ABIRATERONE GLENMARK 250 mg TABLETS

Introduction

Package Leaflet: Information for the User

Abiraterone Glenmark 250 mg 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 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 Abiraterone Glenmark and what is it used for
2. What you need to know before you take Abiraterone Glenmark
3. How to take Abiraterone Glenmark
4. Possible side effects
5. Storage of Abiraterone Glenmark
6. Contents of the pack and other information

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

This medicinal product contains abiraterone acetate. It is used for the treatment of prostate cancer in adult men that has spread to other parts of the body. This medicinal product stops your body from making testosterone; this can slow down the growth of your prostate cancer.

When this medicinal product 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 medicinal product, your doctor will also prescribe another medicinal product 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 Abiraterone Glenmark

Do not take Abiraterone Glenmark

• if you are allergic to abiraterone acetate or any of the other ingredients of this medicinal product (listed in section 6).
• if you are a woman, especially if you are pregnant. This medicinal product 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 medicinal product if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicinal product.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicinal product:

• if you have liver problems
• if you have been told that 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 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 medicinal product known as ketoconazole for prostate cancer
• about the need to take this medicinal product 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 that you have any heart or blood vessel disorder, including heart rhythm problems (arrhythmia), or if you are being treated with medicinal products 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 medicinal product must not be taken in combination with Ra-223 due to a possible increased risk of bone fractures or death.

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

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicinal product.

A

This medicinal product may affect your liver even if you have no symptoms. While you are taking this medicinal product, your doctor will regularly perform blood tests to check for any effect on your liver.

Children and adolescents

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

Other medicinal products and Abiraterone Glenmark

Consult your doctor or pharmacist before taking any other medicinal product.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicinal products. This is important because this medicinal product can increase the effects of a number of medicinal products, including heart medicinal products, sedatives, some diabetes medicinal products, herbal medicinal products (e.g., St. John's Wort), and others. Your doctor may consider changing the dose of these medicinal products. Additionally, some medicinal products may increase or decrease the effects of this medicinal product. This may lead to side effects or this medicinal product 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 medicinal products

• 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 above-mentioned medicinal products.

Abiraterone Glenmark with food

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

Pregnancy and breastfeeding

This medicinal product is not indicated in women.

Pregnant women or women who think they may be pregnant should wear gloves if they need to touch or handle this medicinal product.

This medicinal product may harm the fetus if taken by a pregnant woman.

If you have sex with a woman who can become pregnant, 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 medicinal product will affect your ability to drive or use tools or machines.

Abiraterone Glenmark contains lactose and sodium

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

This medicinal product contains less than 23 mg of sodium (1 mmol) per dose of four 250 mg tablets; this is essentially “sodium-free”.

3. How to take Abiraterone Glenmark

Always take this medicinal product exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How much to take

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

How to take this medicinal product

Take this medicinal product by mouth.

Do not take this medicinal product with food. Taking Abiraterone Glenmark with food may cause your body to absorb more medicinal product than necessary, which can cause side effects.

Take the Abiraterone Glenmark tablets as a single dose once a day on an empty stomach. Abiraterone Glenmark must be taken at least 2 hours after eating and you must not eat for at least 1 hour after taking Abiraterone Glenmark (see section 2, “Abiraterone Glenmark with food”).

Swallow the tablets whole with water. Do not break the tablets.

This medicinal product is given together with a medicinal product called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor has told you.

You will need to take prednisone or prednisolone every day while you are taking this medicinal product.

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.

Your doctor may also prescribe other medicinal products while you are taking this medicinal product 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 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 medicinal product and the amount ingested.

If you forget to take Abiraterone Glenmark

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

If you stop taking Abiraterone Glenmark

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

4. Possible side effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.

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

• Muscle weakness, muscle contractions, or rapid heartbeat (palpitations).

These may 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)

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

• Heart attack, changes in the electrocardiogram (ECG) (prolonged QT interval)
• 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 medicinal product 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 Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Abiraterone Glenmark

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton and/or label of the HDPE bottle. The expiry date refers to the last day of the month shown.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicinal products to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to 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 and packaging

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

Each pack contains a bottle of 120 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Synthon Hispania, S.L.

Calle Castelló 1

08830 Sant Boi de Llobregat, Barcelona

Spain

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Glenmark Pharmaceuticals, s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

You can ask for more information about this medicinal product from the local representative of the marketing authorisation holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Date of last revision of this leaflet:June 2022

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