Bicalutamide Mabo 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Bicalutamide Mabo 50 mg Film-coated Tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Bicalutamide 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 androgens (male sex hormones) 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, an additional hormonal treatment, or in combination with surgical removal of the testicles.

2. What you need to know before taking Bicalutamida Mabo

Do not take Bicalutamida Mabo:

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

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take this medicine:

• If you have any liver disorder or liver 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 regularly perform liver function tests.
• If you have severely impaired kidney function. The medicine should only be taken after your doctor has carefully considered the potential benefits and risks.
• Inform your doctor if you have any heart or blood vessel condition or are being treated for such conditions, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when bicalutamide is used.

Other medicines and Bicalutamida Mabo:

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.

Bicalutamide must not be taken together with the following medicines:

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

Bicalutamide may interfere with certain 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].

If you take bicalutamide together with any of the following medicines, the effects of bicalutamide and/or the other medicines may be affected. Consult your doctor before taking any of the following medicines together with bicalutamide:

• Warfarin or any similar medicine used to prevent blood clotting.
• Cyclosporine (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
• Calcium channel blockers (used to treat high blood pressure or certain heart conditions).
• Cimetidine (used 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 of age).

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

Driving and use of machines:

There is a possibility that the tablets may cause dizziness or drowsiness. If you are affected by these symptoms, you must not drive or operate machinery.

Bicalutamida Mabo contains lactose. This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Bicalutamide Mabo

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

Remember to take your medicine.

Your doctor will tell you how long to take the treatment. 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 1 tablet daily.
• Swallow the tablet whole with water.
• You may take the tablets with or without food.
• Try to take the tablet at the same time each day.

If you take more Bicalutamide Mabo than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 5620420, indicating the name of the medicine and the amount ingested.

If you forget to take Bicalutamide Mabo

If you forget to take your daily dose and remember later, do not take it; wait until your next scheduled dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Bicalutamide Mabo

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

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 have adverse effects, although not everyone experiences them.

Serious adverse reactions

Contact your doctor or pharmacist immediately if you experience any of the following:

Uncommon serious adverse reactions (may affect up to 1 in 100 patients/people):

• Severe allergic reactions that may cause swelling of the face, lips, tongue and/or throat, which can cause difficulty swallowing or breathing, or severe skin itching with appearance of lumps.
• Severe breathing difficulty, sudden worsening of breathing problems, possibly with cough or fever. Some patients taking bicalutamide develop lung inflammation known as interstitial lung disease.
• Yellowing of the skin and eyes (jaundice). These adverse reactions may be symptoms of liver damage.

Rare serious adverse reactions (may affect up to 1 in 1,000 patients/people):

Yellowish skin and whitening of the eyes due to a liver problem (including liver failure).

Other adverse reactions

Inform your doctor if you are concerned about any of the following adverse reactions:

Very common adverse reactions (may affect more than 1 in 10 patients/people):

• Breast tenderness or enlargement of the breast.
• Decreased sexual desire, erection problems, impotence
• Hot flushes.

Common adverse reactions (may affect up to 1 in 10 patients/people):

• Nausea (feeling unwell)
• Diarrhea or constipation
• Dizziness
• Difficulty sleeping
• Skin rash, itching, sweating, excessive body hair
• Feeling of weakness
• Weight gain
• Diabetes mellitus
• Edema
• General pain, pelvic pain
• Chills
• Blood tests may show changes related to liver function
• Decrease in red blood cells, which may cause paleness and lead to weakness or difficulty breathing.

Uncommon adverse reactions (may affect up to 1 in 100 patients/people):

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

Rare adverse reactions (may affect up to 1 in 1,000 patients/people):

• Vomiting
• Dry skin

Very rare adverse reactions (may affect up to 1 in 10,000 patients/people):

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

Adverse reactions with unknown frequency (cannot be estimated from available data): Changes in electrocardiogram ECG (prolongation of QT interval).

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Mabo

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

This medicine does not require any special storage conditions.

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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamide Mabo

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

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

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

Appearance of Bicalutamide Mabo and contents of the pack

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

Each pack contains 30 film-coated tablets.

Marketing Authorization 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 - The Netherlands

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

Date of the most recent revision of this leaflet: January 2015

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/