Abiraterone Qilu 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

Abiraterone Qilu 500 mg film-coated tablets EFG

abiraterone acetate

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Package leaflet contents

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

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

Abiraterone Qilu contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men whose cancer has spread to other parts of the body. Abiraterone causes your body to stop producing testosterone; in this way, it can delay the growth of prostate cancer.

When abiraterone is prescribed at the early 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 developing 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 taking Abiraterone Qilu

Do not take Abiraterone Qilu

• 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. 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 apply to you. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• if you have liver problems
• if you have been told that you have high blood pressure, heart failure, or low levels of potassium in the blood (low potassium levels in the blood 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
• about the need to take this medicine with prednisone or prednisolone
• about possible adverse effects on your bones
• if you have high blood sugar levels.

Inform your doctor if you have been told that you have 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, dark 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 the number of red blood cells in the blood, reduced sex drive, and cases of muscle weakness and/or muscle pain may occur.

Abiraterone must 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 should wait 5 days before starting treatment with Ra-223.

If you are not sure whether 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 perform periodic blood tests to monitor for 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 abiraterone, seek immediate medical attention at a hospital and bring the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Qilu

Consult your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because abiraterone may increase the effects of a number of medicines including those used for heart conditions, tranquilizers, certain diabetes medications, 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 abiraterone. This could lead to adverse effects or cause abiraterone to be less effective than it should be.

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)].

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

Abiraterone Qilu with food

• Do not take this medicine with food (see section 3, "How to take this medicine").
• Taking abiraterone with food may cause adverse effects.

Pregnancy and breastfeeding

This medicine is not intended 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 potential, 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

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

Abiraterone Qilu contains lactose and sodium

• This medicinal product contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.
• This medicinal product contains less than 1 mmol of sodium (23 mg) per dose of two tablets; hence, it is essentially "sodium-free".

3. How to take Abiraterone Qilu

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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 Abiraterone Qilu with food may cause the body to absorb more medication than needed, which can lead to side effects.

- Take Abiraterone Qilu tablets as a single daily dose on an empty stomach. Abiraterone Qilu must be taken at least two hours after eating, and you should not eat for at least one hour after taking Abiraterone Qilu (see section 2, "Abiraterone Qilu with food").

• Swallow the tablets whole with water.
• Do not split the tablets.
• This medicine 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 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 this is necessary. Do not stop taking prednisone or prednisolone unless your doctor tells you to do so.

Your doctor may also prescribe other medicines while you are taking this medicine along with prednisone or prednisolone.

If you take more Abiraterone Qiludel 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Abiraterone Qilu

• 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, contact your doctor immediately.

If you interrupt treatment with Abiraterone Qilu

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 will experience them.

Stop taking abiraterone 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
• decrease in blood potassium levels
• elevations in 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
• 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 inflammation (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, swelling of the face, lips, tongue or throat, 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 adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Qilu

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 the blister after EXP. The expiry date refers to the last day of that month.
No special storage conditions apply for this medicine.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, the cardboard box, and the blister pack after EXP. 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 or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

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Composition of Abiraterone Qilu

• The active substance is abiraterone acetate. Each film-coated tablet contains
  500 mg of abiraterone acetate.

• The other components are monohydrate lactose, hypromellose (E464), sodium croscarmellose (E468), sodium lauryl sulfate (E487), microcrystalline cellulose (E460), magnesium stearate (E572), colloidal anhydrous silica (silicon dioxide) (E551). (see section 2. "Abiraterone Qilu contains lactose and sodium"). The film coating contains poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol (E1521), talc (E533b), iron oxide red (E172), iron oxide black (E172).

Appearance of the product and contents of the container

• Abiraterone Qilu tablets are light purple, film-coated, oval tablets (20.1 mm long x 10.1 mm wide), engraved with "125" on one side.
• Each box contains 56 or 56 x1 film-coated tablets in 4 blisters, with 14 film-coated tablets in each blister.
• Each box contains 60 x1 film-coated tablets in 5 blisters, with 12 film-coated tablets in each blister.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Qilu Pharma Spain S.L.

Paseo de la Castellana 40,

8th floor, 28046 - Madrid

Spain

Manufacturer

Kymos, S.L.
Ronda de Can Fatjó
7B (Parque Tecnológico del Vallès)
Cerdanyola del Vallès, 08290 Barcelona
Spain

Or

Netpharmalab Consulting Services
Carretera de Fuencarral 22
Alcobendas, 28108 Madrid
Spain

Or

MIAS Pharma Limited
Suite 2, Stafford House, Strand Road,
Portmarnock, Co. Dublin,
Ireland

Local Representative:
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya, 53-55
08007 – Barcelona
Spain
Tel.: +34 93 342 7890

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

Date of the most recent review of this leaflet: August 2024

Other sources of information

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