BICALUTAMIDE NORMOGEN 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Normogen 50 mg film-coated tablets EFG

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

Keep this package leaflet, as you may need to read it again.

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

1. What Bicalutamide Normogen is and what it is 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.

Bicalutamide is indicated for the treatment of advanced prostate cancer (daily dose of 50 mg) in combination with a medication called luteinizing hormone-releasing hormone (LHRH) analogue - 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 radiotherapy.

2. What you need to know before taking Bicalutamide Normogen

Do not take Bicalutamide Normogen:

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

Warnings and precautions

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

• 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. Severe liver damage and liver failure have been reported.
• If you have a lung disease called interstitial lung disease. Symptoms may include severe difficulty breathing with cough or fever. Fatal cases have been reported.
• If you have diabetes. Combination treatment with bicalutamide and LHRH analogues may alter your blood sugar levels. Your doctor should adjust your insulin and/or oral antidiabetic medication dosage.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in these cases.
• If you are taking a daily dose of 150 mg of bicalutamide and have heart disease. Your doctor may choose to check your heart function periodically.

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

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

If you are hospitalized, inform the healthcare staff that you are taking Bicalutamide.

Children and adolescents

Bicalutamide should not be administered to children and adolescents under 18 years of age.

Using Bicalutamide Normogen with other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

Do not take bicalutamide with the following medications:

• Terfenadine or astemizole (for hay fever or allergy).
• Cisapride (for stomach disorders).

If you take Bicalutamide 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 bicalutamide:

• Warfarin or any similar medication to prevent blood clotting.
• Cyclosporine (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (a medication used to relieve 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).
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide 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 from other medications), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Taking Bicalutamide Normogen with food and drinks

Bicalutamide Normogen can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking any medication.

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

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

Driving and using machines

This medication may make you feel drowsy, so be careful when driving or using machines.

Bicalutamide Normogen contains lactose and sodium

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 less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Bicalutamide Normogen

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

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

Bicalutamide Normogen can be taken with or without food.

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

If you take more Bicalutamide Normogen 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, phone 91 562 04 20.

If you forget to take Bicalutamide Normogen

Do not take a double dose to make up for forgotten doses; simply continue with your usual treatment.

If you stop taking Bicalutamide Normogen

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

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

4. Possible side effects

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

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

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

Other possible side effects of this medication are:

Very common: may affect more than 1 in 10 patients

• Anemia.
• Dizziness.
• Abdominal pain, constipation, nausea (vomiting).
• Hot flashes.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after discontinuation of therapy, particularly after prolonged treatment.

Common: may affect up to 1 in 10 patients

• Weight gain.
• Drowsiness.
• Myocardial infarction (fatal cases 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 transaminases (liver enzymes), jaundice (yellowing of the skin and eyes).
• Erectile dysfunction.
• Decreased libido, depression.

Uncommon: may affect up to 1 in 100 patients

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

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

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

Frequency not known: cannot be estimated from available data

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

Reporting side effects

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

5. Storage of Bicalutamide Normogen

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 stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bicalutamide Normogen 50 mg tablets

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

• Core: lactose monohydrate, sodium carboxymethyl starch (type A) (potato), povidone, crospovidone, magnesium stearate (E 572).
• Coating: hypromellose (E 464), macrogol 300, titanium dioxide (E171).

Appearance of the product and package contents

Bicalutamide Normogen 50 mg are film-coated tablets, white, round, biconvex, and marked with "B" on one side.

The tablets are available in blister packs, which are presented in a cardboard box. Each box contains 30 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6.

• 28760 Tres Cantos, Madrid (SPAIN).

Date of the last revision of this package leaflet:April 2022.

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