Abiraterone Vipharm

Package Leaflet: Information for the Patient

Abiraterone Vipharm, 500 mg, Coated Tablets

Abiraterone Acetate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, so you can Read it Again if Necessary.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, including those not Mentioned in this Package Leaflet, they should Inform their Doctor or Pharmacist. See Section 4.

Table of Contents of the Package Leaflet

• 1. What is Abiraterone Vipharm and what is it Used for
• 2. Important Information Before Taking Abiraterone Vipharm
• 3. How to Take Abiraterone Vipharm
• 4. Possible Undesirable Effects
• 5. How to Store Abiraterone Vipharm
• 6. Contents of the Package and Other Information

1. What is Abiraterone Vipharm and what is it Used for

Abiraterone Vipharm is a Medication Containing Abiraterone Acetate. It is Used in Adult Men for the Treatment of Prostate Cancer that has Spread to Other Parts of the Body. Abiraterone Vipharm Inhibits the Production of Testosterone in the Body; this may Slow Down the Development of Prostate Cancer.

When Abiraterone Vipharm is Used at an Early Stage of the Disease Responding to Hormonal Therapy, it is Administered Together with Therapy that Reduces Testosterone Levels (Androgen Suppression Therapy).

During the Use of this Medication, the Treating Doctor will also Prescribe the Use of Another Medication Called Prednisone or Prednisolone. This is to Reduce the Risk of High Blood Pressure, Excess Fluid in the Body (Fluid Retention), or Low Potassium Levels in the Blood.

2. Important Information Before Taking Abiraterone Vipharm

When not to Take Abiraterone Vipharm:

• If the Patient is Allergic to Abiraterone or any of the Other Ingredients of this Medication (Listed in Section 6);
• In Women, Especially During Pregnancy. Abiraterone Vipharm is Used Exclusively in Men;
• If the Patient has Severe Liver Damage;
• In Combination with the Medication Ra-223 (Used in the Treatment of Prostate Cancer).

Do not Take this Medication if any of the Above Situations Apply to the Patient. In Case of Doubts, Consult a Doctor or Pharmacist Before Taking this Medication.

Warnings and Precautions

Before Starting to Take this Medication, Discuss it with a Doctor or Pharmacist:

• If the Patient has Liver Diseases;
• If the Patient has 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 the Patient has had Other Heart or Blood Vessel Diseases;
• If the Patient has an Irregular or Rapid Heart Rate;
• If the Patient has Shortness of Breath;
• If the Patient's Body Weight has Increased Rapidly;
• If the Patient has Swelling of the Feet, Ankles, or Legs;
• If the Patient has Taken the Medication Ketokonazole in the Past for the Treatment of Prostate Cancer;
• The Need to Take this Medication with Prednisone or Prednisolone;
• The Possibility of Undesirable Effects Related to Bones;
• If the Patient has High Blood Sugar Levels.

Tell the Doctor if the Patient has any Heart or Blood Vessel Disorders, including Heart Rhythm Disorders (Arrhythmia), or is Taking Medications for these Conditions.

Tell the Doctor if the Patient has Yellowing of the Skin or Eyes, Dark Urine, Severe Nausea or Vomiting, which may be Symptoms of Liver Function Disorders. Rarely, Acute Liver Failure may Occur, which can be Life-Threatening.

There may be a Decrease in the Number of Red Blood Cells, Decreased Sex Drive, Muscle Weakness, and (or) Muscle Pain.

Abiraterone Vipharm must not be Administered in Combination with Ra-223 due to the Possible Increased Risk of Bone Fractures or Death.

If the Patient Intends to Take Ra-223 after Treatment with Abiraterone Vipharm and Prednisone/Prednisolone, they should Wait 5 Days Before Starting Ra-223 Treatment.

In Case of Doubts whether any of the Above Situations Apply to the Patient, Consult a Doctor or Pharmacist Before Taking this Medication.

Blood Tests

Abiraterone Vipharm may Affect Liver Function, and the Patient may not have any Symptoms. During the Use of the Medication, the Treating Doctor will Periodically Prescribe Blood Tests to Check the Effect of the Medication on the Liver.

Children and Adolescents

This Medication is not Used in Children and Adolescents. If Abiraterone Vipharm is Accidentally Swallowed by a Child, Immediately Go to the Hospital with the Patient Information Leaflet to Show it to the Doctor in the Emergency Room.

Abiraterone Vipharm and Other Medications

Before Taking any Medication, Consult a Doctor or Pharmacist.

Tell the Doctor or Pharmacist about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take. This is Important because Abiraterone Vipharm may Enhance the Effect of many Medications, including Heart Medications, Sedatives, some Anti-Diabetic Medications, Herbal Medications (e.g., St. John's Wort), and Others. The Doctor may Change the Doses of these Medications. Also, other Medications may Increase or Decrease the Effect of Abiraterone Vipharm. This may Result in Undesirable Effects or Inadequate Efficacy of Abiraterone Vipharm.

Androgen Suppression may Increase the Risk of Heart Rhythm Disorders. Tell the Doctor if the Patient is Taking Medications:

• 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 Relief Medication and Used in the Treatment of Addiction), Moxifloxacin (Antibiotic), Antipsychotic Medications (Used in Severe Mental Disorders)].

Tell the Doctor if the Patient is Taking any of the Above Medications.

Taking Abiraterone Vipharm with Food

• The Medication must not be Taken with Food (See Section 3, "How to Take Abiraterone Vipharm").
• Taking Abiraterone Vipharm with Food may Cause Undesirable Effects.

Pregnancy and Breastfeeding

Abiraterone Vipharm is not Used in Women.

Pregnant or Possibly Pregnant Women should Wear Gloves if they Need to Handle Abiraterone Vipharm.

The Medication may Harm the Unborn Child if Taken by a Pregnant Woman.

If the Patient has Sexual Intercourse with a Woman who may Become Pregnant, they should Use a Condom and another Effective Contraceptive Method.

If the Patient has Sexual Intercourse with a Pregnant Woman, they should Use a Condom to Protect the Unborn Child.

Driving and Operating Machines

It is Unlikely that this Medication will Affect the Ability to Drive or Operate Tools and Machines.

Abiraterone Vipharm Contains Lactose

If the Patient has been Diagnosed with Intolerance to some Sugars, they should Consult a Doctor Before Taking this Medication.

Abiraterone Vipharm Contains Sodium

The Medication Contains 24 mg of Sodium (a Major Component of Common Salt) per Dose 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 Vipharm

This Medication should Always be Taken as Directed by the Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.

How Much Medication to Take

The Recommended Dose is 1000 mg (Two Tablets) Taken Once a Day.

How to Take the Medication

The Medication should be Taken Orally.

Abiraterone Vipharm must not be Taken with Food.

Take the Medication at Least One Hour Before or at Least Two Hours After Eating (See Section 2, "Taking Abiraterone Vipharm with Food").

Swallow the Tablets Whole with Water.

Do not Crush the Tablets.

Abiraterone Vipharm is Taken with a Medication Called Prednisone or Prednisolone.

Take Prednisone or Prednisolone as Directed by the Doctor.

Take Prednisone or Prednisolone Every Day while Taking Abiraterone Vipharm.

The Amount of Prednisone or Prednisolone Used may be Changed if Necessary.

The Treating Doctor will Inform the Patient if there is a Need to Change the Dose of Prednisone or Prednisolone.

Do not Stop Taking Prednisone or Prednisolone without Consulting a Doctor.

The Treating Doctor may also Prescribe other Medications to the Patient Taking Abiraterone Vipharm and Prednisone or Prednisolone.

Taking a Higher Dose of Abiraterone Vipharm than Recommended

If the Patient Takes more Medication than they Should, they should Immediately Consult a Doctor or Go to the Hospital.

Missing a Dose of Abiraterone Vipharm

If the Patient Forgets to Take Abiraterone Vipharm, Prednisone, or Prednisolone, they should Take the Usual Dose the Next Day.

If the Patient Forgets to Take Abiraterone Vipharm, Prednisone, or Prednisolone for More than One Day, they should Immediately Consult a Doctor.

Stopping the Use of Abiraterone Vipharm

Do not Stop Taking Abiraterone Vipharm or Prednisone/Prednisolone without Consulting a Doctor.

In Case of any Further Doubts about the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although not Everybody gets them.

Stop Taking Abiraterone Vipharm and Immediately Consult a Doctor if the Patient Notices any of the Following Symptoms:

• Muscle Weakness, Tremors (Shaking), or Heart Palpitations. These may be Symptoms of Low Potassium Levels in the Blood.

Other Undesirable Effects Observed:

Very Common(may Occur in more than 1 in 10 Patients):

• 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 Occur in up to 1 in 10 Patients):

• High Lipid Levels in the Blood
• Chest Pain, Heart Rhythm Disorders (Atrial Fibrillation), Heart Failure, Rapid Heart Rate
• Severe Infections, Sepsis
• Bone Fractures
• Nausea
• Blood in the Urine
• Rash.

Uncommon(may Occur in up to 1 in 100 Patients):

• Adrenal Gland Disorders (Related to Electrolyte Imbalance)
• Abnormal Heart Rhythm (Arrhythmia)
• Muscle Weakness and (or) Muscle Pain.

Rare(may Occur in up to 1 in 1000 Patients):

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

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

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

There may be a Loss of Bone Mass in Men Treated for Prostate Cancer. Abiraterone Vipharm in Combination with Prednisone and Prednisolone may Enhance this Effect.

Reporting Undesirable Effects

If any Undesirable Effects Occur, including those not Mentioned in the Package Leaflet, Inform a Doctor, Pharmacist, or Nurse.

Undesirable Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Jerozolimskie Avenue 181C

02-222 Warsaw

Tel.: 22 49-21-301

Fax: 22 49-21-309

Website: https://smz.ezdrowie.gov.pl

Undesirable Effects can also be Reported to the Marketing Authorization Holder.

Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Abiraterone Vipharm

Store the Medication in a Place that is Inaccessible to Children.

Do not Use this Medication after the Expiration Date Stated on the Blister Pack or Bottle and on the Carton after "EXP" and "Expiration Date (EXP)". The Expiration Date Refers to the Last Day of the Specified Month.

There are no Special Precautions for Storing the Medication.

Medications should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Abiraterone Vipharm Contains

• The Active Substance of the Medication is Abiraterone Acetate.
• Each Coated Tablet Contains 500 mg of Abiraterone Acetate.
• Other Ingredients are:

Tablet Core: Lactose Monohydrate, Microcrystalline Cellulose Type 102, Croscarmellose Sodium, Hypromellose 2910, Sodium Lauryl Sulfate, Silica Colloidal Anhydrous, Magnesium Stearate.

Coating: Polyvinyl Alcohol, Titanium Dioxide (E 171), Macrogol 3350, Talc, Iron Oxide Red (E 172), Iron Oxide Black (E 172).

What Abiraterone Vipharm Looks Like and What the Package Contains

Abiraterone Vipharm is an Oval, Purple, Coated Tablet (Approximately 19 mm Long and 11 mm Wide), with the Imprint "A7TN" on one Side and "500" on the Other.

Each Carton with Blister Pack Contains 56 or 60 Coated Tablets.

Each Carton with Single-Dose Blister Pack Contains 56 x 1 or 60 x 1 Coated Tablet.

Each Carton with Bottle Contains 60 Coated Tablets.

Marketing Authorization Holder

Vipharm S.A.

A. and F. Radziwiłłów Street 9

• 05-850 Ożarów Mazowiecki, Tel.: +48 22 679 51 35, Fax: +48 22 678 92 87, Email: [email protected]

Manufacturer

Synthon B.V.

Microweg 22

6545 CM Nijmegen

Netherlands

Synthon Hispania S.L.

Castello 1

08830 Sant Boi de Llobregat

Barcelona

Spain

This Medicinal Product is Authorized for Use in the Member States of the European Economic Area Under the Following Names:

Netherlands

Abirateron Vipharm 500 mg, Film-Coated Tablets

Hungary

Abiraterone Vipharm 500 mg Film Tablet

Slovakia

Abiraterone Vipharm 500 mg

Poland

Abiraterone Vipharm

Czech Republic

Abiraterone Vipharm

Date of Last Revision of the Package Leaflet: