Binabic

Package Leaflet: Information for the Patient

Binabic, 50 mg, Film-Coated Tablets

Bicalutamide

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 Binabic 50 mg and What Is It Used For
• 2. Important Information Before Taking Binabic 50 mg
• 3. How to Take Binabic 50 mg
• 4. Possible Side Effects
• 5. How to Store Binabic 50 mg
• 6. Contents of the Pack and Other Information

1. What Is Binabic 50 mg and What Is It Used For

Bicalutamide, the Active Substance of Binabic 50 mg, Belongs to a Group of Medicines Called Antiandrogens.

• Binabic 50 mg Is Used for the Treatment of Prostate Cancer.
• Binabic 50 mg Works by Blocking Male Sex Hormones Such as Testosterone.

If You Do Not Feel Better or If You Feel Worse, You Should Contact Your Doctor.

2. Important Information Before Taking Binabic 50 mg

When Not to Take Binabic 50 mg

• If You Are Allergic (Hypersensitive) to Bicalutamide or Any of the Other Ingredients of Binabic 50 mg (Listed in Section 6).
• If You Are Taking a Medicine Called Cisapride or Certain Antihistamines (Terfenadine or Astemizole).
• In Women.

Do Not Take Binabic 50 mg If Any of the Above Applies to You. If You Are in Any Doubt, Consult Your Doctor or Pharmacist Before Taking Binabic 50 mg. Binabic 50 mg Must Not Be Given to Children.

Warnings and Precautions

Before Starting Treatment with Binabic 50 mg, You Should Discuss with Your Doctor If:

• You Have Liver Disease.
• You Have Diabetes and Are Taking "LHRH Analogues" Such as Goserelin, Buserelin, Leuprorelin, and Triptorelin.

If You Are Admitted to Hospital, Tell the Medical Staff That You Are Taking Binabic 50 mg. You Should Tell Your Doctor If You Have Any of the Following Conditions: Any Heart or Blood Vessel Disease, Including Heart Rhythm Disorders (Arrhythmia), or If You Are Being Treated with Medicines for These Conditions. During Treatment with Binabic 50 mg, the Risk of Heart Rhythm Disorders May Be Increased.

Binabic 50 mg and Other Medicines

Tell Your Doctor About All the Medicines You Are Taking Now or Have Taken Recently, and About Any Medicines You Plan to Take. Do Not Take Binabic 50 mg If You Are Already Taking the Following Medicines:

• Cisapride (a Medicine Used for Certain Types of Indigestion).
• Certain Antihistamines (Terfenadine or Astemizole).

Tell Your Doctor If You Are Taking Any of the Following Medicines:

• Oral Anticoagulants (Medicines to Prevent Blood Clots).
• Cyclosporin (a Medicine That Suppresses the Immune System).
• Calcium Channel Blockers (Medicines Used for High Blood Pressure and Certain Heart Conditions).

Binabic 50 mg May Interfere with the Action of Certain Medicines Used to Treat Heart Rhythm Disorders (e.g., Quinidine, Procainamide, Amiodarone, and Sotalol), or May Increase the Risk of Heart Rhythm Disorders When Taken with Certain Other Medicines (e.g., Methadone (Used for Pain Relief and in Detoxification Programs), Moxifloxacin (an Antibiotic), or Medicines Used to Treat Serious Mental Disorders).

Pregnancy, Breast-Feeding, and Fertility

Binabic 50 mg Is Contraindicated in Women. It Must Not Be Taken by Women Who Are Pregnant or Breast-Feeding.

Driving and Using Machines

It Is Unlikely That Binabic 50 mg Will Affect Your Ability to Drive or Use Machines. However, as Drowsiness May Occur, You Should Be Cautioned If This Happens.

Binabic 50 mg Contains Lactose

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

Binabic 50 mg 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 Binabic 50 mg

Always Take Binabic 50 mg Exactly as Your Doctor Has Told You. If You Are Not Sure, Check with Your Doctor.

• The Usual Dose of Binabic 50 mg Is One 50 mg Tablet per Day.
• Swallow the Tablet Whole with a Glass of Water.
• It Is Recommended to Take the Medicine at the Same Time Each Day.
• Do Not Stop Taking Binabic 50 mg Without Consulting Your Doctor, Even if You Feel Better. The Decision to Stop Treatment Should Be Made by the Doctor Who Prescribed It for You.

Use in Children and Adolescents

Binabic 50 mg Should Not Be Given to Patients Under 18 Years of Age.

Overdose of Binabic 50 mg

If You Take More Than the Prescribed Dose of Binabic 50 mg, Contact Your Doctor or Go to the Hospital Immediately.

Missed Dose of Binabic 50 mg

• If You Miss a Dose, Do Not Take the Missed Dose, Just Take the Next Dose at the Usual Time.
• Do Not Take a Double Dose to Make Up for the Forgotten Dose.

4. Possible Side Effects

Like All Medicines, Binabic 50 mg Can Cause Side Effects, Although Not Everybody Gets Them.

Allergic Reactions

Uncommon (Affects Less Than 1 in 100 People).

Symptoms May Include:

• Rash, Itching, or Hives on the Skin;
• Swelling of the Face, Lips, Tongue, Throat, Which May Cause Difficulty in Swallowing or Swelling of Other Parts of the Body;
• Shortness of Breath, Wheezing, or Difficulty Breathing.

If You Notice Any of These Side Effects, Contact Your Doctor Immediately.

You Should Also Contact Your Doctor Immediately If You Notice Any of the Following Side Effects:

Very Common(Affects More Than 1 in 10 People)

• Abdominal Pain;
• Blood in the Urine.

Common(Affects Less Than 1 in 10 People)

• Yellowing of the Skin or the Whites of the Eyes (Jaundice). These May Be Signs of Liver Problems or, in Rare Cases (Less Than 1 in 1,000 People), Liver Failure.

Uncommon(Affects Less Than 1 in 100 People)

• Severe Shortness of Breath or Sudden Worsening of Shortness of Breath with a Cough or High Temperature (Fever). These May Be Signs of a Lung Inflammation Called "Interstitial Lung Disease".

Other Side Effects:

Very Common(More Than 1 in 10 People)

• Dizziness,
• Constipation,
• Nausea,
• Breast Tenderness or Swelling,
• Hot Flushes,
• Weakness,
• Swelling,
• Decreased Red Blood Cell Count (Anemia) Which May Cause Weakness or Pale Skin.

Common(Less Than 1 in 10 People)

• Loss of Appetite,
• Decreased Sex Drive,
• Depression,
• Drowsiness,
• Indigestion,
• Bloating,
• Hair Loss,
• Excessive Hair Growth or Regrowth,
• Dry Skin,
• Itching of the Skin,
• Rash,
• Impotence (Erectile Dysfunction),
• Weight Gain,
• Chest Pain,
• Heart Failure,
• Heart Attack.

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

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

Your Doctor May Decide to Perform Regular Blood Tests to Check for Any Changes. The Above List of Possible Side Effects Is Not Meant to Alarm You. You May Not Experience Any of Them. If You Notice Any Side Effects Not Mentioned in This Leaflet, Tell Your Doctor or Pharmacist.

Reporting of Side Effects

If You Experience Any Side Effects, Including Any Not Listed in This Leaflet, Tell Your Doctor, Nurse, or Pharmacist. You Can Also Report Side Effects Directly to the Department of Drug Safety Monitoring of the 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 Binabic 50 mg

Keep This Medicine Out of the Sight and Reach of Children. This Medicine Does Not Require Any Special Storage Conditions. Do Not Use Binabic 50 mg After the Expiry Date Which Is Stated on the Carton and Blister After "Expiry Date". The Expiry Date Refers to the Last Day of That Month. 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 to Protect the Environment.

6. Contents of the Pack and Other Information

What Binabic 50 mg Contains

• The Active Substance Is Bicalutamide: Each Tablet Contains 50 mg of Bicalutamide.
• The Other Ingredients Are: Core: Lactose Monohydrate, Magnesium Stearate, Povidone K-25, Sodium Carboxymethylcellulose (Type A). Coating: Opadry OY-S-9622 Consisting of Hypromellose 5 cp (E464), Titanium Dioxide (E171), Propylene Glycol.

What Binabic 50 mg Looks Like and Contents of the Pack

Binabic 50 mg Are White, Round, Biconvex, Film-Coated Tablets. The Pack Contains 28 or 30 Film-Coated Tablets in Blisters, in a Carton. Not All Packs May Be Available in Your Country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Vipharm S.A., ul. A. i F. Radziwiłłów 9, 05-850 Ożarów Mazowiecki. Manufacturer: Genepharm S.A., 18th klm Marathonus Avenue, 15351 Pallini Attikis, Greece.

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

Poland: Binabic 50 mg, Czech Republic: Binabic 50 mg, Slovakia: Binabic 50 mg.

Date of Last Revision of the Leaflet:08.01.2021