Abiraterone Fresenius Kabi

Package Leaflet: Information for the Patient

Abiraterone Fresenius Kabi, 500 mg, Film-Coated Tablets

Abiraterone Acetate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, so you can Read it Again if Necessary.
• If you have any Further Questions, Ask your Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, including any Undesirable Effects not Listed in this Package Leaflet, they should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What Abiraterone Fresenius Kabi is and what it is Used for
• 2. Important Information Before Taking Abiraterone Fresenius Kabi
• 3. How to Take Abiraterone Fresenius Kabi
• 4. Possible Undesirable Effects
• 5. How to Store Abiraterone Fresenius Kabi
• 6. Package Contents and other Information

1. What Abiraterone Fresenius Kabi is and what it is Used for

Abiraterone Fresenius Kabi is a Medication Containing Abiraterone Acetate. It is Used in Adult Men for the Treatment of Prostate Cancer that has Spread to other Parts of the Body. Abiraterone Fresenius Kabi Inhibits the Production of Testosterone in the Body; this may Slow the Growth of Prostate Cancer.
When Abiraterone Fresenius Kabi is Used at an Early Stage of the Disease Responding to Hormonal Therapy, it is Administered Together with Therapy that Reduces Testosterone Levels (Androgen Suppression Therapy).
During Treatment with this Medication, the Doctor will also Prescribe another Medication Called 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 Fresenius Kabi

When not to Take Abiraterone Fresenius Kabi

• If the Patient is Allergic to Abiraterone Acetate or any of the other Ingredients of this Medication (Listed in Section 6).
• In Women, especially those who are Pregnant. Abiraterone Fresenius Kabi is Used Only in Men;
• If the Patient has Severe Liver Damage;
• In Combination with the Medication Ra-223 (Used in the Treatment of Prostate Cancer).

Do not Take this Medication if any of the Above Situations Apply to the Patient. If in Doubt, Consult a Doctor or Pharmacist Before Taking this Medication.

Warnings and Precautions

Before Starting Treatment with this Medication, Discuss with your Doctor or Pharmacist:

• If the Patient has Liver Disease;
• If the Patient has High Blood Pressure, Heart Failure, or Low Potassium Levels in the Blood (Low Potassium Levels in the Blood may Increase the Risk of Heart Rhythm Disorders);
• If the Patient has had other Heart or Blood Vessel Diseases;
• If the Patient has an Irregular or Rapid Heartbeat;
• If the Patient has Shortness of Breath;
• If the Patient's Body Weight has Increased Rapidly;
• If the Patient has Swelling of the Feet, Ankles, or Legs;
• If the Patient has Taken Ketokonazole in the Past for the Treatment of Prostate Cancer;
• The Need to Take this Medication with Prednisolone;
• The Possibility of Undesirable Effects on the Bones;
• If the Patient has High Blood Sugar Levels.

Tell your Doctor if you have any Heart or Blood Vessel Disorders, including Heart Rhythm Disorders (Arrhythmia), or if you are Taking Medications 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 Fresenius Kabi must not be Administered in Combination with Ra-223, due to the Possible Increased Risk of Bone Fractures or Death.
If the Patient Intends to Take Ra-223 after Treatment with Abiraterone Fresenius Kabi and Prednisolone, they should Wait 5 Days Before Starting Ra-223 Treatment.
If in Doubt whether any of the Above Situations Apply to the Patient, Consult a Doctor or Pharmacist Before Taking this Medication.

Blood Tests

Abiraterone Fresenius Kabi may Affect Liver Function, and the Patient may not have any Symptoms. During Treatment with the Medication, the Doctor will Periodically Prescribe Blood Tests to Check the Effect of the Medication on the Liver.

Children and Adolescents

This Medication is not Used in Children and Adolescents. If Abiraterone Fresenius Kabi is Accidentally Swallowed by a Child, Immediately Go to the Hospital with the Patient Information Leaflet to Show the Doctor in the Emergency Room.

Abiraterone Fresenius Kabi and other Medications

Before Taking any Medication, Consult a Doctor or Pharmacist.
Tell your Doctor or Pharmacist about all Medications you are Currently Taking or have Recently Taken, as well as any Medications you Plan to Take. This is Important, as Abiraterone Fresenius Kabi may Enhance the Effect of many Medications, including Heart Medications, Sedatives, certain Anti-Diabetic Medications, Herbal Medications (e.g., St. John's Wort), and others. The Doctor may Change the Dose of these Medications. Other Medications may also Increase or Decrease the Effect of Abiraterone Fresenius Kabi. This may Result in Undesirable Effects or Inadequate Efficacy of Abiraterone Fresenius Kabi.
Androgen Suppression may Increase the Risk of Heart Rhythm Disorders. Tell your Doctor if you are Taking:

• Medications for Heart Rhythm Disorders (e.g., Quinidine, Procainamide, Amiodarone, and Sotalol);
• Medications that may Increase the Risk of Heart Rhythm Disorders [e.g., Methadone (Pain Relief and Addiction Treatment), Moxifloxacin (Antibiotic), Antipsychotic Medications (Used in Severe Mental Disorders)].

Tell your Doctor if you are Taking any of the Above Medications.

Abiraterone Fresenius Kabi with Food

This Medication must not be Taken with Food (See Section 3. "How to Take Abiraterone Fresenius Kabi").
Taking Abiraterone Fresenius Kabi with Food may Cause Undesirable Effects.

Pregnancy and Breastfeeding

Abiraterone Fresenius Kabi is not Used in Women.
The Medication may Harm an Unborn Child if Taken by a Pregnant Woman.
If the Patient has Sexual Intercourse with a Woman who may Become Pregnant, a Condom and another Effective Contraceptive Method should be Used.
If the Patient has Sexual Intercourse with a Pregnant Woman, a Condom should be Used to Protect the Unborn Child.

Driving and Operating Machinery

It is Unlikely that this Medication will Affect the Ability to Drive or Operate Machinery.

Abiraterone Fresenius Kabi Contains Lactose and Sodium

If the Doctor has Informed the Patient that they have an Intolerance to certain Sugars, the Patient should Consult their Doctor Before Taking this Medication.
This Medication Contains 24 mg of Sodium (a Major Component of Common Salt) per Dose of two 500 mg Film-Coated Tablets. This Corresponds to 1% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Take Abiraterone Fresenius Kabi

This Medication should Always be Taken as Directed by the Doctor. If in Doubt, Consult a Doctor or Pharmacist.

How Much to Take

The Recommended Dose is 1,000 mg (Two 500 mg Tablets) Once a Day.

How to Take this Medication

Oral Administration.
Abiraterone Fresenius Kabi must not be Taken with Food. Taking Abiraterone Fresenius Kabi with Food may Cause the Body to Absorb more of the Medication than Necessary, which may Result in Undesirable Effects.
Abiraterone Fresenius Kabi Tablets should be Taken as a Single Dose Once a Day on an Empty Stomach. Abiraterone Fresenius Kabi should be Taken at Least 2 Hours After Eating and no Food should be Consumed for at Least 1 Hour After Taking Abiraterone Fresenius Kabi (See Section 2. "Taking Abiraterone Fresenius Kabi with Food").
The Tablets should be Swallowed Whole with Water.
The Tablets should not be Crushed.
Abiraterone Fresenius Kabi is Used in Combination with a Medication Called Prednisolone. Prednisolone should be Taken as Directed by the Doctor.
Prednisolone should be Taken Daily During Treatment with Abiraterone Fresenius Kabi.
The Amount of Prednisolone Taken may be Changed if Necessary. The Doctor will Inform the Patient if there is a Need to Change the Dose of Prednisolone. Do not Stop Taking Prednisolone without Consulting a Doctor.
The Doctor may also Prescribe other Medications to the Patient Taking Abiraterone Fresenius Kabi and Prednisolone.

What to do if you Take more Abiraterone Fresenius Kabi than you Should

If you Take more Abiraterone Fresenius Kabi than you Should, Immediately Contact your Doctor or Go to the Hospital.

What to do if you Miss a Dose of Abiraterone Fresenius Kabi

If you Miss a Dose of Abiraterone Fresenius Kabi or Prednisolone, Take the Usual Dose the Next Day.
If you Miss a Dose of Abiraterone Fresenius Kabi or Prednisolone for More than One Day, Immediately Contact your Doctor.

What to do if you Stop Taking Abiraterone Fresenius Kabi

Do not Stop Taking Abiraterone Fresenius Kabi or Prednisolone without Consulting a Doctor.
If you have any Further Questions about Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although not Everybody gets them.

Stop Taking Abiraterone Fresenius Kabi and Immediately Contact your Doctor if you Experience any of the Following Symptoms:

• Muscle Weakness, Muscle Tremors (Tremors), or Heart Palpitations (Palpitations). These may be Symptoms of Low Potassium Levels in the Blood.

Other Undesirable Effects:

Very Common (may Affect more than 1 in 10 Patients):

• 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 Patients):

• High Lipid Levels in the Blood;
• Chest Pain, Heart Rhythm Disorders (Atrial Fibrillation), Heart Failure, Rapid Heart Rate;
• Severe Infections - Sepsis;
• Bone Fractures;
• Indigestion;
• Blood in the Urine;
• Rash.

Uncommon (may Affect up to 1 in 100 Patients):

• 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 Patients):

• 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 (Prolonged QT Interval);
• Severe Allergic Reactions, Causing Difficulty Swallowing or Breathing, Swelling of the Face, Lips, Tongue, or Throat, or Itchy Rash.

There may be a Loss of Bone Mass in Men Treated for Prostate Cancer.
Abiraterone Fresenius Kabi in Combination with Prednisolone may Enhance this Effect.

Reporting Undesirable Effects

If you Experience any Undesirable Effects, including any not Listed in this Package Leaflet, Inform your Doctor or Pharmacist, or Nurse. Undesirable Effects can be Reported Directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Abiraterone Fresenius Kabi

Keep this Medication out of Sight and Reach of Children.
Do not Use this Medication after the Expiration Date Stated on the Carton and Bottle or Blister after "EXP". The Expiration Date Refers to the Last Day of the Month.
There are no Special Storage Instructions for this Medication.
Medications should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and other Information

What Abiraterone Fresenius Kabi Contains

• The Active Substance of the Medication is Abiraterone Acetate.
• Each Film-Coated Tablet Contains 500 mg of Abiraterone Acetate.
• The other Ingredients are: Lactose Monohydrate, Microcrystalline Cellulose Type 102, Sodium Carboxymethylcellulose, Hypromellose 2910, Sodium Lauryl Sulfate, Colloidal Anhydrous Silica, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide (E171), Macrogol 3350, Talc, Iron Oxide Red (E172), Iron Oxide Black (E172).

What Abiraterone Fresenius Kabi Looks like and what the Package Contains

Purple, Oval, Film-Coated Tablets, Approximately 19 mm in Length and 11 mm in Width, with the Imprint "A7TN" on one Side and "500" on the other Side.
Package Sizes:

• Blisters Containing 56 or 60 Film-Coated Tablets, in a Cardboard Box;
• Single-Dose Blisters Containing 56x1 or 60x1 Film-Coated Tablets, in a Cardboard Box;
• A Bottle Containing 60 Film-Coated Tablets, in a Cardboard Box.

Not all Package Sizes may be Marketed.

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Synthon Hispania, S.L.
c/ Castelló, 1
08830 Sant Boi de Llobregat (Barcelona)
Spain

This Medication is Authorized for Marketing in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the Following Names:

Date of Last Revision of the Package Leaflet:20.11.2024