Abirateron Aristo

Package Leaflet: Information for the Patient

Abirateron Aristo, 500 mg, 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.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do not Give it to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, including those not Mentioned in this Package Leaflet, they should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

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

1. What is Abirateron Aristo and what is it Used for

Abirateron Aristo 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. Abirateron Aristo Inhibits the Production of Testosterone in the Body; this may Slow down the Development of Prostate Cancer.

When Abirateron Aristo is Used at an Early Stage of the Disease Responding to Hormonal Therapy, it is Administered Together with a Treatment that Reduces Testosterone Levels (Androgen Suppression Therapy).

During the Use of this Medication, the Treating Doctor will also Prescribe another Medication 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 Abirateron Aristo

When not to Take Abirateron Aristo:

• If the Patient is Allergic to Abiraterone or any other Component of the Medication (listed in Section 6);
• In Women, especially those who are Pregnant. Abirateron Aristo 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. In Case of Doubts, Consult a Doctor or Pharmacist Before Taking this Medication.

Warnings and Precautions

Before Starting to Take this Medication, Discuss it with a Doctor or Pharmacist:

• If the Patient has Liver Problems;
• If the Patient has High Blood Pressure or 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 Heart Rate;
• If the Patient has Shortness of Breath;
• If the Patient has Sudden Weight Gain;
• If the Patient has Swelling of the Feet, Ankles, or Legs;
• If the Patient has Taken the Medication Ketokonazole in the Past for the Treatment of Prostate Cancer;
• If there is a Need to Take this Medication with Prednisone or Prednisolone;
• If there is a Risk of Undesirable Effects Related to Bones;
• If the Patient has High Blood Sugar Levels.

Tell the Doctor if the Patient has any Heart or Blood Vessel Disorders, including Heart Rhythm Disorders (Arrhythmia), or is Taking Medications for these Conditions.

Tell the Doctor if the Patient has Yellowing of the Skin or Eyes, Dark Urine, or 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.

Abirateron Aristo must not be Administered in Combination with Ra-223, due to the Possible Increased Risk of Bone Fractures or Death.

Before Starting Planned Ra-223 Therapy, the Patient must Wait 5 Days after Completing Abirateron Aristo and Prednisone/Prednisolone Therapy.

In Case of Doubts whether any of the Above Situations Apply to the Patient, Consult a Doctor or Pharmacist Before Taking this Medication.

Blood Tests

Abirateron Aristo may Affect Liver Function, and the Patient may not have any Symptoms.

During the Use of the Medication, the Treating 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 Abirateron Aristo is Accidentally Swallowed by a Child, Immediately go to the Hospital, Taking the Patient Information Leaflet to Show the Doctor in the Emergency Room.

Abirateron Aristo and other Medications

Before Taking any Medication, Consult a Doctor or Pharmacist.

Tell the Doctor or Pharmacist about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take. This is Important, as Abirateron Aristo may Enhance the Effect of many Medications, including those for the Heart, 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 Abirateron Aristo, which may Result in Undesirable Effects or Inadequate Efficacy of Abirateron Aristo.

Androgen Suppression may Increase the Risk of Heart Rhythm Disorders. Tell the Doctor if the Patient is Taking Medications:

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

Tell the Doctor if the Patient is Taking any of the Above Medications.

Taking Abirateron Aristo with Food

The Medication must not be Taken with Food (see Section 3, "How to Take Abirateron Aristo").

Taking Abirateron Aristo with Food may Cause Undesirable Effects.

Pregnancy and Breastfeeding

Abirateron Aristo 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 or other 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.

Women who are Pregnant or may Become Pregnant should Wear Protective Gloves when Handling Abirateron Aristo.

Driving and Operating Machines

It is Unlikely that this Medication will Affect the Ability to Drive or Operate Tools and Machines.

Abirateron Aristo Contains Lactose and Sodium

• Abirateron Aristo Contains Lactose (a Type of Sugar). If the Patient has been Diagnosed with Intolerance to some Sugars, they should Consult a Doctor Before Taking this Medication.
• The Medication also Contains 23 mg of Sodium (the Main Component of Table Salt) in each Dose of two 500 mg Tablets. This Corresponds to 1.2% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Take Abirateron Aristo

This Medication should Always be Taken as Directed by the Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.

How much Medication to Take

The Recommended Dose is 1000 mg (two Tablets) Taken once a Day.

How to Take the Medication

• The Medication should be Taken Orally.
• Abirateron Aristo must not be Taken with Food.

Take Abirateron Aristo at least one Hour Before or at least two Hours After Eating

(see Section 2, "Taking Abirateron Aristo with Food").

• Swallow the Tablets Whole with Water.
• Do not Crush the Tablets.
• Abirateron Aristo is Taken with a Medication Called Prednisone or Prednisolone. Prednisone or Prednisolone should be Taken as Directed by the Doctor.
• Prednisone or Prednisolone should be Taken Daily while Taking Abirateron Aristo.
• The Amount of Prednisone or Prednisolone Used may be Changed if Necessary. The Treating Doctor will Inform the Patient if there is a Need to Change the Dose of Prednisone or Prednisolone. Do not Stop Taking Prednisone or Prednisolone without Consulting a Doctor.

The Treating Doctor may also Prescribe other Medications to the Patient Taking Abirateron Aristo and Prednisone or Prednisolone.

Taking more Abirateron Aristo than Prescribed

If the Patient Takes more Medication than they should, they should Immediately Contact their Doctor or go to the Hospital.

Missing a Dose of Abirateron Aristo

If the Patient Forgets to Take Abirateron Aristo, Prednisone, or Prednisolone, they should Take the Usual Dose the Next Day.

If the Patient Forgets to Take Abirateron Aristo, Prednisone, or Prednisolone for more than one Day, they should Immediately Contact their Doctor.

Stopping Abirateron Aristo Treatment

Do not Stop Taking Abirateron Aristo or Prednisone/Prednisolone without Consulting a Doctor.

In Case of any Further Doubts about Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Abirateron Aristo may Cause Undesirable Effects, although not everyone will Experience them.

Stop Taking Abirateron Aristo and Immediately Contact a Doctor if the Patient Notices 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 Include:

Very Common(may Occur in more than 1 in 10 Patients):
Swelling of the Feet or Ankles, Low Potassium Levels in the Blood, Elevated Liver Function Test Results, High Blood Pressure, Urinary Tract Infections, Diarrhea.
Common(may Occur in 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 Infection (Sepsis), Bone Fractures, Nausea, Blood in the Urine, Rash.
Uncommon(may Occur in 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 Occur in up to 1 in 1,000 Patients):
Lung Inflammation (also Known as Allergic Alveolitis). Liver Function Disorder (also Known as Acute Liver Failure).
Frequency Not Known(Cannot be Estimated from the Available Data):
Heart Attack, Changes in ECG (Prolonged QT Interval), and Severe Allergic Reactions, Causing Difficulty Swallowing or Breathing, Facial, Lip, Tongue, or Throat Swelling, or Itchy Rash.
There may be a Loss of Bone Mass in Men Treated for Prostate Cancer. Abirateron Aristo in Combination with Prednisone and Prednisolone may Enhance this Effect.

Reporting Undesirable Effects

If any Undesirable Effects Occur, including those not Mentioned in the Package Leaflet, Inform a Doctor, Pharmacist, or Nurse.

Undesirable Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 the Medication.

5. How to Store Abirateron Aristo

• Store the Medication in a Place that is Inaccessible to Children.
• Do not Use this Medication after the Expiration Date Stated on the Carton and Blister Pack after EXP. The Expiration Date refers to the Last Day of the Month.
• There are no Special Storage Temperature Requirements for the Medication.
• Medications should not be Disposed of in Sewers or Household Waste. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and other Information

What Abirateron Aristo Contains

• The Active Substance of the Medication is Abiraterone Acetate. Each Coated Tablet Contains 500 mg of Abiraterone Acetate.
• Other Ingredients are: Microcrystalline Cellulose Type 102, Sodium Carboxymethylcellulose, Lactose Monohydrate, Magnesium Stearate, Hypromellose 2910, Silicon Dioxide, and Sodium Lauryl Sulfate (see Section 2 "Abirateron Aristo Contains Lactose and Sodium"). The Tablet Coating Contains Black Iron Oxide (E 172), Red Iron Oxide (E 172), Macrogol/Polyvinyl Alcohol Copolymer, Talc, and Titanium Dioxide (E 171).

What Abirateron Aristo Looks Like and Package Contents

• Abirateron Aristo, 500 mg, are Oval, Convex, Coated Tablets of Purple Color, with "500" Engraved on one Side and Smooth on the other Side.
• The Tablets are Supplied in PVC/PVDC/Aluminum Blister Packs Packaged in Cartons Containing 60, 60 x 1, or 112 Coated Tablets.

Not all Pack Sizes may be Marketed.

Marketing Authorization Holder

Aristo Pharma Sp. z o.o.

ul. Baletowa 30

02-867 Warsaw

tel: +48 22 855 40 93

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15,

Münster, 48159

Germany

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

This Medicinal Product is Authorized in the Member States of the European Economic Area under the Following Names:

Austria

Abirateron Aristo 500 mg Film-Coated Tablets

Czech Republic

Abirateron Aristo

Denmark

Abitateron Aristo

Spain

Abiraterona Aristo 500 mg Film-Coated Tablets EFG

Ireland

Abiraterone Aristo 500 mg Film-Coated Tablets

Germany

Abirateron Aristo 500 mg Filmtabletten

Norway

Abirateron Aristo

Poland

Abitateron Aristo

Portugal

Abiraterona Aristo 500 mg Film-Coated Tablets

Slovakia

Abiraterone Aristo

Sweden

Abirateron Aristo

United Kingdom

Abiraterone 500 mg Film-Coated Tablets

Italy

Abiraterone Aristo 500 mg Film-Coated Tablets

Date of Last Revision of the Package Leaflet:May 2023