Abiraterone Sinthon

Package Leaflet: Information for the Patient

Abiraterone Synthon, 500 mg Film-Coated Tablets

Abiraterone acetate

Read All of This Leaflet Carefully Before Taking This Medicine.

• You should 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. 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 Synthon and What is it Used For
• 2. Before You Take 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 contains the active substance 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 stopping 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 in patients who are responding to hormone therapy, it is given together with a treatment that lowers testosterone levels (androgen deprivation 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 (oedema), or low potassium levels in the blood.

2. Before You Take Abiraterone Synthon

Do Not Take Abiraterone Synthon:

• if you are allergic to abiraterone or any of the other ingredients of this medicine (listed in section 6);
• in women, especially if pregnant. Abiraterone Synthon is for use in men only;
• if you have severe liver damage;
• in combination with a medicine called Ra-223 (used to treat prostate cancer).

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Abiraterone Synthon.

Warnings and Precautions

Before taking this medicine, discuss with your doctor or pharmacist:

• if you have liver disease;
• if you have high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of abnormal heart rhythms);
• if you have had other heart problems or blood vessel problems;
• if you have an irregular or fast heart rhythm;
• if you have shortness of breath;
• if you have gained weight quickly;
• if you have swelling of your feet, ankles, or legs;
• if you have taken a medicine called ketoconazole in the past to treat prostate cancer;
• the need to take this medicine with prednisone or prednisolone;
• the possibility of side effects affecting the bones;
• if you have high blood sugar levels.

Tell your doctor if you have any heart or blood vessel problems, including abnormal heart rhythms (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 can be signs of liver problems. Rarely, acute liver failure can occur, which can be life-threatening.

There may be a decrease in red blood cells, decreased sex drive, muscle weakness, and/or muscle pain.

Abiraterone Synthon must 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 applies to you, talk to your doctor or pharmacist before taking Abiraterone Synthon.

Blood Tests

Abiraterone Synthon may affect your liver and you may not have any symptoms. While taking this medicine, your doctor will periodically do blood tests to check how the medicine is affecting your liver.

Children and Adolescents

This medicine is not for use in children and adolescents. If Abiraterone Synthon is accidentally swallowed by a child, seek medical advice immediately and take the package leaflet with you to show to the doctor.

Abiraterone Synthon with Other Medicines

Before taking any medicine, consult your doctor or pharmacist.

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take. This is important because Abiraterone Synthon can increase the effects of many medicines, including heart medicines, sedatives, certain anti-diabetic medicines, herbal medicines (such as St. John's Wort), and others. Your doctor may need to adjust the dose of these medicines.

Also, other medicines may increase or decrease the effects of Abiraterone Synthon. This can lead to side effects or Abiraterone Synthon not working properly.

Androgen deprivation therapy may increase the risk of abnormal heart rhythms. Tell your doctor if you are taking medicines for:

• abnormal heart rhythms (e.g., quinidine, procainamide, amiodarone, and sotalol);
• medicines that may increase the risk of abnormal heart rhythms [e.g., methadone (a pain reliever and used for drug addiction), moxifloxacin (an antibiotic), antipsychotic medicines (used for 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, Breast-Feeding, and Fertility

Abiraterone Synthon is not for use 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 if they need to handle Abiraterone Synthon tablets.
• If you have sex with a woman who may become pregnant, you should use a condom or other effective birth control method.
• If you have sex with a pregnant woman, 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 machines.

Abiraterone Synthon Contains Lactose and Sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The medicine contains 24 mg of sodium (a major component of cooking salt) in each dose of two 500 mg tablets. This is approximately 1% of the maximum recommended daily intake of sodium for adults.

3. How to Take Abiraterone Synthon

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

How Much to Take

The recommended dose is 1000 mg (two 500 mg tablets) taken once a day.

How to Take

• Take by mouth.
• Do not take Abiraterone Synthon with food. Taking Abiraterone Synthon with food may cause more of the medicine to be absorbed by the body than is needed, which can cause side effects.
• Take one dose of Abiraterone Synthon once a day on an empty stomach. Take Abiraterone Synthon at least 2 hours after eating and do not eat for at least 1 hour after taking Abiraterone Synthon (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 your doctor tells you.
• Take prednisone or prednisolone every day while taking Abiraterone Synthon.
• The amount of prednisone or prednisolone you take may need to be changed in case of an emergency. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without talking to 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, talk to a doctor or go to a hospital immediately.

If You Forget to Take Abiraterone Synthon

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

If You Stop Taking Abiraterone Synthon

Do not stop taking Abiraterone Synthon or prednisone or prednisolone without talking to your doctor.

If you have any further questions on the use of this product, 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 Synthon and Contact a Doctor Immediately If You Notice Any of the Following:

• Muscle weakness, trembling (tremors), or heart pounding (palpitations). These may be signs 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 blood pressure
• Urinary tract infections
• Diarrhea

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

• High levels of fats in the blood
• Chest pain, abnormal heart rhythms (atrial fibrillation), heart failure, fast heart rate
• Severe infection - sepsis
• Bone fractures
• Nausea
• Blood in the urine
• Rash

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

• Adrenal gland problems (related to disturbances in the body's water and electrolyte balance)
• 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 the electrocardiogram (ECG) (prolongation of the QT interval), and severe allergic reactions
• Causing difficulty swallowing or breathing, swelling of the face, lips, tongue, or throat, or itchy rash.

Bone loss (osteoporosis) may occur in men treated for prostate cancer. Abiraterone Synthon in combination with prednisone and prednisolone may make this worse.

Reporting of Side Effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in the [insert national agency] Adverse Reaction Reporting Scheme, [insert contact details]. 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 which is stated on the blister, bottle, or carton after "EXP" and "Expiry Date". The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 500 mg of abiraterone acetate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide black (E 172), iron oxide red (E 172).

What Abiraterone Synthon Looks Like and Contents of the Pack

Oval, film-coated tablets, purple in color, approximately 19 mm in length and 11 mm in width, with "A7TN" engraved on one side and "500" on the other.

Pack sizes:

• Blister packs containing 56, 60, or 112 film-coated tablets in a cardboard box;
• Unit dose blister packs containing 56 x 1 or 60 x 1 film-coated tablets in a cardboard box;
• Bottles containing 60 film-coated tablets in a cardboard box.

Marketing Authorisation 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: 21/08/2024