Abirateron Aristo

Package Leaflet: Information for the Patient

Abirateron Aristo, 250 mg, Tablets

Abiraterone Acetate

Read All of This Leaflet Carefully Before Taking This Medicine.

• 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 of the Following Side Effects, or Any Other Unlisted Side Effects, Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet

• 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 Side Effects
• 5. How to Store Abirateron Aristo
• 6. Contents of the Pack and Other Information

1. What Is Abirateron Aristo and What Is It Used For

Abirateron Aristo Is a Medicinal Product 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 Works by Reducing the Production of Testosterone in the Body; This Can Help Slow Down the Growth of Prostate Cancer.
When Abirateron Aristo Is Used at an Early Stage of the Disease Responding to Hormonal Therapy, It Is Given Together with a Treatment That Lowers Testosterone Levels (Androgen Suppression Therapy).
During Treatment with This Medicinal Product, Your Doctor Will Also Prescribe Another Medicinal Product 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 You Are Allergic to Abiraterone or Any of the Other Ingredients of This Medicinal Product (Listed in Section 6);
• In Women, Especially During Pregnancy. Abirateron Aristo Is Only Used in Men;
• If You Have Severe Liver Damage;
• In Combination with Ra-223 (Used for the Treatment of Prostate Cancer).

Do Not Take This Medicinal Product If Any of the Above Applies to You. If You Are in Doubt, Consult Your Doctor or Pharmacist Before Taking This Medicinal Product.

Warnings and Precautions

Before Starting Treatment with This Medicinal Product, Discuss with Your Doctor or Pharmacist:

• If You Have Liver Problems;
• If You Have High Blood Pressure or Heart Failure or Low Potassium Levels in the Blood (Low Potassium Levels in the Blood May Increase the Risk of Abnormal Heart Rhythm);
• If You Have Had Other Heart or Blood Vessel Diseases;
• If You Have Irregular or Rapid Heartbeat;
• If You Have Shortness of Breath;
• If You Have Sudden Weight Gain;
• If You Have Swelling of the Feet, Ankles, or Legs;
• If You Have Taken a Medicinal Product Called Ketokonazole in the Past for the Treatment of Prostate Cancer;
• If There Is a Need to Take This Medicinal Product with Prednisone or Prednisolone;
• If There Is a Risk of Side Effects Related to the Bones;
• If You Have High Blood Sugar Levels.

Tell Your Doctor If You Have Any Heart or Blood Vessel Disorders, Including Abnormal Heart Rhythm (Arrhythmia), or If You Are Taking Medicines for These Conditions.
Tell Your Doctor If You Have Yellowing of the Skin or Eyes, Dark Urine, or Severe Nausea or Vomiting, Which May Be Signs of Liver 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 Given 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 Finishing Treatment with Abirateron Aristo and Prednisone/Prednisolone.
If You Are in Doubt Whether Any of the Above Applies to You, Consult Your Doctor or Pharmacist Before Taking This Medicinal Product.

Blood Tests

Abirateron Aristo May Affect Liver Function, and You May Not Have Any Symptoms.
During Treatment with This Medicinal Product, Your Doctor Will Periodically Prescribe Blood Tests to Check the Effect of the Medicinal Product on the Liver.

Children and Adolescents

This Medicinal Product Is Not Used in Children and Adolescents. If Abirateron Aristo Is Accidentally Swallowed by a Child, Go to the Hospital Immediately, Taking the Package Leaflet with You to Show to the Doctor in the Emergency Room.

Abirateron Aristo and Other Medicinal Products

Before Taking Any Medicinal Product, Consult Your Doctor or Pharmacist.
Tell Your Doctor or Pharmacist About All Medicinal Products You Are Currently Taking or Have Recently Taken, as Well as Any Medicinal Products You Plan to Take. This Is Important Because Abirateron Aristo May Enhance the Effect of Many Medicinal Products, Including Medicines for the Heart, Sedatives, Certain Anti-Diabetic Medicinal Products, Herbal Medicines (e.g., St. John's Wort), and Others. Your Doctor May Change the Dose of These Medicinal Products. Other Medicinal Products May Also Increase or Decrease the Effect of Abirateron Aristo. This May Result in Side Effects or Inadequate Effect of Abirateron Aristo.
Androgen Suppression May Increase the Risk of Abnormal Heart Rhythm. Tell Your Doctor If You Are Taking Medicines for:

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

Tell Your Doctor If You Are Taking Any of the Above Medicines.

Taking Abirateron Aristo with Food

Do Not Take This Medicinal Product with Food (See Section 3, "How to Take Abirateron Aristo").
Taking Abirateron Aristo with Food May Cause Side Effects.

Pregnancy and Breastfeeding

Abirateron Aristo Is Not Used in Women. This Medicinal Product May Harm the Unborn Child If Taken by a Pregnant Woman.
If You Have Sexual Intercourse with a Woman Who May Become Pregnant, Use a Condom or Other Effective Contraceptive Method.
If You Have Sexual Intercourse with a Pregnant Woman, Use a Condom to Protect the Unborn Child.
Abirateron Aristo, 250 mg, Tablets
Women Who Are Pregnant or May Become Pregnant Should Wear Protective Gloves When Handling Abirateron Aristo.

Driving and Using Machines

It Is Unlikely That This Medicinal Product Will Affect Your Ability to Drive or Use Tools/Machines.

Abirateron Aristo Contains Lactose and Sodium

• Abirateron Aristo Contains Lactose (a Type of Sugar). If You Have Been Told That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicinal Product.
• The Medicinal Product Also Contains 23.2 mg of Sodium (the Main Component of Common Salt) in Each Dose of Four 250 mg Tablets. This Is Equivalent to 1.2% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Take Abirateron Aristo

Always Take This Medicinal Product Exactly as Your Doctor Has Told You. If You Are in Doubt, Consult Your Doctor or Pharmacist.

How Much to Take

The Recommended Dose Is 1000 mg (Four Tablets) Taken Once a Day.

How to Take

• Take by Mouth.
• Do Not Take Abirateron Aristo with Food.

Take Abirateron Aristo at Least One Hour Before or at Least Two Hours After Food

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

• Swallow the Tablets Whole with a Glass of Water.
• Do Not Crush the Tablets.
• Abirateron Aristo Is Taken with a Medicinal Product Called Prednisone or Prednisolone. Take Prednisone or Prednisolone as Directed by Your Doctor.
• Prednisone or Prednisolone Should Be Taken Every Day While Taking Abirateron Aristo.
• The Amount of Prednisone or Prednisolone Taken May Be Changed If Necessary. Your Doctor Will Inform You If There Is a 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 to You While You Are Taking Abirateron Aristo and Prednisone or Prednisolone.

If You Take More Abirateron Aristo Than You Should

If You Take More of This Medicinal Product Than You Should, Contact Your Doctor or Go to the Hospital Immediately.

If You Forget to Take Abirateron Aristo

If You Miss a Dose of Abirateron Aristo, Prednisone, or Prednisolone, Take the Usual Dose the Next Day.
If You Miss a Dose of Abirateron Aristo, Prednisone, or Prednisolone for More Than One Day, Contact Your Doctor Immediately.

If You Stop Taking Abirateron Aristo

Do Not Stop Taking Abirateron Aristo or Prednisone or Prednisolone Without Consulting Your Doctor.
If You Have Any Further Questions on the Use of This Medicinal Product, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicinal Product Can Cause Side Effects, Although Not Everybody Gets Them.

Stop Taking Abirateron Aristo and Contact Your Doctor Immediately If You Notice Any of the Following Symptoms:

• Muscle Weakness, Muscle Tremors, or Heart Palpitations. These May Be Signs of Low Potassium Levels in the Blood.

Other Side Effects Include:

Very Common(May Affect More Than 1 in 10 People):
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 Affect Up to 1 in 10 People):
High Lipid Levels in the Blood, Chest Pain, Abnormal Heart Rhythm (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). Liver 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 of Side Effects

If You Experience Any Side Effects, or Any Other Unlisted Side Effects, Tell Your Doctor or Pharmacist, or Nurse. Side Effects Can Be Reported Directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: 22 49-21-301, Fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side Effects Can Also Be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of This Medicinal Product.

5. How to Store Abirateron Aristo

• Keep This Medicinal Product Out of the Sight and Reach of Children.
• Do Not Use This Medicinal Product After the Expiry Date Stated on the Carton and Blister Label After EXP. The Expiry Date Refers to the Last Day of the Month.
• There Are No Special Storage Conditions for This Medicinal Product.
• Store in the Original Package to Protect from Light.
• 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 Abirateron Aristo Contains

• The Active Substance Is Abiraterone Acetate. Each Tablet Contains 250 mg of Abiraterone Acetate.
• The 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").

What Abirateron Aristo Looks Like and Contents of the Pack

• Abirateron Aristo, 250 mg, Is an Oval, Biconvex, Uncoated White to Off-White Tablet with "250" Engraved on One Side and a Smooth Surface on the Other.
• The Tablets Are Supplied in HDPE Bottles with a Capacity of 100 ml, with a PP Child-Resistant Closure and a Desiccant. Each Bottle Contains 120 Tablets. Each Pack Contains One Bottle.

Marketing Authorization Holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
Phone: +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 250 mg Tablets
Czech Republic
Abirateron Aristo
Denmark
Abitateron Aristo
Spain
Abiraterona Aristo 250 mg Tablets EFG
Ireland
Abitaterone Aristo 250 mg Tablets
Germany
Abirateron Aristo 250 mg Tablets
Norway
Abirateron Aristo
Poland
Abitateron Aristo
Portugal
Abiraterona Aristo 250 mg Tablets
Slovakia
Abiraterone Aristo
Sweden
Abirateron Aristo
United Kingdom
Abitaterone Aristo 250 mg Tablets
Italy
Abiraterone Aristo 250 mg Tablets

Date of Last Revision of the Leaflet: