Patient Information

Abiraterone Glenmark 500 mg Film-Coated Tablets

Abiraterone acetate

Read this Patient Information 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

This medication contains abiraterone acetate. It is used for the treatment of prostate cancer in adult men who have spread to other parts of the body. This medication makes your body stop producing testosterone; in this way it can delay the growth of prostate cancer.

When this medication is prescribed in the initial stages of disease and there is still a response to hormonal treatment, it is used together with a treatment to reduce testosterone (androgen deprivation therapy).

When you take this medication, your doctor will also prescribe another medication called prednisone or prednisolone, to reduce the possibility of suffering an increase in blood pressure, that you accumulate too much fluid in your body (fluid retention) or that you decrease the levels of a chemical called potassium in your blood.

Do not take Abiraterona 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 should only be used in male patients.
• if you have a serious 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 that you have high blood pressure or heart failure or low levels of potassium in the blood (low levels of potassium 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 heart rhythm
• if you have difficulty breathing
• if you have gained weight rapidly
• 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 levels of sugar in the blood.

Inform your doctor if you have been told that you have any heart or blood vessel problems, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.

Inform your doctor if you have 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 failure (called acute liver failure) may occur, which can be fatal.

You may experience a decrease in the number of red blood cells in the blood, reduced libido, and cases of muscle weakness and/or muscle pain.

This medicine should not be administered in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.

If you plan to take Ra-223 after treatment with this medicine and prednisone/prednisolone, you should wait 5 days before starting the treatment with Ra-223.

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 make periodic blood tests to monitor any effect on your liver.

Children and adolescents

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

Other medicines and Abiraterona Glenmark

Consult your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is important because this medicine may increase the effects of a range of medicines including heart medicines, tranquilizers, 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, which may lead to side effects or this medicine not working as well as it should.

The androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are being treated with 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), moxifloxacine (an antibiotic), antipsychotics (used for severe mental illnesses)].

Consult with your doctor if you are taking any of the medicines listed above.

Abiraterona Glenmark with food

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

Pregnancy and breastfeeding

This medicine is not indicated in women.

Pregnant women or those who may be pregnant should wear gloves if they need to touch or handle this medicine.

This medicine may be harmful to the fetus if a pregnant woman takes it.

If you have sexual intercourse with a fertile woman, you should use a condom and another effective contraceptive method.

If you have sexual intercourse with a pregnant woman, you should use a condom to protect the fetus.

Driving and operating machines

It is unlikely that this medicine will affect your ability to drive and use tools or machines.

Abiraterona Glenmark contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, 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 medication

Take this medication orally.

Do not take this medication with food. Taking Abiraterona Glenmark with food may cause the body to absorb more medication than necessary, which may lead to adverse effects.

Take Abiraterona Glenmark tablets as a single dose once a day with an empty stomach. Abiraterona Glenmark should be taken at least two hours after eating and no food should be consumed at least one hour after taking Abiraterona Glenmark (see section 2, “Abiraterona Glenmark with food”).

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

This medication is administered along with a medication 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 taking this medication.

It may be necessary to adjust the amount of prednisone or prednisolone you take in case of a medical emergency. Your doctor will inform you if you need to modify 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 medications while you are taking this medication and prednisone or prednisolone.

If you take more Abiraterona 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Abiraterona Glenmark

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

If you interrupt treatment with Abiraterona Glenmark

Do not stop taking this medication or prednisone or prednisolone unless your doctor tells you to. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Abiraterona Glenmark and see your doctor immediately if you experience any of the following effects:

• Muscle weakness, muscle spasms, or rapid heart rate (palpitations).

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

Other side effects are:

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

Common(may affect up to 1 in 10 people):

Uncommon(may affect up to 1 in 100 people):

Rare(may affect up to 1 in 1,000 people):

Unknown frequency(frequency cannot be estimated from available data):

This medicine may cause bone density loss 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and/or the HDPE bottle label and/or the blister pack. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and themedications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the containers and the medications you no longer need. By doing so, you will help protect the environment.

Composition of Abiraterona Glenmark 500 mg film-coated tablets

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

Appearance of the product and contents of the package

The film-coated tablets of Abiraterona Glenmark 500 mg are oval in shape, violet in color, approximately 19 mm in length, and 11 mm in width, marked with "A7TN" on one face and "500" on the other face.

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) blister packs. Each package contains a bottle with 60 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31, Gröbenzell

Germany

Responsible for manufacturing:

Synthon Hispania, S.L.

Calle Castelló 1

08830 Sant Boi de Llobregat, Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

Glenmark Pharmaceuticals, s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viso Farmacéutica, S.L.U

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: June 2022

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