Abiraterone Orion

Package Leaflet: Information for the Patient

Abiraterone Orion, 500 mg, Film-Coated 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 Side Effects, Tell Your Doctor or Pharmacist. See Section 4.

Contents of the Pack

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

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

Abiraterone Orion 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. This Medicine Works by Reducing the Amount of Testosterone in the Body; This Can Slow Down the Growth of Prostate Cancer.

When This Medicine Is Used in Early Stages of Hormone-Responsive Prostate Cancer, It Is Given Together with a Medication to Lower Testosterone Levels (Androgen Deprivation Therapy).

While Taking 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, or Low Potassium Levels in the Blood.

2. Before You Take Abiraterone Orion

When Not to Take Abiraterone Orion

• 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. This Medicine Is Only Used in Men;
• In Patients with Severe Liver Damage;
• In Combination with 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, Consult Your Doctor or Pharmacist Before Taking This Medicine.

Warnings and Precautions

Before Starting Treatment with Abiraterone Orion, Discuss with Your Doctor or Pharmacist:

• If You Have Liver Disease;
• 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 Heart Rhythm Disorders);
• If You Have Had Other Heart or Blood Vessel Diseases in the Past;
• 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 Ketoconazole in the Past to Treat Prostate Cancer;
• The Need to Take This Medicine with Prednisone or Prednisolone;
• The Possibility of Side Effects Related to Bones;
• If You Have High Blood Sugar Levels;
• If You Have Had Other Heart or Blood Vessel Diseases in the Past, Including Heart Rhythm Disorders (Arrhythmia), or Have Been Treated with Medicines Used for These Conditions;
• If You Have Yellowing of the Skin or Eyes, Dark Urine, 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 Red Blood Cells, Decreased Sex Drive (Libido), Muscle Weakness, and (or) Muscle Pain.

This Medicine Must Not Be Used 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 and Prednisone/Prednisolone, You Should Wait 5 Days Before Starting Ra-223 Treatment.

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

Blood Tests

This Medicine May Affect Liver Function, and You May Not Have Any Symptoms.

During Treatment with This Medicine, Your Doctor Will Regularly Prescribe Blood Tests to Check the Effect of the Medicine on the Liver.

Children and Adolescents

This Medicine Is Not Intended for Use in Children and Adolescents.

If This Medicine Is Accidentally Swallowed by a Child, Seek Immediate Medical Attention and Bring the Package Leaflet to Show the Doctor.

Abiraterone Orion and Other Medicines

Before Taking Any Medicine, Consult Your Doctor or Pharmacist.

Tell Your Doctor or Pharmacist About All Medicines You Are Currently Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.

This Is Important Because This Medicine May Enhance the Effects of Many Medicines, Including Heart Medicines, Sedatives, Certain Anti-Diabetic Medicines, Herbal Medicines (e.g., 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 Effect of This Medicine.

This Can Result in Side Effects or Reduced Effectiveness of This Medicine.

Androgen Deprivation Therapy May Increase the Risk of Heart Rhythm Disorders.

Tell Your Doctor If You Are Taking Medicines Used to Treat Heart Rhythm Disorders (e.g., Quinidine, Procainamide, Amiodarone, and Sotalol);

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

Abiraterone Orion with Food

• Do Not Take This Medicine with Food (See Section 3, "How to Take Abiraterone Orion").
• Taking This Medicine with Food May Cause Side Effects.

Pregnancy and Breastfeeding

This Medicine Is Not Used in Women.

• This Medicine 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.

Driving and Using Machines

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

Abiraterone Orion Contains Lactose

This Medicine Contains 241 Mg of Lactose (as Lactose Monohydrate) per Tablet.

If You Have Been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking This Medicine.

Other Excipients

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

3. How to Take Abiraterone Orion

Always Take This Medicine Exactly as Your Doctor Has Told You.

If You Are Not Sure, Consult Your Doctor or Pharmacist.

What Dose to Take

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

How to Take Abiraterone Orion

• Take This Medicine by Mouth.
• Do Not Take This Medicine with Food.
• Take the Tablets as a Single Dose Once a Day on an Empty Stomach.
• Take This Medicine at Least 2 Hours After Eating and Do Not Eat for at Least 1 Hour After Taking This Medicine (See Section 2, "Abiraterone Orion with Food").
• Swallow the Tablets Whole with a Glass of Water.
• Do Not Crush the Tablets.
• This Medicine Is Taken with a Medicine Called Prednisone or Prednisolone.
• Take Prednisone or Prednisolone as Directed by Your Doctor.
• Take Prednisone or Prednisolone Every Day While Taking This Medicine.
• 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 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 This Medicine and Prednisone or Prednisolone.

If You Take More Abiraterone Orion Than You Should

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

If You Forget to Take Abiraterone Orion

• If You Forget to Take This Medicine or Prednisone or Prednisolone, Take the Usual Dose the Next Day.
• If You Forget to Take This Medicine or Prednisone or Prednisolone for More Than a Day, Contact Your Doctor Immediately.

If You Stop Taking Abiraterone Orion

Do Not Stop Taking This Medicine or Prednisone or Prednisolone Without Consulting Your Doctor.

If You Have Any Further Questions on the Use of This Medicine, 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 This Medicine and Contact Your Doctor Immediately If You Notice Any of the Following:

Tell Your Doctor or Pharmacist If You Experience Any of the Following:

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

Additional Side Effects:

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 Levels of Fats in the Blood, Chest Pain, Heart Rhythm Disorders (Atrial Fibrillation), Heart Failure, Fast Heartbeat, Severe Infections - 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 1000 People):
Lung Inflammation (Also Known as Allergic Alveolitis).
Liver Failure (Also Known as Acute Liver Failure).
Frequency Not Known (Frequency Cannot Be Estimated from the Available Data):
Heart Attack, Changes in ECG (Prolonged 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 Treated for Prostate Cancer. This Medicine in Combination with Prednisone and Prednisolone May Enhance This Effect.

Reporting Side Effects

If You Experience Any Side Effects, Tell Your Doctor or Pharmacist.

Side Effects Can Be Reported Directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Phone: +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.

Reporting Side Effects Will Help to Gather More Information on the Safety of This Medicine.

5. How to Store Abiraterone Orion

• Keep This Medicine Out of the Sight and Reach of Children.
• Do Not Use This Medicine After the Expiry Date Stated on the Carton, Label, and Blister.
• There Are No Special Storage Conditions for This Medicine.
• 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 to Protect the Environment.

6. Contents of the Pack and Other Information

What Abiraterone Orion Contains

• The Active Substance Is Abiraterone Acetate. Each Tablet Contains 500 Mg of Abiraterone Acetate.
• The Other Ingredients Are: Tablet Core: Lactose Monohydrate, Microcrystalline Cellulose Type 102, Sodium Carboxymethylcellulose, Hypromellose 2910, Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, and Magnesium Stearate. Tablet Coating Opadry II 85F90093 Purple: Polyvinyl Alcohol, Titanium Dioxide (E 171), Macrogol 3350, Talc, Iron Oxide Red (E 172), Iron Oxide Black (E 172).

What Abiraterone Orion Looks Like and Contents of the Pack

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

Pack Sizes:

Blister: 56 Tablets

Marketing Authorization Holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
Synthon Hispania S.L.
Calle De Castelló 1
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
Netherlands