Abiraterone Mylan 1000 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Abiraterone Mylan 500 mg film-coated tablets EFG

Abiraterone Mylan 1,000 mg film-coated tablets

abiraterone acetate

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Abiraterone Mylan contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men whose cancer has spread to other parts of the body. Abiraterone Mylan causes your body to stop producing testosterone; this can help slow the growth of prostate cancer.

When Abiraterone Mylan is prescribed at an early stage of the disease and there is still a response to hormone treatment, it is used in combination with a treatment to reduce testosterone (androgen deprivation therapy).

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 (build-up of fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before taking 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 intended for use only in male patients.
• 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 apply to you. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 levels 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 fast 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 previously taken a medicine known as ketoconazole for prostate cancer.
• about the need to take this medicine with prednisone or prednisolone.
• about possible adverse effects on your bones.
• if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorder, 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, darkened urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, liver function failure (called acute hepatic failure) may occur, which can lead to death.

A decrease in red blood cell count, reduced sexual desire, and cases of muscle weakness and/or muscle pain may occur.

Abiraterone Mylan must 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 Abiraterone Mylan and prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223.

If you are unsure whether any of the above apply 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 taking this medicine, your doctor will perform periodic blood tests to monitor 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, go immediately to the hospital and bring the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Mylan

Talk to your doctor or pharmacist before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because Abiraterone Mylan may increase the effects of a number of medicines, including medicines for the heart, tranquilizers, certain diabetes medicines, herbal medicines (e.g., St. John’s wort), and others. Your doctor may consider adjusting the dose of these medicines. In addition, some medicines may increase or decrease the effects of Abiraterone Mylan. This could lead to adverse effects or cause Abiraterone Mylan to be less effective.

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).
• 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 serious mental illnesses)].

Discuss with 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 adverse effects.

Pregnancy and breastfeeding

Abiraterone Mylan is not indicated for use in women.

• This medicine may be harmful to the fetus if taken by a pregnant woman.
• Pregnant women or women who suspect they may be pregnant must wear gloves if they need to handle or touch Abiraterone Mylan.
• 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, you must use a condom to protect the fetus.

Driving and using machines

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

Abiraterone Mylan contains lactose and sodium

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

3. How to take Abiraterone Mylan

Follow exactly the instructions given by your doctor for taking this medicine. If in 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 daily.

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 more of the medicine than needed, which could lead to adverse effects.
• Take Abiraterone Mylan tablets as a single daily dose on an empty stomach. Abiraterone Mylan should be taken at least two hours after eating, and no food should be taken for at least one hour after taking Abiraterone Mylan (see section 2, "Taking Abiraterone Mylan with food").
• Swallow the tablets with water.
• For 500 mg: Do not split the tablets.
• For 1,000 mg: The tablets may be divided to facilitate swallowing.
• Abiraterone Mylan is administered together with a medicine 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 Abiraterone Mylan.
• If you have a medical emergency, the dose of prednisone or prednisolone you are taking may need to be adjusted. Your doctor will advise you if the dose of prednisone or prednisolone needs to be changed. Do not stop taking prednisone or prednisolone unless instructed by your doctor.

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, consult your doctor or go to hospital immediately.

If you forget to take Abiraterone Mylan

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

If you stop taking Abiraterone Mylan

Do not stop taking Abiraterone Mylan or prednisone or prednisolone unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Abiraterone Mylan and contact your doctor immediately if you experience any of the following:

• Muscle weakness, muscle spasms, or increased heart rate (palpitations).

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

Other adverse effects include:

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

Fluid retention in the legs or feet, decreased blood potassium levels, increased liver function test results, 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, tachycardia, serious infections called sepsis, bone fractures, indigestion, blood in the urine, skin rash.

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

Adrenal gland problems (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 inflammation (also known as allergic alveolitis).

Liver function failure (also known as acute liver failure).

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

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

Bone mineral 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 adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton, blister, and bottle after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Pack contents and other information

Contents of Abiraterone Mylan

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

The other components are:

Tablet core: croscarmellose sodium (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”.

Appearance of the product and contents of the pack

Abiraterone Mylan 500 mg film-coated tablets are brown, oval-shaped (19 mm long x 10 mm wide), with “500” engraved on one side, and available in blister packs containing 56 or 60 tablets, and in unit-dose perforated blister packs containing 56 x 1 or 60 x 1 tablets.

Abiraterone Mylan 1,000 mg film-coated tablets are white or almost white, oval-shaped (23 mm long x 11 mm wide), with a score on one side and plain 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 unit-dose 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 certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review 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.