Abiraterone Msn

Package Leaflet: Information for the User

Abiraterone MSN, 250 mg, Film-Coated Tablets

Abiraterone MSN, 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 Side Effects, or Any Other Side Effects Not Mentioned in This Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet:

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

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

Abiraterone MSN 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. Abiraterone MSN Works by Blocking the Production of Testosterone in the Body; This Can Slow Down the Growth of Prostate Cancer.

When Abiraterone MSN Is Used at an Early Stage of the Disease Responding to Hormonal Therapy, It Is Given Together with 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 Retention, or Low Potassium Levels in the Blood.

2. Important Information Before Taking Abiraterone MSN

When Not to Take Abiraterone MSN

• -If You Are Allergic (Hypersensitive) to Abiraterone Acetate or Any of the Other Ingredients of This Medicine (Listed in Section 6).
• -In Women, Especially Those Who Are Pregnant. Abiraterone MSN 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 This Medicine, 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 Abnormal Heart Rhythm)
• If You Have Had Other Heart 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 Bones
• If You Have High Blood Sugar Levels

Tell Your Doctor If You Have Any Heart or Blood Vessel Disorders, Including Abnormal Heart Rhythms (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 Disorders. Rarely, Acute Liver Failure May Occur, Which Can Be Life-Threatening.

There May Be a Decrease in Red Blood Cells, Decreased Sex Drive, Muscle Weakness, and (or) Muscle Pain.

Abiraterone MSN Must Not Be Taken 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 MSN and Prednisone/Prednisolone, You Should Wait 5 Days Before Starting Ra-223 Treatment.

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

Blood Tests

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

Abiraterone MSN with Other Medicines

Before Taking Any Other 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 MSN 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 Change the Doses of These Medicines. Other Medicines May Also Increase or Decrease the Effect of Abiraterone MSN. This May Result in Side Effects or Inadequate Effect of Abiraterone MSN.

Androgen Suppression May Increase the Risk of Abnormal Heart Rhythms. Tell Your Doctor If You Are Taking Medicines:

• Used to Treat Abnormal Heart Rhythms (e.g., Quinidine, Procainamide, Amiodarone, and Sotalol)
• That May Increase the Risk of Abnormal Heart Rhythms [e.g., Methadone (Pain Reliever and Used for Addiction Treatment), Moxifloxacin (Antibiotic), Antipsychotic Medicines (Used for Severe Mental Disorders)]

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

Abiraterone MSN with Food

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

Pregnancy and Breastfeeding

Abiraterone MSN Is Not Used in Women.

• The Medicine May Harm the Unborn Child If Taken by a Pregnant Woman.
• -Women Who Are Pregnant or May Become Pregnant Should Use Protective Gloves When Handling Abiraterone MSN.
• -If You Have Sexual Intercourse with a Woman Who May Become Pregnant, You Should Use a Condom Together with Another Effective Contraceptive Method.
• -If You Have Sexual Intercourse 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 MSN Contains Lactose and Sodium

• Abiraterone MSN Contains Lactose. If You Have Been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking This Medicine.
• This Medicine Contains 27 Mg of Sodium (a Major Component of Common Salt) per Daily Dose of 1000 Mg (Four 250 Mg Tablets or Two 500 Mg Tablets). This Is Equivalent to 1.35% of the Maximum Recommended Daily Intake of Sodium for Adults.

3. How to Take Abiraterone MSN

This Medicine Should Always Be Taken Exactly as Prescribed by Your Doctor. If You Are in Doubt, Consult Your Doctor or Pharmacist.

How Much to Take

The Recommended Dose Is 1000 Mg (Four 250 Mg Tablets or Two 500 Mg Tablets) Taken Once a Day.

How to Take the Medicine

• -The Medicine Should Be Taken Orally.
• -Abiraterone MSN Must Not Be Taken with Food. Taking Abiraterone MSN with Food May Cause More of the Medicine to Be Absorbed by the Body Than Is Necessary, Which May Cause Side Effects.
• -Abiraterone MSN Tablets Should Be Taken as a Single Dose Once a Day on an Empty Stomach. Abiraterone MSN Should Be Taken at Least 2 Hours After Eating and No Food Should Be Consumed for at Least 1 Hour After Taking Abiraterone MSN (See Section 2, "Taking Abiraterone MSN with Food").
• The Tablets Should Be Swallowed Whole with a Glass of Water.
• The Tablets Should Not Be Crushed.
• Abiraterone MSN Is Taken with a Medicine Called Prednisone or Prednisolone. You Should Take Prednisone or Prednisolone as Prescribed by Your Doctor.
• You Should Take Prednisone or Prednisolone Every Day While Taking Abiraterone MSN.
• The Amount of Prednisone or Prednisolone You Take May Be Changed If Necessary.

Your Doctor Will Inform You If You Need to Change the Dose of Prednisone or Prednisolone You Are Taking. Do Not Stop Taking Prednisone or Prednisolone Without Consulting Your Doctor.

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

If You Take More Abiraterone MSN 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 MSN

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

If You Stop Taking Abiraterone MSN

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

• Muscle Weakness, Muscle Tremors, or Heart 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 Ankles, 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 Lipid Levels in the Blood, Chest Pain, Abnormal Heart Rhythms (Atrial Fibrillation), Heart Failure, Rapid Heart Rate, Severe Infections Called 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).
Liver Failure (Also Known as Acute Liver Failure).
Frequency Not Known(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.
In Men Treated for Prostate Cancer, There May Be a Loss of Bone Mass. Abiraterone MSN in Combination with Prednisone or Prednisolone May Increase the Loss of Bone Mass.

Reporting of Side Effects

If You Experience Any Side Effects, or Any Other Side Effects Not Mentioned in This Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can Be Reported Directly to the Department of Drug Safety, Ministry of Health, or to the Marketing Authorization Holder.

5. How to Store Abiraterone MSN

• 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 After EXP. The Expiry Date Refers to the Last Day of the Month.
• 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 MSN Contains

• The Active Substance Is Abiraterone Acetate.
• Each Film-Coated Tablet Contains 250 Mg of Abiraterone Acetate, Which Corresponds to 223 Mg of Abiraterone.
• Each Film-Coated Tablet Contains 500 Mg of Abiraterone Acetate, Which Corresponds to 446 Mg of Abiraterone.
• The Other Ingredients Are: Lactose Monohydrate, Sodium Croscarmellose (E 468), Hypromellose 2910, 3 Mpa.S (E 464), Sodium Lauryl Sulfate, Microcrystalline Cellulose (E 460), Silica Colloidal Anhydrous (E 551), Magnesium Stearate (E 470b), Polyvinyl Alcohol (E 1203), Titanium Dioxide (E 171), Macrogol 3350 (E 1521), Talc (E 553b), Iron Oxide Red (E 172), Iron Oxide Yellow (E 172) - Only for 250 Mg, Iron Oxide Black (E 172) - Only for 500 Mg (See Section 2, "Abiraterone MSN Contains Lactose and Sodium")

What Abiraterone MSN Looks Like and Contents of the Pack

[250 Mg]: Abiraterone MSN Tablets Are Oval, Film-Coated Tablets, Beige in Color, Approximately 16 Mm in Length and 9 Mm in Width, with "MA" Engraved on One Side and "21" on the Other.

[500 Mg]: Abiraterone MSN Tablets Are Oval, Film-Coated Tablets, Purple in Color, Approximately 20 Mm in Length and 10 Mm in Width, with "MA" Engraved on One Side and "22" on the Other.

Pack Sizes:

250 Mg:

Blisters Containing 120 Film-Coated Tablets, in a Cardboard Box.

Perforated Unit-Dose Blisters Containing 120 X 1 Film-Coated Tablet, in a Cardboard Box.

500 Mg:

Blisters Containing 60 Film-Coated Tablets, in a Cardboard Box.

Perforated Unit-Dose Blisters Containing 56 X 1, 60 X 1, 112 X 1 Film-Coated Tablet, in a Cardboard Box.

Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder and Manufacturer/Importer

Marketing Authorization Holder:

MSN Labs Europe Limited

KW20A Corradino Park

Paola, PLA 3000

Malta

Phone: (+48) 699 711 147

Manufacturer/Importer:

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

MSN Labs Europe Limited

KW20A Corradino Park

Paola, PLA 3000

Malta

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

Netherlands:

Abirateron MSN 250 Mg Filmomhulde Tabletten

Abirateron MSN 250 Mg Filmomhulde Tabletten

Bulgaria:

Абиратерон MSN 250 Mg Филмирани Таблетки

Абиратерон MSN 500 Mg Филмирани Таблетки

Czech Republic:

Abiraterone MSN

Hungary:

Abiraterone MSN 250 Mg Filmtabletta

Abiraterone MSN 500 Mg Filmtabletta

Croatia:

Abirateron MSN 250 Mg Filmom Obložene Tablete

Abirateron MSN 500 Mg Filmom Obložene Tablete

Poland:

Abiraterone MSN

Romania:

Abirateronă MSN 250 Mg Comprimate Filmate

Abirateronă MSN 500 Mg Comprimate Filmate

Slovenia:

Abirateron MSN 250 Mg Filmsko Obložene Tablete

Abirateron MSN 500 Mg Filmsko Obložene Tablete

Slovakia:

Abiraterón MSN

Date of Last Revision of the Leaflet: