Abiraterone Glenmark 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Abiraterone Glenmark 500 mg film-coated tablets EFG

Abiraterone acetate

Read the entire package 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, 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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. How to store Abiraterone Glenmark
6. Contents of the pack and other information

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

This medicine contains abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. This medicine stops your body from 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 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 is intended for use only 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 taking this medicine:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low levels of potassium in your blood (low potassium levels 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, darkened 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 red blood cell count, 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 do not have any symptoms. While you are 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, seek immediate medical attention and bring 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 heart medications, 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 this medicine. This could lead to adverse effects or reduce the effectiveness of this medicine.

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 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 or touch this medicine.

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 use tools or machines.

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 with him before taking this medicine.

This medicine contains 24 mg of sodium (a main component of cooking/table salt) in each two-tablet dose of 500 mg. This corresponds to 1% of the maximum recommended daily intake of sodium for an adult.

3. How to take Abiraterone Glenmark

Follow exactly the instructions given by your doctor for taking this medicine. 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 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 intended, which could lead to adverse effects.

Take the 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 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 advise you if any change in the dose of prednisone or prednisolone 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 the hospital immediately.

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

If you forget to take Abiraterone Glenmark

• If you forget to take this medicine or forget to take 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 instructed by your doctor. 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 side effects:

• Muscle weakness, muscle twitching, 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 potassium levels in the blood
• Increased 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
• Severe 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)
• Liver dysfunction (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible side 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 Glenmark

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/or the label of the HDPE bottle and/or the blister. The expiry date is 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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other 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 components are monohydrate lactose, 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 of the product and contents of the pack

Abiraterone Glenmark 500 mg film-coated tablets are violet, oval-shaped tablets approximately 19 mm in length and 11 mm in width, 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 packed in transparent or opaque (white) blisters. Each pack may contain a bottle with 60 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

The Netherlands

Glenmark Pharmaceuticals, s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

For further information about this medicinal product, please contact 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 Member States of the European Economic Area 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 for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.