BICALUTAMIDE TECNIGEN 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide TecniGen 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

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

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

Bicalutamida TecniGen 50 mg is indicated for the treatment of advanced prostate cancer in combination with a medicine called 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 you take Bicalutamida TecniGen

Do not take Bicalutamida TecniGen:

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

If you are a woman.

If you are taking terfenadine or astemizole, which are used to treat allergies, or cisapride, which is used to treat heartburn and acid reflux.

Bicalutamida TecniGen should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bicalutamida TecniGen:

• If you have any liver problems. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor will need to perform regular liver function tests. Serious liver damage and liver failure have been reported.
• If you have a lung disease called interstitial lung disease. Symptoms of this may include severe difficulty breathing with cough or fever. Serious cases, including death, have been reported.
• If you have diabetes. The combined treatment of bicalutamide with LHRH analogues may affect your blood sugar levels. Your doctor will need to adjust your insulin and/or antidiabetic medication.
• 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 any heart or blood vessel disorders or are being treated for them, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Bicalutamida TecniGen.

If you are admitted to hospital, inform the medical staff that you are taking Bicalutamida TecniGen 50 mg.

Children and adolescents

Bicalutamida TecniGen should not be given to children and adolescents under 18 years of age.

Taking Bicalutamida TecniGen with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Do not take bicalutamide with the following medicines:

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

If you take Bicalutamida TecniGen with any of the following medicines, the effect of bicalutamide and the other medicines 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).
• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures or as an anaesthetic before and during surgery).
• Calcium channel blockers (to treat high blood pressure or certain heart diseases) e.g. diltiazem or verapamil.
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal skin and nail infections).

Bicalutamida TecniGen 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 for detoxification from other medicines), moxifloxacin (an antibiotic), or antipsychotics used to treat severe mental illnesses).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Bicalutamida TecniGen should not be taken by women, including pregnant or breastfeeding women.

Male fertility may be reduced temporarily due to treatment with bicalutamide, including temporary infertility.

Driving and using machines

Bicalutamida TecniGen may make you feel drowsy. Be careful when driving or using machines.

Bicalutamida TecniGen contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Bicalutamida TecniGen

Follow exactly the instructions of your doctor for taking this medicine. If you are unsure, ask your doctor or pharmacist again.

• The usual dose for adults is one tablet (50 mg) 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 Bicalutamida TecniGen than you should

If you take more than you should, contact your doctor or the nearest hospital. In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Bicalutamida TecniGen

Do not take a double dose to make up for a forgotten dose. Simply continue with your normal treatment schedule.

If you stop taking Bicalutamida TecniGen

Do not stop taking this medicine unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bicalutamida TecniGen can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, tell your doctor immediately or go to the casualty department of your nearest hospital. These serious side effects are very rare.

• Severe skin rash, severe itching of the skin (with lumps), hives, skin peeling or blistering.
• Swelling of the face or neck, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing.
• Difficulty breathing or sudden worsening of breathing difficulties, 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 side effects of this medicine are:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Weight gain
• Somnolence
• Heart attack (including deaths), heart failure
• Stomach pain, flatulence (gas)
• Chest pain
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching
• Loss of appetite
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes)
• Impotence
• Decreased libido, depression

Uncommon: may affect up to 1 in 100 people

• Interstitial lung disease (a lung disease). Serious cases, including death, have been reported.
• Allergic reactions (hypersensitivity), skin swelling, hives

Rare: may affect up to 1 in 1,000 people

• Liver failure. Serious cases, including death, have been reported.

Frequency not known:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamida TecniGen

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

Do not store above 30°C.

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 further information

Composition of Bicalutamida TecniGen

The active substance is bicalutamide.

Each tablet contains 50 mg of bicalutamide.

The other ingredients (excipients) are:

Core:Lactose monohydrate, crospovidone, povidone, magnesium stearate.

Coating:Opadry II 85F28751 (polyvinyl alcohol, macrogol 3000, titanium dioxide (E171), and talc).

Appearance and packaging of the product

Bicalutamida TecniGen is presented as film-coated tablets.

The tablets are round and white.

Each pack contains 30 tablets in PVC/PVdC/Aluminium blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América.

Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer:

Tecnimede - Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dois Portos

Portugal

Date of last revision of this leaflet:December 2014

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