BICALUTAMIDE MABO 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Mabo 50 mg film-coated tablets EFG

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Bicalutamida Mabo is and what it is used for.
2. What you need to know before you take Bicalutamida Mabo
3. How to take Bicalutamida Mabo
4. Possible side effects.
5. Storage of Bicalutamida Mabo
6. Contents of the pack and other information.

1. What Bicalutamida Mabo is and what it is used for

Bicalutamide 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 the treatment of advanced prostate cancer. It is taken together with a medicine called a luteinizing hormone-releasing hormone (LHRH) analogue, or as part of a combination hormonal treatment, or after surgical removal of the testicles.

2. What you need to know before taking Bicalutamida Mabo

Do not takeBicalutamida Mabo:

If you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Consult your doctor or pharmacist before taking this medicine:

• If you have any liver problems. This medicine should only be taken after your doctor has carefully weighed up the potential benefits and risks. If this is the case, your doctor will need to perform regular blood tests to check how well your liver is working.
• If you have severe kidney problems. This medicine should only be taken after your doctor has carefully weighed up the potential benefits and risks.
• Tell your doctor if you have any heart or blood vessel problems or are being treated for them, including medicines to control your heart rate (arrhythmias). The risk of heart rhythm problems may increase when taking bicalutamide.

Other medicines and Bicalutamida Mabo:

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

Bicalutamide should not be taken with the following medicines:

• Terfenadine or astemizole (for hay fever or allergy).
• Cisapride (for stomach problems).

Bicalutamide 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 taken with other medicines [e.g. methadone (used for pain relief and for detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses].

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

• Warfarin or any similar medicine to prevent blood clotting.
• Ciclosporin (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
• Calcium channel blockers (to treat high blood pressure or certain heart diseases).
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Children and adolescents

This medicine should not be given to children or adolescents (under 18 years).

Pregnancy and breastfeeding:This is not applicable as this medicine is not used in women.

Driving and using machines:

There is a possibility that the tablets may make you feel dizzy or sleepy. If you are affected by these symptoms, do not drive or operate machinery.

Bicalutamida Mabo 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.

3. How to take Bicalutamida Mabo

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how long to take this medicine. Do not stop treatment before your doctor tells you to. If you are admitted to hospital, inform the medical staff that you are taking bicalutamide.

The usual dose is:

• In adults, the usual dose is one tablet daily.
• Swallow the tablet whole with water.
• You can take the tablets with or without food.
• Try to take the tablet at the same time each day.

If you take more Bicalutamida Mabo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxic Information Service, telephone 91 5620420, stating the name of the medicine and the amount taken.

If you forget to take Bicalutamida Mabo

If you forget to take your daily dose and remember later, do not take it. Wait until it is time for your next dose.

If you stop taking Bicalutamida Mabo

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.

Serious side effects

Seek immediate medical attention if you experience any of the following:

Uncommon serious side effects(may affect up to 1 in 100 people):

• Severe allergic reactions that can cause swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing or breathing, or severe itching of the skin with hives.
• Severe difficulty breathing, sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking bicalutamide develop a lung disease called interstitial lung disease.
• Yellowing of the skin and eyes (jaundice). These side effects may be symptoms of liver damage.

Rare serious side effects(may affect up to 1 in 1,000 people):

Yellowing of the skin and eyes due to liver problems (including liver failure).

Other side effects

Tell your doctor if you are concerned about any of the following side effects:

Very common side effects(may affect more than 1 in 10 people):

• Breast tenderness or enlargement.
• Decreased sex drive, erectile dysfunction, impotence.
• Hot flushes.

Common side effects(may affect up to 1 in 10 people):

• Nausea (feeling sick).
• Diarrhea or constipation.
• Dizziness.
• Difficulty sleeping.
• Skin rash, itching, sweating, excess body hair.
• Feeling weak.
• Weight gain.
• Diabetes.
• Edema.
• Pain, pelvic pain.
• Chills.
• Blood tests may show changes in liver function.
• Decrease in red blood cells, which can cause pale skin and weakness or shortness of breath.

Uncommon side effects(may affect up to 1 in 100 people):

• Loss of appetite, weight loss.
• Depression.
• Increased blood sugar levels.
• Somnolence.
• Shortness of breath.
• Dry mouth, indigestion, flatulence (gas).
• Hair loss.
• Need to urinate at night, blood in the urine.
• Abdominal pain, chest pain, headache, back pain, neck pain.

Rare side effects(may affect up to 1 in 1,000 people):

• Vomiting.
• Dry skin.

Very rare side effects(may affect up to 1 in 10,000 people):

• Chest pain and heart failure (which may be associated with difficulty breathing, especially when exerting oneself, rapid heart rate, swelling of arms and legs, and skin spots), irregular heartbeat, and abnormal electrocardiogram results.
• Decrease in blood platelets, which can increase the risk of bleeding or bruising.

Side effects with unknown frequency(cannot be estimated from the available data): changes in the electrocardiogram (ECG) (prolongation of the QT interval).

*The frequency obtained from clinical trials/safety studies, if no data are available, the frequency will be unknown.

Reporting of side effects

If you experience 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 Bicalutamida Mabo

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

This medicine does not require any special storage conditions.

Keep the medicine in its original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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 other information

Composition of Bicalutamida Mabo

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other ingredients are:

Core:lactose monohydrate, povidone, crospovidone, sodium lauryl sulfate, magnesium stearate,

Coating:lactose monohydrate, hypromellose, titanium dioxide (E-171), and polyethylene glycol.

Appearance of Bicalutamida Mabo and pack contents

White, round, biconvex tablets marked with BCM 50 on one side; available in blister packs.

Each pack contains 30 film-coated tablets.

Marketing authorisation holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

SYNTHON BV Microweg, 22, P.O.Box 7071 (Nijmegen) - NL-6545 - Netherlands

or SYNTHON HISPANIA, S.L. Castello 1, Poligono Las Salinas. (Sant Boi de Llobregat (Barcelona)) - 08830 - Spain

Date of last revision of this leaflet:January 2015

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/