Abiraterone sandoz

Package leaflet: Information for the user

Abiraterone Sandoz, 250 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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the 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 is a medicine containing abiraterone acetate. It is used in adult men for the treatment of metastatic prostate cancer (cancer of the prostate gland that has spread to other parts of the body). Abiraterone Sandoz inhibits the production of testosterone in the body; this may slow down the progression of prostate cancer.
When Abiraterone Sandoz is used at an early stage of hormone-sensitive disease, it is given together with androgen-deprivation therapy (treatment that lowers testosterone levels).
While taking this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention (fluid build-up), or low potassium levels in the blood.

2. Important information before using Abiraterone Sandoz

When not to use Abiraterone Sandoz

• if the patient is allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6);
• in women, especially during pregnancy. Abiraterone is intended for use in men only;
• if the patient has severe liver impairment;
• in combination with Ra-223 (used in the treatment of prostate cancer).

Do not take this medicine if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using this medicine.

Warnings and precautions

Before starting to take this medicine, discuss with your doctor or pharmacist if:

• the patient has liver problems;
• the patient has high blood pressure, heart failure, or low blood potassium levels (low blood potassium levels may increase the risk of heart rhythm disturbances);
• the patient has other heart or blood vessel diseases;
• the patient has irregular or rapid heartbeat;
• the patient experiences shortness of breath;
• the patient has experienced rapid weight gain;
• the patient has swelling of the feet, ankles, or legs;
• the patient previously used ketoconazole for the treatment of prostate cancer;
• the necessity of taking this medicine with prednisone or prednisolone;
• the possibility of bone-related adverse effects;
• the patient has high blood sugar levels.

Tell the doctor if the patient has any heart or blood vessel disorders, including heart rhythm problems (arrhythmia), or is taking medicines for these conditions.

Tell the doctor if the patient develops yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver problems. Rarely, liver dysfunction (referred to as acute liver failure) may occur, which can lead to death.

There may be a decrease in red blood cell count, reduced sex drive (libido), muscle weakness and/or muscle pain.

Abiraterone Sandoz must not be used in combination with Ra-223 due to a possible increased risk of bone fractures or death.

If the patient plans to receive Ra-223 after treatment with Abiraterone Sandoz and prednisone/prednisolone, a 5-day interval should be observed before starting Ra-223 therapy.

If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before using this medicine.

Blood tests

Abiraterone may affect liver function, and the patient may not experience any symptoms.

During treatment, the doctor will periodically order blood tests to monitor the medicine's effect on the liver.

Children and adolescents

This medicine is not intended for use in children and adolescents. If abiraterone is accidentally ingested by a child or adolescent, seek immediate medical attention at a hospital, bringing along the patient leaflet to show the emergency room doctor.

Abiraterone Sandoz and other medicines

Before taking any medicine, consult a doctor or pharmacist.

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is important because abiraterone may enhance the effects of many medicines, including heart medications, sedatives, certain antidiabetic drugs, herbal remedies (e.g. St. John's wort), and others. The doctor may adjust the doses of these medicines. Other medicines may also increase or decrease the effect of abiraterone, potentially leading to adverse effects or reduced efficacy of abiraterone.

Androgen suppression may increase the risk of heart rhythm disturbances. Inform the doctor if the patient is taking any of the following medicines:

• used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• that may increase the risk of heart rhythm disturbances [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe psychiatric disorders)].

Inform the doctor if the patient is taking any of the above-mentioned medicines.

Taking Abiraterone Sandoz with food

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

Pregnancy and breastfeeding

Abiraterone Sandoz is not intended for use in women.

• This medicine may harm the unborn child if taken by a pregnant woman.
• If the patient has sexual intercourse with a woman who could become pregnant, a condom or other effective method of contraception must be used.
• If the patient has sexual intercourse with a pregnant woman, a condom must be used to protect the unborn child.

Driving and operating machinery

It is unlikely that this medicine affects the ability to drive, use tools, or operate machinery.

Abiraterone Sandoz contains lactose and sodium

• If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Abiraterone Sandoz

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
How much medicine to take
The recommended dose is 1000 mg (four 250 mg tablets) taken once daily.
Taking Abiraterone Sandoz

• Take orally.

• Abiraterone Sandoz must not be taken with food.

• Abiraterone Sandoz should be taken at least one hour before or at least two hours after eating (see section 2, "Taking Abiraterone Sandoz with food").

• Swallow the tablets whole with water.

• Do not crush the tablets.

• Abiraterone Sandoz is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.

• Take prednisone or prednisolone every day during treatment with Abiraterone Sandoz.

• The dose of prednisone or prednisolone may need to be adjusted in certain situations. Your doctor will inform you if a change in the dose of prednisone or prednisolone is necessary. Do not stop taking prednisone
  or prednisolone without consulting your doctor.
  Your doctor may also prescribe other medicines for you while you are taking Abiraterone
  Sandoz and prednisone or prednisolone.
  Taking more Abiraterone Sandoz than prescribed
  If you take more medicine than you should, contact your doctor immediately or go to a hospital.
  Missing a dose of Abiraterone Sandoz

• If you forget to take Abiraterone Sandoz, prednisone or prednisolone, take your usual dose the next day.

• If you forget to take Abiraterone Sandoz, prednisone or prednisolone for more than one day, contact your doctor immediately.

Stopping Abiraterone Sandoz treatment
Do not stop taking Abiraterone Sandoz or prednisone or prednisolone without consulting your doctor.
If you have any further questions about how to use this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Abiraterone Sandoz and contact your doctor immediately if you experience any of the following symptoms:

• Muscle weakness, muscle twitching (tremors), or rapid heartbeat (palpitations). These may be signs of low blood potassium levels.

Other side effects include:
Very common (may occur in more than 1 in 10 patients):
Swelling of the legs or feet, low blood potassium levels, increased liver function test results, high blood pressure, urinary tract infections, diarrhoea.
Common (may occur in less than 1 in 10 patients):
High blood lipid (fat) levels, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, fast heartbeat, severe infection – sepsis, bone fractures, indigestion, blood in urine, rash.
Uncommon (may occur in less than 1 in 100 patients):
Adrenal gland disorders (related to disturbances in water and electrolyte balance), irregular heartbeat (arrhythmia), muscle weakness and/or muscle pain.
Rare (may occur in less than 1 in 1000 patients):
Lung inflammation (also known as allergic alveolitis). Acute liver failure.
Frequency not known (cannot be estimated from available data):
Heart attack, changes in ECG (QT interval prolongation), and severe allergic reactions causing difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Loss of bone mass may occur in men treated for prostate cancer. Abiraterone Sandoz in combination with prednisone or prednisolone may worsen this effect.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the responsible entity.
Reporting side effects helps 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 cardboard pack and on the bottle label after EXP. The expiry date refers to the last day of the stated month.
• There are no special storage instructions for this medicine.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Abiraterone Sandoz contains

• The active substance is abiraterone acetate. Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients are: sodium croscarmellose, sodium lauryl sulfate, povidone K30, microcrystalline cellulose type 102, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (see section 2 “Abiraterone Sandoz contains lactose and sodium”). Coating Opadry II 85F200051 Purple: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Abiraterone Sandoz looks like and contents of the pack
Abiraterone Sandoz, 250 mg, film-coated tablets
White to almost white, oval film-coated tablets with an imprint “250” on one side.
The tablets are packed in:

• Aluminium/OPA/Aluminium/PVC or Aluminium/PVC/PE/PVDC foil blisters containing 120 film-coated tablets in a cardboard box.
• Perforated single-dose blisters made of Aluminium/OPA/Aluminium/PVC or Aluminium/PVC/PE/PVDC foil containing 120x1 film-coated tablets in a cardboard box.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
This product is authorised in the European Economic Area (EEA) member countries under the following names:
Bulgaria Abirateron 250 mg film-coated tablets
Cyprus Abiraterone PharOS 250 mg film-coated tablets
Czech Republic Abiraterone Sandoz
Germany Abirateron HEXAL 250 mg Filmtabletten
Denmark Abirateron Sandoz
Estonia Abiraterone Sandoz
Greece Abiraterone/Sandoz 250 mg film-coated tablets
Croatia Abirateron Sandoz 250 mg film-coated tablets
Ireland Abiraterone 250 mg film-coated tablets
Italy Abiraterone Sandoz
Netherlands Abirateron Sandoz 250 mg, filmomhulde tabletten
Norway Abirateron Sandoz
Poland Abiraterone Sandoz
Portugal Abiraterona Sandoz
Sweden Abirateron Sandoz
Slovakia Abiraterón Sandoz 250 mg film-coated tablets
For more detailed information about this medicine, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
(logo of the marketing authorisation holder)