Abiraterone Mylan

Package leaflet: Information for the patient

Abiraterone Mylan 500 mg film-coated tablets, 1000 mg film-coated tablets

abiraterone acetate
Please read all of this leaflet carefully before 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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 for the treatment of prostate cancer in adult men that has spread to other parts of the body.
Abiraterone Mylan stops the body's production of testosterone; this may slow down the growth of prostate cancer.
When Abiraterone Mylan is prescribed at the early stage of the disease that 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 blood levels of a chemical known as potassium.

2. What you need to know before taking Abiraterone Mylan

Do not take Abiraterone Mylan

• 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 Mylan 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 the above apply to you. If you are unsure, 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 levels of potassium in your blood (low potassium levels may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have an irregular or fast 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 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 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, 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 Mylan 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 Mylan 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 Mylan may affect the liver, and you may not experience any symptoms. While taking this medicine, your doctor will periodically perform blood tests to monitor for any effects of Abiraterone Mylan on the liver.

Children and adolescents

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

Other medicines and Abiraterone Mylan

Ask your doctor or pharmacist for advice 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 may increase the effects of certain medicines, including those for the heart, tranquilizers, some 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 Mylan. This could lead to unwanted side effects or Abiraterone Mylan may not work as effectively.

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, and sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

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

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 harm an unborn baby if taken during pregnancy.
• Pregnant women or women who could be pregnant must wear gloves if they need to touch or handle Abiraterone Mylan.
• If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.
• 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 Mylan contains lactose and sodium

• This medicine 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 less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Abiraterone Mylan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much to take
The recommended dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) once daily.

Taking 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 medicine than needed, leading to unwanted side effects.
• Take Abiraterone Mylan tablets as a single daily dose on an empty stomach. Abiraterone Mylan should be taken at least two hours after food, and you must not eat for at least one hour after taking Abiraterone Mylan (see section 2, "Abiraterone Mylan with food").
• Swallow the tablets with some water.
• For 500 mg tablets: do not break the tablets.
• For 1000 mg tablets: the tablets may be divided to aid swallowing.
• Abiraterone Mylan 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 Mylan.
• Your doctor may instruct you to adjust the dose of prednisone or prednisolone in certain situations, such as during times of stress. Your doctor will inform you if you need to change your dose. 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 Abiraterone Mylan than you should, contact 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, speak to your doctor as soon as possible.

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 doubts 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 everyone gets them.
If you notice any of the side effects listed below, stop taking Abiraterone Mylan and contact a doctor immediately:

• Muscle weakness, muscle spasms, or a pounding sensation of the 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)
High levels of fats in the blood, chest pain, irregular heartbeats (atrial fibrillation), heart failure, increased heart rate, 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) (prolongation of the QT interval), and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Loss of bone tissue may occur in men being treated for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase bone tissue loss.

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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 label of the bottle after Exp. 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 Mylan contains
The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg or 1000 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).
Tablet coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol (E1521), and talc (E553b). Additionally, the 500 mg tablets contain red iron oxide (E172) and black iron oxide (E172).
See section 2 “Abiraterone Mylan contains lactose and sodium”.

Description of the appearance of Abiraterone Mylan and contents of the pack
Abiraterone Mylan 500 mg film-coated tablets: oval-shaped tablets (19 mm length x 10 mm width), brown in colour, imprinted with “500” on one side, available in blisters containing 56 or 60 tablets, and in perforated unit-dose blister packs containing 56 x 1 or 60 x 1 tablets.
Abiraterone Mylan 1000 mg film-coated tablets: oval-shaped tablets (23 mm length x 11 mm width), white to off-white in colour, with a score line on one side and smooth on the other side, available in bottles containing 28 or 30 tablets, and also available in blisters containing 28 or 30 tablets, and in perforated unit-dose blister packs containing 28 x 1 or 30 x 1 tablets.
The bottle also contains an oxygen-absorbing cartridge. Do not ingest the oxygen-absorbing cartridge, as it may be harmful to health.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Remedica Ltd.,
Aharnon Street,
Limassol Industrial Estate,
3056 Limassol,
Cyprus

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕОД Viatris
Тел: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft
Tel: + 420 222 004 400 Tel: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300
Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tfl: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86300
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel: + 48 22 546 64 00
France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00
Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu