BICALUTAMIDE TEVA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Bicalutamide Teva 50 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to takethis medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Bicalutamide Teva and what is it used for
2. What you need to know before taking Bicalutamide Teva
3. How to take Bicalutamide Teva
4. Possible side effects
5. Storage of Bicalutamide Teva
6. Package contents and additional information

1. What is Bicalutamide Teva and what is it used for

Bicalutamide belongs to a group of medications called anti-androgens, which means it interferes with some of the actions of androgens (male sex hormones) in the body.

This medication is indicated in adult males for certain prostate pathologies, along with other treatments, such as medications that reduce androgen levels in the body.

2. What you need to know before taking Bicalutamide Teva

Do not take Bicalutamide Teva:

• If you are allergic to bicalutamide or any of the other components of this medication (listed in section 6).

• If you are taking terfenadine or astemizole, which are used to treat allergies, or cisapride, which is used to treat heartburn and acid reflux.

• Bicalutamide should not be taken by women, nor should it be administered to children or adolescents.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamide Teva

• If you are taking any other medication, including those you have purchased, particularly if you are taking oral anticoagulants (to prevent blood clots).
• If you have any liver disorder or disease. The medication should only be taken after your doctor has carefully considered the potential benefits and risks. If this is the case, your doctor should regularly perform liver function tests. If severe liver dysfunction occurs, treatment with Bicalutamide Teva should be discontinued. Fatal cases have been reported.
• If you have diabetes. Combined treatment with bicalutamide and LHRH analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or anti-diabetic medication dosage.

• If you have any heart or blood vessel condition, including heart rhythm problems (arrhythmias). The risk of heart rhythm problems may increase when using Bicalutamide Teva.

In case of hospitalization, inform the healthcare staff that you are taking bicalutamide.

Only stop taking the tablets if your doctor tells you to do so.

Other medications and Bicalutamide Teva

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription. See the "Warnings and precautions" section.

Bicalutamide Teva may interfere with some medications used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g., methadone (used for pain relief and detoxification), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Pregnancy, breastfeeding, and fertility:

Bicalutamide should not be taken by women, including pregnant or breastfeeding women.

Driving and using machines:

It is unlikely that this medication will adversely affect your ability to drive or operate machinery. However, you should be cautious if you experience drowsiness.

This medication contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains sodium.This medication contains less than 1 mmol of sodium (23mg) per tablet; it is essentially "sodium-free".

3. How to take Bicalutamide Teva

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with bicalutamide. Do not stop treatment before your doctor tells you to do so.

Recommended dose:

• In adults, the recommended dose is 1 tablet per day.
• Swallow the tablet whole with water.
• Try to take the tablet at the same time every day.

If you take more Bicalutamide Teva than you should:

If you ingest a dose higher than normal, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicology Information Service; Telephone 91562 04 20.

If you forget to take Bicalutamide Teva:

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Contact your doctor or pharmacist immediately if you experience any of the following:

Very common(may affect more than 1 in 10 patients)

• abdominal pain
• blood in the urine

Common(may affect up to 1 in 10 patients)

• liver function impairment that can cause yellowing of the skin and the whites of the eyes (jaundice),

Uncommon(may affect up to 1 in 100 patients)

• severe breathing difficulties or sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking bicalutamide develop interstitial lung disease. Fatal cases have been reported.
• severe skin itching (with hives) or swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.

Rare(may affect up to 1 in 1,000 patients)

• liver failure (severe liver function impairment) that can be associated with the following symptoms (affecting less than 1 in 10 patients): jaundice, itching, nausea, loss of appetite, easy bruising, and drowsiness. Fatal cases have been reported.

Tell your doctor if you are concerned about any of the following side effects:

Very common(may affect more than 1 in 10 patients):

• reduction in red blood cell count, which can make the skin pale and cause weakness or difficulty breathing,
• dizziness,
• blood in the urine
• abdominal pain
• constipation,
• nausea (discomfort),
• feeling of weakness,
• skin rash
• sensitivity or increased breast size.

• hot flashes.
• edema,

Common(may affect up to 1 in 10 patients):

• loss of appetite, decreased appetite
• decreased sex drive, erectile dysfunction,
• depression,
• drowsiness,
• chest pain, muscle skeletal pain,
• myocardial infarction (fatal cases have been reported), heart failure
• stomach pain
• gas (flatulence),
• changes in blood tests related to liver function.
• hair loss,
• excessive hair growth/re-growth of hair,
• dry skin,
• skin rash,
• weight gain.

Uncommon(may affect up to 1 in 100 patients):

• interstitial lung disease (inflammation of the lungs). Fatal cases have been reported.
• allergic reactions (hypersensitivity), skin swelling, hives.

Rare(may affect up to 1 in 1,000 patients):

• liver failure. Fatal cases have been reported.
• increased skin sensitivity to sunlight.

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

• changes in the electrocardiogram (ECG) (QT prolongation)

Do not be alarmed by this list of possible side effects, as you may not experience any of them.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bicalutamide Teva

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Store in the original packaging.

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Bicalutamide Teva

Each film-coated tablet contains 50 mg of bicalutamide.

The other components are: microcrystalline cellulose (Avicel PH-102), povidone (PVP K-30), sodium croscarmellose, sodium lauryl sulfate, lactose monohydrate, anhydrous colloidal silica, magnesium stearate.

Coating: Opadry OY-GM-28900 white (hypromellose (E 464), polydextrose (E 1200), titanium dioxide (E 171), macrogol 4000) and purified water.

Appearance of the product and package contents

Bicalutamide Teva is presented in the form of round, film-coated tablets, white or almost white, engraved with "93" on one side and "220" on the other.

Each package contains 30 film-coated tablets packaged in transparent PVC/PVdC-aluminum blisters.

Marketing authorization holder and manufacturer

Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

Alcobendas, 28108 Madrid

Manufacturer:

Teva Pharmaceutical Works Private Limited Company.

Pallagi út 13

Debrecen

Hungary

Date of the last revision of this package leaflet:November 2021

"Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/ "