BICALUTAMIDE 150 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Bicalutamide Accord, 150 mg, Film-Coated Tablets
   1. Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.
   2. Contents of the Pack and Other Information
3. What Bicalutamide Accord Is and What It Is Used For
4. Before You Take Bicalutamide Accord
   1. When Not to Take Bicalutamide Accord:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Tests
   5. Bicalutamide Accord and Other Medicines
   6. Pregnancy, Breast-Feeding
   7. Fertility
   8. Driving and Using Machines
   9. Sun Exposure or Ultraviolet (UV) Radiation
   10. Bicalutamide Accord Contains Lactose
   11. Bicalutamide Accord Contains Sodium
5. How to Take Bicalutamide Accord
   1. Use in Children and Adolescents
   2. If You Take More Bicalutamide Accord Than You Should
   3. If You Forget to Take Bicalutamide Accord
6. Possible Side Effects
   1. If You Experience Any of the Following Side Effects, Tell Your Doctor Immediately, as You May Need Urgent Medical Attention.
   2. Other Possible Side Effects
   3. Reporting of Side Effects
7. How to Store Bicalutamide Accord
8. Contents of the Pack and Other Information
   1. What Bicalutamide Accord Contains
   2. What Bicalutamide Accord Looks Like and Contents of the Pack
   3. Marketing Authorization Holder
   4. Manufacturer/Importer
   5. This Medicinal Product Is Authorized in the Member States of the European Economic Area Under the Following Names:
   6. Date of Last Revision of the Leaflet: September 2024

Package Leaflet: Information for the User

Bicalutamide Accord, 150 mg, Film-Coated Tablets

Bicalutamide

Read All of This Leaflet Carefully Before You Start 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 and Other Information

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

1. What Bicalutamide Accord Is and What It Is Used For

Bicalutamide Accord Contains the Active Substance Bicalutamide. Bicalutamide Is a Medicinal Product Belonging to the Group of Anti-Androgens. Anti-Androgens Block the Effects of Male Sex Hormones (Androgens).
Bicalutamide Is Used in the Treatment of Adult Men with Prostate Cancer Without Metastases When Castration and Other Treatments Are Contraindicated or Unacceptable.
It May Be Used in Combination with Radiotherapy or Surgical Treatment of the Prostate as Part of Early Treatment Programs.

2. Before You Take Bicalutamide Accord

When Not to Take Bicalutamide Accord:

• If You Are Allergic (Hypersensitive) to Bicalutamide or Any of the Other Ingredients of This Medicinal Product (Listed in Section 6);
• In Women;
• If You Are Currently Taking Cisapride (Used for the Treatment of Heartburn and Gastroesophageal Reflux), Terfenadine or Astemizole (Used for the Treatment of Allergies).

Bicalutamide Accord Must Not Be Used in Children.
If Any of the Above Applies to You, Do Not Take Bicalutamide Accord. If You Are in Doubt, Consult Your Doctor or Pharmacist Before Taking Bicalutamide Accord.

Warnings and Precautions

Before Starting Treatment with Bicalutamide Accord, Discuss This with Your Doctor or Pharmacist If:

• You Have Liver Function Disorders; Your Doctor Will Prescribe Blood Tests Before and During Treatment with Bicalutamide;

with Bicalutamide;

• You Have Any Heart or Blood Vessel Disease, Including Heart Rhythm Disorders (Arrhythmia) or Are Being Treated with Medicines for These Diseases; the Risk of Heart Rhythm Disorders May Increase During Treatment with Bicalutamide;
• You Are Taking Bicalutamide and You (and/or) Your Partner Should Use Effective Contraception During and for 130 Days After Treatment with Bicalutamide; If You Have Questions About Contraception, Consult Your Doctor (See Section "Pregnancy, Breast-Feeding and Fertility")

If You Are Hospitalized, Inform the Medical Staff That You Are Taking Bicalutamide Accord.

Children and Adolescents

Bicalutamide Accord Must Not Be Used in Children and Adolescents.

Tests

Your Doctor May Prescribe Blood Tests to Monitor Changes in Your Blood Count.

Bicalutamide Accord and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking Now or Have Recently Taken, Including Those Obtained Without a Prescription and Herbal Medicines. If You Are Taking Bicalutamide Accord with Other Medicines, the Effect of Bicalutamide Accord and the Effects of Other Medicines May Be Altered.
Do Not Take Bicalutamide Accord If You Are Taking:

• Cisapride (Used for the Treatment of Heartburn and Gastroesophageal Reflux),
• Terfenadine or Astemizole (Used for the Treatment of Allergies).

Bicalutamide Accord May Interact with Certain Medicines Used to Treat Heart Rhythm Disorders (E.g., Quinidine, Procainamide, Amiodarone, and Sotalol) or May Increase the Risk of Heart Rhythm Disorders If Used with Other Medicines [E.g., Methadone (Pain Relief Medication and Used as Part of Drug Addiction Therapy), Moxifloxacin (Antibiotic), Antipsychotic Medicines (Used for Severe Mental Illnesses)].
You Should Also Tell Your Doctor or Pharmacist If You Are Taking:

• Midazolam (Used to Relieve Anxiety Before Surgery or Other Procedures or as a Sedative Before and During Surgery); If You Are Taking Bicalutamide and Are Going to Have Surgery or Are Feeling Anxious in the Hospital, Tell Your Doctor or Dentist;
• Warfarin (Blood-Thinning Medication);
• Cyclosporin (Medicine That Suppresses the Immune System to Prevent Rejection of Transplanted Organs or Bone Marrow); Your Doctor May Prescribe Blood Tests Because Bicalutamide May Increase the Level of Cyclosporin in the Blood;
• Cimetidine (Used for the Treatment of Gastroesophageal Reflux or Stomach Ulcer);
• Ketoconazole (Used for the Treatment of Fungal Infections).

Pregnancy, Breast-Feeding

Bicalutamide Accord Is Contraindicated in Women.

Fertility

Bicalutamide Accord May Cause Temporary Infertility in Men.

Driving and Using Machines

It Is Unlikely That Bicalutamide Accord Will Affect Your Ability to Drive or Use Machines. However, Some Patients May Experience Drowsiness After Taking Bicalutamide Accord. If This Happens, Consult Your Doctor or Pharmacist.

Sun Exposure or Ultraviolet (UV) Radiation

Avoid Direct Exposure to Sunlight or Ultraviolet (UV) Radiation If You Are Taking Bicalutamide.

Bicalutamide Accord Contains Lactose

If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Consult Your Doctor Before Taking This Medicinal Product.

Bicalutamide Accord Contains Sodium

This Medicinal Product Contains Less Than 1 Mmol (23 Mg) of Sodium Per Tablet, Which Means It Is Essentially Sodium-Free.

3. How to Take Bicalutamide Accord

Always Take This Medicinal Product Exactly as Your Doctor Has Told You. If You Are Not Sure, Consult Your Doctor or Pharmacist.
The Recommended Dose Is One Tablet per Day. Swallow the Tablet Whole with a Glass of Water.
Try to Take Your Medicine at the Same Time Each Day. Do Not Stop Taking This Medicinal Product, Even If You Feel Better, Unless Your Doctor Tells You to.

Use in Children and Adolescents

Bicalutamide Accord Must Not Be Used in Children.

If You Take More Bicalutamide Accord Than You Should

If You Have Taken More Than the Prescribed Dose, Contact Your Doctor or Go to the Hospital Immediately.

If You Forget to Take Bicalutamide Accord

If You Miss a Dose, Skip It and Take the Next Tablet at the Usual Time.
Do Not Take a Double Dose to Make Up for a Forgotten Dose.
If You Have Any Further Questions on the Use of This Medicinal Product, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicinal Product Can Cause Side Effects, Although Not Everybody Gets Them.

If You Experience Any of the Following Side Effects, Tell Your Doctor Immediately, as You May Need Urgent Medical Attention.

Allergic Reactions(Not Very Common, Affects Less Than 1 in 100 People).
Include Sudden Onset of:

• Rash, Itching, Hives;
• Swelling of the Face, Lips, Tongue, Throat, or Other Parts of the Body;
• Difficulty Breathing, Wheezing, Shortness of Breath.

Not Very Common(Affects Less Than 1 in 100 People):

• Severe Shortness of Breath or Sudden Increase in Shortness of Breath, Sometimes with Cough and Fever. These May Be Symptoms of a Condition Called Interstitial Lung Disease.

Other Possible Side Effects

Very Common(Affects More Than 1 in 10 People):

• Skin Rash;
• Breast Tenderness and Swelling;
• Feeling of Weakness.

Common(Affects Less Than 1 in 10 People):

• Yellowing of the Skin or Whites of the Eyes (Jaundice); These Symptoms May Be Caused by Liver Disease or, in Rare Cases (Affects Less Than 1 in 1,000 People), Liver Failure;
• Abdominal Pain;
• Blood in the Urine;
• Hot Flushes;
• Nausea;
• Itching;
• Dry Skin;
• Difficulty Achieving an Erection (Erectile Dysfunction);
• Weight Gain;
• Decreased Sex Drive and Decreased Fertility;
• Hair Loss;
• Excessive Hair Growth;
• Decreased Red Blood Cell Count (Anemia), Which May Cause Tiredness and Pale Skin;
• Loss of Appetite;
• Depression;
• Drowsiness;
• Indigestion;
• Dizziness;
• Constipation;
• Bloating (Passing Gas);
• Chest Pain;
• Swelling.

Rare(Affects Less Than 1 in 1,000 People):

• Increased Sensitivity of the Skin to Sunlight.

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

• Changes in the Electrocardiogram (ECG) (Prolongation of the QT Interval).

Your Doctor May Prescribe Blood Tests to Monitor Changes in Your Blood Count.

Reporting of 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 Monitoring, 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 Medicinal Product.

5. How to Store Bicalutamide Accord

Keep This Medicinal Product Out of the Sight and Reach of Children.
Do Not Use This Medicinal Product After the Expiry Date Which Is Stated on the Carton and Blister After: Expiry Date (EXP). The Expiry Date Refers to the Last Day of That Month.
There Are No Special Storage Conditions for This Medicinal Product.
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 Bicalutamide Accord Contains

The Active Substance Is Bicalutamide. One Film-Coated Tablet Contains 150 Mg of Bicalutamide.
The Other Ingredients Are:
Tablet Core: Lactose Monohydrate, Carboxymethylcellulose Sodium (Type A), Povidone K30, Magnesium Stearate.
Opadry 02B580014 White: Hypromellose 5 Mpas, Titanium Dioxide (E 171), Macrogol 400.

What Bicalutamide Accord Looks Like and Contents of the Pack

White or Almost White, Round, Biconvex Film-Coated Tablets with a Diameter of About 10 Mm, with the Marking "IO1" on One Side and a Smooth Surface on the Other.
The Tablets Are Packaged in Transparent PVC/PVDC/Aluminum Blisters and a Cardboard Box.
Package Sizes: 7, 28, 30, 60, 90, or 100 Tablets.
Not All Package Sizes May Be Marketed.

Marketing Authorization Holder

Accord Healthcare Polska Sp. Z O.O.
Ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. Z O.O.
Ul. Lutomierska 50
95-200 Pabianice
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona, Spain

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

Date of Last Revision of the Leaflet: September 2024