PATIENT INFORMATION LEAFLET

Wibical 150 mg Film-Coated Tablets EFG

Bicalutamide

Read this 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. Do not give it to others, even if they have the same symptoms of illness 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 pack and additional information

Wibical belongs to a group of medications known as anti-androgens, meaning it interferes with some of the actions of androgens (male sex hormones) in the body.

This medication is used in adult males to treat prostate cancer without metastasis, in cases where there is a high risk of progression of the same. It can be used alone or in combination with other therapeutic methods such as surgical removal of the prostate gland or radiation therapy.

Do not take Wibical:

• if you are allergic to bicalutamide or any of the other components of this medication (listed in section 6)
• if you are a woman
• if you are taking terfenadine or astemizol, which are used to treat allergies, or cisaprida, which is used to treat heartburn and acid reflux.

Bicalutamide must not be administered to children and adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Wibical.

•If you have any liver disorder or disease that affects your liver. The medication 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. Fatal cases (severe liver changes and liver failure) have been reported.

•If you have a lung inflammation called interstitial lung disease. Symptoms of this may include severe difficulty breathing with cough or fever. Fatal cases have been reported.

•If you are taking any medication, including those obtained without a prescription. In particular, if you are taking medications that thin the blood or medications to prevent blood clotting.

•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 a heart disease. Your doctor may choose to check your heart function periodically.

•If you have any heart or blood vessel disease or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Bicalutamide 150 mg.

Inform your doctor if you have any of the above conditions, and he will take this into account during your treatment with Bicalutamide.

In case of hospital admission, inform the hospital 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 taking Wibical and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.

Children and adolescents

Wibical must not be administered to children and adolescents under 18 years of age.

Other medications and Wibical

Inform your doctor if you are using or have recently used other medications or if you may need to take any other medication, including those obtained without a prescription and herbal remedies.

Do not take bicalutamide with the following medications:

• Terfenadine or astemizol (for hay fever or allergy).
• Cisaprida (for stomach disturbances).

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

• Particularly, inform your doctor if you are taking medications that thin the blood, such as warfarin.

• Ciclosporina (used to suppress the immune system to prevent and treat organ transplant rejection or bone marrow transplant rejection).
• Midazolam (a medication used to alleviate anxiety before surgery or certain procedures or as an anesthetic before and during surgery).

• Calcium channel blockers (for example, diltiazem or verapamil). These medications are used to treat high blood pressure or certain heart diseases).

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

Wibical 150 mg may interfere with some medications used to treat heart rhythm problems (for example: quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (for example: metadona (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using any medication.

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

Wibical may have an effect on male fertility that may be reversible.

Driving and operating machines

Wibical may cause drowsiness, so you should be careful when driving or operating machines.

Wibicalcontains lactose.

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Wibical contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet, taken once a day.
• Swallow the tablet whole with a glass of water.
• Try to take the tablet at the same time every day.

If you take more Wibical than you should

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

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

If you forget to take Wibical

Do not take a double dose to compensate for the missed doses, simply continue with your regular treatment.

If you interrupt treatment with Wibical

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

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

Like all medicines, this medicine may cause side 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 side effects are veryserious.

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

• Difficulty breathing or sudden worsening of breathing difficulty, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine.
• Abdominal pain.
• Yellow discoloration of the skin or 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

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

Common: between 1 and 10 in 100 patients

• Weight gain.
• Anemia.
• Dizziness, somnolence.
• Abdominal pain, constipation, indigestion, flatulence (gas), nausea (urge to vomit).
• Blood in the urine.
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Loss of appetite.
• Confusion.
• Chest pain, swelling.
• Liver toxicity, elevated levels of transaminases (liver enzymes), jaundice (yellow discoloration of skin and eyes).
• Impotence.
• Decreased libido.
• Depression.

Uncommon: between 1 and 10 in 1,000 patients

• Interstitial lung disease (a lung inflammation). Fatalities have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

Rare: between 1 and 10 in 10,000 patients

• Liver failure. Fatalities have been reported.
• Increased sensitivity to sunlight.

Cannot be estimated from available data

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister and box after CAD. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Wibical 150 mg film-coated tablets

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

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

Appearance of the product and content of the packaging

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

Available in packs of 30 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization 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

O

Synthon Hispania

Castello 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

SPAIN

Last review date of this leaflet: February 2021.

Other sources of information

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