BICALUTAMIDE KERN PHARMA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Kern Pharma 50 mg film-coated tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Bicalutamide Kern Pharma and what is it used for

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

This medicine is indicated for certain prostate conditions, along with other treatments such as drugs that reduce the body's androgen levels.

2. What you need to know before you take Bicalutamide Kern Pharma

Do not take Bicalutamide Kern Pharma

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

Bicalutamide should not be taken by women or males under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Bicalutamide Kern Pharma.

• 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 regularly perform liver function tests on you.
• If you have diabetes. Combination treatment of bicalutamide with luteinizing hormone-releasing hormone (LHRH) analogues may affect your blood sugar levels. Your doctor will adjust your insulin dose and/or anti-diabetic medicines.
• Tell your doctor 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 Bicalutamide Kern Pharma.

If you are admitted to hospital, inform the medical staff that you are taking Bicalutamide.

Taking Bicalutamide Kern Pharma with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken or might take any other medicines.

Bicalutamide should not be taken with the following medicines:

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

If you take bicalutamide 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 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).

Bicalutamide Kern Pharma 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 of other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Bicalutamide Kern Pharma contains lactose

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

3. How to take Bicalutamide Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long your treatment will last. Do not stop treatment before your doctor tells you to.

Recommended dose:

• In adults, the usual dose is 1 tablet per day.
• Swallow the tablet whole with water.
• Try to take the tablet at the same time each day.

If you take more Bicalutamide Kern Pharma than you should

If you ingest a higher dose 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bicalutamide Kern Pharma

Do not take a double dose to make up for forgotten doses.

If you forget a dose, do not take an extra tablet, simply continue with your usual treatment.

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

4. Possible side effects

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

Serious side effects:

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

Rare but 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 the appearance of bumps.
• Severe breathing difficulties, sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking Bicalutamide develop a lung condition called interstitial lung disease.

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

Yellowing of the skin and eyes due to a liver problem (including very rare 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, erection problems, impotence.
• Hot flashes.

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

• Nausea (feeling sick).
• Diarrhea or constipation.
• Dizziness.
• Difficulty sleeping.
• Skin rash, itching, sweating, excess body hair.
• Feeling weak.
• Weight gain.
• Diabetes mellitus.
• Edema.
• General pain, pelvic pain.
• Chills.
• Blood tests may be affected according to liver function.
• Decrease in red blood cells, which can cause paleness and weakness or difficulty breathing.

Uncommon 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 making an effort, resulting in a rapid heartbeat, swelling of the 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.

Unknown side effects:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Kern Pharma

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

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

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date is the last day of the month shown.

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 Bicalutamide Kern Pharma

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

Appearance of the product and pack contents

Bicalutamide Kern Pharma is presented as white, round, and biconvex film-coated tablets. Each pack contains 30 film-coated tablets in PVC/Aluminum blisters.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

TECNIMEDE Sociedade Técnico-Medicinal, S.A.

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

Date of the last revision of this package leaflet: December 2014.

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