Binabic

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Binabic 50 mg is and what it is 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 Binabic 50 mg is and what it is used for

Bicalutamide, the active substance in Binabic 50 mg, belongs to a group of medicines called
antiandrogens.

• Binabic 50 mg is used in the treatment of 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 using Binabic 50 mg

When not to use Binabic 50 mg

• if the patient is 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 antihistamine medicines (terfenadine or astemizole).
• in women. Binabic 50 mg must not be taken if any of the above situations apply. If in doubt, consult a 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, discuss with the doctor if:

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

If hospitalised, inform medical staff that the patient is taking Binabic 50 mg.

Inform the doctor if the patient has any of the following:

• any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or if
• the patient is being treated with medicines used for these conditions.

While taking Binabic 50 mg, the risk of heart rhythm disorders may be increased.

Binabic 50 mg and other medicines

Tell the 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 50 mg if the patient is already taking any of the following medicines:

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

Inform the treating doctor if the patient is taking any of the following:

• oral anticoagulants (oral blood-thinning medicines).
• cyclosporine (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 together with certain other medicines (e.g. methadone (used for pain relief and in detoxification programmes for drug-dependent individuals), moxifloxacin (an antibiotic), or medicines used to treat serious psychiatric disorders).

Pregnancy, breastfeeding and fertility

Binabic 50 mg must not be used in women. It is contraindicated in women who are pregnant or breastfeeding.

Driving and operating machinery

It is unlikely that Binabic 50 mg affects the ability to drive or operate machinery. However, due to the possibility of drowsiness occurring after taking Binabic 50 mg, caution should be exercised if this symptom occurs.

Binabic 50 mg contains lactose monohydrate

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

Binabic 50 mg 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 50 mg

Binabic 50 mg should always be used as directed by the doctor. If in doubt,
consult the doctor.

• The usual dose of Binabic 50 mg 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 50 mg should not be given to patients under 18 years of age.
Overdose of Binabic 50 mg
In case of taking more than the recommended dose, seek immediate medical advice from a doctor
or go to a hospital.
Missed dose of Binabic 50 mg

• 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 reactions

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

• rash, itching, or hives on the skin;
• 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 reactions occur, seek medical advice as soon as possible.

Seek immediate medical advice also if any of the following adverse reactions occur:
very common (in more than 1 out of 10 treated patients)

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

common (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 (less than 1 in 1000 people), liver failure.

uncommon (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 disease called "interstitial lung disease".
  Other adverse reactions:
  very common (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 (anaemia) manifested by fatigue or pale skin.

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

• loss of appetite,
• decreased libido,
• 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,
• myocardial infarction.
  frequency not known (frequency cannot be estimated from available data)
• changes in ECG (prolongation of QT interval).

The doctor may recommend periodic blood tests to monitor for any potential changes.
The above list of possible adverse reactions 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 reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Binabic 50 mg

Keep the medicine out of the sight and reach of children.
No special storage instructions are required.
Do not use Binabic 50 mg after the expiry date stated on the packaging.
The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
• Other components of the medicinal product are: Core: monohydrate lactose, magnesium stearate, povidone K 25, sodium carboxymethyl starch (type A). Coating: Opadry OY-S-9622 white, composition: hypromellose (E 464), titanium dioxide (E 171), propylene glycol.

What Binabic 50 mg looks like and contents of the pack
Binabic 50 mg is a white, round, biconvex film-coated tablet.
The cardboard pack contains 28 film-coated tablets packed in blisters.
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in the Czech Republic, country of export: 44/569/08-C
Parallel Import Authorisation Number: 196/22

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Poland Binabic 50 mg
Czech Republic Binabic 50 mg
Slovakia Binabic 50 mg