Abiraterone Cipla 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Abiraterone Cipla 500 mg film-coated tablets EFG

Abiraterone acetate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains abiraterone acetate. It is used to treat prostate cancer in adult men when the cancer has spread to other parts of the body. This medicine causes your body to stop producing testosterone, thereby helping to slow the growth of prostate cancer.

When this medicine is prescribed at earlier stages of the disease and there is still response to hormonal treatment, it is used in combination 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 high blood pressure, fluid retention (build-up of fluid in the body), or low levels of a chemical substance called potassium in your blood.

2. What you need to know before starting Abiraterone Cipla

Do not take Abiraterone Cipla

• 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 you are pregnant. This medicine 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 apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low blood potassium levels (low blood potassium may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have a fast or irregular heartbeat
• if you have difficulty breathing
• if you have gained weight rapidly
• if you have swelling in your feet, ankles, or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• regarding the need to take this medicine with prednisone or prednisolone
• regarding possible adverse effects on your 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 (arrhythmia), or if you are being treated with medicines for these conditions.

Inform your doctor if you develop yellowing of the skin or eyes, darkened urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, liver function failure (called acute liver failure) may occur, which can lead to death.

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

This medicine must not be administered 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 Ra-223 treatment.

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

Blood tests

This medicine may affect your liver even if you have no symptoms. While taking this medicine, your doctor will perform periodic blood tests to monitor any effects on your liver.

Children and adolescents

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

Other medicines and Abiraterone Cipla

Talk to your doctor or pharmacist before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because this medicine may increase the effects of a number of medicines, including medicines for the heart, tranquilizers, some medicines for diabetes, herbal medicines (e.g., St. John’s wort), and others. Your doctor may consider adjusting the dose of these medicines. In addition, some medicines may increase or decrease the effects of this medicine. This may lead to adverse effects or cause this medicine to be less effective.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking 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 serious mental illnesses)].

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

Abiraterone Cipla 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 adverse effects.

Pregnancy and breastfeeding

This medicine is not indicated for use in women.

• This medicine may be harmful to the fetus if taken by a pregnant woman.
• If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.
• If you have sexual intercourse 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 operate tools or machinery.

Abiraterone Cipla contains lactose and sodium

• This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
• This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially “sodium-free.”

3. How to take Abiraterone Cipla

Follow exactly your doctor's instructions for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is 1,000 mg (two tablets) once daily.

How to take this medicine

• Take this medicine by mouth.
• Do not take this medicine with food. Taking this medicine with food may cause your body to absorb more medicine than needed, which could lead to side effects.
• Take this medicine as a single daily dose on an empty stomach. This medicine should be taken at least two hours after eating, and you should not eat for at least one hour after taking this medicine (see section 2, “Abiraterone Cipla with food”).
• Swallow the tablets whole with water.
• Do not split the tablets.
• This medicine is administered together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• You will need to take prednisone or prednisolone every day while you are taking this medicine.
• If you have a medical emergency, the dose of prednisone or prednisolone you are taking may need to be adjusted. Your doctor will tell 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 this medicine and prednisone or prednisolone.

If you take more Abiraterone Cipla 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Abiraterone Cipla

• If you forget to take this medicine or prednisone or prednisolone, take your usual 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 Abiraterone Cipla

Do not stop taking this medicine or prednisone or prednisolone unless your doctor tells you to. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Abiraterone Cipla and contact your doctor immediately if you experience any of the following effects:

• Muscle weakness, muscle cramps, or increased heart rate (palpitations). These may be signs of low potassium levels in your blood.

Other adverse effects are:

Very common (may affect more than 1 in 10 people):
Fluid retention in the legs or feet, decreased blood potassium levels, elevated liver function tests, 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, tachycardia, serious infections called sepsis, bone fractures, indigestion, blood in the urine, skin rash.

Uncommon (may affect up to 1 in 100 people):
Adrenal gland problems (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).
Failure of liver function (also called acute liver failure).

Not known (frequency cannot be estimated from available data):
Heart attack, changes in electrocardiogram (ECG) (QT prolongation), and severe allergic reactions with difficulty swallowing or breathing, swollen face, lips, tongue or throat, or itchy rash.

Loss of bone density may occur in men receiving treatment for prostate cancer. This medicine, when used in combination with prednisone or prednisolone, may increase this loss of bone density.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Cipla

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Cipla 500 mg film-coated tablets

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, sodium lauryl sulfate (see section 2, “Abiraterone Cipla contains lactose and sodium”). The film coating contains ferric ferrous oxide NF/iron oxide black, iron oxide red (E172), macrogol/PEG, partially hydrolysed polyvinyl alcohol, talc, titanium dioxide (E171).

Nature of the product and pack contents

• The tablets are purple, oval-shaped, bevelled biconvex edge, film-coated, marked with “A” on one side and “500” on the other. Dimensions: 7.00 mm - 8.00 mm thickness; 20.1 ± 0.2 mm length; 10.1 ± 0.2 mm width.
• The tablets may be packed in transparent PVC/PE/PVdC blisters with a plain aluminium foil laminate coated with lacquer, heat-sealed, or in perforated unit dose blisters containing 56 and 60 film-coated tablets.
• Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp, Belgium

Local Representative

Cipla Europe NV, Spanish branch

C/Guzmán el Bueno, 133 Edif Britannia - 28003 - Madrid, Spain

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

Date of the most recent review of this leaflet: February 2026

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