Prospect: information for the user

Bicalutamide TecniGen 50 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed to you, and you must not give it to other people, even if they have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

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

2. What you need to know before starting to take Bicalutamide TecniGen.

3. How to take Bicalutamide TecniGen.

4. Possible adverse effects

5. Storage of Bicalutamide TecniGen.

6. Contents of the package and additional information

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

Bicalutamida TecniGen 50 mg is indicated for the treatment of advanced prostate cancer in combination with a medication called a luteinizing hormone-releasing hormone (LHRH) analogue – an additional hormonal treatment – or concurrently with surgical removal of the testicles.

Do not take Bicalutamida TecniGen:

If you are allergic to bicalutamida or any of the other components of this medication (listed in section 6).

If you are a woman.

If you are taking terfenadina or astemizol, which is used to treat allergies, or cisaprida, which is used to treat heartburn and acid reflux.

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

Warnings and precautions

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

• If you have any liver disorder or disease.The medication should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor should regularly perform liver function tests. Fatal cases (severe liver changes and liver failure) have been reported.

• If you have a lung inflammation called interstitial lung disease.Symptoms of this may include severe difficulty breathing with cough or fever. Fatal cases have been reported.

• If you have diabetes. The combined treatment of bicalutamida with luteinizing hormone-releasing hormone (LHRH) analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dose.

• If you have severe kidney problems.Care should be taken, as there is no experience with the use of bicalutamida in these cases.

• If you have any heart or blood vessel disease or are being treated for it, including medications to control heart rhythm (arrhythmias).The risk of heart rhythm problems may increase when using Bicalutamida TecniGen.

In case of hospital admission, inform the healthcare staff that you are taking Bicalutamida TecniGen 50 mg.

Children and adolescents

Bicalutamida TecniGen should not be administered in children and adolescents under 18 years old.

Use of Bicalutamida TecniGen with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Do not take bicalutamida with the following medications:

- Terfenadina or astemizol (for hay fever or allergy).

- Cisaprida (for stomach disturbances).

If you take Bicalutamida TecniGen with any of the following medications, the effect of bicalutamida and the other medications may be affected.

Consult your doctor before taking any of the following medications with bicalutamida:

- Warfarina or any medication similar to prevent blood coagulation.

- Ciclosporina (used to reduce the immune system to prevent and treat organ or bone marrow transplant rejection).

- Midazolam (medication used to alleviate anxiety before surgery or certain procedures or as an anesthetic before and during surgery).

- Calcium channel blockers (to treat high blood pressure or certain heart diseases) For example, diltiazem or verapamilo.

- Cimetidina (to treat stomach ulcers).

- Ketoconazol (used to treat fungal infections of the skin and nails).

Bicalutamida TecniGen may interfere with some medications used to treat heart rhythm problems (for example: quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (for example: metadona (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic) or antipsychotics used to treat severe mental illnesses).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. Bicalutamida TecniGen should not be taken by women, including pregnant women or breastfeeding mothers.

The fertility of men may be temporarily reduced due to bicalutamida treatment, even with transient infertility.

Driving and operating machinery

Bicalutamida TecniGen may make you feel drowsy, so you should be careful when driving or operating machinery.

Bicalutamida TecniGen contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• The usual dose for adults is one tablet (50 mg) per day.

• Swallow the tablet whole with water.

• Try to take the tablet at the same time every day.

If you take more Bicalutamida TecniGen than you should

If you ingest a dose higher than the usual dose, contact your doctor or the nearest hospital. In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Bicalutamida TecniGen

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

If you interrupt treatment with Bicalutamida TecniGen

Do not stop taking this medication even if you feel well, unless your doctor tells you otherwise.If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Bicalutamida TecniGen may cause side effects, although not everyone will experience them.

If you notice any of the following symptoms, immediately inform your doctor or visit the nearest hospital emergency department.These side effects are very serious.

• Skin rash, severe skin itching (with blisters), hives, skin peeling, or formation of blisters or scabs.

• Swelling of the face, neck, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.

• Difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or fever. These may be signs of interstitial lung disease.These may be signs of interstitial lung disease.

• Blood in the urine.

• Abdominal pain.

• Yellow discoloration of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medication are:

Very common: may affect more than 1 in 10 patients

• Anemia

• Dizziness.

• Abdominal pain, constipation, nausea (urge to vomit).

• Drowsiness.

• Blood in the urine.

• Skin rash.

• Weakness, swelling.

• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after treatment is stopped, particularly after prolonged treatment.

Common: may affect up to 1 in 10 patients

• Weight gain.

• Somnolence.

• Myocardial infarction (fatalities have been reported), heart failure.

• Stomach pain, flatulence (gas).

• Chest pain

• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.

• Decreased appetite.

• Liver toxicity, elevated liver enzymes, jaundice (yellow discoloration of skin and eyes).

• Erectile dysfunction.

• Decreased libido, depression.

Uncommon: may affect up to 1 in 100 patients

• Interstitial lung disease (a lung inflammation). Fatalities have been reported.

• Allergic reactions (hypersensitivity), skin swelling, urticaria.

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

• Liver failure. Fatalities have been reported.

Unknown frequency:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use. Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30 °C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bicalutamida TecniGen

The active ingredient is bicalutamide.

Each tablet contains 50 mg of bicalutamide.

The other components (excipients) are:

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

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

Appearance of the product and contents of the packaging

Bicalutamida TecniGen is presented in the form of coated tablets.

The tablets are round and white.

Each package contains 30 tablets in PVC/PVdC/Aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

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

Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing

Tecnimede - Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dois Portos

Portugal

Date of the last review of this leaflet: December 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/