Abiraterone Sandoz

Package Leaflet: Information for the User

Abiraterone Sandoz, 1000 mg, Film-Coated Tablets

Abiraterone Acetate

Read All of This Leaflet Carefully Before Taking This Medicine Because It Contains Important Information for You.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medicine Has Been Prescribed for You Only. Do Not Pass It on to Others. It May Harm Them, Even if Their Signs of Illness Are the Same as Yours.
• If You Get 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 and Other Information

• 1. What Is Abiraterone Sandoz and What Is It Used For
• 2. Before You Take Abiraterone Sandoz
• 3. How to Take Abiraterone Sandoz
• 4. Possible Side Effects
• 5. How to Store Abiraterone Sandoz
• 6. Contents of the Pack and Other Information

1. What Is Abiraterone Sandoz and What Is It Used For

Abiraterone Sandoz Is a Medicinal Product Containing Abiraterone Acetate. It Is Used in Adult Men to Treat Prostate Cancer That Has Spread to Other Parts of the Body, as Well as in Adult Men to Treat Prostate Cancer That Has Not Spread to Other Parts of the Body.
Abiraterone Sandoz Works by Reducing the Production of Testosterone in the Body; This Can Slow Down the Growth of Prostate Cancer.
When Abiraterone Sandoz Is Used at an Early Stage of the Disease in Response to Hormone Therapy, It Is Given Together with a Therapy That Lowers Testosterone Levels (Androgen Deprivation 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. Before You Take Abiraterone Sandoz

When Not to Take Abiraterone Sandoz

• If You Are Allergic to Abiraterone Acetate or Any of the Other Ingredients of This Medicinal Product (Listed in Section 6).
• In Women, Especially During Pregnancy. Abiraterone Is Used Only in Men.
• If You Have Severe Liver Damage
• In Combination with Ra-223 (Used to Treat Prostate Cancer).

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

Warnings and Precautions

Before You Start Taking This Medicinal Product, Discuss This with Your Doctor or Pharmacist:

• If You Have Liver Problems;
• 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 Rhythm);
• If You Have Had Other Heart or Blood Vessel Diseases;
• If You Have an Irregular or Rapid Heartbeat;
• If You Have Shortness of Breath;
• If Your Body Weight Has Increased in a Short Time;
• If You Have Swelling of the Feet, Ankles, or Legs;
• If You Have Taken the Medicinal Product Ketokonazole in the Past to Treat Prostate Cancer;
• The Need to Take This Medicinal Product with Prednisone or Prednisolone;
• The Possibility of Side Effects Related to Bones;
• If You Have High Blood Sugar Levels.

Tell Your Doctor If You Have Any Heart or Blood Vessel Diseases, 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, Severe Nausea or Vomiting, Which May Be Signs of Liver Problems. Rarely, Liver Problems (Called Acute Liver Failure) May Occur, Which Can Be Life-Threatening.
There May Be a Decrease in Red Blood Cells, Decreased Sex Drive (Libido), Muscle Weakness, and (or) Muscle Pain.
Abiraterone Sandoz 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 Sandoz and Prednisone/Prednisolone, You Should Wait 5 Days Before Starting Ra-223 Treatment.
If You Are Not Sure If Any of the Above Applies to You, Talk to Your Doctor or Pharmacist Before Taking This Medicinal Product.

Blood Tests

Abiraterone May Affect Liver Function, and You May Not Have Any Symptoms.
During Treatment with This Medicinal Product, Your Doctor Will Regularly 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 Abiraterone Is Accidentally Swallowed by a Child or Adolescent, You Should Immediately Go to the Hospital and Bring This Leaflet with You to Show to the Doctor.

Abiraterone Sandoz and Other Medicinal Products

Before Taking Any Medicinal Product, Ask Your Doctor or Pharmacist for Advice.
Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, as Well as Medicines You Plan to Take. This Is Important Because Abiraterone May Increase the Effect of Many Medicines, Including Medicines for the Heart, Sedatives, Certain Anti-Diabetic Medicines, Herbal Medicines (Such as St. John's Wort), and Others. Your Doctor May Change the Dose of These Medicines. Other Medicines May Also Increase or Decrease the Effect of Abiraterone.
This May Result in Side Effects or Abiraterone Not Working Properly.
Androgen Deprivation Therapy May Increase the Risk of Abnormal Heart Rhythm. Tell Your Doctor If You Are Taking Medicines:

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

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

Taking Abiraterone Sandoz with Food

• This Medicinal Product Must Not Be Taken with Food (See Section 3, "How to Take Abiraterone Sandoz").
• Taking Abiraterone Sandoz with Food May Cause Side Effects.

Pregnancy and Breast-Feeding

Abiraterone Sandoz 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, You Should Use a Condom or Other Effective Contraception 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 Medicinal Product Will Affect Your Ability to Drive or Use Tools and Machines.

Abiraterone Sandoz Contains Lactose and Sodium

• Abiraterone Sandoz Contains Lactose (a Type of Sugar). If You Have Been Diagnosed with an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicinal Product.
• This Medicinal Product Contains Less Than 1 Mmol (23 Mg) of Sodium per Dose, Which Means It Is Essentially "Sodium-Free".

3. How to Take Abiraterone Sandoz

This Medicinal Product Should Always Be Taken Exactly as Prescribed by Your Doctor or Pharmacist. If You Are Not Sure, Ask Your Doctor or Pharmacist.

How Much to Take

The Recommended Dose Is 1000 Mg (One Tablet) Taken Once a Day.

How to Take

• Take by Mouth.
• Do Not Take Abiraterone Sandoz with Food.
• Take Abiraterone Sandoz at Least 1 Hour Before or at Least 2 Hours After Food(See Section 2, "Taking Abiraterone Sandoz with Food").
• Swallow the Tablets with a Glass of Water. The Tablet Can Be Divided into Equal Doses.
• Abiraterone Sandoz Is Taken Together with a Medicinal Product Called Prednisone or Prednisolone. Take Prednisone or Prednisolone as Prescribed by Your Doctor.
• Take Prednisone or Prednisolone Every Day While Taking Abiraterone Sandoz.
• 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 Abiraterone Sandoz and Prednisone or Prednisolone.

If You Take More Abiraterone Sandoz 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 Abiraterone Sandoz

• If You Forget to Take Abiraterone Sandoz, Prednisone, or Prednisolone, Take the Normal Dose the Next Day.
• If You Forget to Take Abiraterone Sandoz, Prednisone, or Prednisolone for More Than One Day, Contact Your Doctor Immediately.

If You Stop Taking Abiraterone Sandoz

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

4. Possible Side Effects

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

Stop Taking Abiraterone Sandoz and Contact Your Doctor Immediately If You Notice Any of the Following:

• Muscle Weakness, Muscle Tremors (Trembling), or Heart Pounding (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, Increased Liver Function Test Results, High Blood Pressure, Urinary Tract Infections, Diarrhea.
Common(May Affect Up to 1 in 10 People):
High Levels of Lipids (Fats) in the Blood, Chest Pain, Abnormal Heart Rhythm (Atrial Fibrillation), Heart Failure, Rapid Heartbeat, 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 Electrolyte Imbalance), Abnormal Heart Rhythm (Arrhythmia), Muscle Weakness and (or) Muscle Pain.
Rare(May Affect Up to 1 in 1000 People):
Lung Inflammation (Also Known as Hypersensitivity Pneumonitis). Acute Liver Failure.
Frequency Not Known(Cannot Be Estimated from the Available Data):
Heart Attack, Changes in the ECG (Prolonged Qt Interval), and Severe Allergic Reactions, Causing Difficulty Swallowing or Breathing, Face, Lip, Tongue, or Throat Swelling, or Itchy Rash.
There May Be a Loss of Bone Mass in Men Treated for Prostate Cancer. Abiraterone Sandoz in Combination with Prednisone and Prednisolone May Increase This Effect.

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Pharmacist or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. You Can Also Report Side Effects Directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
You Can Also Report Side Effects to the Marketing Authorization Holder.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicinal Product.

5. How to Store Abiraterone Sandoz

• Keep This Medicinal Product Out of the Sight and Reach of Children.
• Do Not Use This Medicinal Product After the Expiry Date Which Is Stated on the Carton and Blister After EXP. The Expiry Date Refers to the Last Day of That Month.
• There Are No Special Storage Conditions for This Medicinal Product.
• 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 Sandoz Contains

• The Active Substance Is Abiraterone Acetate. Each Tablet Contains 1000 Mg of Abiraterone Acetate.
• The Other Ingredients Are: Croscarmellose Sodium, Sodium Lauryl Sulfate, Povidone K30, Microcrystalline Cellulose Type 102, Lactose Monohydrate, Colloidal Anhydrous Silica, Magnesium Stearate (See Section 2, "Abiraterone Sandoz Contains Lactose and Sodium"). Coating - Opadry II 85F18422 White: Polyvinyl Alcohol, Titanium Dioxide (E 171), Macrogol 3350, Talc.

What Abiraterone Sandoz Looks Like and Contents of the Pack

• Abiraterone Sandoz Tablets Are White or Almost White, Oval, Film-Coated with a Score Line on One Side and Smooth on the Other, 23.1 Mm x 11.1 Mm in Size.
• The Film-Coated Tablets Are Packaged in:
• Aluminum/OPA/Aluminum/PVC Blister Packs Containing 30 Film-Coated Tablets in a Carton,
• Perforated Unit-Dose Aluminum/OPA/Aluminum/PVC Blister Packs Containing 30x1 Film-Coated Tablet in a Carton.

Marketing Authorization Holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056, Limassol
Cyprus
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526, Ljubljana
Slovenia

This Medicinal Product Is Authorized in the Member States of the European Economic Area (EEA) and in the United Kingdom (Northern Ireland) Under the Following Names:

Netherlands
Abiraterone Sandoz 1000 mg, filmomhulde tabletten
Austria
Abirateron Sandoz 1000 mg – Filmtabletten
Czech Republic
Abiraterone Sandoz
Germany
Abirateron HEXAL 1000 mg Filmtabletten
Denmark
Abirateron Sandoz
Estonia
Abiraterone Sandoz
Spain
Abiraterona 1.000 mg comprimidos recubiertos con película
Finland
Abirateron Sandoz 1000 mg kalvopäällysteinen tabletti
France
ABIRATERONE SANDOZ 1000 mg, comprimé pelliculé
Greece
Abiraterone/Sandoz επικαλυμμένα με λεπτό υμένιο δισκία 1000 mg
Croatia
Abirateron Sandoz 1000 mg filmom obložene tablete
Hungary
Abiraterone Sandoz 1000 mg filmtabletta
Italy
Abiraterone Sandoz GmbH
Lithuania
Abiraterone Sandoz 1000 mg plėvele dengtos tabletės
Latvia
Abiraterone Sandoz 1000 mg apvalkotās tabletes
Norway
Abirateron Sandoz
Poland
Abiraterone Sandoz
Portugal
Abiraterona Sandoz
Sweden
Abirateron Sandoz
Slovakia
Abiraterón Sandoz 1000 mg filmom obalené tablety
Northern Ireland
Abiraterone Sandoz 1000 mg film-coated tablets

For Further Information on This Medicinal Product, Contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of Last Revision of the Leaflet:07/2024
(Logo of the Marketing Authorization Holder)