ABIRATERONE MYLAN 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Abiraterone Mylan 500 mg film-coated tablets EFG

Abiraterone Mylan 1000 mg film-coated tablets

abiraterone acetate

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Abiraterone Mylan and what is it used for

Abiraterone Mylan contains the active substance abiraterone acetate. It is used for the treatment of prostate cancer in adult men that has spread to other parts of the body. Abiraterone Mylan works by stopping your body from making testosterone; this can slow down the growth of your prostate cancer.

When Abiraterone Mylan is prescribed in the early stages of the disease and you are still responding to hormone treatment, it is used together with treatment to lower testosterone levels (androgen deprivation treatment).

When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone to reduce the risk of high blood pressure, fluid retention (water retention) or low levels of potassium in your blood.

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

Do not take Abiraterone 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. Abiraterone Mylan is for use in male patients only.
• if you have severe 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 not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before you start 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 in your blood can increase your risk of heart rhythm problems).
• if you have had other heart or blood vessel problems.
• if you have a fast or irregular heart beat.
• if you have difficulty breathing.
• if you have gained weight quickly.
• 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 blood sugar levels.

Tell your doctor if you have been told you have any heart or blood vessel disease, including heart rhythm problems (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 urine, or severe nausea or vomiting, as these can be signs or symptoms of liver problems. Rarely, liver failure (acute hepatic failure) can occur, which can be life-threatening.

A decrease in the number of red blood cells in your blood, reduced sexual desire and cases of muscle weakness and/or muscle pain may occur.

Abiraterone Mylan must not be taken 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 Abiraterone Mylan and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

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

Blood tests

Abiraterone Mylan may affect your liver, even if you do not have any symptoms. While you are taking this medicine, your doctor will regularly perform blood tests to check for any effect on your liver.

Children and adolescents

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

Other medicines and Abiraterone Mylan

Consult 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 Mylan can increase the effects of a number of medicines including heart medicines, sedatives, some diabetes medicines, herbal medicines (e.g. St. John's Wort) and others. Your doctor may consider changing the dose of these medicines. Also, some medicines may increase or decrease the effects of Abiraterone Mylan. This can lead to side effects or Abiraterone Mylan not working as well as it should.

Androgen deprivation treatment may increase the risk of heart rhythm problems. Tell 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 your doctor if you are taking any of the medicines listed above.

Taking Abiraterone Mylan with food

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

Pregnancy and breast-feeding

Abiraterone Mylan is not indicated in women.

• This medicine may harm your unborn baby if you take it when you are pregnant.
• Pregnant women or women who think they may be pregnant should wear gloves if they need to touch or handle Abiraterone Mylan.
• If you have sex with a woman who can become pregnant, you must use a condom and another effective method of birth control.
• If you have sex with a pregnant woman, you must use a condom to protect the baby.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use tools or machines.

Abiraterone Mylan contains lactose and sodium

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

3. How to take Abiraterone Mylan

Follow exactly the instructions of your doctor. If you are not sure, consult your doctor or pharmacist again.

How much to take

The recommended dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) once a day.

How to take this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Mylan with food. Taking Abiraterone Mylan with food can make your body absorb more of the medicine than needed and this can cause side effects.
• Take the Abiraterone Mylan tablets as a single dose once a day on an empty stomach. Abiraterone Mylan must be taken at least 2 hours after eating and no food must be taken for at least 1 hour after taking Abiraterone Mylan(see section 2, “Taking Abiraterone Mylan with food”).
• Swallow the tablets with water.
• For 500 mg:Do not break the tablets.
• For 1000 mg:The tablets can be divided to make swallowing easier.
• Abiraterone Mylan is given together with a medicine called prednisone or prednisolone.
• Take prednisone or prednisolone exactly as your doctor tells you.
• You will have to take prednisone or prednisolone every day while you are taking Abiraterone Mylan.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. Your doctor will tell 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.

It is also possible that your doctor will prescribe other medicines while you are taking Abiraterone Mylan and prednisone or prednisolone.

If you take more Abiraterone Mylan than you should

If you take more than you should, talk to a doctor or go to a hospital immediately.

If you forget to take Abiraterone Mylan

• If you forget to take Abiraterone Mylan or prednisone or prednisolone, take your normal dose the next day.
• If you forget to take Abiraterone Mylan or prednisone or prednisolone for more than one day, talk to your doctor immediately.

If you stop taking Abiraterone Mylan

Do not stop taking Abiraterone Mylan 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.

Stop taking Abiraterone Mylan and see a doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions or fast heart beat (palpitations).

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

Other side effects are:

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

Fluid retention in your legs or feet, low levels of potassium in your blood, increased liver tests, high blood pressure, urinary tract infection, diarrhoea.

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

High levels of fat in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, fast heart beat (tachycardia), severe infections called sepsis, bone fractures, indigestion, blood in your urine, skin rash.

Uncommon(may affect up to 1 in 100 people):

Problems with your 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).

Liver failure (also called acute hepatic failure).

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

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

Bone density loss may occur in men receiving treatment for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase this bone density 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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Mylan

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 carton, blister and bottle after “EXP”. The expiry date refers to the last day of that month.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Abiraterone Mylan contents

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

The other ingredients are:

Tablet core: sodium croscarmellose (E468), sodium lauryl sulfate, povidone, microcrystalline cellulose (E460), lactose monohydrate, colloidal anhydrous 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 red iron oxide (E172) and black iron oxide (E172).

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

Product appearance and container contents

Abiraterone Mylan 500 mg film-coated tabletsare 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 or 60 tablets, and in unit dose blister packs containing 56 x 1 or 60 x 1 tablets.

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

Only some pack sizes may be marketed.

Marketing authorization holder

Mylan Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate

Dublin 13,

Ireland.

Manufacturer

Remedica Ltd.,

Aharnon Street,

Limassol Industrial Estate,

3056 Limassol,

Cyprus

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.