Binabic

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Binabic, 50 mg, film-coated tablets
Bicalutamide
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, nurse, or pharmacist. See section 4.

Leaflet contents

1. What Binabic is and what it is 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 Binabic is and what it is used for

Bicalutamide, the active substance in Binabic, belongs to a group of medicines called antiandrogens.

• Binabic is used in 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 using Binabic

When not to use Binabic

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

Binabic should not be taken if any of the above situations apply to the patient. If in doubt, contact a doctor or pharmacist before taking Binabic.
Binabic must not be given to children.
Warnings and precautions
Before starting treatment with Binabic, discuss with your doctor if:

• the patient has liver disease,
• the patient has diabetes and is being treated with LHRH analogues such as goserelin, buserelin, leuprorelin, and triptorelin.

If hospitalised, inform the medical staff that Binabic is being taken.
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Inform your doctor if any of the following apply to the patient:
any heart or blood vessel diseases, including heart rhythm disorders (arrhythmia), or if the patient is being treated with medicines for these conditions. Treatment with Binabic may increase the risk of heart rhythm disorders.
Binabic and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Binabic if the patient is already taking the following medicines:

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

Inform your doctor if the patient is taking any of the following medicines:

• oral anticoagulants (oral blood thinners),
• cyclosporine (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 heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when taken together with certain other medicines (e.g. methadone (used to relieve pain and in detoxification programmes for drug-dependent individuals), moxifloxacin (an antibiotic), or medicines used to treat serious mental illnesses).
Pregnancy, breastfeeding and fertility
The use of Binabic in women is contraindicated. Binabic must not be used in pregnant women or women who are breastfeeding.
Driving and operating machinery
It is unlikely that Binabic affects the ability to drive or operate machinery. However, as drowsiness may occur after taking Binabic, caution should be exercised if this symptom occurs.
Binabic contains monohydrate lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Binabic contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Binabic

Binabic must always be used exactly as directed by the physician. In case of doubt, consult your doctor.

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

Use in children and adolescents
Binabic must not be given to patients under 18 years of age.
Overdose of Binabic
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In case of overdose, seek immediate medical advice or go to hospital.
Missed dose of Binabic

• If a dose is missed, do not take the missed dose; instead, take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions
Occurring uncommonly (less frequently than in 1 out of 100 treated patients).
Symptoms may include sudden onset of such reactions as:

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

If any of the above adverse effects occur, contact your doctor as soon as possible.
You should also contact your doctor immediately if any of the following adverse effects occur:
Very commonly (in more than 1 out of 10 treated patients)

• abdominal pain,
• presence of blood in the urine.

Commonly (in less than 1 out of 10 treated patients)

• yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver dysfunction or, in rare cases (in less than 1 out of 1,000 people), liver failure.

Uncommonly (in less than 1 out of 100 treated patients)

• severe shortness of breath or sudden worsening of breath with cough or high fever. These may be symptoms of a lung inflammation known as "interstitial lung disease".

Other adverse effects:
Very commonly (in more than 1 out of 10 treated patients)

• dizziness,
• constipation,
• nausea,
• breast tenderness and swelling,
• hot flushes,
• fatigue,
• swelling,
• decreased number of red blood cells (anemia), manifesting as weakness or pale skin.

Commonly (in less than 1 out of 10 treated patients)

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

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

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

• changes in ECG (prolongation of QT interval).

Your doctor may recommend periodic blood tests to monitor for possible changes.
The above list of possible adverse effects should not cause concern, as the patient may not experience any of them. If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, nurse or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Binabic

Keep the medicine out of sight and reach of children.
No special storage instructions apply.
Do not use the medicine Binabic after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 carboxymethyl starch (type A). Coating: Opadry OY-S-9622 with the composition: hypromellose (E 464), titanium dioxide (E 171), propylene glycol.

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What Binabic looks like and contents of the pack
White, round, biconvex coated tablets.
28 or 30 coated tablets packed in PVC/PVDC/Al blisters, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
Vipharm S.A., ul. A. i F. Radziwiłłów 9, 05-850 Ożarów Mazowiecki, Poland
Manufacturer:
Genepharm S.A., 18th km Marathonos Avenue, 153 51 Pallini Attikis, Greece
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in the Czech Republic, country of export: 44/569/08-C
Parallel import authorisation number: 391/22
This medicinal product is authorised in the European Economic Area countries under the following names:
Poland Binabic
Czech Republic Binabic
Slovakia Binabic
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