Patient leaflet - Abiraterone Accord 250 mg tablets

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

Abiraterone Accord 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 Accord stops your body from making testosterone; this can slow the growth of prostate cancer.

When Abiraterone Accord 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 Accord

Do not take Abiraterone Accord

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 Accord 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 Accord 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 Accord 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

This medicine 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 Accord 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 Accord 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 Accord 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 Accord. This may lead to side effects or to Abiraterone Accord 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 Accord with food

This medicine must not be taken with food (see section 3, “Taking this medicine”).
Taking Abiraterone Accord with food may cause side effects.

Pregnancy and breast-feeding

Abiraterone Accord 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 this medicine.
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 Accord 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 also contains less than 1 mmol sodium (23 mg) in a four tablet, that is to say essentially ‘sodium-free’.

3. How to take Abiraterone Accord

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 (four tablets) once a day.

Taking this medicine

Take this medicine by mouth.
Do not take Abiraterone Accord with food.
Take Abiraterone Accord at least one hour before or at least two hours after eating (see section 2, “Abiraterone Accord with food”).
Swallow the tablets whole with water.
Do not break the tablets.
Abiraterone Accord 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 Accord.
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 Accord and prednisone or prednisolone.

If you take more Abiraterone Accord 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 Accord

If you forget to take Abiraterone Accord or prednisone or prednisolone, take your usual dose the following day.
If you forget to take Abiraterone Accord or prednisone or prednisolone for more than one day, talk to your doctor without delay. If you stop taking Abiraterone Accord

Do not stop taking Abiraterone Accord 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 Accord 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 Accord 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Abiraterone Accord

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 and the bottle label. 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 Accord contains

The active substance is abiraterone acetate. Each tablet contains 250 mg abiraterone acetate.
The other ingredients are lactose monohydrate, cellulose, microcrystalline (E460),
croscarmellose sodium (E468), povidone (E1201), sodium laurilsulfate, silica, colloidal anhydrous and magnesium stearate (E572) (see section 2, “Abiraterone Accord contains lactose and sodium”).

What Abiraterone Accord looks like and contents of the pack

Abiraterone Accord tablets are white to off-white oval tablet, approximately 16 mm long by 9.5 mm wide, debossed with “ATN” on one side and “250” on the other side.
The tablets are provided in a HDPE bottle with a child-resistant polypropylene closure. Each bottle contains 120 tablets. Each carton contains one bottle.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

Manufacturers

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Synthon B.V.

Microweg 22

6545 CM Nijmegen

The Netherlands

LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona, Spain

Accord Healthcare Polska Sp. z.o.o. ul.Lutomierska 50,

95-200, Pabianice,

Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta