Abiral

Package Leaflet: Information for the Patient

Abiral, 500 mg, 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.

Table of Contents of the Leaflet

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

1. What Is Abiral and What Is It Used For

Abiral Is a Medicine That Contains Abiraterone Acetate. It Is Used in Adult Men for the Treatment of Prostate Cancer That Has Spread to Other Parts of the Body. Abiral Works by Blocking the Production of Testosterone in the Body; This Can Slow Down the Growth of Prostate Cancer. When Abiral Is Used at an Early Stage of the Disease That Responds to Hormonal Therapy, It Is Given Together with a Therapy That Lowers Testosterone Levels (Androgen Suppression 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 Buildup in the Body (Fluid Retention), or Low Potassium Levels in the Blood.

2. Important Information Before Taking Abiral

When Not to Take Abiral

• 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. Abiral 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 Medicine If Any of the Above Applies to You. If You Are in Doubt, Consult Your Doctor or Pharmacist Before Taking This Medicine.

Warnings and Precautions

Before Starting Treatment with Abiral, 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 Can Increase the Risk of Heart Rhythm Disorders)

Potassium Levels in the Blood Can Increase the Risk of Heart Rhythm Disorders

• If You Have Had Other Heart Diseases or Blood Vessel Diseases
• If You Have an Irregular or Rapid 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 Medicine Ketokonazole in the Past for the Treatment of Prostate Cancer
• 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 or Blood Vessel Disorders, Including Heart Rhythm Disorders (Arrhythmia) or If You Are Taking Medicines for These Disorders. Tell Your Doctor If You Have Yellowing of the Skin or Eyes, Dark Urine, Severe Nausea or Vomiting, Which Can Be Signs of Liver Function Disorders. Rarely, Liver Failure (Called Acute Liver Failure) Can Occur, Which Can Be Life-Threatening. A Decrease in Red Blood Cells, Decreased Sex Drive, Muscle Weakness, and (or) Muscle Pain Can Occur. Abiral Must Not Be Given 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 Abiral and Prednisone/Prednisolone, You Should Wait 5 Days Before Starting Ra-223 Treatment. If You Are in Doubt Whether Any of the Above Applies to You, Consult Your Doctor or Pharmacist Before Taking This Medicine.

Blood Tests

Abiral Can 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 Used in Children and Adolescents. If Abiral 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.

Abiral 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 Abiral Can Enhance the Effect 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 Change the Dose of These Medicines. Other Medicines Can Also Increase or Decrease the Effect of Abiral, Which Can Result in Side Effects or Reduced Effect of Abiral. Androgen Suppression Can 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)
• That Can Increase the Risk of Heart Rhythm Disorders [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 Abiral with Food

Do Not Take This Medicine with Food (See Section 3 "How to Take Abiral"). Taking Abiral with Food Can Cause Side Effects.

Pregnancy, Breastfeeding, and Fertility

Abiral Is Not Used in Women. This Medicine Can Harm an Unborn Child If Taken by a Pregnant Woman. If You Have Sex with a Woman Who May Become Pregnant, Use a Condom or Other Effective Contraceptive Method. If You Have Sex 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/Machines.

Abiral Contains Lactose and Sodium

Abiral Contains Lactose. If You Have Been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking This Medicine. This Medicine Contains 23 Mg of Sodium (a Major Component of Common Salt) per Daily Dose, Consisting of Two 500 Mg Tablets. This Corresponds to 1.2% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Take Abiral

Always Take This Medicine 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 (Two Tablets) Taken Once a Day.

How to Take

• Take the Medicine Orally.
• Do Not Take Abiral with Food.
• Taking Abiral with Food Can Cause More of the Medicine to Be Absorbed by the Body Than Necessary, Which Can Cause Side Effects.
• Take Abiral as a Single Dose Once a Day on an Empty Stomach. Take Abiral at Least 2 Hours After a Meal and Do Not Eat for at Least 1 Hour After Taking Abiral (See Section 2, "Taking Abiral with Food").
• Swallow the Tablets Whole with a Glass of Water.
• Do Not Crush the Tablets.
• Take Abiral Together with a Medicine Containing Prednisone or Prednisolone. Take Prednisone or Prednisolone as Directed by Your Doctor.
• Take Prednisone or Prednisolone Every Day While Taking Abiral.
• The Amount of Prednisone or Prednisolone Used May Need to Be Changed in Case of an Emergency. 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 Abiral and Prednisone or Prednisolone.

If You Take More Abiral Than You Should

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

If You Forget to Take Abiral

If You Forget to Take Abiral or Prednisone or Prednisolone, Take the Usual Dose the Next Day. If You Forget to Take Abiral or Prednisone or Prednisolone for More Than One Day, Contact Your Doctor Immediately.

Stopping Abiral Treatment

Do Not Stop Taking Abiral 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 Abiral and Contact Your Doctor Immediately If You Notice Any of the Following

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

Other 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 Lipid Levels in the Blood, Chest Pain, Heart Rhythm Disorders (Atrial Fibrillation), Heart Failure, Rapid 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 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 the ECG (Prolonged QT Interval), and Severe Allergic Reactions, Causing Difficulty Swallowing or Breathing, Swelling of the Face, Lips, Tongue, or Throat, or Itchy Rash.
In Men Treated for Prostate Cancer, Bone Density Loss Can Occur. Abiral in Combination with Prednisone or Prednisolone Can Enhance This Effect.

Reporting Side Effects

If You Experience Any Side Effects, Including Any Possible Side Effects Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. You Can Also Report Side Effects Directly to the Department of Drug Safety Monitoring, Office for Registration 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 Medicine.

5. How to Store Abiral

Keep This Medicine Out of the Sight and Reach of Children. Do Not Use This Medicine After the Expiry Date Stated on the Carton or Blister After "EXP:". The Expiry Date Refers to the Last Day of the Month Stated. This Medicine Does Not Require Special Storage Conditions. 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 Abiral Contains

• The Active Substance Is Abiraterone Acetate. Each Coated Tablet Contains 500 Mg of Abiraterone Acetate.
• The Other Ingredients Are: Microcrystalline Cellulose Type 102, Sodium Carboxymethylcellulose, Lactose Monohydrate, Magnesium Stearate, Hypromellose (Type 2910), Silica Colloidal Anhydrous, Sodium Lauryl Sulfate (See Section 2 "Abiral Contains Lactose and Sodium"). The Tablet Coating Contains: Iron Oxide Black (E 172), Iron Oxide Red (E 172), Macrogol/Polyvinyl Alcohol Graft Copolymer, Talc, and Titanium Dioxide (E 171).

What Abiral Looks Like and Contents of the Pack

Abiral Is Available as Oval, Biconvex, Coated Tablets, Purple in Color, with "500" Engraved on One Side of the Tablet and a Smooth Surface on the Other Side. Blisters of PVC/PVDC/Aluminum Are Packaged in Cardboard Boxes Containing 56 or 60 Coated Tablets. Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder

+pharma Arzneimittel GmbH
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
To Obtain More Detailed Information on This Medicine, Please Contact the Representative of the Marketing Authorization Holder:
+pharma Polska Sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel: +48 12 262 32 36
e-mail: [email protected]
Date of Last Revision of the Leaflet:November 2023