WIBICAL 150 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Wibical 150 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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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. Storage of Wibical

Contents of the pack and further information

1. What is Wibical and what is it used for

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

This medicine is used in adult men to treat prostate cancer that has not spread to other parts of the body, in cases where there is a high risk of the cancer spreading. It can be used alone or in combination with other treatments 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 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 given to children and adolescents under 18 years.

Warnings and precautions

Consult 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 need to regularly check your liver function. Serious liver damage and liver failure have been reported.
• If you have a lung disease called interstitial lung disease. The symptoms of this may include severe difficulty breathing with cough or fever. Serious cases, including death, 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 severe kidney problems. Caution is needed as there is no experience with the use of bicalutamide in these cases.
• If you have heart disease. Your doctor may decide to check your heart function regularly.

Tell your doctor if you have any heart or blood vessel disease, or if you are being treated for this, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Bicalutamide 150 mg.

If any of the above applies to you, tell your doctor, who will take it into account during your treatment with Bicalutamide.

If you are admitted to hospital, inform the medical staff that you are taking Bicalutamide 150 mg.

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

Children and adolescents

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

Other medicines and Wibical

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

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. Consult 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 rejection or bone marrow transplantation).
• 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 diseases.

• Cimetidine (for stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Wibical 150 mg 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), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Please note that these warnings may also apply to medicines that you have used in the past.

Pregnancy, 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 any 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, consult them before taking this medicine.

Wibical contains sodium

This medicine contains less than 1 mmol 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 is one tablet, once a day.
• Swallow the tablet whole with a glass of water.
• Try to take the tablet at the same time each day.

If you take more Wibical than you should

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

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

If you forget to take Wibical

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

If you stop taking Wibical

Do not stop taking this medicine 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 casualty department of your nearest hospital. These serious side effects are very rare.

• Skin rash, severe itching of the skin (with lumps), hives, skin peeling or blistering.
• Swelling of the face or neck, lips, tongue or throat, which may cause difficulty breathing or swallowing.

• Breathing difficulties 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 or eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine include:

Very common: more than 1 in 10 patients

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

Common: between 1 and 10 in 100 patients

• Weight gain.
• Anaemia.
• Dizziness, drowsiness.
• Abdominal pain, constipation, indigestion, flatulence (gas), nausea (feeling sick).
• Blood in the urine.
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite.
• Hot flushes.
• Chest pain, swelling.
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes).
• Erectile dysfunction.
• Decreased libido.
• Depression.

Uncommon: between 1 and 10 in 1,000 patients

• Interstitial lung disease (inflammation of the lungs). Serious cases, including death, have been reported.
• Allergic reactions (hypersensitivity), skin swelling, hives.

Rare: between 1 and 10 in 10,000 patients

• Liver failure. Serious cases, including death, have been reported.
• Increased sensitivity to sunlight.

Cannot be estimated from the available data

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

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Wibical

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month stated.

No special storage conditions are required.

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 further information

Composition of Wibical 150 mg film-coated tablets EFG

• The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.
• The other ingredients of the tablet core are: lactose monohydrate, magnesium stearate, crospovidone, povidone K-29/32, sodium lauryl sulfate

The ingredients of the tablet coating are: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171).

Appearance and packaging

White, round, biconvex film-coated tablets with the text BCM 150 engraved on one side.

Available in packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

GP-Pharm, S.A.

Polígono Industrial Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona)

SPAIN

Manufacturer(s):

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Or

Synthon Hispania

Castello 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Date of last revision of this leaflet:February 2021.

Other sources of information

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