Abiraterone Sandoz

Patient Information Leaflet

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

Generic medicine
Please 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Abiraterone Sandoz 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 Sandoz stops the body from producing testosterone; this may slow down the growth of prostate cancer.
When Abiraterone Sandoz is prescribed at the initial stage of the disease, which still responds to hormone therapy, it is used together with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine is used to reduce the possibility of developing high blood pressure, too much fluid in the body (fluid retention), or low levels in the blood of a chemical known as potassium.

2. What you should know before taking Abiraterone Sandoz

Do not take Abiraterone Sandoz

• 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 is intended for use only in male patients.
• if you have severe liver damage.
• in combination with Ra-223 (used to treat prostate cancer). Do not take this medicine if you fall into any of these categories. If you have any doubts, 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 blood potassium levels (hypokalaemia) (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 rapid 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 together with prednisone or prednisolone
• about the 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 disorders, including
heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions.
Inform your doctor if you develop yellowing of the skin or eyes, dark-coloured urine, or severe nausea
or vomiting, as these may be signs or symptoms of liver problems. Rarely, impaired liver function
(known as acute liver failure) may occur, which can be fatal.
Reduction in red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain may occur.
Abiraterone must not be given in combination with Ra-223 due to a possible increased risk of fractures or death.
If you are planning to receive Ra-223 after treatment with abiraterone 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 may affect the liver and may not cause symptoms. While taking this medicine, your doctor will periodically perform blood tests to check for any effects on the liver.
Children and adolescents
This medicine is not indicated for use in children and adolescents. If abiraterone 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 Sandoz
Ask your doctor or pharmacist for advice before taking any medicine.
Inform 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 certain medicines, including those for heart conditions, tranquillisers, 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. This could lead to unwanted side effects or abiraterone may not work as effectively as it should.
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, sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for treatment of opioid dependence), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Inform your doctor if you are taking any of the medicines listed above.
Abiraterone Sandoz with food

• This medicine must not be taken with food (see section 3 “How to take this medicine”).
• Taking Abiraterone Sandoz with food may cause adverse effects.

Pregnancy and breastfeeding
Abiraterone Sandoz is not indicated for use in women.

• This medicine may harm the unborn baby if taken during pregnancy.
• 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, 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 Sandoz contains lactose and sodium

• If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take Abiraterone Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is 1,000 mg (four tablets/two tablets) once daily.
How to take this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Sandoz with food.
• Take Abiraterone Sandoz at least one hour before or at least two hours after eating (see section 2 “Abiraterone Sandoz with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone Sandoz is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as instructed by your doctor.
• You must take prednisone or prednisolone every day while taking Abiraterone Sandoz.
• Your doctor may instruct you to adjust the dose of prednisone or prednisolone in certain emergency situations. Your doctor will inform you if you need to change the dose of prednisone or prednisolone. 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 Sandoz and prednisone or prednisolone.
If you take more Abiraterone Sandoz than you should
If you take more Abiraterone Sandoz than you should, contact your doctor or go to hospital immediately.
If you forget to take Abiraterone Sandoz

• If you forget to take Abiraterone Sandoz or prednisone or prednisolone, take your usual dose the next day.
• If you forget to take Abiraterone Sandoz or prednisone or prednisolone for more than one day, speak to your doctor without delay.

If you stop taking Abiraterone Sandoz
Do not stop taking Abiraterone Sandoz or prednisone or prednisolone unless your doctor tells you to.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the side effects listed below, stop taking Abiraterone Sandoz and contact a doctor immediately:

• muscle weakness, muscle spasms, or a pounding 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 heartbeat (atrial fibrillation), heart failure, rapid heartbeat, 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) – QT interval prolongation, and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or hives.
Loss of bone tissue may occur in men treated for prostate cancer. Abiraterone Sandoz in combination with prednisone or prednisolone may increase bone tissue loss.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abiraterone Sandoz

• 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 on the 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 Sandoz contains

• The active substance is abiraterone acetate. Each tablet contains 250 mg or 500 mg of abiraterone acetate.

The other components are:
Core: croscarmellose sodium, sodium lauryl sulfate, povidone (E1201), microcrystalline cellulose (E460), lactose monohydrate, colloidal anhydrous silica (E551), magnesium stearate (E470b) (see section 2, “Abiraterone Sandoz contains lactose and sodium”).
Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b)
For 500 mg only: red iron oxide (E172), black iron oxide (E172)

Description of the appearance of Abiraterone Sandoz and contents of the pack

• Abiraterone Sandoz tablets are film-coated, white to off-white in colour, with "250" engraved on one side.
• Abiraterone Sandoz tablets are film-coated, oval-shaped, purple in colour, with "500" engraved on one side.

The tablets are supplied in:

250 mg:

• OPA/Alu/PVC//Alu or PVC/PE/PVDC//Aluminium blisters containing 120 film-coated tablets
• OPA/Alu/PVC//Alu or PVC/PE/PVDC//Aluminium blisters with unit dose breakable perforations containing 120x1 film-coated tablets
• High-density polyethylene (HDPE) bottle, with an oxygen-absorbing container, closed with a child-resistant polypropylene (PP) screw cap, containing 120 film-coated tablets

500 mg:

• OPA/Alu/PVC//Alu or PVC/PE/PVDC//Aluminium blisters containing 56, 60, 84, or 112 film-coated tablets
• OPA/Alu/PVC//Alu or PVC/PE/PVDC//Aluminium blisters with unit dose breakable perforations containing 56x1, 60x1, 84x1, or 112x1 film-coated tablets
• High-density polyethylene (HDPE) bottle, with an oxygen-absorbing container, closed with a child-resistant polypropylene (PP) screw cap, containing 60 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.,
L.go U. Boccioni 1,
21040 Origgio (VA),
Italy

Manufacturer
Remedica Ltd,
Aharnon Street, Limassol Industrial Estate,
3056 Limassol,
Cyprus
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia