Abiraterone Medical Vallei

Package Leaflet: Information for the User

Abiraterone Medical Valley, 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 of the Following Symptoms, Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Package Leaflet

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

1. What Is Abiraterone Medical Valley and What Is It Used For

Abiraterone Medical Valley 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 Production of Testosterone in the Body; This Can Help 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 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, or Low Potassium Levels in the Blood.

2. Important Information Before Taking Abiraterone Medical Valley

When Not to Take Abiraterone Medical Valley

• 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 the Medicine Ra-223 (Used to Treat 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 Abiraterone Medical Valley, Discuss the Following 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 the Medicine Ketokonazole in the Past to Treat Prostate Cancer
• The Need to Take This Medicine with Prednisone or Prednisolone
• The Possibility of Bone-Related Side Effects
• If You Have High Blood Sugar Levels.

Tell Your Doctor If You Have Had Any Other Heart or Blood Vessel Diseases in the Past, Including Heart Rhythm Disorders (Arrhythmia), or If You Have Been Treated with Medicines Used 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, Acute Liver Failure Can 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 Medical Valley Must Not Be Used in Combination with the Medicine Ra-223, Due to the Increased Risk of Bone Fractures or Death.

If You Plan to Take Ra-223 After Treatment with Abiraterone Medical Valley 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

Abiraterone Medical Valley 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 Abiraterone Medical Valley Is Accidentally Swallowed by a Child, Seek Immediate Medical Attention at a Hospital, Bringing This Leaflet with You to Show the Doctor.

Abiraterone Medical Valley with 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 Abiraterone Medical Valley 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 Abiraterone Medical Valley, Which May Result in Side Effects or Reduced Effectiveness of Abiraterone Medical Valley.

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

Tell Your Doctor About Taking Any of the Above Medicines.

Abiraterone Medical Valley with Food

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

Pregnancy and Breastfeeding

Abiraterone Medical Valley Is Not Used in Women.

• This Medicine May Harm an Unborn Baby If Taken by a Pregnant Woman.
• If You Have Sex with a Woman Who May Become Pregnant, Use a Condom or Other Effective Birth Control Method.
• If You Have Sex 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/Machines.

Abiraterone Medical Valley Contains Lactose and Sodium

• Abiraterone Medical Valley Contains Lactose (a Type of Sugar). If You Have Been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking This Medicine.
• This Medicine Contains 24 Mg of Sodium (a Major Component of Common Salt) per Dose of Two Tablets. This Is Equivalent to 1.2% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Take Abiraterone Medical Valley

Always Take This Medicine Exactly as Your Doctor Has Told You. If You Are in Doubt, Consult Your Doctor or Pharmacist.

What Dose to Take

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

How to Take Abiraterone Medical Valley

• This Medicine Should Be Taken Orally.
• Do Not Take Abiraterone Medical Valley with Food.Taking Abiraterone Medical Valley with Food May Cause Side Effects.
• Take the Tablets as a Single Dose Once a Day on an Empty Stomach. Take Abiraterone Medical Valley at Least 2 Hours After Eating and Do Not Eat for at Least 1 Hour After Taking Abiraterone Medical Valley (See Section 2, "Abiraterone Medical Valley with Food").

Swallow the Tablets Whole with Water.

Do Not Crush the Tablets.

Take Abiraterone Medical Valley with the Medicine Prednisone or Prednisolone. Take Prednisone or Prednisolone as Directed by Your Doctor.

Take Prednisone or Prednisolone Every Day While Taking Abiraterone Medical Valley.

The Amount of Prednisone or Prednisolone You Take May Need to Be Changed in Case of an Emergency. Your Doctor Will Inform 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 Abiraterone Medical Valley and Prednisone or Prednisolone.

If You Take More Abiraterone Medical Valley Than You Should

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

If You Forget to Take Abiraterone Medical Valley

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

If You Stop Taking Abiraterone Medical Valley

Do Not Stop Taking Abiraterone Medical Valley 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 Abiraterone Medical Valley and Contact Your Doctor Immediately If You Notice Any of the Following Symptoms:

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

Additional 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, Heart Rhythm Disorders (Atrial Fibrillation), Heart Failure, Fast Heart Rate, 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).
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, Facial, Lip, Tongue, or Throat Swelling, or Itchy Rash.
Bone Loss May Occur in Men Treated for Prostate Cancer. Abiraterone Medical Valley in Combination with Prednisone and Prednisolone May Enhance This Effect.

Reporting Side Effects

If You Experience Any Side Effects, Including Those 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 181 C, 02-222 Warsaw, Phone: +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 Abiraterone Medical Valley

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

6. Contents of the Pack and Other Information

What Abiraterone Medical Valley Contains

• The Active Substance Is Abiraterone Acetate. Each Film-Coated Tablet Contains 500 Mg of Abiraterone Acetate, Equivalent to 446 Mg of Abiraterone.
• The Other Ingredients Are: Croscarmellose Sodium, Lactose Monohydrate, Sodium Lauryl Sulfate, Hypromellose 2910, Microcrystalline Cellulose (Silicified), Colloidal Anhydrous Silica, Magnesium Stearate (See Section 2, "Abiraterone Medical Valley Contains Lactose and Sodium"). The Tablet Coating Contains Polyvinyl Alcohol, Titanium Dioxide (E 171), Macrogol 3350, Talc, Yellow Iron Oxide (E 172), Red Iron Oxide (E 172), Black Iron Oxide (E 172),

What Abiraterone Medical Valley Looks Like and Contents of the Pack

• Abiraterone Medical Valley Tablets Are Oval, Red-Brown, Film-Coated Tablets with "500" Engraved on One Side.
• Each 30-Day Carton Contains 60 Film-Coated Tablets.

Marketing Authorization Holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Email: safety@medicalvalley.se

Manufacturer

Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
C/ La Vallina s/n

• 24193 - Villaquilambre, León Spain

Laboratorios Liconsa, S.A.
Av. Miralcampo 7
19200 Azuqueca de Henares, Guadalajara
Spain

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

Denmark
Abirateron Medical Valley
Finland
Abirateron Medical Valley 500 Mg Kalvopäällysteinen Tabletti
Iceland
Abirateron Medical Valley 500 Mg Filmuhúðaðar Töflur
Netherlands
Abirateron Xiromed 500 Mg Filmomhulde Tabletten
Germany
Abirateron AXiromed 500 Mg Filmtabletten
Norway
Abirateron Medical Valley
Poland
Abiraterone Medical Valley
Sweden
Abirateron Medical Valley 500 Mg Filmdragerade Tabletter
Italy
Abiraterone Medical Valley 500 Mg Compresse Rivestite con Film
Date of Last Revision of the Leaflet:02/2025