ABIRATERONE MYLAN 500 mg FILM-COATED TABLETS

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 (which is 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 that you have high blood pressure or heart failure or low levels of potassium in your blood (low levels of potassium 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 that you have any heart or blood vessel disorder, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these disorders.

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 (called acute hepatic failure) can occur, which can be life-threatening.

A decrease in the number of red blood cells in your blood, reduced sex drive, 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 effects 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 therapy 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, which is essentially “sodium-free”.

3. How to take Abiraterone Mylan

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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 may cause your body to absorb too much of the medicine 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 eaten 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 them easier to swallow.
• Abiraterone Mylan is given together with a medicine called prednisone or prednisolone.
• Take prednisone or prednisolone exactly as your doctor has told you.
• You will need 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.

Your doctor may also 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 your doctor or go to the 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 your doctor immediately if you get any of the following:

• Muscle weakness, muscle spasms, or a 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, diarrhea.

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 (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 thinning (loss of bone density) may occur in men who are treated for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase this bone thinning.

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. Package Contents and Additional Information

Abiraterone Mylan Contents

The active ingredient 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 Package 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 face, 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 face 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 medicine 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 medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.