Abirateron Teva

Package Leaflet: Information for the User

Abirateron Teva, 500 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 or Pharmacist.
• -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 Experience Any of the Following Symptoms, Tell Your Doctor or Pharmacist. See Section 4.

Contents of the Pack and Other Information

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

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

Abirateron Teva Contains the Active Substance Abiraterone Acetate. It Is Used in Adult Men for the Treatment of Prostate Cancer That Has Spread to Other Parts of the Body. Abirateron Teva Works by Reducing the Amount of Testosterone in the Body; This Can Slow Down the Growth of Prostate Cancer.

When Abirateron Teva Is Used in Patients Whose Disease Has Responded to Hormone Therapy, It Is Given Together with a Medication to Lower Testosterone Levels (Androgen Deprivation Therapy).

During Treatment with Abirateron Teva, Your 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. Before You Take Abirateron Teva

When Not to Take Abirateron Teva

• If You Are Allergic to Abiraterone Acetate or Any of the Other Ingredients of This Medicine (Listed in Section 6).
• In Women, Especially Those Who Are Pregnant. Abirateron Teva Is for Use in Men Only.
• If You Have Severe Liver Damage.
• In Combination with Ra-223 (Used for the Treatment of Prostate Cancer).

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

Warnings and Precautions

Before Taking This Medicine, Discuss 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 Rhythms);

• If You Have Had Other Heart Problems or Blood Vessel Problems.
• If You Have an Irregular or Fast Heartbeat.
• If You Have Shortness of Breath.
• If Your Body Weight Has Increased Rapidly.
• If You Have Swelling of the Feet, Ankles, or Legs.
• If You Have Taken the Medication Ketokonazole in the Past for Prostate Cancer Treatment.
• The Need to Take This Medicine with Prednisone or Prednisolone.
• The Possibility of Side Effects Related to the Bones.
• If You Have High Blood Sugar Levels.

Tell Your Doctor If You Have Any Heart Problems or Blood Vessel Problems, Including Abnormal Heart Rhythms (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 Problems. In Rare Cases, Liver Failure (Called Acute Liver Failure) May Occur, Which Can Be Life-Threatening.

There May Be a Decrease in Red Blood Cell Count, Decreased Sex Drive (Libido), Muscle Weakness, and/or Muscle Pain.

Abirateron Teva 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 Abirateron Teva 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, Consult Your Doctor or Pharmacist Before Taking This Medicine.

Blood Tests

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

Children and Adolescents

This Medicine Is Not for Use in Children and Adolescents. If Abirateron Teva Is Accidentally Swallowed by a Child or Adolescent, Seek Immediate Medical Attention, Taking the Patient Information Leaflet with You to Show to the Doctor.

Abirateron Teva with Other Medicines

Before Taking Any Medication, Consult Your Doctor or Pharmacist.

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take. This Is Important Because Abirateron Teva May 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. Other Medicines May Also Increase or Decrease the Effects of Abirateron Teva, Which May Result in Side Effects or Reduced Effectiveness of Abirateron Teva.

Androgen Deprivation Therapy May Increase the Risk of Abnormal Heart Rhythms. Tell Your Doctor If You Are Taking Medicines for Abnormal Heart Rhythms (Such as Quinidine, Procainamide, Amiodarone, and Sotalol) or Medicines That May Increase the Risk of Abnormal Heart Rhythms [Such as Methadone (Pain Relief and Addiction Treatment) and Moxifloxacin (Antibiotic)].

Taking Abirateron Teva with Food

• This Medicine Must Not Be Taken with Food (See Section 3 "How to Take Abirateron Teva").
• Taking Abirateron Teva with Food May Cause Side Effects.

Pregnancy and Breastfeeding

Abirateron Teva Is Not for Use in Women.

• - The Medicine May Harm the Unborn Baby If Taken by a Pregnant Woman.
• - Women Who Are Pregnant or May Become Pregnant Should Wear Protective Gloves When Handling Abirateron Teva.
• - 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 Baby.

Driving and Using Machines

It Is Unlikely That This Medicine Will Affect Your Ability to Drive or Use Tools and Machines.

Abirateron Teva Contains Lactose and Sodium

Abirateron Teva Contains Lactose. If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicine.

Abirateron Teva Contains Sodium. This Medicine Contains Less Than 1 Mmol (23 Mg) of Sodium per Tablet, Which Means It Is Essentially "Sodium-Free".

3. How to Take Abirateron Teva

Always Take This Medicine Exactly as Your Doctor or Pharmacist Has Told You. If You Are Not Sure, Consult 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 It

• Take by Mouth.
• Do Not Take Abirateron Teva with Food.Taking Abirateron Teva with Food May Cause More of the Medicine to Be Absorbed by the Body Than Is Necessary, Which May Cause Side Effects.
• Take Abirateron Teva as a Single Dose Once a Day on an Empty Stomach. Take Abirateron Teva at Least 2 Hours After a Meal and Do Not Eat for at Least 1 Hour After Taking Abirateron Teva (See Section 2, "Taking Abirateron Teva with Food").
• Swallow the Tablets Whole with a Glass of Water.
• Do Not Crush the Tablets.
• Take Abirateron Teva with a Medication Called Prednisone or Prednisolone. Take Prednisone or Prednisolone as Directed by Your Doctor.
• Take Prednisone or Prednisolone Every Day While Taking Abirateron Teva.
• 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 Consulting Your Doctor.

Your Doctor May Also Prescribe Other Medicines for You to Take with Abirateron Teva and Prednisone or Prednisolone.

If You Take More Abirateron Teva Than You Should

If You Take More Abirateron Teva Than You Should, Contact Your Doctor or Go to the Hospital Immediately.

If You Forget to Take Abirateron Teva

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

Stopping Abirateron Teva Treatment

Do Not Stop Taking Abirateron Teva or Prednisone or Prednisolone Without Consulting 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 Abirateron Teva and Contact Your Doctor Immediately If You Notice Any of the Following Symptoms:

• Muscle Weakness, Muscle Tremors, or Heart Pounding (Palpitations). These May Be Symptoms 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 Fat Levels in the Blood, Chest Pain, Abnormal Heart Rhythms (Atrial Fibrillation), Heart Failure, Fast Heartbeat, Severe Infections (Septicaemia), 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 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 ECG (Prolonged QT Interval), and Severe Allergic Reactions, Causing Difficulty Swallowing or Breathing, Face, Lip, Tongue, or Throat Swelling, or Itchy Rash.

In Men Treated for Prostate Cancer, There May Be a Loss of Bone Mass. Abirateron Teva in Combination with Prednisone and Prednisolone May Increase This Effect.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, Tell Your Doctor or Pharmacist.

Side Effects Can Be Reported Directly to the Department of Medicinal Product Monitoring, Urzad Rejestracji Produktow Leczniczych, Wyrobów Medycznych i Produktow Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.

Side Effects Can Also Be Reported to the Marketing Authorization Holder.

By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Abirateron Teva

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 Carton and Blister After EXP. The Expiry Date Refers to the Last Day of That Month.

Do Not Store Above 25°C.

Do Not Throw Away Any Medicines via Wastewater or Household Waste. Ask Your Pharmacist How to Throw Away Medicines You No Longer Use. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Abirateron Teva Contains

• The Active Substance Is Abiraterone Acetate. Each Tablet Contains 500 Mg of Abiraterone Acetate, Which Corresponds to 446.3 Mg of Abiraterone.
• The Other Ingredients Are Lactose Monohydrate, Sodium Lauryl Sulfate, Croscarmellose Sodium, Microcrystalline Cellulose Type 101, Microcrystalline Cellulose Type 102, Povidone K30, Magnesium Stearate, and Colloidal Anhydrous Silica. The Coating Contains Partially Hydrolyzed Polyvinyl Alcohol (E1203), Titanium Dioxide (E 171), Macrogol (E1521), Talc (E553b), and Yellow Iron Oxide (E172).

What Abirateron Teva Looks Like and Contents of the Pack

Abirateron Teva Is a Yellow, Prolonged-Release Tablet with the Imprint "A436" on One Side.

Abirateron Teva Is Available in Blisters Containing 14, 56, 60, or 120 Film-Coated Tablets or in Perforated Unit-Dose Blisters Containing 14x1, 56x1, 60x1, or 120x1 Film-Coated Tablets.

Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer/Importer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa, 2600

Bulgaria

Teva Operations Poland Sp. z o.o.

Ul. Mogilska 80

31-546 Krakow

Merckle GmbH

Graf-Arco-Str. 3

89079 Ulm

Baden-Wuerttemberg

Germany

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

In Order to Obtain More Detailed Information, Please Consult Your Local Representative of the Marketing Authorization Holder:

Teva Pharmaceuticals Polska Sp. z o.o.

Ul. Emilii Plater 53

00-113 Warsaw

Tel: (22) 345 93 00.

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

Member State - Marketing Authorization Holder

Austria

Abirateron ratiopharm 500 mg Filmtabletten

Belgium

Abirateron Teva 500 mg filmomhulde tabletten/comprimés pélliculés/Filmtabletten

Bulgaria

Абиратерон Тева 500 mg филмирани таблетки

Abiraterone Teva 500 mg film-coated tablets

Czech Republic

Abirateron Teva

Germany

Abirateronacetat-ratiopharm 500 mg Filmtabletten

Denmark

Abirateron Teva

Estonia

Abirateron Teva

Greece

Abiraterone Acetate/Teva 500 mg Επικαλυμμένα με λεπτό υμένιο δισκία

Spain

Abiraterona acetato Teva 500 mg comprimidos recubiertos con película EFG

Finland

Abiraterone ratiopharm 500 mg tabletti, kalvopäällysteinen

France

ABIRATERONE TEVA 500mg, comprimé

Croatia

Abirateron Teva 500 mg filmom obložene tablete

Hungary

Abirateron Teva 500 mg filmtabletta

Ireland

Abiraterone Acetate Teva 500 mg Film-coated tablets

Iceland

Abirateron Teva

Italy

Abiraterone Teva

Lithuania

Abiraterone Teva 500 mg plėvele dengtos tabletės

Latvia

Abiraterone Teva 500 mg apvalkotās tabletes

Netherlands

Abirateronacetaat Teva 500 mg, filmomhulde tabletten

Norway

Abirateron Teva

Poland

Abirateron Teva

Portugal

Abirateron Teva

Romania

Abirateronă Teva 500 mg comprimate filmate

Sweden

Abirateron Teva

Slovenia

Abirateron Teva 500 mg filmsko obložene tablete

Slovakia

Abiraterón Teva 500 mg filmom obalené tablety

United Kingdom

Abiraterone Acetate Teva 500 mg Film-coated Tablets

Date of Last Revision of the Leaflet: December 2023