Abiraterone Mylan - patient leaflet, side effects, dosage

Patient leaflet - Abiraterone Mylan

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Abiraterone Mylan 500 mg film-coated tablets

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.

What is in this leaflet

1. What Abiraterone Mylan is and what it is used for
2. What you need to know before you take 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 that has spread to other parts of the body. Abiraterone Mylan stops your body from making testosterone; this can slow the growth of prostate cancer.

When Abiraterone Mylan is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy).

When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as 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 pregnant. Abiraterone Mylan is for use in male patients only.
– if you have severe liver damage.
– in combination with Ra-223 (which is used to treat prostate cancer).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to 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 told you have high blood pressure or heart failure or low blood potassium (low blood potassium may increase the risk of heart rhythm problems).
– if you have had other heart or blood vessel problems.
– if you have an irregular or rapid heart rate.
– if you have shortness of breath.
– if you have gained weight rapidly.
– if you have swelling in the feet, ankles, or legs.
– if you have taken a medicine known as ketoconazole in the past for prostate cancer.
– about the need to take this medicine with prednisone or prednisolone.
– about possible effects on your bones.
– if you have high blood sugar.

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

Tell your doctor if you have yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death.

Decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.

Abiraterone Mylan must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.

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

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

Blood monitoring

Abiraterone Mylan may affect your liver, and you may not have any symptoms. When you are taking this medicine, your doctor will check your blood periodically to look for any effects on your liver.

Children and adolescents

This medicine is not for use in children and adolescents. If Abiraterone Mylan is accidentally ingested by a child or adolescent, go to the hospital immediately and take the package leaflet with you to show to 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 a number of medicines including heart medicines, tranquilisers, some medicines for diabetes, herbal medicines (e.g., St John’s wort) and others. Your doctor may want to change the dose of these medicines. Also, some medicines may increase or decrease the effects of Abiraterone Mylan. This may lead to side effects or to 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 receiving medicine:

– used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol).
– known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and

part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

Tell 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 side effects.

Pregnancy and breast-feeding

Abiraterone Mylan is not for use in women.

- This medicine may cause harm to the unborn child if it is taken by women who are pregnant.
- Women who are pregnant or who may be pregnant should wear gloves if they need to touch or handle Abiraterone Mylan.
- If you are having sex with a woman who can become pregnant, use a condom and another effective birth control method.
- If you are having sex with a pregnant woman, use a condom to protect the unborn child.

Driving and using machines

This medicine is not likely to affect your being able to drive and use any tools or machines.

Abiraterone Mylan contains lactose and sodium

– This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
– This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Abiraterone Mylan

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

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

Taking this medicine

– Take this medicine by mouth.
- Do not take Abiraterone Mylan with food. Taking Abiraterone Mylan with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
- Take Abiraterone Mylan tablets as a single dose once daily on an empty stomach. Abiraterone Mylan must be taken at least two hours after eating and food must not be eaten for at least one hour after taking Abiraterone Mylan. (see section 2, “Abiraterone Mylan with food”).
– Swallow the tablets with water.
- For 500 mg: Do not break the tablets.
- For 1000 mg: Tablets can be divided to make it easier to swallow.
– Abiraterone Mylan is taken with a medicine called prednisone or prednisolone. Take the prednisone or prednisolone exactly as your doctor has told you.
– You need to take prednisone or prednisolone every day while you are taking Abiraterone Mylan.
– The amount of prednisone or prednisolone you take may need to change if you have a medical emergency. 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 a 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 following day.
– If you forget to take Abiraterone Mylan or prednisone or prednisolone for more than one day, talk to your doctor without delay.

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 notice any of the following: – Muscle weakness, muscle twitches or a pounding heart beat (palpitations). These may be signs that the level of potassium in your blood is low.

Other side effects include:

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

Fluid in your legs or feet, low blood potassium, liver function test increases, high blood pressure, urinary tract infection, diarrhoea.

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

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

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

Adrenal gland problems (related to salt and water problems), 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).

Failure of the liver to function (also called acute liver failure).

Not known (frequency cannot be estimated from the available data):

Heart attack, changes in ECG – electrocardiogram (QT prolongation), and serious allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue or throat, or an itchy rash.

Bone loss may occur in men treated for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase bone 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. 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 which is stated on the carton, blister and bottle after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Abiraterone Mylan contains

The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg or 1000 mg abiraterone acetate.

The other ingredients are:

Tablet core : croscarmellose sodium (E468), sodium laurilsulfate, povidone, microcrystalline cellulose (E460), lactose monohydrate, silica colloidal anhydrous (E551) and magnesium stearate (E470b).

Film-coat : 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’.

What Abiraterone Mylan looks like 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” debossed on one side and available in blister packs containing 56, 60 tablets and in perforated unit dose blister packs containing, 56 × 1, 60 × 1 tablets.

Abiraterone Mylan 1000 mg film-coated tablets are white to off-white, oval-shaped (23 mm long x 11 mm wide), with a break line 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, 30 tablets and in perforated unit dose blister packs containing, 28 × 1, 30 × 1 tablets. The bottle also contains an oxygen absorbing canister. Do not swallow the oxygen absorbing canister as this may be harmful to your health.

Not all pack sizes may be marketed.

Marketing Authorisation 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgique/Belgien

Mylan bvba/sprl

Tél/Tel: + 32 (0)2 658 61 00

BtnrapuH

Maü.iaH EOOfl

Ten: +359 2 44 55 400

Česká republika

Mylan Healthcare CZ.s.r.o.

Tel: + 420 222 004 400

Danmark

Viatris ApS

Tlf: +45 28 11 69 32

Deutschland

Mylan Healthcare GmbH

Tel: +49 800 0700 800

Eesti

BGP Products Switzerland GmbH Eesti filiaal

Tel: + 372 6363 052

EZZáóa

Generics Pharma Hellas EnE

Tn^: +30 210 993 6410

España

Mylan Pharmaceuticals, S.L

Tel: + 34 900 102 712

France

Mylan S.A.S

Tel: +33 4 37 25 75 00

Hrvatska

Mylan Hrvatska d.o.o.

Tel: +385 1 23 50 599

Ireland

Mylan Ireland Limited

Tel: +353 1 8711600

Ísland

Icepharma hf

Sími: +354 540 8000

Italia

Mylan Italia S.r.l.

Tel: + 39 02 612 46921

Lietuva

Mylan Healthcare UAB

Tel: +370 5 205 1288

Luxembourg/Luxemburg

Mylan bvba/sprl

Tel: + 32 (0)2 658 61 00

(Belgique/Belgien)

Magyarország

Mylan EPD Kft

Tel: + 36 1 465 2100

Malta

V.J. Salomone Pharma Ltd

Tel: + 356 21 22 01 74

Nederland

Mylan BV

Tel: +31 (0)20 426 3300

Norge

Viatris AS

Tel: + 47 66 75 33 00

Österreich

Arcana Arzneimittel GmbH

Tel: +43 1 416 2418

Polska

Mylan Healthcare Sp. z. o.o.

Tel: + 48 22 546 64 00

Portugal

Mylan, Lda.

Tel: + 351 21 412 72 56

Romania

BGP Products SRL

Tel: +40 372 579 000

Slovenija

Mylan Healthcare d.o.o.

Tel: + 386 1 23 63 180

Slovenská republika

Mylan s.r.o.

Tel: +421 2 32 199 100

Suomi/Finland

Viatris OyPuh/Tel: +358 20 720 9555

Kùnpoç

Varnavas Hadjipanayis Ltd

TnÀ: +357 2220 7700

Sverige

Mylan AB

Tel: + 46 855 522 750

Latvija

Mylan Healthcare SIA

Tel: +371 676 055 80

United Kingdom (Northern Ireland)

Mylan IRE Healthcare Limited

Tel: +353 18711600

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1)

Hazard ratio < 1 favours abiraterone acetate