BICALUTAMIDE 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Bicalutamide Accord, 50 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents:
3. What is Bicalutamide Accord and What is it Used for
4. Important Information Before Taking Bicalutamide Accord
   1. When Not to Take Bicalutamide Accord
   2. Warnings and Precautions
   3. Other Medications and Bicalutamide Accord
   4. Bicalutamide Accord with Food and Drink
   5. Pregnancy, Breastfeeding and Fertility
   6. Driving and Operating Machines
   7. Bicalutamide Accord Contains Lactose
   8. Bicalutamide Accord Contains Sodium
5. How to Take Bicalutamide Accord
   1. Taking More than the Recommended Dose of Bicalutamide Accord
   2. Missing a Dose of Bicalutamide Accord
   3. Stopping Treatment with Bicalutamide Accord
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Bicalutamide Accord
8. Package Contents and Other Information
   1. What Bicalutamide Accord Contains
   2. What Bicalutamide Accord Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer/Importer
   5. This Medicinal Product is Authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the Following Names:
   6. Country Marketing Authorization Holder
   7. Date of Last Revision of the Leaflet: September 2024

Package Leaflet: Information for the Patient

Bicalutamide Accord, 50 mg, Film-Coated Tablets

Bicalutamide

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

• Keep this Package Leaflet, as You May Need to Read it Again.
• Consult a Doctor or Pharmacist if You Have any Further Questions.
• 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 any of the Side Effects get Serious, or if You Notice any Side Effects not Listed in this Leaflet, Please Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Bicalutamide Accord and What is it Used for
• 2. Important Information Before Taking Bicalutamide Accord
• 3. How to Take Bicalutamide Accord
• 4. Possible Side Effects
• 5. How to Store Bicalutamide Accord
• 6. Package Contents and Other Information

1. What is Bicalutamide Accord and What is it Used for

Bicalutamide Accord Contains the Active Substance Bicalutamide and Belongs to a Group of Medications Called Anti-Androgens. These Medications Block the Action of Androgens - Male Sex Hormones.
One of the Effects of Androgen Action is to Stimulate the Growth of Tumors. Anti-Androgens Inhibit this Growth.
This Medication is Used to Inhibit the Growth of Prostate Cancer and Improve the Quality of Life (Palliative Treatment).
This Medication is Prescribed Only to Men with Non-Operable Prostate Cancer with Metastases, who have had their Testicles Completely or Partially Removed, or who are Taking an LHRH Agonist (a Type of Medication that Inhibits the Production of Testosterone in the Body).

2. Important Information Before Taking Bicalutamide Accord

When Not to Take Bicalutamide Accord

• If the Patient is Allergic to Bicalutamide or any of the Other Ingredients of this Medication (Listed in Section 6).
• In Women (including Pregnant or Breastfeeding Women)
• If the Patient is Taking a Medication Called Cisapride or Certain Antihistamines (Terfenadine, Astemizole)

If any of the Above Applies to the Patient, do not Take Bicalutamide Accord. If the Patient has any Doubts whether the Above Applies to them Before Taking this Medication, they Should Consult a Doctor or Pharmacist.
Bicalutamide Accord Should not be Given to Children.

Warnings and Precautions

Before Starting Treatment with Bicalutamide Accord, Consult a Doctor or Pharmacist.

• Tell the Doctor if the Patient has Heart or Blood Vessel Disease, including Heart Rhythm Disorders (Arrhythmia) or if the Patient is Taking Medications to Treat these Conditions. The Risk of Heart Rhythm Disorders may Increase During Bicalutamide Treatment.
• If the Patient has Liver Disease. The Doctor will Regularly Monitor Liver Function.
• If the Patient is Taking Blood-Thinning Medications or Medications to Prevent Blood Clots
• If the Patient has Diabetes and is Already Taking LHRH Antagonists (e.g. Goserelin, Buserelin, Leuprolide or Triptorelin). The Active Substance of this Medication (Bicalutamide) may have a Negative Effect on Blood Sugar Levels. Therefore, the Doctor will Regularly Check Blood Sugar Levels.
• In Case of Hospitalization, Inform the Medical Staff about Taking Bicalutamide Accord.
• During Treatment with Bicalutamide Accord and for 130 Days After Completion of Therapy, the Patient and their Partner Should Use Effective Contraception. If there are any Questions about Birth Control, Consult a Doctor or Pharmacist.

Other Medications and Bicalutamide Accord

Tell the Doctor or Pharmacist about all Medications Currently Being Taken or Recently Taken, as well as Medications Planned to be Taken, including those Available Without a Prescription and Herbal Medications. Bicalutamide may Affect the Way Other Medications Work, and Other Medications may Affect the Way Bicalutamide Works.
Bicalutamide Accord Should not be Taken with any of the Following Medications:

• Cisapride (Used to Treat Stomach Disorders),
• Certain Antihistamines (Terfenadine or Astemizole).

Bicalutamide may Interfere with the Action of Certain Medications Used to Treat Heart Rhythm Disorders (e.g. Quinidine, Procainamide, Amiodarone and Sotalol) or may Increase the Risk of Heart Rhythm Disorders when Used with Other Medications (e.g. Methadone (Used to Relieve Pain and for Detoxification During Addiction Treatment), Moxifloxacin (an Antibiotic), Antipsychotic Medications Used for Severe Mental Illness).
Inform the Doctor or Pharmacist if the Patient is Taking any of the Following Medications:

• Oral Blood-Thinning Medications (e.g. Warfarin, Coumarin Derivatives)
• Cyclosporine (Used to Suppress the Immune System)
• Cimetidine (Used to Treat Stomach Diseases)
• Ketoconazole (Used to Treat Fungal Infections)
• Calcium Channel Blockers (Used to Treat High Blood Pressure or Certain Heart Diseases)

Bicalutamide Accord with Food and Drink

This Medication can be Taken with or Without Food. This does not Affect the Amount of Medication Absorbed into the Bloodstream.

Pregnancy, Breastfeeding and Fertility

The Use of Bicalutamide Accord in Women is Contraindicated. Do not Use this Medication in Pregnant or Breastfeeding Women.
Bicalutamide Accord may Cause Temporary Infertility or Impotence in Men.

Driving and Operating Machines

It has not been Established that Bicalutamide Accord Affects the Ability to Drive or Operate Machines. If the Patient Experiences Drowsiness, they Should Exercise Caution when Performing these Activities.

Bicalutamide Accord Contains Lactose

Lactose is a Type of Sugar. If the Patient has been Diagnosed with Intolerance to some Sugars, they Should Consult a Doctor Before Taking this Medication.

Bicalutamide Accord Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which means it is Considered "Sodium-Free".

3. How to Take Bicalutamide Accord

This Medication Should Always be Taken as Directed by the Doctor.

• The Recommended Dose is one 50 mg Tablet per Day. This Applies to all Adult Men.
• The Tablet Should be Swallowed Whole with a Glass of Water.
• Do not Stop Taking this Medication, even if the Patient Feels Well, unless the Doctor Advises Otherwise.

Taking More than the Recommended Dose of Bicalutamide Accord

In Case of Taking More than the Recommended Dose of Bicalutamide Accord, Consult a Doctor or Go to the Nearest Hospital Immediately. Bring the Medication Packaging with You.

Missing a Dose of Bicalutamide Accord

If a Dose is Missed, it can be Taken on the Same Day as Soon as Remembered.
If the Patient Remembers the Next Day that they Missed a Dose the Previous Day, they Should Skip the Missed Dose and Take the Next Dose at the Usual Time that Day.
Do not Take a Double Dose to Make up for a Missed Tablet.

Stopping Treatment with Bicalutamide Accord

The Medication Should be Taken as Directed by the Doctor or Pharmacist. If the Patient Intends to Stop Taking this Medication, they Should First Consult a Doctor. Stopping or Interrupting Treatment with this Medication may Cause Side Effects.
If the Patient has any Further Questions about Taking this Medication, they Should Consult a Doctor, Pharmacist or Nurse.

4. Possible Side Effects

Like all Medications, Bicalutamide Accord can Cause Side Effects, although not Everybody gets them.
The Following Side Effects may Occur During Treatment with this Medication:
Very Common (affects more than 1 in 10 Patients):

• Anemia
• Dizziness
• Hot Flashes
• Nausea
• Constipation
• Abdominal Pain
• Hematuria (Blood in the Urine)
• Gynecomastia (Breast Enlargement)
• Breast Tenderness and/or Surrounding Area
• Weakness (Asthenia)
• Fluid Retention (Edema)

Common(affects no more than 1 in 10 Patients):

• Loss of Appetite
• Severe Depression
• Decreased Sex Drive (Decreased Libido)
• Drowsiness
• Insufficient Heart Contraction (Heart Failure)
• Myocardial Infarction; Fatal Cases have been Reported
• Digestive Disorders. This may be Characterized by a Feeling of Fullness in the Upper Abdomen, Stomach Pain, Belching, Nausea, Vomiting and Heartburn (Dyspepsia).
• Bloating
• Liver Function Disorders [Increased Activity of Certain Liver Enzymes (Aminotransferases), Jaundice]
• Liver and Bile Duct Diseases
• Itching (Pruritus)
• Dry Skin
• Hair Loss (Alopecia)
• Skin Rash
• Excessive Hair Growth (Hirsutism)
• Impotence
• Chest Pain
• Weight Gain

Uncommon(affects no more than 1 in 100 Patients):

• Allergic Reactions, such as Sudden Fluid Accumulation in the Skin and Mucous Membranes (e.g. Throat or Tongue), Difficulty Breathing and/or Itching and Skin Rash, often as an Allergic Reaction (Angioedema), or Skin Rash with Severe Itching and Hives.
• Interstitial Lung Disease; Fatal Cases have been Reported

Rare(affects no more than 1 in 1000 Patients)

• Decreased Liver Function (Liver Failure); Fatal Cases have been Reported
• Sensitivity to Sunlight

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

• Changes in the ECG Recording (Prolonged QT Interval)

The Doctor may Prescribe a Blood Test to Check for any Changes in the Blood.
The Patient Should not be Concerned about the Listed Side Effects, as none of them may Occur.

Reporting Side Effects

If any Side Effects Occur, including any not Listed in this Leaflet, Inform a Doctor or Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https:// smz.ezdrowie.gov.pl
Side Effects can also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather more Information on the Safety of this Medication

5. How to Store Bicalutamide Accord

• There are no Special Precautions for Storing the Medicinal Product.
• Store in a Place Out of Sight and Reach of Children.
• Do not Use this Medication after the Expiration Date Stated on the Blister Pack and Carton after "Expiration Date (EXP)". The Expiration Date Refers to the Last Day of the Given Month.
• 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. Package Contents and Other Information

What Bicalutamide Accord Contains

The Active Substance of the Medication is Bicalutamide.
Each Film-Coated Tablet Contains 50 mg of Bicalutamide.
Excipients
Tablet Core
Lactose Monohydrate
Croscarmellose Sodium
Povidone K-30
Magnesium Stearate
Coating
Hypromellose
Macrogol 400
Titanium Dioxide (E171)

What Bicalutamide Accord Looks Like and Contents of the Package

Bicalutamide Accord 50 mg Film-Coated Tablets are Round, Biconvex, White to Off-White, with the Engraving "B 50" on one Side and Smooth on the Other.
Bicalutamide Accord 50 mg Film-Coated Tablets are Packaged in Blisters, which may Contain: 14, 20, 28, 30, 60, 84, 90, 98 or 100 Tablets.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, 32009,
Greece

This Medicinal Product is Authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the Following Names:

Country Marketing Authorization Holder

Estonia
Bicalutamide Accord 50mg Film-Coated Tablets
Ireland
Bicalutamide 50mg Film-Coated Tablets
Italy
Bicalutamide AHCL 50 mg Film-Coated Tablets
Latvia
Bicalutamide Accord 50 mg Film-Coated Tablets
Portugal
Bicalutamide Accord 50 mg Film-Coated Tablets
Spain
Bicalutamide Accord 50 mg Film-Coated Tablets
EFG
Netherlands
Bicalutamide Accord 50 mg Film-Coated Tablets
United Kingdom
(Northern Ireland)
Bicalutamide 50mg Film-Coated Tablets
Bulgaria
Bicalutamide Accord 50mg Film-Coated Tablets
Cyprus
Bicalutamide Accord 50mg Film-Coated Tablets
Lithuania
Bicalutamide Accord 50 mg Film-Coated Tablets
Poland
Bicalutamide Accord
Romania
Bicalutamide Accord 50 mg Film-Coated Tablets

Date of Last Revision of the Leaflet: September 2024