Label: information for theuser

Bicalutamida Teva 50 mg film-coated tablets EFG

Read this label carefully before starting to takethis medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult yourdoctororpharmacist.
• This medication has been prescribed to you alone,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 any adverse effects, consult your doctororfarmacist, even if they are not listed in this label.See section 4.

1. What isBicalutamida Tevaand for what it is used

2. What you need to know before starting totakeBicalutamida Teva

3. How to takeBicalutamida Teva

4. Possible adverse effects

5. Storage of Bicalutamida Teva

6. Contents of the package and additional information

Bicalutamida 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 in conjunction with other treatments, such as medications that reduce the levels of androgens in the body.

Do not take Bicalutamida Teva:

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

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

• Bicalutamida 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 Bicalutamida 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 possible benefits and risks. If this is the case, your doctor should regularly perform liver function tests. If severe liver function alteration occurs, treatment with Bicalutamida Teva should be interrupted. Fatal cases have been reported.
• If you have diabetes. The combined treatment of bicalutamida with LHRH analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dosage.

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

In case of hospital admission, inform the healthcare staff that you are taking bicalutamida.

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

Other medications and Bicalutamida Teva

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

Bicalutamida Teva may interact with some medications used to treat heart rhythm problems (e.g. quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g. metadona (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses).

Pregnancy, breastfeeding, and fertility:

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

Driving and operating machinery:

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

This medication contains lactose.If your doctor has told you that you have a certain sugar intolerance, 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”.

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

Your doctor will inform you of the duration of your treatment with bicalutamida. Do not stop treatment before your doctor tells you to.

Recommended dose:

• The recommended dose for adults 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 Bicalutamida 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 Toxicological Information Service; Telephone 91562 04 20.

If you forgot to take Bicalutamida Teva:

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may 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 deterioration that may cause yellowing of the skin and the white of the eyes (jaundice),

Uncommon(may affect up to 1 in 100 patients)

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

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

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

Inform 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 the number of red blood cells that may cause pale skin and cause weakness or difficulty breathing,
• Dizziness,
• Blood in the urine
• Abdominal pain
• Constipation,
• Nausea (discomfort),
• Feeling of weakness,
• Skin rash
• Sensitivity or enlargement of the breast.

• Hot flushes.
• Swelling,

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

• Loss of appetite, decreased appetite
• Decreased libido, 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 test results 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):

• Pulmonary interstitial disease (an inflammation of the lungs). Fatal cases have been reported.
• Allergic reactions (hypersensitivity), swelling of the skin, urticaria.

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

• Liver failure. Fatal cases have been reported.
• Increased skin sensitivity to sunlight.

Unknown frequency(the frequency cannot be estimated from the available data)

• Changes in the electrocardiogram ECG (prolongation of QT)

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 type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medications. By doing so, you will help protect the environment.

Composition of Bicalutamida Teva

Each film-coated tablet contains 50 mg of Bicalutamida.

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 contents of the packaging

Bicalutamida Teva is presented in the form of round, film-coated tablets, white or off-white, engraved with “ 93” on one side and with “ 220” on the other.

Each pack contains 30 film-coated tablets in a transparent PVC/PVdC blister with aluminum.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

Alcobendas, 28108 Madrid

Responsible for manufacturing:

Teva Pharmaceutical Works Private Limited Company.

Pallagi út 13

Debrecen

Hungary

Last review date of this leaflet: November 2021

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ ”