PATIENT INFORMATION LEAFLET

Wibical 50 mg Film-Coated Tablets

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 pass it on to others even if their symptoms are the same. It may harm them.

- If you experience any side effects, talk to your doctor or pharmacist or nurse. Even if they do not appear in this leaflet, see section 4.

1. What is Wibical and what it is used for.

2. What you need to know before taking Wibical.

3. How to take Wibical.

4. Possible side effects.

5. Storage of Wibical.

6. Contents of the pack and additional information.

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

This medication is used in the treatment of advanced prostate cancer (daily dose of 50 mg) in combination with a medication called a luteinizing hormone-releasing hormone (LHRH) analog - an additional hormonal treatment - or concurrently 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 radiation therapy.

Do not take Wibical:

• If you are allergic to the active ingredient 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.

Wibical should 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 may affect 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 will 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 diabetes. The combined treatment of bicalutamida with LHRH analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dosage.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamida in these cases.
• If you are taking a daily dose of 150 mg of bicalutamida and have a heart disease. Your doctor may choose to check your heart function periodically.

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

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

Inform hospital 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. Consult your doctor if you have any questions about contraceptive methods.

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

Children and adolescents:

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

Other medications and Wibical:

Inform your doctor or pharmacist 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 bicalutamida with the following medications:

• Terfenadine or astemizol (for hay fever or allergies).
• 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 bicalutamida:

• In particular, inform your doctor if you are taking blood-thinning medications such as warfarina.
• Ciclosporina (used to reduce the immune system to prevent and treat organ 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 (e.g., diltiazem or verapamil. These medications are used to treat high blood pressure or certain heart diseases).
• Cimetidina (to treat stomach ulcers).
• Ketoconazol (used to treat fungal infections of the skin and nails).

Wibical may interfere with medications used to treat heart rhythm problems (e.g., quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g., metadona (used to relieve pain and for 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 and lactation and fertility:
Consult your doctor or pharmacist before using a medication if you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant.

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

Wibical contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them 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.Incaseofdoubt,consultdea your doctor or pharmacist.

• The recommended dose for adults is 1 tablet per day (equivalent to 50 mg of bicalutamida) or 3 tablets per day (equivalent to 150 mg of bicalutamida).

• Swallow the tablet(s) whole with the help of water.

• Try to take the tablet(s) at the same time every day.

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

If you take more Wibical than you should:

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone (91 5620420), indicating the medication and the amount ingested.

If you forget to take Wibical:

Do not take a double dose to compensate for the missed dose, 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 can 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 very serious.

• Skin rash, severe skin itching (with blisters), hives, skin peeling, or the formation of blisters or scabs.
• 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 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 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 (urge to vomit).
• Confusion.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after treatment is stopped, particularly after prolonged treatment.

Common: between 1 and 10 in 100 patients

• Weight gain.
• Drowsiness.
• Myocardial infarction (fatalities 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 (yellow discoloration of skin and eyes).
• Erectile dysfunction.
• Decreased libido
• Depression.

Uncommon: between 1 and 10 in 1000 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:

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

Frequency not known:cannot be estimated from available data

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through the Spanish System for 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.

Keepthis medicationout of sightandout of reachof children.

No special storage conditions are required.

Store in the original packaging to protect it from light and moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Wibical

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

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

GP-PHARM, S.A.

Industrial estate el Vinyets-els Fogars, sector 2, Comarcal C-244, km22,

08777 Sant Quintí de Mediona

SPAIN

Responsible for manufacturing:

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

Synthon Hispania, S.L.

Castelló 1, Industrial estate las Salinas,

08830 Sant Boi de Llobregat,

Spain

Last review date of this leaflet:

February 2021.

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