ABIRATERONE GLENMARK 500 mg FILM-COATED TABLETS

Introduction

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Abiraterone Glenmark 500 mg film-coated tablets EFG

Abiraterone acetate

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• Keep this leaflet, as 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 Glenmark and what is it used for
2. What you need to know before you start taking Abiraterone Glenmark
3. How to take Abiraterone Glenmark
4. Possible side effects
5. Storage of Abiraterone Glenmark
6. Contents of the pack and further information

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

This medicine 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 medicine makes your body stop producing testosterone; this can delay the growth of prostate cancer.

When this medicine 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 taking this medicine, your doctor will also prescribe another medicine 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 start taking Abiraterone Glenmark

Do not take Abiraterone Glenmark

• 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. This medicine is only to 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 unsure, 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 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 rate
• 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 fatal.

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

This medicine should not be taken 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 if any of the above applies 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 regular blood tests to check for any effect 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, they should go to the hospital immediately and bring this leaflet with them to show the emergency doctor.

Other medicines and Abiraterone Glenmark

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 this medicine 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 this medicine. This can lead to side effects or this medicine 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); or medicines 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 Glenmark with food

• This medicine must not be taken with food (see section 3, “How to take this medicine”).
• Taking Abiraterone Glenmark with food can cause more medicine to be absorbed by the body than necessary and may cause side effects.

Pregnancy and breastfeeding

This medicine 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 medicine.

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

If you have sex with a woman of childbearing age, 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 medicine will affect your ability to drive or use tools or machines.

Abiraterone Glenmark contains lactose and sodium

This medicine contains lactose. 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 (a major 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 Glenmark

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How much to take

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

How to take this medicine

Take this medicine orally.

Do not take this medicine with food. Taking Abiraterone Glenmark with food can cause more medicine to be absorbed by the body than necessary and may cause side effects.

Take the Abiraterone Glenmark tablets as a single dose once a day on an empty stomach. Abiraterone Glenmark should be taken at least 2 hours after eating and no food should be consumed 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 medicine is given together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as your doctor tells you.

You will need to take prednisone or prednisolone every day while taking this medicine.

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 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 Glenmark than you should

If you take more than you should, talk to 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, phone: 91 562 04 20, stating 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 normal 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 Glenmark

Do not stop taking this medicine 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 Glenmark and see 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, fast 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 (called acute hepatic failure)

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

• Heart attack, changes in the electrocardiogram (ECG) (prolonged QT)
• 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 medicine 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 and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side 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 which is stated on the carton and/or the label of the HDPE bottle and/or the blister. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Abiraterone Glenmark 500 mg film-coated tablets

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

Appearance and pack contents

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

Each blister pack contains 56, 56 x 1, 60, 60 x 1, 90, 90 x 1, 112, or 112 x 1 film-coated tablets. The film-coated tablets may be packaged in transparent or opaque (white) blisters. Each pack contains a bottle with 60 film-coated tablets.

Not all pack sizes may be marketed.

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 obtain further information on this medicine from the local representative of the marketing authorisation holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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