Abiraterone Pharmascience

Package Leaflet: Information for the Patient

Abiraterone Pharmascience, 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 Side Effects, Including Any Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Contents of the Pack

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

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

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

When Abiraterone Pharmascience Is Used at an Early Stage of the Disease in Patients Whose Cancer Has Responded to Hormone Treatment, It Is Given Together with a Treatment 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 (Fluid Build-Up in the Body), or Low Potassium Levels in the Blood.

2. Before You Take Abiraterone Pharmascience

Do Not Take Abiraterone Pharmascience

• If You Are Allergic to Abiraterone or Any of the Other Ingredients of This Medicine (Listed in Section 6),
• In Women, Especially If Pregnant. Abiraterone Pharmascience 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 Abiraterone Pharmascience.

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 Heart Rhythm Problems),
• If You Have Had Other Heart or Blood Vessel Diseases,
• If You Have an Irregular or Fast 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 Medicine Ketokonazole in the Past to Treat Prostate Cancer,
• If You Need to Take This Medicine with Prednisone or Prednisolone,
• If You May Have Side Effects on the Bones,
• If You Have High Blood Sugar Levels.

Tell Your Doctor If You Have Any Heart or Blood Vessel Diseases, Including Heart Rhythm Problems (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.

You May Have a Decrease in Red Blood Cells, Decreased Sex Drive (Libido), Muscle Weakness, and/or Muscle Pain.

Abiraterone Pharmascience Must Not Be Taken with a Medicine Called Ra-223 Due to the Possible Increased Risk of Bone Fractures or Death. If You Are Going to Take Ra-223 After Treatment with Abiraterone Pharmascience 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 Abiraterone Pharmascience.

Blood Tests

Abiraterone Pharmascience May Affect Your Liver and You May Not Have Any Symptoms. While Taking This Medicine, Your Doctor Will Regularly Prescribe Blood Tests to Check How It Affects Your Liver.

Children and Adolescents

This Medicine Is Not Used in Children and Adolescents. If Abiraterone Pharmascience Is Accidentally Swallowed by a Child or Adolescent, Go to the Hospital Immediately with the Patient Information Leaflet to Show to the Doctor.

Abiraterone Pharmascience with Other Medicines

Before Taking Any Medicine, 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 Pharmascience May Increase the Effects of Many Medicines, Including Medicines for the Heart, Sedatives, Certain Diabetes 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 Effects of Abiraterone Pharmascience. This May Result in Side Effects or the Medicine Not Working Properly.

Androgen Deprivation Therapy May Increase the Risk of Heart Rhythm Problems. Tell Your Doctor If You Are Taking Medicines:

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

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

Taking Abiraterone Pharmascience with Food

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

Pregnancy, Breast-Feeding, and Fertility

Abiraterone Pharmascience 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 or Other Effective Contraception Method.
• 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 Pharmascience Contains Lactose and Sodium

• Abiraterone Pharmascience Contains Lactose (a Type of Sugar). If You Have Been Told You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicine.
• This Medicine Contains Less Than 1 Mmol of Sodium (23 Mg) per Two Tablets, Which Is the Daily Dose, and Is Therefore Considered "Sodium-Free".

3. How to Take Abiraterone Pharmascience

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 This Medicine by Mouth.
• Do Not Take Abiraterone Pharmascience with Food. Taking Abiraterone Pharmascience with Food May Cause Side Effects.
• Abiraterone Pharmascience TabletsShould Be Taken as a Single Dose Once a Day on an Empty Stomach. Abiraterone Pharmascience Should Be Taken at Least 2 Hours After Eating and No Food Should Be Consumed for at Least 1 Hour After Taking This Medicine (See Section 2, "Taking Abiraterone Pharmascience with Food").
• Swallow the Tablets Whole with a Glass of Water.
• Do Not Crush the Tablets.
• Abiraterone Pharmascience 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 Abiraterone Pharmascience.
• The Amount of Prednisone or Prednisolone You Take May Need to Be Changed in Case of a Medical 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 Talking to Your Doctor.

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

If You Take More Abiraterone Pharmascience Than You Should

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

If You Forget to Take Abiraterone Pharmascience

• If You Miss a Dose of Abiraterone Pharmascience or Prednisone or Prednisolone, Take the Usual Dose the Next Day.
• If You Miss a Dose of Abiraterone Pharmascience or Prednisone or Prednisolone for More Than One Day, Contact Your Doctor Immediately.

Stopping Abiraterone Pharmascience Treatment

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

• Muscle Weakness, Muscle Tremors (Shakiness), 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 Legs, Low Potassium Levels in the Blood, Increased Liver Enzyme Levels, 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, Heart Rhythm Problems (Atrial Fibrillation), Heart Failure, Fast Heart Rate, Severe Infections - Sepsis, Bone Fractures, Indigestion, 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 (Prolonged QT Interval), and Severe Allergic Reactions, Causing Difficulty Swallowing or Breathing, Face, Lip, Tongue, or Throat Swelling, or Itchy Rash.
Bone Loss May Occur in Men with Prostate Cancer Treated with Abiraterone Pharmascience. Abiraterone Pharmascience in Combination with Prednisone and Prednisolone May Increase This Effect.

Reporting of Side Effects

If You Experience Any Side Effects, Including Any Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. You Can Also Report Side Effects Directly to the Regulatory Authority via the Website: https://smz.ezdrowie.gov.pl . You Can Also Report Side Effects to the Marketing Authorization Holder.

5. How to Store Abiraterone Pharmascience

• 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, after "EXP". The Expiry Date Refers to the Last Day of That 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 Pharmascience Contains

• The Active Substance Is Abiraterone Acetate. Each Film-Coated Tablet Contains 500 Mg of Abiraterone Acetate. The Other Ingredients Are Lactose Monohydrate, Croscarmellose Sodium, Hypromellose 2910 (15 Mpas), Sodium Lauryl Sulfate (See Section 2 "Abiraterone Pharmascience Contains Lactose and Sodium"), Microcrystalline Cellulose (Siliconized), Colloidal Anhydrous Silica, and Magnesium Stearate. The Tablet Coating Contains Black Iron Oxide (E 172), Red Iron Oxide (E 172), Macrogol 3350, Polyvinyl Alcohol, Talc, and Titanium Dioxide (E 171).

What Abiraterone Pharmascience Looks Like and Contents of the Pack

Abiraterone Pharmascience Is Purple, Oval, Biconvex Film-Coated Tablets with a Score Line on Both Sides, with "A" Engraved on One Side and "500" on the Other.

Each Carton Contains 60 Film-Coated Tablets in 5 Blisters of PVC/PE/PVDC/Aluminium, Each Containing 12 Film-Coated Tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharmascience International Limited
Lampousas 1
1095 Nicosia
Cyprus

Manufacturer

Bluepharma Indústria Farmacêutica, S.A.

• S. Martinho do Bispo 3045-016 Coimbra Portugal

Bluepharma Indústria Farmacêutica S.A.
Eiras, Rua Adriano Lucas
3020-430 Coimbra
Portugal
For Further Information on This Medicine, Contact the Marketing Authorization Holder: PDG Cetus Pharma Sp. z o.o., ul. Sokratesa 11B,
01-909 Warsaw, Tel.: + 48 606 383 970, E-Mail: [email protected]

This Medicine Is Authorized in the Member States of the European Economic Area Under the Following Names:

Hungary

Abiraterone Pharmascience 500 Mg Filmtabletta

Bulgaria

Абиратерон Фармасайънс 500 Мг Филмирани Таблетки

Croatia

Abiraterone Pharmascience 500 Mg Filmom Obložene Tablete

Cyprus

Abiraterone Pharmascience 500 Mg Επικαλυμμένα Με Λεπτό Υμένιο Δισκία

Poland

Abiraterone Pharmascience

Slovenia

Abirateron Pharmascience 500 Mg Filmsko Obložene Tablete
Date of Last Revision of the Leaflet:12/2023