WIBICAL 50 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Wibical 50 mg film-coated tablets EFG

Bicalutamide

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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Wibical and what is it used for.
2. What you need to know before you take Wibical.
3. How to take Wibical.
4. Possible side effects.
5. Storing Wibical.
6. Contents of the pack and other information.

1. What is Wibical and what is it used for

Wibical belongs to a group of medicines called anti-androgens, which means it interferes with some of the actions of male sex hormones (androgens) in the body.

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

It is also used in 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 you take Wibical

Do not take Wibical:

• If you are allergic to the active substance 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.

Wibical should not be given to children and adolescents under 18 years of age.

Warnings and precautions:Talk to your doctor or pharmacist before taking Wibical:

• If you have any liver problems. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor will regularly perform liver function tests. Serious 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 are taking any other medicines, including those obtained without a prescription. In particular, if you are taking medicines that thin the blood or medicines to prevent blood clots.
• If you have diabetes. The combined treatment of bicalutamide with LHRH analogues may alter your blood sugar levels. Your doctor will adjust your insulin dose and/or anti-diabetic medicines.
• 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 problems or are being treated for them, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Wibical.

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

In case of hospitalization, inform the healthcare staff that you are taking Wibical.

If you are taking Wibical, you and/or your partner should use a contraceptive method while you are being treated with Wibical and for 130 days after the end of treatment. Ask your doctor if you have any questions about contraceptive methods.

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

Children and adolescents

Wibical should not be given to children and adolescents under 18 years of age.

Other medicines and Wibical

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription and herbal medicines.

Do not take bicalutamide with the following medicines:

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

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

• In particular, tell your doctor if you are taking blood-thinning medicines such as warfarin.
• Ciclosporin (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 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 (for stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Wibical 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).

Please note that these warnings may also apply to medicines that you have used some time ago.

Pregnancy and breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Wibical should not be taken by women, including pregnant or breastfeeding women.

Wibical may have an effect on male fertility, which may be reversible.

Driving and using machines:Wibical may make you feel drowsy, so be careful when driving or using machines.

Wibical contains lactose

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

Wibical contains sodium

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

3. How to take Wibical

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose for adults is 1 tablet a day (equivalent to 50 mg of bicalutamide) or 3 tablets a day (equivalent to 150 mg of bicalutamide).
• Swallow the tablet(s) whole with a glass of water.
• Try to take the tablet(s) at the same time each day.

In patients with prostate cancer without metastasis who have a high risk of disease progression, another formulation (Wibical 150 mg) is available on the market, which facilitates therapeutic compliance, as you would take the 150 mg dose in a single tablet.

If you take more Wibical than you should

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone (91 5620420), indicating the medicine and the amount taken.

If you forget to take Wibical

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

If you stop taking Wibical

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

If you have any further questions on the use of this product, 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 serious side effects, tell your doctor immediately or go to the emergency department of your 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 may 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: in more than 1 in 10 patients

• Anemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Flushing.
• 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: in less than 1 in 10 patients but more than 1 in 100 patients

• Weight gain.
• Drowsiness.
• Heart attack (fatal cases have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes).
• Erectile dysfunction.
• Decreased libido.
• Depression.

Uncommon: in less than 1 in 100 patients but more than 1 in 1,000 patients

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

Rare: in less than 1 in 1,000 patients but more than 1 in 10,000 patients

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

Frequency not known: cannot be estimated from the available data

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Health Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Wibical

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

No special storage conditions are required.

Keep the medicine in the original package to protect it from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Wibical

- The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.

- The other ingredients are: lactose monohydrate, povidone, crospovidone, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide (E-171), and macrogol.

Appearance of the product and pack contents

This medicine is presented in the form of film-coated tablets, white, round, biconvex, and marked with BCM 50 on one side. Each pack contains 30 film-coated tablets.

Marketing authorization holder

GP-PHARM, S.A.

Polígono industrial el Vinyets-els Fogars, sector 2, carretera Comarcal C-244, km22,

08777 Sant Quintí de Mediona

SPAIN

Manufacturer

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

Synthon Hispania, S.L.

Castelló 1, Polígono las Salinas,

08830 Sant Boi de Llobregat,

Spain

Date of last revision of this leaflet

February 2021.

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/.