BINABIC 150 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Binabic, 150 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
3. What is Binabic 150 mg and what is it used for
4. Important information before taking Binabic 150 mg
   1. When not to take Binabic 150 mg
   2. Warnings and precautions
   3. Children and adolescents
   4. Tests
   5. Binabic 150 mg and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Sunlight or ultraviolet radiation (UV)
   9. Binabic 150 mg contains lactose
   10. Binabic 150 mg contains sodium
5. How to take Binabic 150 mg
   1. Use in children and adolescents
   2. Overdose of Binabic 150 mg
   3. Missed dose of Binabic 150 mg
6. Possible side effects
   1. Seek immediate medical attention if you experience any of the following side effects - you may need urgent medical treatment:
   2. Allergic reactions
   3. You should also contact your doctor immediately if you experience any of the following side effects:
   4. Other side effects:
   5. Reporting side effects
7. How to store Binabic 150 mg
8. Contents of the pack and other information
   1. What Binabic 150 mg contains
   2. What Binabic 150 mg looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the package leaflet: 08.01.2021

Package Leaflet: Information for the Patient

Binabic, 150 mg, Film-Coated Tablets

Bicalutamide

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine 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, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Binabic 150 mg and what is it used for
• 2. Important information before taking Binabic 150 mg
• 3. How to take Binabic 150 mg
• 4. Possible side effects
• 5. How to store Binabic 150 mg
• 6. Contents of the pack and other information

1. What is Binabic 150 mg and what is it used for

Binabic 150 mg contains the active substance bicalutamide, which belongs to a group of medicines called anti-androgens.

• Binabic 150 mg is used for the treatment of prostate cancer.
• Binabic 150 mg works by blocking male sex hormones such as testosterone.

2. Important information before taking Binabic 150 mg

When not to take Binabic 150 mg

• in women
• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6)
• if you are taking a medicine containing cisapride or certain antihistamines (terfenadine or astemizole)

Binabic 150 mg should not be given to children.
Do not take Binabic 150 mg if any of the above applies to you. If you are in any doubt, consult your doctor or pharmacist before taking Binabic 150 mg.

Warnings and precautions

Before starting treatment with Binabic 150 mg, discuss with your doctor or pharmacist:

• if you have liver function disorders. Your doctor will recommend blood tests before and during treatment with Binabic 150 mg.
• if you have any heart or blood vessel disease, including irregular heart rhythm (arrhythmia) or if you are taking medicines for these conditions. The risk of irregular heart rhythm may be increased during treatment with bicalutamide.
• if you are taking Binabic 150 mg, you and (or) your partner should use effective contraception during treatment and for 130 days after stopping treatment with Binabic 150 mg. If you have any questions about contraception, consult your doctor.

In case of hospitalization, inform the medical staff that you are taking Binabic 150 mg.

Children and adolescents

Binabic 150 mg is contraindicated in children and adolescents.

Tests

Your doctor may order blood tests to check for any changes in your blood.

Binabic 150 mg and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, including those obtained without a prescription and herbal medicines. If you are taking bicalutamide with other medicines, the effect of bicalutamide or the other medicines may be altered.
Do not take Binabic 150 mg if you are already taking any of the following medicines:

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

Bicalutamide may affect 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 to relieve pain and in detoxification programs for drug addicts), moxifloxacin (an antibiotic), or medicines used to treat severe mental illnesses)].
You should also inform your doctor if you are taking any of the following medicines:

• oral anticoagulants (blood thinners). Your doctor may recommend blood tests before and during treatment with Binabic 150 mg.
• cyclosporin (a medicine that suppresses the immune system).
• calcium channel blockers (medicines used for high blood pressure and certain heart diseases).
• cimetidine (a medicine used for stomach ulcers).
• ketoconazole (a medicine used for fungal infections).

Pregnancy, breastfeeding, and fertility

Binabic 150 mg is contraindicated in women.

Driving and using machines

It is unlikely that bicalutamide will affect your ability to drive or use machines. However, some people may occasionally feel drowsy while taking bicalutamide. If you experience drowsiness, consult your doctor or pharmacist.

Sunlight or ultraviolet radiation (UV)

Avoid direct exposure to intense sunlight or ultraviolet radiation (UV) while taking bicalutamide.

Binabic 150 mg contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Binabic 150 mg 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 150 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
The recommended dose of Binabic 150 mg is one 150 mg tablet once a day.
Swallow the tablet 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 stop treatment should be made by your doctor.

Use in children and adolescents

Binabic 150 mg is contraindicated in children.

Overdose of Binabic 150 mg

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

Missed dose of Binabic 150 mg

If you miss a dose, skip the missed dose and take the next dose as scheduled. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Seek immediate medical attention if you experience any of the following side effects - you may need urgent medical treatment:

Allergic reactions

Uncommon (affects less than 1 in 100 people).
Symptoms may include sudden onset of:

• rash, itching, blisters on the skin,
• swelling of the face, lips, tongue, throat, or other parts of the body,
• difficulty breathing, wheezing, or shortness of breath,

You should also contact your doctor immediately if you experience any of the following side effects:

common(affects less than 1 in 10 people)

• yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver function disorders or, in rare cases (less than 1 in 1000 people), liver failure,
• abdominal pain,
• blood in the urine.

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".

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

• changes in the ECG (QT interval prolongation)

Other side effects:

very common(affects more than 1 in 10 people)

• skin rash,
• breast tenderness and swelling,
• weakness.

common(affects less than 1 in 10 people)

• hot flushes,
• nausea,
• itching of the skin,
• dry skin,
• erectile dysfunction (impotence),
• weight gain,
• reduced sex drive and fertility,
• hair loss,
• regrowth of hair or excessive hair growth,
• reduced red blood cell count (anemia) which may cause weakness or pale skin,
• loss of appetite,
• depression,
• drowsiness,
• indigestion,
• dizziness,
• constipation,
• bloating,
• chest pain,
• swelling.

rare(affects less than 1 in 1000 people)

• increased sensitivity of the skin to sunlight

Your doctor may recommend regular blood tests.
The above list of possible side effects is not intended to alarm you, as you may not experience any of them.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
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,
phone: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Binabic 150 mg

Keep this medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date. The expiry date refers to the last day of the month stated.
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 150 mg contains

• The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.
• The other ingredients are: Core: lactose monohydrate, povidone K-25, sodium carboxymethylcellulose (type A), magnesium stearate Coating: Opadry OY-S-9622 consisting of: hypromellose 5CP, titanium dioxide (E 171), propylene glycol

What Binabic 150 mg looks like and contents of the pack

Binabic 150 mg are white, round, biconvex film-coated tablets with a dividing line on one side. The dividing line on the tablet is only to facilitate breaking and not to divide into equal doses.
The tablets are packaged in a carton containing 28 or 30 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Vipharm S.A..
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Manufacturer
Genepharm S.A.
18th klm Marathonus Avenue
15351 Pallini Attikis
Greece

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

Poland
Binabic
Czech Republic
Binabic 150 mg
Slovakia
Binabic 150 mg

Date of last revision of the package leaflet: 08.01.2021