Abiraterone Glenmark 250 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Abiraterone Glenmark 250 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, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Abiraterone Glenmark is and what it is used for
2. What you need to know before taking Abiraterone Glenmark
3. How to take Abiraterone Glenmark
4. Possible adverse effects
5. Storage of Abiraterone Glenmark
6. Package contents and additional information

1. What is Abiraterone Glenmark and what is it used for?

This medicine contains abiraterone acetate. It is used to treat prostate cancer in adult men when the disease has spread to other parts of the body. This medicine reduces testosterone production in your body; thus, it can slow down the progression 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 developing high blood pressure, fluid retention (accumulation of excess 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 Glenmark

Do not take Abiraterone Glenmark

• 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 in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low blood potassium levels (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
• 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 disorder, 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 (known as acute liver failure) may occur, which can lead to death.

A decrease in the number of red blood cells, reduced sex drive, 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 treatment with Ra-223.

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 you are taking this medicine, your doctor will carry out regular 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 takes this medicine, go immediately to hospital and take the package leaflet with you to show the emergency doctor.

Other medicines and Abiraterone Glenmark

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 could lead to adverse reactions or make the medicine 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 detoxification from drug addiction), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

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

Abiraterone Glenmark 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 intended for use in women.

Pregnant women or women who suspect they may be pregnant must wear gloves if they need to handle this medicine.

This medicine may be harmful to the unborn baby 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 method of contraception.

If you have sexual intercourse with a pregnant woman, you must 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 machinery.

Abiraterone Glenmark contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per dose of four 250 mg tablets; i.e., essentially “sodium-free”.

3. How to take Abiraterone Glenmark

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

How much to take

The recommended dose is 1,000 mg (four 250 mg tablets) once daily.

How to take this medicine

Take this medicine by mouth.

Do not take this medicine with food. Taking Abiraterone Glenmark with food may cause your body to absorb more medicine than needed, which could lead to adverse effects.

Take Abiraterone Glenmark tablets as a single daily dose on an empty stomach. Abiraterone Glenmark should be taken at least two hours after eating and no food should be consumed for at least one hour after taking Abiraterone Glenmark (see section 2, “Abiraterone Glenmark 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 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 advise you if this is necessary. 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 Glenmark than you should

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

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

If you forget to take Abiraterone Glenmark

• 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 stop taking Abiraterone Glenmark

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 Glenmark and contact your doctor immediately if you experience any of the following symptoms:

• Muscle weakness, muscle cramps, or increased heart rate (palpitations).

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

Other adverse effects include:

Very common (may affect more than 1 in 10 people):

• Fluid retention in the legs or feet
• Decreased blood potassium levels
• Elevated liver function test results
• 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 disturbances in salt and water balance)
• 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)
• Liver function failure (also known as acute liver failure)

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

• Heart attack, changes in electrocardiogram-ECG (QT prolongation)
• 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. This medicine, when used in combination with prednisone or prednisolone, may increase bone density loss.

Reporting of adverse effects

If you experience any adverse effect, consult 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiraterone Glenmark

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

Do not use this medicine after the expiry date stated on the HDPE bottle container and/or label. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abiraterone Glenmark 250 mg tablets

• The active substance is abiraterone acetate.
• Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, povidone, sodium lauryl sulfate, colloidal anhydrous silica and magnesium stearate.

Appearance of the product and contents of the container

Abiraterone Glenmark 250 mg tablets are white or almost white, oval-shaped tablets, approximately 16 mm long and 9.5 mm wide, marked with “ATN” on one side and “250” on the other.

Each pack contains one bottle with 120 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturing Responsible Parties:

Synthon Hispania, S.L.
Calle Castelló 1
08830 Sant Boi de Llobregat, Barcelona
Spain

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Glenmark Pharmaceuticals, s.r.o.
Fibichova 143
56617 Vysoké Mýto
Czech Republic

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: June 2022

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