GRUMABIX 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Grumabix 250 mgfilm-coated tabletsEFG

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

1. What is Grumabix and what is it used for

Grumabix 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. This medicine stops your body from making testosterone; this can slow down the growth of your prostate cancer.

When this medicine 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 therapy).

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, or low potassium levels in your blood.

2. What you need to know before you take Grumabix

Do not take Grumabix

• 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. This medicine is only for use 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 in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicine:

• 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 the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have a fast or irregular heart rate
• 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 or symptoms of liver problems. Rarely, acute liver failure (a sudden severe liver disorder) 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.

This medicine must not be taken in combination with Ra-223 due to a possible increased risk of bone fracture or death.

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

If you are unsure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

This medicine may affect your liver even if you do not have any symptoms. While you are taking this medicine, your doctor will regularly perform blood tests to check for any effect on your liver.

Children and adolescents

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

Other medicines and Grumabix

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 this medicine can increase the effects of a number of medicines, including medicines for the heart, sedatives, some medicines for diabetes, 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 this medicine. This can lead to side effects or this medicine may not work as well as it should.

Androgen deprivation therapy 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.

Grumabix with food

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

Pregnancy and breastfeeding

This medicine is not indicated in women.

• This medicine may harm the fetus if taken by a pregnant woman.
• Pregnant women or women who think they may be pregnant should wear gloves if they need to touch or handle this medicine.
• If you have sex with a woman of childbearing age, you must use a condom and another effective contraceptive method.
• If you have sex with a pregnant woman, you must use a condom to protect the fetus.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use tools or machines.

Grumabix contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains 5.88 mg of sodium (the main component of cooking/table salt) in each tablet. This is equivalent to 0.3% of the maximum daily intake of sodium recommended for an adult.

3. How to take Grumabix

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are in doubt, consult your doctor or pharmacist again.

How much to take

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

How to take this medicine

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

It is also possible that your doctor will prescribe other medicines while you are taking this medicine and prednisone or prednisolone.

If you take more Grumabix than you should

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

If you forget to take Grumabix

• If you forget to take this medicine or prednisone or prednisolone, take your normal dose the next day.
• If you forget to take this medicine or prednisone or prednisolone for more than one day, consult your doctor immediately.

If you stop taking Grumabix

Do not stop taking this medicine 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 this medicine and contact your doctor immediately if you experience any of the following:

• Muscle weakness, muscle contractions, or rapid heartbeat (palpitations). These can 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, elevated 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 heartbeat (atrial fibrillation), heart failure, rapid heartbeat, 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 liver failure).

Not known(frequency 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. This medicine in combination with prednisone or prednisolone may increase this bone density loss.

Reporting of side effects

If you experience 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 Grumabix

• 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.
• The expiry date refers to the last day of the month shown.
• No special storage conditions are required.
• Medicines should 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

Composition of Grumabix

• The active substance is abiraterone acetate.

Each film-coated tablet contains 250 mg of abiraterone acetate.

• The other ingredients are: lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol 4000, talc (see section 2, "Grumabix contains lactose and sodium").

Appearance and packaging

They are white or almost white, oval, biconvex film-coated tablets, 16 mm in length, with 250 engraved on one side.

Grumabix 250 mg film-coated tablets EFG are available in OPA/Aluminum/PVC/Aluminum blisters inserted in a cardboard box. Each box contains 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Adamed Pharma S.A.

Pienków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Poland

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

Date of last revision of this leaflet: December 2022

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/.