Abiraterone Glenmark

Package Leaflet: Information for the User

Abiraterone Glenmark, 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 Signs of Illness Are the Same as Yours.
• If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack

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

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

Abiraterone Glenmark 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 Glenmark Works by Reducing the Amount of Testosterone in the Body; This Can Slow Down the Growth of Prostate Cancer.
When Abiraterone Glenmark Is Used at an Early Stage of the Disease in Patients Who Are Responding to Hormone Therapy, It Is Given Together with a Therapy That Lowers Testosterone Levels (Androgen Deprivation Therapy).
While Taking 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 (Oedema), or Low Potassium Levels in the Blood.

2. Before You Take Abiraterone Glenmark

When Not to Take Abiraterone Glenmark

• If You Are Allergic to Abiraterone Acetate or Any of the Other Ingredients of This Medicine (Listed in Section 6).
• In Women, Especially If Pregnant. Abiraterone Glenmark Is Only Used in Men.
• If You Have Severe Liver Damage.
• In Combination with 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 Glenmark.

Warnings and Precautions

Before Taking Abiraterone Glenmark, Talk to Your Doctor or Pharmacist If:

• You Have Liver Disease
• 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)
• You Have Had Other Heart or Blood Vessel Diseases
• You Have an Irregular or Fast Heartbeat
• You Have Shortness of Breath
• Your Body Weight Has Increased in a Short Period
• You Have Swelling of the Feet, Ankles, or Legs
• You Have Taken a Medicine Called Ketokonazole in the Past to Treat Prostate Cancer
• You Need to Take This Medicine with Prednisone or Prednisolone
• There Is a Possibility of Side Effects Affecting the Bones
• You Have High Blood Sugar Levels

Tell Your Doctor If You Have Been Told You Have Any Heart or Blood Vessel Disease, Including Abnormal Heart Rhythm (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 Can Be Signs of Liver Disease. Rarely, Abnormal Liver Function (Called Acute Liver Failure) Can Occur, Which Can Be Life-Threatening.
There May Be a Decrease in Red Blood Cells, Decreased Sex Drive, Muscle Weakness, and (or) Muscle Pain.
Do Not Take Abiraterone Glenmark with Ra-223 Due to an Increased Risk of Bone Fractures or Death.
If You Plan to Take Ra-223 After Treatment with Abiraterone Glenmark and Prednisone or Prednisolone, 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 Glenmark.

Blood Tests

Abiraterone Glenmark May Affect Liver Function, and You May Not Have Any Symptoms. While Taking 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 Glenmark Is Accidentally Swallowed by a Child, Go to the Emergency Department of a Hospital Immediately, Taking the Package Leaflet with You to Show to the Doctor.

Abiraterone Glenmark with Other Medicines

Before Taking Any Medicine, Talk to Your Doctor or Pharmacist.
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 Glenmark Can Increase the Effect of Many Medicines, Including Medicines for the Heart, Sedatives, Certain Anti-Diabetic Medicines, Herbal Medicines (Such as St. John's Wort), and Others. Your Doctor May Change the Dose of These Medicines. Also, Some Medicines May Increase or Decrease the Effect of Abiraterone Glenmark. This Can Cause Side Effects or Abiraterone Glenmark Not to Work Properly.
Androgen Deprivation Therapy May Increase the Risk of Abnormal Heart Rhythm. Tell Your Doctor If You Are Taking Medicines:

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

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

Abiraterone Glenmark with Food

• Do Not Take This Medicine with Food (See Section 3, "How to Take Abiraterone Glenmark").
• Taking Abiraterone Glenmark with Food May Cause Side Effects.

Pregnancy and Breast-Feeding

Abiraterone Glenmark Is Not Used in Women.

Women Who Are Pregnant or May Become Pregnant Should Wear Protective Gloves When Handling Abiraterone Glenmark.

This Medicine May Harm the 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 Birth Control 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 or Machines.

Abiraterone Glenmark Contains Lactose and Sodium

If You Have Been Told You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicine.
Abiraterone Glenmark, 500 mg, Film-Coated Tablets
This Medicine Contains 24 mg of Sodium (a Major Component of Common Salt) in Each Dose, Consisting 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 Glenmark

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 500 mg Tablets) Taken Once a Day.

How to Take This Medicine

Take This Medicine by Mouth.
Do Not Take Abiraterone Glenmark with Food. Taking Abiraterone Glenmark with Food May Cause Side Effects.
Take Abiraterone Glenmark as a Single Dose Once a Day on an Empty Stomach. Abiraterone Glenmark Must Be Taken at Least 2 Hours After Eating and Food Can Be Taken at Least 1 Hour After Taking Abiraterone Glenmark (See Section 2, "Abiraterone Glenmark with Food").
Swallow the Tablets Whole with a Glass of Water.
Do Not Crush the Tablets.
Take Abiraterone Glenmark 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 Glenmark.
The Amount of Prednisone or Prednisolone You Take May Need to Be Changed in Case of an Emergency. Your Doctor Will Tell You If You Need to Change the Dose of Prednisone or Prednisolone. Do Not Stop Taking Prednisone or Prednisolone Unless Your Doctor Tells You To.
Your Doctor May Also Prescribe Other Medicines to Take While You Are Taking Abiraterone Glenmark and Prednisone or Prednisolone.

If You Take More Abiraterone Glenmark Than You Should

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

If You Forget to Take Abiraterone Glenmark

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

Stopping Abiraterone Glenmark

Do Not Stop Taking Abiraterone Glenmark or Prednisone or Prednisolone Without Talking to Your Doctor.
If You Have Any Further Questions on the Use of This Product, 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 Glenmark and Contact Your Doctor Immediately If You Notice Any of the Following:

• Muscle Weakness, Muscle Tremors (Tremors), 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 Ankles
• Low Potassium Levels in the Blood
• High 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 Rhythm (Atrial Fibrillation), Heart Failure, Fast Heart Rate
• Severe Infection (Called 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 Called 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.

Bone Loss May Occur in Men with Prostate Cancer. Abiraterone Glenmark Taken with Prednisone or Prednisolone May Increase Bone Loss.

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. You Can Also Report Side Effects Directly to the Department of Drug Safety, 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 Abiraterone Glenmark

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 and Blister 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 Glenmark Contains

Abiraterone Glenmark, 500 mg, Film-Coated Tablets

• The Active Substance Is Abiraterone Acetate.
• Each Film-Coated Tablet Contains 500 mg of Abiraterone Acetate.
• The Other Ingredients Are: Lactose Monohydrate, Microcrystalline Cellulose Type 102, Sodium Croscarmellose, Hypromellose 2910, Sodium Lauryl Sulfate, Silica Colloidal Anhydrous, and Magnesium Stearate (Core); Polyvinyl Alcohol, Macrogol 3350, Talc, Titanium Dioxide (E 171), Iron Oxide Red (E 172), and Iron Oxide Black (E 172) (Coating).

What Abiraterone Glenmark Looks Like and Contents of the Pack

Abiraterone Glenmark, 500 mg, Film-Coated Tablets
Abiraterone Glenmark, 500 mg Are Purple, Oval, Film-Coated Tablets, Approximately 19 mm in Length and 11 mm in Width, with "A7TN" Engraved on One Side and "500" on the Other Side.
Each Blister Contains 60 Film-Coated Tablets. The Film-Coated Tablets May Be Packaged in Transparent or Non-Transparent (White) Blisters.

Marketing Authorization Holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer/Importer

Synthon Hispania, S.L.
C/ Castelló 1, 08830 Sant Boi de Llobregat, Barcelona
Spain
Synthon B.V.
Microweg 22, 6545 CM Nijmegen
Netherlands
Glenmark Pharmaceuticals s.r.o.
Fibichova 143/II, 566 17 Vysoké Mýto
Czech Republic
Glenmark Arzneimittel GmbH
Industriestr. 31, Gröbenzell, 82194
Germany

For Further Information on This Medicine, Contact the Local Representative of the Marketing Authorization Holder:

Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]

Date of Last Revision of the Leaflet: