Bicalutamide Normogen 150 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Bicalutamida Normogen 150 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Bicalutamida Normogen is and what it is used for.
2. What you need to know before taking Bicalutamida Normogen.
3. How to take Bicalutamida Normogen.
4. Possible adverse effects.
5. How to store Bicalutamida Normogen.
6. Contents of the pack and other 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 non-metastatic prostate cancer in cases where there is a high risk of disease 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 starting to take 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 must not be given to children and adolescents under 18 years of age.

Warnings and precautions

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

• If you have any liver disorder or liver disease. This medicine should only be taken after your doctor has carefully considered the potential benefits and risks. In such cases, your doctor should regularly perform liver function tests. Deaths (severe liver changes and liver failure) have been reported.
• If you have a lung inflammation called interstitial lung disease. Symptoms may include severe shortness of breath 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 must adjust your insulin dose and/or antidiabetic medications accordingly.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in such cases.
• If you have heart disease. Your doctor may decide to periodically monitor your cardiac function.

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

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

If you are admitted to hospital, inform healthcare staff that you are taking Bicalutamide.

Children and adolescents

Bicalutamide must 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 might need to use any other medicines.

Do not take bicalutamide with the following medicines:

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

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

• Warfarin or any similar medicine used to prevent blood clotting.
• Cyclosporine (used to suppress 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 anaesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart conditions).
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide may interfere with some medicines used to treat heart rhythm disorders (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 drugs), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

Taking Bicalutamide Normogen with food and drink

Bicalutamide Normogen may be taken with or without food.

Pregnancy, breast-feeding and fertility

Consult your doctor or pharmacist before taking any medicine.

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

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

Driving and using machines

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

Bicalutamide Normogen contains lactose and sodium

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

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

3. How to take Bicalutamida Normogen

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily.

• Swallow the tablet(s) whole with water and do not chew.
• Try to take the tablet(s) at the same time each day.

Bicalutamida Normogen may be taken with or without food.

If you take more Bicalutamida Normogen than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Bicalutamida Normogen

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

If you stop taking Bicalutamida Normogen

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

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

4. Possible adverse effects

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

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

• Skin rash, severe skin itching (with lumps), hives, skin peeling, or formation of blisters or crusts.
• 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 problems, 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 adverse effects of this medicine are:

Very common: may affect more than 1 in 10 patients

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

Common: may affect up to 1 in 10 patients

• Weight gain.
• Anaemia.
• Dizziness, drowsiness.
• Abdominal pain, constipation, stomach pain, flatulence (gas), nausea (feeling sick).
• Blood in the urine.
• Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching.
• Loss of appetite, hot flushes.
• Chest pain, swelling.
• Liver toxicity, elevated transaminase levels (liver enzymes), jaundice (yellowing of 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 electrocardiogram (ECG) (prolongation of QT interval).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System of Pharmacovigilance for Human Medicines: https://www.notificaram.es. By reporting adverse 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 any special storage conditions.

Store in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamide Normogen 150 mg tablets

• The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.

• The other components are:

• Core: lactose monohydrate, sodium carboxymethyl starch (type A) (from potato), povidone, crospovidone, magnesium stearate (E 572)

• Coating: hypromellose (E 464), macrogol 300, titanium dioxide (E 171)

Appearance of the product and contents of the pack

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

The tablets are available in blisters packed 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 most recent revision of this leaflet: April 2022

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