Patient leaflet - Abiraterone 250 mg film-coated tablets

1. What Abiraterone is and what it is used for

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

When Abiraterone 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

Do not take Abiraterone

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 is for
use in male patients only.
if you have severe liver damage.
in combination with radium (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 must not be given in combination with radium (Ra-223) due to a possible increase in the risk of bone fracture or death.

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

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

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

Pregnancy and breast-feeding

Abiraterone 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 acetate. - 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 contains lactose and sodium

Abiraterone contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
For 250 mg:
This medicine contains 26.16 mg sodium (main component of cooking/table salt) in a four tablet daily dose. This is equivalent to 1.3% of the recommended maximum daily dietary intake of sodium for an adult.
For 500 mg:
This medicine contains 26.18 mg sodium (main component of cooking/table salt) in a two tablet daily dose. This is equivalent to 1.31% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to take Abiraterone

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

For 250 mg:

The recommended dose is 1,000 mg (four tablets) once a day. For 500 mg:

The recommended dose is 1,000 mg (two tablets) once a day.

Taking this medicine

Take this medicine by mouth.
Do not take Abiraterone with food. Taking Abiraterone 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 tablets as a single dose once daily on an empty stomach. Abiraterone must be taken at least two hours after eating and food must not be eaten for at least one hour after taking Abiraterone (see section 2, “Abiraterone with food”). - Swallow the tablets whole with water.
Do not break the tablets.
Abiraterone 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.

Package leaflet: Information for the user

Abiraterone 250 mg film-coated tablets Abiraterone 500 mg film-coated tablets

abiraterone acetate

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 and prednisone or prednisolone.

If you take more Abiraterone 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

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

If you stop taking Abiraterone

Do not stop taking Abiraterone 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 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 Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/ 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

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, bottle or blister 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 contains

For 250 mg:

The active substance is abiraterone acetate. Each film-coated tablet contains 250 mg abiraterone acetate.

The other ingredients are Lactose monohydrate, Croscarmellose sodium, Hydroxy propylmethyl cellulose, Sodium Lauryl Sulphate, Silicified Microcrystalline Cellulose, Colloidal Silicon Dioxide, Magnesium Stearate, (see section 2, “Abiraterone contains lactose and sodium”).

Film coating contains:

Opadry white: Poly vinyl alcohol – Part. Hydrolyzed, Titanium dioxide, Macrogol/PEG, Talc

For 500 mg:

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

Film coating contains:

Opadry Purple: Poly vinyl alcohol – Part. Hydrolyzed, Titanium dioxide, Macrogol/PEG, Talc, Iron Oxide Red, Ferrosoferric oxide/ Black Iron oxide.

What Abiraterone looks like and contents of the pack

For 250 mg:
Abiraterone 250 mg film-coated tablets are White, oval shaped, film-coated tablets debossed with “A250” on one side and plain on other side.
Abiraterone 250 mg film-coated tablets are available in HDPE bottle pack (with & without desiccant).
For 500 mg:
Abiraterone film-coated tablets are Purple, oval shaped, film-coated tablets debossed with “A500” on one side and plain on other side.
Abiraterone 500 mg Film-coated tablets are available in blister pack.

Pack sizes:

For 250 mg:

HDPE pack (with & without desiccant): 120 film-coated tablets

For 500 mg:

Blister pack: 56, 60 & 120 film-coated tablets.

Perforated unit dose: 56×1, 60×1 & 120×1 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eugia (UK) Limited

1 Roundwood Avenue,

Stockley Park,

Uxbridge,

UB11 1AF

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Milpharm Limited

1 Roundwood Avenue

Stockley Park, Uxbridge