ABIRATERONE DR. REDDY'S 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet:Information for the User

Abiraterone Dr. Reddys 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 symptoms are the same as yours.
• If you experience 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 Dr. Reddys and what is it used for
2. What you need to know before you take Abiraterone Dr. Reddys
3. How to take Abiraterone Dr. Reddys
4. Possible side effects

5 Storage of Abiraterone Dr. Reddys

1. Contents of the pack and other information

1. What is Abiraterone Dr. Reddys and what is it used for

Abiraterone Dr. Reddys 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 makes your body stop producing testosterone; this can slow down the growth of prostate cancer.

When Abiraterone Dr. Reddys is prescribed in the early stages of the disease and there is still a response to hormonal treatment, it is used together with a treatment to reduce testosterone (androgen deprivation therapy).

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

2. What you need to know before you take Abiraterone Dr. Reddys

Do not take Abiraterone Dr. Reddys:

• 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 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 the blood (low potassium levels in the 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 rhythm
• 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, liver failure (called acute hepatic failure) can occur, which can be life-threatening.

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

Abiraterone should not be given 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 abiraterone and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

If you are unsure 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 do not have any symptoms. While you are taking this medicine, your doctor will perform regular blood tests to check for any effects on your liver.

Children and adolescents

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

Other medicines and Abiraterone Dr. Reddys

Consult your doctor or pharmacist 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 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. Additionally, 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 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.

Abiraterone Dr. Reddys with food

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

Taking abiraterone with food can cause the body to absorb more medicine than necessary, which can cause side effects.

Pregnancy and breastfeeding

Abiraterone Dr. Reddys is not indicated in women.

Pregnant women or women who may become pregnant should wear gloves if they need to touch or handle Abiraterone Dr. Reddys.

This medicine can be harmful to the fetus 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 contraceptive method.

If you have sex with a pregnant woman, you should 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.

Abiraterone Dr. Reddys contains lactose and sodium

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

This medicine contains 24 mg of sodium (main component of cooking/table salt) in each dose of two 500 mg tablets. This is equivalent to 1% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterone Dr. Reddys

Follow the instructions for administration of this medicine exactly as indicated 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 (two 500 mg tablets) once a day.

How to take this medicine

Take this medicine orally.

Do not take abiraterone with food.

Taking abiraterone with food can cause the body to absorb more medicine than necessary, which 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 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 instructed by your doctor.

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 it is necessary 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 abiraterone and prednisone or prednisolone.

If you take more Abiraterone Dr. Reddys than you should

If you take more 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, indicating the medicine and the amount ingested.

If you forget to take Abiraterone Dr. Reddys

If you forget to take abiraterone or prednisone or prednisolone, take your usual 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 Dr. Reddys

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 Dr. Reddys 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
• 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 heartbeat (atrial fibrillation), heart failure, rapid heartbeat
• Severe infections called sepsis
• Bone fractures
• Indigestion
• Blood in the urine
• 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)

Not known(frequency cannot be estimated from the available data):

• Heart attack, changes in the electrocardiogram (ECG) (QT prolongation)
• 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 Dr. Reddys 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Dr. Reddys

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/or HDPE bottle and/or blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 Abiraterone Dr. Reddys

• The active substance is abiraterone acetate.
• Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate (tablet core); polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, red iron oxide (E 172), black iron oxide (E 172) (tablet coating).

Appearance of the product and pack contents

Abiraterone Dr. Reddys 500 mg are film-coated tablets, purple, oval-shaped, approximately 19 mm long and 11 mm wide, engraved with “A7TN” on one side and “500” on the other side.

Each blister pack contains 14, 56, 56x1, 60, 60x1, or 112 film-coated tablets.

Each HDPE bottle contains a bottle with 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08039 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

545 CM Nijmegen

Netherlands

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

Date of last revision of this leaflet:March 2024

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