Bicalutamide Normogen 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bicalutamide Normogen 50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to 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. How to store Bicalutamide 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 known as anti-androgens, which means that it interferes with certain actions of androgens (male sex hormones) in the body.

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

It is also indicated for the treatment of non-metastatic prostate cancer in cases where there is a high risk of disease progression (150 mg daily dose). It may 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 Bicalutamida Normogen

Do not take Bicalutamida 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, used to treat allergies, or cisapride, 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 taking Bicalutamida Normogen.

• If you have any liver disorder or disease. This medicine should only be taken after your doctor has carefully considered the potential benefits and risks. If this applies to you, your doctor should regularly perform liver function tests. Deaths have been reported (due to severe liver changes and liver failure).
• If you have a lung inflammation called interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Deaths have been reported.
• If you have diabetes. Treatment with bicalutamide together with luteinizing hormone-releasing hormone (LHRH) analogues may alter your blood sugar levels. Your doctor must adjust your dose of insulin and/or antidiabetic medicines.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in such cases.
• If you are taking a daily dose of 150 mg of bicalutamide and have heart disease. Your doctor may choose to periodically monitor your heart function.

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

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.

Taking Bicalutamida Normogen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 rejection of organ or bone marrow transplants).
• 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 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 Bicalutamida Normogen with food and drinks

Bicalutamida 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, including transient infertility.

Driving and using machines

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

Bicalutamida 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., 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 1 tablet daily (equivalent to 50 mg of bicalutamide) or 3 tablets daily (equivalent to 150 mg of bicalutamide).
• Swallow the tablet(s) whole with water and do not chew them.
• Try to take the tablet(s) at the same time each day.

Bicalutamida Normogen may be taken with or without food.

For patients with non-metastatic prostate cancer who are at high risk of disease progression, another formulation is available on the market (Bicalutamida Normogen 150 mg film-coated tablets) which facilitates therapeutic compliance, as you would take the 150 mg dose in a single tablet.

If you take more Bicalutamida Normogen than you should

If you ingest more than the normal dose, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 regular treatment.

If you stop taking Bicalutamida Normogen

Do not stop taking this medicine even if you feel well, unless your doctor advises 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 can cause adverse effects, although not everyone experiences 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 people

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Hot flushes.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after stopping therapy, particularly after prolonged treatment.

Common: may affect up to 1 in 10 people

• Weight gain.
• Drowsiness.
• Heart attack (fatalities have been reported), heart failure.
• Stomach pain, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated transaminase levels (liver enzymes), jaundice (yellowing of skin and eyes).
• Erectile dysfunction.
• Decreased sex drive, depression.

Uncommon: may affect up to 1 in 100 people

• Interstitial lung disease (an inflammation of the lungs). Fatalities have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

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

• Liver failure. Fatalities 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 the 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 may also report them directly via the Spanish Pharmacovigilance System 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 collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamide Normogen 50 mg tablets

• The active substance is bicalutamide. Each tablet contains 50 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 (E171).

Appearance of the product and contents of the pack

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

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 review of this leaflet: April 2022

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