Binabic

Leaflet attached to the packaging: patient information.

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Binabic, 50 mg, film-coated tablets

Bicalutamide

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, nurse, or pharmacist. 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 packaging 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 antiandrogens.

• Binabic is used to treat prostate cancer.
• Binabic works by blocking male sex hormones such as testosterone.

The patient should contact their doctor if they do not feel any improvement or if they feel worse.

2. Important information before taking Binabic

When not to take Binabic

• if the patient is allergic (hypersensitive) to bicalutamide or any of the other ingredients of Binabic (listed in section 6),
• when taking the medicine with a medicine called cisapride or certain antihistamines (terfenadine or astemizole),
• in women.

Binabic should not be taken if any of the above situations apply to the patient. In case of any doubts, before taking Binabic, the patient should consult their doctor or pharmacist.
Binabic should not be given to children.

Warnings and precautions

Before starting to take Binabic, the patient should discuss with their doctor if:

• the patient has liver disease,
• the patient has diabetes and is taking "LHRH analogues" such as goserelin, buserelin, leuprorelin, and triptorelin.

In case of hospitalization, the patient should inform the medical staff that they are taking Binabic.
Page 1 5
The patient should inform their doctor if they experience any of the following situations:
any heart or blood vessel disease, including arrhythmia (irregular heartbeat) or if the patient is being treated with medicines used to treat these diseases. During treatment with Binabic, the risk of arrhythmia may be increased.

Binabic and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Binabic should not be taken if the patient is already taking the following medicines:

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

The patient should inform their doctor about taking the following medicines:

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

Binabic may interfere with the action of certain medicines used to treat arrhythmia (such as quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of arrhythmia when taken with certain other medicines (such as methadone (used to relieve pain and in detoxification programs for people addicted to opioids), moxifloxacin (an antibiotic), or medicines used to treat serious mental illnesses).

Pregnancy, breastfeeding, and fertility

Binabic should not be used in women. It should not be used in pregnant or breastfeeding women.

Driving and using machines

It is unlikely that Binabic will affect the ability to drive or use machines. However, due to the possibility of drowsiness after taking Binabic, caution should be exercised if this symptom occurs.

Binabic contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Binabic contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Binabic

Binabic should always be taken as directed by the doctor. In case of doubts, the doctor should be consulted.

• The usual dose of Binabic is one 50 mg tablet per day.
• The tablet should be swallowed whole, with a glass of water.
• It is recommended to take the medicine at the same time every day.
• The treatment should not be stopped even if the patient's condition improves. The decision to stop treatment should be made by the doctor who prescribed it.

Use in children and adolescents

Binabic should not be given to patients under 18 years of age.

Overdose of Binabic

Page 2 5
In case of overdose, the patient should immediately consult their doctor or go to the hospital.

Missed dose of Binabic

• In case of a missed dose, the patient should not take the missed dose, but take the next dose at the usual time.
• A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, Binabic can cause side effects, although not everybody gets them.

Allergic reactions

Uncommon (less than 1 in 100 patients).
Symptoms may include sudden onset of reactions such as:

• rash, itching, or hives on the skin,
• swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or swelling of other parts of the body,
• shortness of breath, wheezing, or difficulty breathing.

In case of any of these side effects, the patient should immediately consult their doctor.

The patient should also immediately consult their doctor in case of the following side effects:

very common(more than 1 in 10 patients)

• abdominal pain,
• blood in the urine.

common(less than 1 in 10 patients)

• yellowing of the skin or eyes (jaundice). This may be a sign of liver dysfunction or, in rare cases (less than 1 in 1000 patients), liver failure.

uncommon(less than 1 in 100 patients)

• severe shortness of breath or sudden worsening of shortness of breath with cough or high fever. This may be a sign of a lung disease called "interstitial lung disease".

Other side effects:

very common(more than 1 in 10 patients)

• dizziness,
• constipation,
• nausea,
• breast tenderness or swelling,
• hot flashes,
• weakness,
• edema,
• decreased red blood cell count (anemia) manifested as weakness or pale skin.

common(less than 1 in 10 patients)

• loss of appetite,
• decreased libido,
• depression,
• drowsiness,
• indigestion,
• bloating,

Page 3 5

• hair loss,
• regrowth of hair or excessive hair growth,
• dry skin,
• itching skin,
• rash,
• erectile dysfunction (impotence),
• weight gain,
• chest pain,
• heart failure,
• myocardial infarction.

frequency not known(frequency cannot be estimated from the available data)

• changes in ECG (QT interval prolongation).

The doctor may recommend regular blood tests to check for any changes.
The above list of possible side effects should not cause concern, as the patient may not experience any of them. If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, nurse, or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Binabic

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
Binabic should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Binabic contains

• The active substance of Binabic is bicalutamide: each tablet contains 50 mg of bicalutamide.
• The other ingredients of Binabic are: Core:lactose monohydrate, magnesium stearate, povidone K 25, sodium carboxymethylcellulose (type A). Coating:Opadry OY-S-9622 with the composition: hypromellose (E 464), titanium dioxide (E 171), propylene glycol.

Page 4 5

What Binabic looks like and what the packaging contains

White, round, biconvex film-coated tablets.
28 or 30 film-coated tablets packaged in PVC/PVDC/Al blisters, in a cardboard box.
For more detailed information, the patient should 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 44/569/08-C

Parallel import authorization number: 391/22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland
Binabic
Czech Republic
Binabic
Slovakia
Binabic
Date of leaflet approval: 31.10.2022
[Information about the trademark]
Page 5 5