ABIRATERONE OLPHA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abiraterone Olpha 500 mg film-coated tablets EFG

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.

Contents of the pack

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

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

Abiraterone contains the active substance abiraterone acetate. It is used for the treatment of prostate cancer in adult men that has spread to other parts of the body. Abiraterone works by stopping your body from making testosterone; this can slow down the growth of your prostate cancer.

When abiraterone is prescribed in the early stages of the disease and you are still responding to hormone treatment, it is used together with treatment to lower testosterone levels (androgen deprivation treatment).

When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone to reduce the risk of high blood pressure, fluid retention (water retention) or low potassium levels in your blood.

2. What you need to know before you take Abiraterone Olpha

Do not take Abiraterone Olpha

• 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 you are pregnant. Abiraterone should only be used in male patients.
• if you have severe liver disease.
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Tell your doctor or pharmacist before you start taking abiraterone:

• if you have liver problems
• if you have been told you have high blood pressure or heart failure or low potassium levels in your blood (low potassium levels in your blood can increase your risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have a fast or irregular heart beat
• if you have difficulty breathing
• if you have gained weight quickly
• if you have swelling in your feet, ankles or legs
• if you have taken in the past a medicine known as ketoconazole for prostate cancer
• about the need to take this medicine with prednisone or prednisolone
• about possible side effects on your bones
• if you have high blood sugar levels.

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

Tell your doctor if you have yellowing of the skin or eyes, dark urine, or severe nausea or vomiting, as these can be signs of liver problems. Rarely, liver failure (acute hepatic failure) can occur, which can be life-threatening.

A decrease in red blood cell count, reduced sexual desire and cases of muscle weakness and/or muscle pain may occur.

Abiraterone should not be taken with Ra-223 due to a possible increased risk of bone fracture or death.

If you plan to take Ra-223 after treatment with abiraterone and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment.

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

Blood tests

Abiraterone may affect your liver, even if you have no symptoms. While you are taking this medicine, your doctor will do regular blood tests to check for any effect on your liver.

Children and adolescents

This medicine should not be used in children and adolescents. If a child or adolescent accidentally takes abiraterone, they should go to the hospital immediately and take this leaflet with them to show to the emergency doctor.

Other medicines and Abiraterone Olpha

Consult your doctor or pharmacist before taking any other medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because abiraterone can increase the effects of a number of medicines including heart medicines, sedatives, some diabetes medicines, herbal medicines (e.g. St John's Wort) and others. Your doctor may consider changing the dose of these medicines. Also, some medicines may increase or decrease the effects of abiraterone. This can lead to side effects or 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 being treated with medicines:

• used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol);
• that increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Consult your doctor if you are taking any of the medicines listed above.

Taking Abiraterone Olpha with food

This medicine should not be taken with food (see section 3, “How to take this medicine”).

Taking abiraterone with food can cause side effects.

Pregnancy and breast-feeding

Abiraterone is not indicated in women. This medicine may harm the unborn baby if taken by a pregnant woman.

If you have sex with a woman who can become pregnant, you should use a condom and another effective method of birth control.

If you have sex with a pregnant woman, you should 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 use tools or machines.

Abiraterone Olpha contains lactose and sodium

• Abiraterone Olpha contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

• This medicine contains 23 mg of sodium (a major component of cooking/table salt) in each dose of two Abiraterone Olpha 500 mg tablets. This is equivalent to 1.2% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterone Olpha

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How much to take

The recommended dose is 1,000 mg (two Abiraterone Olpha 500 mg tablets) once a day.

How to take this medicine

• Take this medicine by mouth.
• Do not take abiraterone with food.Taking abiraterone with food can make your body absorb more medicine than necessary and this can cause side effects.
• Take the abiraterone tablets as a single dose once a day on an empty stomach. Abiraterone should be taken at least 2 hours after eating and no food should be consumed for at least 1 hour after taking abiraterone (see section 2, “Abiraterone Olpha with food”).
• Swallow the tablets whole with water.
• Do not break the tablets.
• Abiraterone is given together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor has told you.
• You will need to take prednisone or prednisolone every day while you are taking abiraterone.
• If you have a medical emergency, it may be necessary to adjust the amount of prednisone or prednisolone you take. 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 Olpha than you should

If you take more abiraterone than you should, consult your doctor or go to the hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Abiraterone Olpha

If you forget to take abiraterone or prednisone or prednisolone, take your normal dose the next day.

If you forget to take abiraterone or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you stop taking Abiraterone Olpha

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 product, 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 Olpha and see your doctor immediately if you notice any of the following:

• Muscle weakness, muscle contractions or fast heart beat (palpitations).

These may be signs of low potassium levels in your blood.

Other side effects are:

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 tests, high blood pressure, urinary tract infection, diarrhea.

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

High levels of fats in the blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, fast heart beat, severe infections 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 problems with salt and water), 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).

Liver failure (also called acute hepatic failure).

Frequency not known(cannot be estimated from the available data):

Heart attack, changes in the electrocardiogram (ECG) (prolonged QT), and severe allergic reactions with difficulty swallowing or breathing, face, lips, tongue or throat swelling, or itchy rash.

Bone density loss may occur in men receiving treatment for prostate cancer. Abiraterone in combination with prednisone or prednisolone may increase this bone density 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 Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Olpha

• 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 blister after EXP. The expiry date is the last day of the month stated.

• This medicine does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Abiraterone Olpha contains

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg abiraterone acetate.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose (type 2910), anhydrous colloidal silica and sodium lauryl sulfate (see section 2, “Abiraterone Olpha contains lactose and sodium”).

The coating contains black iron oxide (E172), red iron oxide (E172), macrogol poly (vinyl alcohol) graft copolymer, talc and titanium dioxide (E171).

Appearance and packaging

• Abiraterone Olpha 500 mg film-coated tablets are violet, oval, biconvex, film-coated tablets engraved with “500” on one side and plain on the other.
• The tablets are packaged in blisters in cardboard boxes containing 56 or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Manufacturer

Haupt Pharma Münster GmbH,

Schleebrüggenkamp 15,

48159, Münster,

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: June 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/