Wibical 150 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Wibical 150 mg film-coated tablets EFG
Bicalutamide
Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Wibical is and what it is used for
- What you need to know before taking Wibical
- How to take Wibical
- Possible side effects
- How to store Wibical
Pack contents 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 adult men to treat non-metastatic prostate cancer in cases where there is a high risk of disease progression. 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 taking Wibical
Do not take Wibical:
- if you are allergic to bicalutamide 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.
Bicalutamide 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. The medicine should only be taken after your doctor has carefully considered the potential benefits and risks. If this applies to you, your doctor should perform regular liver function tests. Deaths (severe liver changes and liver failure) have been reported.
•If you have a lung inflammation called 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 to prevent blood clots.
•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 heart disease. Your doctor may decide to check your heart function periodically.
Inform your doctor if you have any heart or blood vessel condition or are being treated for one, 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 situations apply to you, inform your doctor, who will take them into account during your treatment with Bicalutamide.
If you are admitted to hospital, inform healthcare professionals that you are taking Bicalutamide 150 mg.
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.
Children and adolescents
Wibical must not be given to children and adolescents under 18 years of age.
Other medicines and Wibical
Tell your doctor if you are using or have recently used any other medicines, or if you may need to take any other medicines, including over-the-counter medicines and herbal remedies.
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 together 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 rejection of a transplanted organ or bone marrow transplant).
-
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 (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 from other drugs), 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 using 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 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 taking this medicine. If you are unsure, consult your doctor or pharmacist again.
- The recommended dose is one tablet once daily.
- 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 the prescribed dose, contact your doctor or nearest hospital.
In case of overdose or accidental ingestion, contact the Toxicology Information Service immediately at telephone number: 91 562 04 20.
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 can 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 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 problems, 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 adverse 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 stopping therapy, particularly after prolonged treatment.
Common: in 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/hair regrowth, dry skin, itching.
- Loss of appetite.
- Hot flush.
- Chest pain, swelling.
- Liver toxicity, elevated transaminase levels (liver enzymes), jaundice (yellowing of skin and eyes).
- Erectile dysfunction.
- Decreased sexual desire.
- Depression.
Uncommon: in between 1 and 10 in 1,000 patients
- Interstitial lung disease (a lung inflammation). Fatal cases have been reported.
- Allergic reactions (hypersensitivity), skin swelling, urticaria.
Rare: in between 1 and 10 in 10,000 patients
- Liver failure. Fatal cases have been reported.
- Increased sensitivity to sunlight.
Cannot be estimated from the 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.
Do not use this medicine after the expiry date stated on the blister and carton following EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of the specified month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 150 mg film-coated tablets EFG
- The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.
- The other components of the tablet core are: monohydrate lactose, magnesium stearate, crospovidone, povidone K-29/32, sodium lauryl sulfate.
The components of the tablet coating are: monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E 171).
Appearance of the product and contents of the pack
White, round, biconvex film-coated tablets, with the code "BCM 150" engraved on one side.
Available in packs of 30 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and 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
The Netherlands
Or
Synthon Hispania
Castello 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
Date of the most recent review of this leaflet: February 2021.
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/