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Leaflet: Information for the User

Bicalutamide Kern Pharma 50 mg Film-Coated Tablets

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Bicalutamida 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.

This medication is indicated for certain prostate pathologies in conjunction with other treatments, such as medications that reduce the levels of androgens in the body.

Do not take Bicalutamida Kern Pharma

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

Bicalutamida should not be taken by women or men under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamida Kern Pharma.

• If you have any liver disorder or disease that affects your liver. 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.
• 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 dosage.
• Inform your doctor if you have any heart or blood vessel disorder or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Bicalutamida Kern Pharma.

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

Taking Bicalutamida Kern Pharma with other medications

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

Bicalutamida should not be taken with the following medications:

• Terfenadine or astemizol (for hay fever or allergy).
• Cisapride (for stomach disorders).

If you take bicalutamida 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:

• Warfarin or any medication similar to prevent blood coagulation.
• Ciclosporin (used to reduce 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 skin and nail infections).

Bicalutamida Kern Pharma may interfere with some medications 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 medications (e.g. methadone (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses).

Pregnancy, breastfeeding, and fertility

Bicalutamida should not be taken by women, including pregnant women or breastfeeding mothers.

Driving and operating machines

There is a possibility that bicalutamida may make you feel dizziness or somnolence. If you are affected by these symptoms, you should not drive or operate machines.

Bicalutamida Kern Pharma contains lactose

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

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

Remember to take your medication.

Your doctor will inform you of the duration of your treatment. Do not discontinue treatment before your doctor tells you to.

Recommended dose:

• The usual dose for adults is 1 tablet per day.
• Swallow the tablet whole with water.
• Try to take the tablet at the same time every day.

If you take more Bicalutamida Kern Pharma than you should

If you ingest a dose higher than normal, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Bicalutamida Kern Pharma

Do not take a double dose to compensate for the missed doses.

If you forget a dose, do not ingest an additional tablet; simply continue with your regular treatment.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, bicalutamide may cause side effects, although not everyone will experience them.

Severe side effects:

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

Less common side effects, which can be severe (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 skin itching with the appearance of blisters.
• Severe difficulty breathing, sudden worsening of breathing difficulty, possibly with cough or fever. Some patients taking Bicalutamide develop a lung inflammation called interstitial lung disease.

Rare side effects, which can be severe (may affect up to 1 in 1,000 people):

Yellowing of the skin and eyes due to a liver problem (including very rarely liver failure).

Other side effects:

Inform 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):

• Increased sensitivity or breast tenderness.
• Decreased libido, erectile dysfunction, impotence.
• Hot flashes.

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

• Nausea (feeling unwell).
• Diarrhea or constipation.
• Dizziness.
• Difficulty sleeping.
• Rash on the skin, itching, sweating, excessive body hair.
• Feeling weak.
• Weight gain
• Diabetes mellitus.
• Edema.
• Generalized pain, pelvic pain.
• Chills.
• Blood tests may be altered according to liver function.
• Decreased red blood cells, which can cause paleness and cause weakness or difficulty breathing.

Less common side effects(may affect up to 1 in 100 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 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, producing a rapid heartbeat, swelling of arms and legs, and skin motes), irregular heartbeat, and abnormal electrocardiogram results.
• Decreased platelets in the blood, which may increase the risk of bleeding or hematomas.

Unknown side effects:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required. Store in the original packaging.

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.

Medications 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 point of 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 Kern Pharma

• The active principle is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other components are: lactose monohydrate, povidone K-30, sodium glycolate starch (potato starch) and magnesium stearate in the tablet core and hypromellose, titanium dioxide (E-171) and macrogol 400 in the coating.

Appearance of the product and contents of the packaging

Bicalutamida Kern Pharma is presented in the form of coated tablets with a white film coating, round and biconvex. Each package contains 30 coated tablets conditioned in PVC/Aluminum blisters.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

TECNIMEDE Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria, Dois Portos, 2565-187, Portugal

Last review date of this leaflet: December 2014.

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