-223.

If you are unsure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterona Mylan may affect your liver, even if you have no symptoms. While taking this medicine, your doctor will make periodic blood tests to monitor any effect on your liver.

Children and adolescents

This medicine should not be used in children or adolescents. If a child or adolescent accidentally ingests Abiraterona Mylan, they should immediately go to the hospital and bring the package insert with them to show to the emergency doctor.

Other medicines and Abiraterona Mylan

Consult your doctor or pharmacist before taking any other medicine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is important because Abiraterona Mylan may increase the effects of a range of medicines, including heart medicines, tranquilizers, some diabetes medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medicines. Additionally, some medicines may increase or decrease the effects of Abiraterona Mylan, which may lead to side effects or Abiraterona Mylan not working as well as it should.

The androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are being treated with medicines:

• used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol).
• that increase the risk of heart rhythm problems (e.g., methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)).

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

Taking Abiraterona Mylan with food

• This medicine should not be taken with food (see section 3, “How to take Abiraterona Mylan”).
• Taking Abiraterona Mylan with food may cause side effects.

Pregnancy and breastfeeding

Abiraterona Mylan is not indicated in women.

• This medicine may be harmful to the fetus if a pregnant woman takes it.
• Pregnant women or those who may be pregnant should wear gloves if they need to touch or handle Abiraterona Mylan.
• If you have sexual relations with a fertile woman, you should use a condom and another effective contraceptive method.
• If you have sexual relations with a pregnant woman, you should use a condom to protect the fetus.

Driving and operating machines

This medicine is unlikely to affect your ability to drive and use tools or machines.

Abiraterona Mylan contains lactose and sodium

• This medicine contains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.
• This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is 1,000 mg (two 500 mg tablets or one 1,000 mg tablet) once a day.

How to take this medication

• Take this medication orally.
• Do not take Abiraterona Mylan with food. Taking Abiraterona Mylan with food may cause the body to absorb more of the medication than necessary, which may lead to adverse effects.
• Take Abiraterona Mylan tablets as a single dose once a day with an empty stomach. Abiraterona Mylan should be taken at least two hours after eating and no food should be taken for at least one hour after taking Abiraterona Mylan(see section 2, “Taking Abiraterona Mylan with food”).
• Swallow the tablets with water.
• For 500 mg:Do not break the tablets.
• For 1,000 mg:The tablets can be divided to facilitate swallowing.
• Abiraterona Mylan is administered with a medication called prednisone or prednisolone.
• Take prednisone or prednisolone exactly as instructed by your doctor.
• You will need to take prednisone or prednisolone every day while taking Abiraterona Mylan.
• If you have a medical emergency, you may need to adjust the amount of prednisone or prednisolone you take. Your doctor will let you know if you need to modify the amount of prednisone or prednisolone you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

You may also be prescribed other medications while taking Abiraterona Mylan and prednisone or prednisolone.

If you take more Abiraterona Mylan than you should

If you take more than you should, consult your doctor or go to the hospital immediately.

If you forget to take Abiraterona Mylan

• If you forget to take Abiraterona Mylan or prednisone or prednisolone, take the usual dose the next day.
• If you forget to take Abiraterona Mylan or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you interrupt treatment with Abiraterona Mylan

Do not stop taking Abiraterona Mylan or prednisone or prednisolone unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Abiraterona Mylan and seek medical attention immediately if you experience any of the following side effects:

• Muscle weakness, muscle cramps, or rapid heartbeat (palpitations).

These may be signs of low potassium levels in your blood.

Other side effects are:

Very common(may affect more than 1 in 10 people):

Fluid retention in the legs or feet, low potassium levels in the blood, elevated liver function test results, high blood pressure, urinary tract infections, diarrhea.

Common(may affect up to 1 in 10 people):

High levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation), heart failure, tachycardia, severe infections 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 issues with salt and water), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.

Rare(may affect up to 1 in 1,000 people):

Pulmonary irritation (also known as allergic alveolitis).

Failure of liver function (also known as acute liver failure).

Frequency not known(cannot be estimated from available data):

Heart attack, changes in the electrocardiogram-ECG (prolongation of QT), and severe allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue, or throat, or itchy rash.

This medicine may cause bone density loss in men receiving treatment for prostate cancer. Abiraterona in combination with prednisone or prednisolone may increase this bone density loss.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, blister pack, and bottle after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Abiraterone Mylan Content

The active ingredient is abiraterone acetate. Each film-coated tablet contains 500 mg or 1,000 mg of abiraterone acetate.

The other components are:

Core tablet : sodium croscarmellose (E468), sodium lauryl sulfate, povidone, microcrystalline cellulose (E460), lactose monohydrate, anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Film coating : polyvinyl alcohol, titanium dioxide (E171), macrogol (E1521), and talc (E553b). In addition, the 500 mg tablets contain iron oxide red (E172) and iron oxide black (E172).

See section 2 "Abiraterone Mylan contains lactose and sodium."

Appearance of the product and contents of the package

Abiraterone Mylan 500 mg film-coated tablets are brown, oval-shaped (19 mm in length x 10 mm in width), with "500" engraved on one side and are available in blister packs containing 56, 60 tablets, and in perforated blister packs containing 56 x 1, 60 x 1 tablets.

Abiraterone Mylan 1,000 mg film-coated tablets are white or almost white, oval-shaped (23 mm in length x 11 mm in width), with a groove on one side and a flat surface on the other side, available in bottles containing 28 or 30 tablets, and also available in blister packs containing 28 or 30 tablets, and in perforated blister packs containing 28 x 1 or 30 x 1 tablets. The bottle also contains an oxygen absorber. Do not ingest the oxygen absorber, as it may be harmful to your health.

Only some package sizes may be commercially available.

Marketing authorization holder

Mylan Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate

Dublin 13,

Ireland.

Responsible for manufacturing

Remedica Ltd.,

Aharnon Street,

Limassol Industrial Estate,

3056 Limassol,

Cyprus

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu .