Abiraterone Sinthon

Package Leaflet: Information for the Patient

Abiraterone Synthon, 250 mg, Tablets

Abiraterone acetate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Abiraterone Synthon and what is it used for
• 2. Important information before taking Abiraterone Synthon
• 3. How to take Abiraterone Synthon
• 4. Possible side effects
• 5. How to store Abiraterone Synthon
• 6. Contents of the pack and other information

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

Abiraterone Synthon is a medicine that contains abiraterone acetate. It is used in adult men to treat prostate cancer that has spread to other parts of the body. Abiraterone Synthon works by blocking the production of testosterone in the body; this can slow down the growth of prostate cancer.

When Abiraterone Synthon is used at an early stage of the disease that responds to hormonal therapy, it is given together with therapy that reduces testosterone levels (androgen suppression therapy).

During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention, or low potassium levels in the blood.

2. Important information before taking Abiraterone Synthon

When not to take Abiraterone Synthon:

• in women, especially during pregnancy. Abiraterone Synthon is only used in men;
• in combination with the medicine Ra-223 (used to treat prostate cancer).

Do not take this medicine if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with this medicine, discuss it with your doctor or pharmacist:

• the need to take this medicine with prednisone or prednisolone;
• the possibility of side effects related to bones;

Tell your doctor if you have any heart or blood vessel disorders, including heart rhythm disturbances (arrhythmia), or if you are taking medicines for these conditions.

Tell your doctor if you have yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver function disorders. Rarely, acute liver failure may occur, which can be life-threatening.

There may be a decrease in the number of red blood cells, decreased sex drive, muscle weakness, and (or) muscle pain.

Abiraterone Synthon should not be taken in combination with Ra-223 due to the possible increased risk of bone fractures or death.

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

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone Synthon may affect liver function, and you may not have any symptoms. During treatment with this medicine, your doctor will periodically order blood tests to check the effect of the medicine on the liver.

Children and adolescents

This medicine is not used in children and adolescents. If Abiraterone Synthon is accidentally swallowed by a child, you should immediately go to the hospital, taking this leaflet with you to show it to the doctor in the emergency room.

Abiraterone Synthon and other medicines

Before taking any medicine, consult your doctor or pharmacist.

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. This is important because Abiraterone Synthon may enhance the effect of many medicines, including heart medicines, sedatives, certain anti-diabetic medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may change the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone Synthon, which may result in side effects or inadequate effect of Abiraterone Synthon.

Androgen suppression may increase the risk of heart rhythm disturbances. Tell your doctor if you are taking medicines:

• used to treat heart rhythm disturbances (e.g., quinidine, procainamide, amiodarone, and sotalol);
• that may increase the risk of heart rhythm disturbances [e.g., methadone (pain reliever and used to treat addiction), moxifloxacin (antibiotic), antipsychotic medicines (used to treat severe mental disorders)].

Tell your doctor if you are taking any of the above medicines.

Taking Abiraterone Synthon with food

• Do not take this medicine with food (see section 3, "How to take Abiraterone Synthon").
• Taking Abiraterone Synthon with food may cause side effects.

Pregnancy, breastfeeding, and fertility

Abiraterone Synthon is not used in women.

• The medicine may harm an unborn child if taken by a pregnant woman.
• Women who are pregnant or may become pregnant should wear protective gloves when handling Abiraterone Synthon.
• If you have sexual intercourse with a woman who may become pregnant, you should use a condom or other effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, you should use a condom to protect the unborn child.

Driving and using machines

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

Abiraterone Synthon contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per dose of four 250 mg tablets, so it is considered "sodium-free".

3. How to take Abiraterone Synthon

Always take this medicine exactly as your doctor has told you.

How much to take

The recommended dose is 1000 mg (four 250 mg tablets) taken once a day.

How to take the medicine

• Take orally.
• Do not take Abiraterone Synthon with food.
• Take Abiraterone Synthon at least 1 hour before or at least 2 hours after food (see section 2, "Taking Abiraterone Synthon with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Abiraterone Synthon is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as directed by your doctor.
• Take prednisone or prednisolone every day while taking Abiraterone Synthon.
• The amount of prednisone or prednisolone taken may be changed if necessary. Your doctor will inform you if you need to change the dose of prednisone or prednisolone.

Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines for you to take with Abiraterone Synthon and prednisone or prednisolone.

If you take more Abiraterone Synthon than you should

If you take more Abiraterone Synthon than you should, contact your doctor or go to the hospital emergency department immediately.

If you forget to take Abiraterone Synthon

• If you forget to take Abiraterone Synthon, prednisone, or prednisolone, take the usual dose the next day.
• If you forget to take Abiraterone Synthon, prednisone, or prednisolone for more than one day, contact your doctor immediately.

Stopping treatment with Abiraterone Synthon

Do not stop taking Abiraterone Synthon or prednisone/prednisolone without consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Abiraterone Synthon can cause side effects, although not everybody gets them.

Stop taking Abiraterone Synthon and contact your doctor immediately if you notice any of the following symptoms:

• Muscle weakness, tremors (shaking), or heart palpitations (palpitations). These may be symptoms of low potassium levels in the blood.

Other side effects:

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

• Swelling of the feet or ankles
• Low potassium levels in the blood
• High liver enzyme levels
• High blood pressure
• Urinary tract infections
• Diarrhea

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

• High lipid levels in the blood
• Chest pain, heart rhythm disturbances (atrial fibrillation), heart failure, rapid heart rate
• Severe infection - sepsis
• Bone fractures
• Nausea
• Blood in the urine
• Rash

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

• Adrenal gland disorders (related to electrolyte imbalance)
• 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)
• Acute liver failure

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

• Heart attack, changes in ECG (QT interval prolongation), and severe allergic reactions
• Cause difficulty swallowing or breathing, face, lip, tongue, or throat swelling, or itchy rash.

Bone loss may occur in men treated for prostate cancer. Abiraterone Synthon in combination with prednisone and prednisolone may enhance this effect.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the "national reporting system" listed in the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides

Al. Jerozolimskie 181C

PL-02 222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abiraterone Synthon

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

Do not use this medicine after the expiry date stated on the bottle and carton after "EXP" and "Expiry date (EXP)". The expiry date refers to the last day of the month.

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Abiraterone Synthon contains

• The active substance is abiraterone acetate.
• Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K29/32, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.

What Abiraterone Synthon looks like and contents of the pack

Abiraterone Synthon is available as white to off-white, oval tablets (16 mm long and 9.5 mm wide), with "ATN" engraved on one side and "250" on the other.

Pack size: 120 tablets in a bottle, in a carton.

Marketing authorization holder

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

Manufacturer

Synthon Hispania S.L.

Castelló 1

08830 Sant Boi de Llobregat

Barcelona

Spain

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

Date of last revision of the leaflet: