Binabic

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Binabic, 50 mg, Film-Coated Tablets

Bicalutamide

Read the Leaflet Carefully Before Taking the Medicinal Product

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet

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

1. What is Binabic and What is it Used For

Bicalutamide, the active substance of Binabic, belongs to a group of medicines called anti-androgens.

• Binabic is used for the treatment of prostate cancer.
• Binabic works by blocking male sex hormones such as testosterone.

Contact your doctor if you do not feel better or if you feel worse.

2. Important Information Before Taking Binabic

When Not to Take Binabic

• if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of Binabic (listed in section 6);
• if you are taking a medicine called cisapride or certain antihistamines (terfenadine or astemizole);
• in women. You should not take Binabic if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Binabic. Binabic should not be given to children.

Warnings and Precautions

Before starting treatment with Binabic, 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, inform the medical staff that you are taking Binabic.
Inform your doctor if you have any of the following conditions:
any heart or blood vessel disease, including irregular heart rhythm (arrhythmia) or if you are being treated with medicines for these conditions. During treatment with Binabic, there may be an increased risk of irregular heart rhythm.

Binabic 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 if you are already taking the following medicines:

• cisapride (a medicine used for certain types of indigestion);
• certain antihistamines (terfenadine or astemizole).

Inform your doctor if you are taking any of the following medicines:

• oral medicines to prevent blood clotting (oral anticoagulants);
• cyclosporin (a medicine that suppresses the immune system);
• calcium channel blockers (medicines used for high blood pressure and certain heart diseases).

Binabic may interfere with the action of certain medicines used to treat irregular heart rhythm (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of irregular heart rhythm 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 illnesses).

Pregnancy, Breast-Feeding, and Fertility

Binabic should not be taken by women. You should not take Binabic if you are pregnant or breast-feeding.

Driving and Using Machines

It is unlikely that Binabic will affect your ability to drive or use machines. However, as drowsiness may occur when taking Binabic, be cautious if this symptom occurs.

Binabic Contains Lactose Monohydrate

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 Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to Take Binabic

Always take Binabic exactly as your doctor has told you. If you are not sure, ask your doctor.

• The usual dose of Binabic is one 50 mg tablet per day.
• Swallow the tablet whole with water.
• It is recommended to take the medicine at the same time each day.
• Do not stop taking Binabic 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 should not be given to patients under 18 years of age.

Overdose

If you have taken more than the prescribed dose of Binabic, contact your doctor or go to the hospital immediately.

Missed Dose

• 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 a forgotten dose.

4. Possible Side Effects

Like all medicines, Binabic 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 experience any of these side effects, contact your doctor immediately.

Also, Contact Your Doctor Immediately if You Experience 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 whites of the eyes (jaundice). These may be signs of liver problems or, in rare cases (less than 1 in 1000 people), liver failure.

Uncommon(affects less than 1 in 100 people)

• severe shortness of breath or sudden worsening of shortness of breath with cough or high temperature (fever). These may be signs of a lung disease called "interstitial lung disease".

Other Side Effects:

Very Common(affects more than 1 in 10 people)

• dizziness,
• constipation,
• nausea,
• breast tenderness or swelling,
• hot flushes,
• weakness,
• swelling,
• reduced red blood cell count (anemia) which may cause weakness or pale skin.

Common(affects less than 1 in 10 people)

• loss of appetite,
• reduced sex drive,
• depression,
• drowsiness,
• indigestion,
• bloating,
• hair loss,
• regrowth of hair or excessive hair growth,
• dry skin,
• itching of the skin,
• rash,
• erectile dysfunction (impotence),
• weight gain,
• chest pain,
• heart failure,
• heart attack. Frequency Not Known(frequency cannot be estimated from the available data)
• changes in ECG (prolongation of QT interval). Your doctor may recommend regular blood tests to check for any changes.

The above list of possible side effects is not exhaustive, and you may not experience any of them. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, nurse, or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Binabic

Keep this medicinal product out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use Binabic after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Binabic 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 containing: hypromellose (E464), titanium dioxide (E171), propylene glycol.

What Binabic Looks Like and Contents of the Pack

Binabic are white, round, biconvex film-coated tablets.
The pack contains 28 film-coated tablets packaged in PVC/PVDC/Aluminum blisters.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in the Czech Republic, the Country of Export:

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Manufacturer:

Genepharm S.A.
18th klm Marathonos Avenue
153 51 Pallini Attikis
Greece

Parallel Importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in the Czech Republic, the country of export: 44/569/08-C
Parallel import authorization number: 192/25
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 Approval of the Leaflet: 27.05.2025

[Information about the trademark]