BICALUTAMIDE NORMOGEN 150 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Bicalutamide Normogen150 mg film-coated tablets EFG

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the 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 medicines called anti-androgens, which means that it interferes with some of the actions of androgens (male sex hormones) in the body.

Bicalutamide is used in adult men to treat prostate cancer without metastasis, in cases where there is a high risk of progression. 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 ingredients of this medicine (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 medicine 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. Severe liver damage and liver failure have been reported.
• If you have a lung inflammation called interstitial lung disease. Symptoms may include severe difficulty breathing with cough or fever. Fatal cases have been reported.
• If you have diabetes. Combined treatment with bicalutamide and luteinizing hormone-releasing hormone (LHRH) analogues may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dose.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in these cases.
• If you have heart disease. Your doctor may choose to check your heart function periodically.

Tell your doctor if you have any heart or blood vessel disorder or are being treated for it, 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, who 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.

Use of Bicalutamide Normogen with other medicines

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

Do not take bicalutamide with the following medicines:

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

If you take Bicalutamide with any of the following medicines, the effect of this and the other medicines may be affected. Consult your doctor before taking any of the following medicines with bicalutamide:

• Warfarin or any similar medicine to prevent blood clotting.
• Ciclosporin (used to reduce the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (a medicine 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 medicines are used to treat high blood pressure or certain heart diseases)
• Cimetidine (to treat stomach ulcers)
• Ketoconazole (used to treat fungal skin and nail infections)

Bicalutamide may interfere with some medicines 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 medicines (e.g., methadone (used for pain relief and detoxification from other medicines), 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 medicine.

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

Male fertility may be temporarily reduced due to treatment with bicalutamide, even with transient infertility.

Driving and using machines

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

Bicalutamide Normogen contains lactose and sodium

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

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

3. How to take Bicalutamide Normogen

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

• 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.

If you take more Bicalutamide Normogen than you should

If you ingest a higher dose 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 medicine even if you feel well, unless your doctor tells you to do so.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 medicine are:

Very common: may affect more than 1 in 10 patients

• Skin rash.
• Weakness.
• Increased breast size and breast tenderness. Breast size increase may not resolve spontaneously after stopping therapy, particularly after prolonged treatment.

Common: may affect up to 1 in 10 patients

• Weight gain.
• Anemia.
• Dizziness, drowsiness.
• Abdominal pain, constipation, stomach pain, flatulence (gas), nausea (vomiting).
• Blood in the urine.
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite. Hot flashes.
• Chest pain, swelling.
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of skin and eyes).
• Erectile dysfunction.
• Decreased sexual desire, 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, hives.

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 not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Normogen

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

This medicine does not require special storage conditions.

Store in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Bicalutamide Normogen 150 mg tablets

• The active ingredient is bicalutamide. Each tablet contains 150 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 (E-171)

Appearance of the product and package contents

Bicalutamide Normogen 150 mg are film-coated tablets, white, round, and biconvex.

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 leaflet:April 2022

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