Binabic

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Binabic, 50 mg, Film-Coated Tablets

Bicalutamide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed 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 to treat prostate cancer.
• Binabic 50 mg 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 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).
• when taking a medicine called cisapride or certain antihistamines (terfenadine or astemizole).
• in women. Do not take Binabic 50 mg if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before taking Binabic 50 mg. Binabic 50 mg should not be given to children.

Warnings and precautions

Before starting treatment with Binabic 50 mg, 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 hospitalized, inform the staff that you are taking Binabic 50 mg.

Tell 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 50 mg, the risk of irregular heart rhythm may be increased.

Binabic 50 mg and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as 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). Inform your doctor about taking 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 50 mg may interfere with the action of certain medicines used to treat irregular heart rhythms (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of irregular heart rhythms when taken with certain other medicines (e.g., methadone (used for pain relief 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 50 mg is contraindicated in women. Do not take Binabic 50 mg if you are pregnant or breastfeeding.

Driving and using machines

It is unlikely that Binabic 50 mg will affect your ability to drive or use machines. However, be cautious if you experience drowsiness after taking Binabic 50 mg.

Binabic 50 mg contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Binabic 50 mg contains sodium

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

3. How to take Binabic 50 mg

Always take Binabic 50 mg exactly as your doctor has told you. If you are unsure, consult your doctor.

• The usual dose of Binabic 50 mg is one 50 mg tablet once a day.
• Swallow the tablet whole with water.
• It is recommended to take the medicine at the same time every day.
• Do not stop taking the medicine even if you feel better. The decision to stop treatment should be made by the doctor who prescribed it.

Use in children and adolescents

Binabic 50 mg should not be given to patients under 18 years of age.

Taking a higher dose of Binabic 50 mg than recommended

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

Missing a dose of Binabic 50 mg

• If you miss a dose, do not take the missed dose, just take the next one at the usual time.
• Do not take a double dose to make up for the missed 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 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.

You should 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 eyes (jaundice). This may be a sign 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 cough or high temperature (fever). This may be a sign 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 flashes,
• 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,
• decreased sex drive,
• depression,
• drowsiness,
• indigestion,
• bloating,
• hair loss,
• regrowth of hair or excessive hair growth,
• dry skin,
• itching 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 (prolonged QT interval).

Your doctor may recommend regular blood tests to check for any changes. The above list of possible side effects should not cause concern, as 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 or pharmacist. Side effects can be reported 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Binabic 50 mg

Keep the medicine out of the sight and reach of children. There are no special storage instructions. Do not take Binabic 50 mg 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 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 white, containing: hypromellose (E 464), titanium dioxide (E 171), propylene glycol.

What Binabic 50 mg looks like and contents of the pack

Binabic 50 mg are white, round, biconvex film-coated tablets. The cardboard packaging of the medicine contains 28 film-coated tablets packed in 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:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw Marketing authorization number in the Czech Republic, the country of export:44/569/08-C

Parallel import authorization number: 196/22

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 leaflet approval: 6.05.2022
[Information about the trademark]