Abiraterone Rihter

Package Leaflet: Information for the User

Abiraterone Richter, 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 Symptoms Are the Same as Yours.
• If You Experience Any of the Following Side Effects, or Any Other Side Effects Not Mentioned in This Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Contents of the Pack

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

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

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

When Abiraterone Richter 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 Medicine, Your Doctor Will Also Prescribe Another Medicine Called Prednisone or Prednisolone. This Is to Reduce the Risk of High Blood Pressure, Fluid Retention (Edema), or Low Potassium Levels in the Blood.

2. Before You Take Abiraterone Richter

Do Not Take Abiraterone Richter:

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

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

Warnings and Precautions

Before You Start Taking This Medicine, Talk to Your Doctor or Pharmacist If:

• You Have Liver Disease;
• 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);
• You Have Had Other Heart or Blood Vessel Diseases;
• You Have an Irregular or Rapid Heartbeat;
• You Have Shortness of Breath;
• Your Body Weight Has Increased Rapidly;
• You Have Swelling of the Feet, Ankles, or Legs;
• You Have Taken the Medicine Ketokonazole in the Past to Treat Prostate Cancer;
• You Need to Take This Medicine with Prednisone or Prednisolone;
• There Is a Possibility of Side Effects Related to the Bones;
• 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 Failure (Called Acute Liver Failure) May Occur, Which Can Be Life-Threatening.

A Decrease in Red Blood Cells, Decreased Sex Drive (Libido), Muscle Weakness, and (or) Muscle Pain May Occur.

Abiraterone Richter 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 Richter 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 Medicine.

Blood Tests

Abiraterone Richter May Affect the Liver, 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 Used in Children and Adolescents. If Abiraterone Richter Is Accidentally Swallowed by a Child or Adolescent, Go to the Hospital Immediately, Taking the Patient Information Leaflet with You to Show to the Doctor in the Emergency Room.

Abiraterone Richter with Other Medicines

Before Taking Any Medicine, 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 Abiraterone Richter May Increase the Effect of Many Medicines, Including Medicines for the Heart, Sedatives, Certain Anti-Diabetic Medicines, Herbal Medicines (e.g., St. John's Wort), and Others. Your Doctor May Need to Change the Dose of These Medicines. Also, Other Medicines May Increase or Decrease the Effect of Abiraterone Richter. This May Result in Side Effects or Reduced Effect of Abiraterone Richter.

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

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

Taking Abiraterone Richter with Food

Do Not Take This Medicine with Food (See Section 3, "How to Take Abiraterone Richter").

Taking Abiraterone Richter with Food May Cause Side Effects.

Pregnancy and Breastfeeding

Abiraterone Richter Is Not Used in Women.

• This Medicine May Harm the Unborn Child If Taken by a Pregnant Woman.
• If You Have Sex with a Woman Who May Become Pregnant, You Should Use a Condom and Another Effective Method of Contraception.
• If You Have Sex with a Pregnant Woman, You Should Use a Condom to Protect the Unborn Child.

Driving and Using Machines

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

Abiraterone Richter Contains Lactose and Sodium

This Medicinal Product Contains 240.5 Mg of Lactose. If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicine.

This Medicine Contains 24 Mg of Sodium (the Main Component of Common Salt) in Each Dose Consisting of Two 500 Mg Tablets. This Is Equivalent to 1% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Take Abiraterone Richter

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

How Much to Take

The Recommended Dose Is 1000 Mg (Two Tablets) Taken Once a Day.

How to Take It

• Take by Mouth.
• Do Not Take Abiraterone Richter with Food.Taking Abiraterone Richter with Food May Cause Side Effects.
• Take the Tablets on an Empty Stomach. Take the Abiraterone Richter Tablets as a Single Dose Once a Day, at Least 2 Hours After Eating and Not Eat for at Least 1 Hour After Taking the Tablets(See Section 2, "Taking Abiraterone Richter with Food").
• Swallow the Tablets Whole with a Glass of Water.
• Do Not Crush the Tablets.
• Take Abiraterone Richter with a Medicine Called Prednisone or Prednisolone. Take Prednisone or Prednisolone as Directed by Your Doctor.
• Take Prednisone or Prednisolone Every Day While Taking Abiraterone Richter.
• The Amount of Prednisone or Prednisolone You Take May Need to Be Changed. Your Doctor Will Tell You If You Need to Change the Dose.

Do Not Stop Taking Prednisone or Prednisolone Without Talking to Your Doctor.

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

If You Take More Abiraterone Richter Than You Should

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

If You Forget to Take Abiraterone Richter

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

If You Stop Taking Abiraterone Richter

Do Not Stop Taking Abiraterone Richter or Prednisone or Prednisolone Without Talking to 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 Abiraterone Richter and Contact Your Doctor Immediately If You Notice Any of the Following:

• 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 Legs.
• Low Potassium Levels in the Blood.
• High Results of Liver Function Tests.
• High Blood Pressure.
• Urinary Tract Infections.
• Diarrhea.

Common(May Affect Up to 1 in 10 People):

• High Levels of Lipids in the Blood.
• Chest Pain, Abnormal Heart Rhythm (Atrial Fibrillation), Heart Failure, Rapid Heart Rate.
• Severe Infection Called 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 1,000 People):

• Lung Inflammation (Also Known as Allergic Alveolitis).
• Liver Failure (Also Known as Acute Liver Failure).

Frequency Not Known(Cannot Be Estimated from the Available Data):

• Heart Attack, Changes in the ECG (Electrocardiogram) - Prolongation of the QT Interval, and Severe Allergic Reactions with Difficulty Swallowing or Breathing, Swelling of the Face, Lips, Tongue, or Throat, or Itchy Rash.

Bone Loss May Occur in Men with Prostate Cancer Treated with Abiraterone Richter. Abiraterone Richter in Combination with Prednisone and Prednisolone May Increase Bone Loss.

Reporting of Side Effects

If You Experience Any Side Effects, or Any Other Side Effects Not Mentioned in This Leaflet, Tell Your Doctor or Pharmacist or Nurse. Side Effects Can Be Reported to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to Store Abiraterone Richter

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 Blister and Carton After EXP.

The Expiry Date Refers to the Last Day of the Month.

There Are No Special Storage Conditions for This Medicine.

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 Abiraterone Richter Contains

The Active Substance 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, Silica Colloidal Anhydrous, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide (E 171), Macrogol 3350, Talc, Iron Oxide Red (E 172), Iron Oxide Black (E 172).

What Abiraterone Richter Looks Like and Contents of the Pack

Abiraterone Richter Film-Coated Tablets Are Purple, Oval, Approximately 19 Mm Long and 11 Mm Wide, with "A7TN" Engraved on One Side and "500" on the Other Side.

The Tablets Are Available in Blisters of PVC/PVDC/Aluminum in a Cardboard Box. Each Pack Contains 60 Film-Coated Tablets.

Marketing Authorisation Holder

Gedeon Richter Polska Sp. z o.o.

Ul. Ks. J. Poniatowskiego 5

05-825 Grodzisk Mazowiecki

Manufacturer

Synthon Hispania, S.L.

C/Castelló 1

Sant Boi de Llobregat,

08830 Barcelona

Spain

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

Gedeon Richter Plc.

Gyömrői út 19-21

1103 Budapest

Hungary

This Medicinal Product Is Authorised in the Member States of the European Economic Area Under the Following Names:

Bulgaria:

Abiraterone Richter 500 mg film-coated tablets

Czech Republic:

Abiraterone Richter 500 mg coated tablets

Estonia:

Abiraterone Richter

Hungary:

Abiraterone Richter 500 mg filmtabletta

Latvia:

Abiraterone Richter 500 mg film-coated tablets

Lithuania:

Abiraterone Richter 500 mg film-coated tablets

Poland:

Abiraterone Richter

Romania:

Abiraterone Richter 500 mg film-coated tablets

For Any Further Information on This Medicinal Product, Please Contact:

Gedeon Richter Polska Sp. z o.o.

Medical Department

Ul. Ks. J. Poniatowskiego 5

05-825 Grodzisk Mazowiecki

Tel.: +48 (22) 755 96 48

lekalert@grodzisk.rgnet.org

Date of Last Revision of the Leaflet: November 2022