Package Insert: Information for the User

Bicalutamide Normogen 50 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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.

Bicalutamida is indicated for the treatment of advanced prostate cancer (daily dose of 50 mg) in combination with a medication called a luteinizing hormone-releasing hormone (LHRH) analog – an additional hormonal treatment or in conjunction with surgical removal of the testicles.

It is also indicated for the treatment of prostate cancer without metastasis, in cases where there is a high risk of progression of the disease (daily dose of 150 mg). It can be used alone or in combination with other therapeutic methods such as surgical removal of the prostate gland or radiation therapy.

Do not take Bicalutamida Normogen:

• If you are allergic to bicalutamida or any of the other components of this medication (listed in section 6).
• If you are a woman.
• 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 administered to children and adolescents under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamida Normogen.

• 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. Fatal cases (severe liver changes and liver failure) have been reported.
• If you have a lung inflammation called interstitial lung disease. Symptoms of this may include severe difficulty breathing with cough or fever. Fatal cases have been reported.
• If you have diabetes. The combined treatment of bicalutamida with luteinizing hormone-releasing hormone (LHRH) analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dosage.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamida in these cases.
• If you are taking a daily dose of 150 mg of bicalutamida and have a heart disease. Your doctor may choose to check your cardiac function periodically.

Inform your doctor if you have any heart or blood vessel disease or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Bicalutamida.

If any of the above situations apply to you, inform your doctor, who will take it into account during your treatment with Bicalutamida.

Inform hospital staff that you are taking Bicalutamida.

Children and adolescents

Bicalutamida should not be administered to children and adolescents under 18 years old.

Use of Bicalutamida Normogen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take bicalutamida with the following medications:

• Terfenadine or astemizol (for hay fever or allergy)
• Cisaprida (for stomach disturbances)

If you take Bicalutamida with any of the following medications, the effect of this and the other medications may be affected. Consult your doctor before taking any of the following medications with bicalutamida:

• Warfarin or any medication similar to prevent blood coagulation.
• Ciclosporina (used to reduce the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (medication used to alleviate anxiety before surgery or certain procedures or as an anesthetic before and during surgery)
• Calcium channel blockers (e.g., diltiazem or verapamil. These medications are used to treat high blood pressure or certain heart diseases)
• Cimetidina (to treat stomach ulcers)
• Ketoconazol (used to treat fungal infections of the skin and nails)

Bicalutamida may interfere 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).

Taking Bicalutamida Normogen with food and drinks

Bicalutamida Normogen can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking any medication

Bicalutamida is contraindicated in women. Women should not take this medication, including pregnant women or breastfeeding mothers.

Male fertility may be temporarily reduced due to bicalutamida treatment, including temporary infertility.

Driving and operating machinery

This medication may make you feel drowsy, so you should be careful when driving or operating machinery.

Bicalutamida Normogen contains lactose and sodium

This medication contains lactose.SIf your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

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

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

• The recommended dose is 1 tablet per day (equivalent to 50 mg of bicalutamida) or 3 tablets per day (equivalent to 150 mg of bicalutamida).
• Swallow the tablet(s) whole with water and do not crush it.
• Try to take the tablet(s) at the same time every day.

Bicalutamida Normogen can be taken with or without food.

In patients with prostate cancer without metastasis who have a high risk of disease progression, there is another available presentation (Bicalutamida Normogen 150 mg film-coated tablets) that facilitates therapeutic compliance, as you would take the dose of 150 mg in a single tablet.

If you take more Bicalutamida Normogen than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Bicalutamida Normogen

Do not take a double dose to compensate for the missed doses, simply continue with your regular treatment.

If you interrupt treatment with Bicalutamida Normogen

Do not stop taking this medication even if you feel well, unless your doctor tells you otherwise.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you notice any of the following symptoms, inform your doctor immediately or visit the nearest hospital emergency department. These side effects are very serious.

• Skin rash, severe skin itching (with blisters), hives, skin peeling or formation of blisters or scabs.
• Swelling of the face or neck, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
• Difficulty breathing or sudden worsening of breathing difficulty, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine.
• Abdominal pain.
• Yellow discoloration of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine are:

Very common: may affect more than 1 in 10 patients

• Anemia.
• Dizziness.
• Abdominal pain, constipation, nausea (urge to vomit).
• Hot flashes.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after treatment is stopped, particularly after prolonged treatment.

Common:may affect up to 1 in 10 patients

• Weight gain.
• Drowsiness.
• Myocardial infarction (fatalities have been reported), heart failure.
• Stomach pain, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated liver enzymes, jaundice (yellow discoloration of skin and eyes).
• Erectile dysfunction.
• Decreased libido, depression.

Uncommon;may affect up to 1 in 100 patientspatients

• Interstitial lung disease (a lung inflammation). Fatalities have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

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

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

Frequency not known: cannot be estimated from available data

• Changes in the electrocardiogram ECG (prolongation of the QT interval).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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.

This medication does not require special storage conditions.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Bicalutamida Normogen 50 mg tablets

• The active ingredient is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other components are:

- Core: lactose monohydrate, carboxymethylcellulose sodium (type A) (from potato), povidone, crospovidone, magnesium stearate (E 572)

- Coating: hypromellose (E 464), macrogol 300, titanium dioxide (E171).

Appearance of the product and content of the packaging

Bicalutamida Normogen 50 mg are film-coated tablets, white, round, biconvex, and marked with “B” on one face.

The tablets are available in blisters that are presented in a cardboard box. Each box contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

– 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:April 2022

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