Wibical 50 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Wibical is 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. How to store Wibical.
6. Contents of the pack and other information.

1. What Wibical is and what it is used for

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

This medicine is used in the treatment of advanced prostate cancer (daily dose of 50 mg) in combination with a drug called a 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 non-metastatic prostate cancer in cases where there is a high risk of disease progression (daily dose of 150 mg). 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 taking Wibical

Do not take Wibical:

• If you are allergic to the active substance or to 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.

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

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

• 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. In such cases, your doctor should regularly perform liver function tests. Deaths (due to severe liver changes and liver failure) have been reported.
• If you have lung inflammation known as interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Deaths have been reported.
• If you are taking any medicines, including those obtained without a prescription. In particular, if you are taking blood-thinning medicines or medicines used to prevent blood clots.
• If you have diabetes. Combined treatment with bicalutamide and LHRH analogues may affect your blood sugar levels. Your doctor may need to adjust your insulin dose and/or your 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 bicalutamide and have heart disease. Your doctor may choose to monitor your heart function periodically.

Inform your doctor if you have any heart or blood vessel condition or are being treated for such conditions, including medicines used 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.

If you are admitted to hospital, inform healthcare staff that you are taking Wibical.

If you are taking Wibical, you and/or your partner must use an effective method of contraception during treatment 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 must not be given to children and adolescents under 18 years of age.

Other medicines and Wibical

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal products.

Do not take bicalutamide together with the following medicines:

• Terfenadine or astemizole (for hay fever or allergies).
• Cisapride (for stomach disorders).

If you take Wibical together with any of the following medicines, the effect of these medicines and of Wibical may be affected. Consult your doctor before taking any of the following medicines with bicalutamide:

• In particular, inform your doctor if you are taking blood-thinning medicines such as warfarin.
• Cyclosporine (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 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 conditions).
• Cimetidine (to treat 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 medication detoxification), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

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

Pregnancy, breastfeeding, and fertility If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

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

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

Driving and use of machines: Wibical may make you feel drowsy, so you should be cautious when driving or operating machinery.

Wibical contains lactose

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.

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

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.

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

For patients with non-metastatic prostate cancer who are at high risk of disease progression, another formulation is available on the market (Wibical 150 mg), 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 ingest a higher than normal dose, contact your doctor or nearest hospital.

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

If you forget to take Wibical:

Do not take a double dose to make up for missed doses; simply continue with your regular treatment schedule.

If you stop taking Wibical:

Do not stop taking this medicine even if you feel well, unless your doctor tells you 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 may 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: in more than 1 out of every 10 patients

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

Common: between 1 and 10 out of every 100 patients

• Weight gain.
• Drowsiness.
• Heart attack (fatal cases have been reported), heart failure.
• Indigestion, 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 sexual desire.
• Depression.

Uncommon: between 1 and 10 out of every 1,000 patients

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

Rare: between 1 and 10 out of every 10,000 patients

• Liver failure. Fatal cases have been reported.
• Increased sensitivity 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. Wibical Storage

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

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are: monohydrate lactose, povidone, crospovidone, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide (E-171), and macrogol.

Appearance of the medicine and contents of the pack

This medicine is available as white, round, biconvex film-coated tablets 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, km 22,
08777 Sant Quintí de Mediona
SPAIN

Manufacturer:

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

or

Synthon Hispania, S.L.
Castelló 1, Polígono las Salinas,
08830 Sant Boi de Llobregat,
Spain

Date of the most recent review of this leaflet:
February 2021.

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