Bicalutamide Kern Pharma 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bicalutamide Kern Pharma 50 mg film-coated tablets EFG

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

Leaflet contents:

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

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

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

This medicine is indicated for certain prostate disorders, in combination with other treatments, such as drugs that reduce the levels of androgens in the body.

2. What you need to know before taking Bicalutamida Kern Pharma

Do not take Bicalutamida Kern Pharma

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

Bicalutamida must not be taken by women or males under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bicalutamida Kern Pharma.

• If you have any disorder or disease affecting your liver. 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 tests to monitor your liver function.
• If you have diabetes. Treatment with bicalutamide together with luteinizing hormone-releasing hormone (LHRH) analogues may alter your blood sugar levels. Your doctor must adjust your dose of insulin and/or antidiabetic medicines.
• Inform your doctor if you have any heart or blood vessel condition or are being treated for such a condition, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when Bicalutamida Kern Pharma is used.

If you are admitted to hospital, inform healthcare staff that you are taking Bicalutamida.

Taking Bicalutamida Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Bicalutamida must not be taken together with the following medicines:

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

If you take bicalutamide together with any of the following medicines, the effect 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 rejection of organ or bone marrow transplants).
• Calcium channel blockers (for treating high blood pressure or certain heart conditions).
• Cimetidine (for treating stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamida Kern Pharma 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).

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Bicalutamide may cause dizziness or drowsiness. If you experience these symptoms, you should not drive or operate machinery.

Bicalutamida Kern Pharma contains lactose

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

3. How to take Bicalutamide Kern Pharma

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 the treatment before your doctor tells you to do so.

Recommended dose:

• In adults, the usual dose is 1 tablet daily.
• 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 take more than the prescribed dose, contact your doctor or nearest hospital.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 missed doses.

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

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

4. Possible adverse effects

Like all medicines, bicalutamide can cause adverse effects, although not everyone experiences them.

Serious adverse effects:

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

Uncommon adverse effects, which are serious (may affect up to 1 in 100 people):

• Severe allergic reactions which may cause swelling of the face, lips, tongue and/or throat, leading to difficulty swallowing or breathing, or severe skin itching with appearance of lumps.

• Severe breathing difficulties, sudden worsening of breathing problems, possibly with cough or fever. Some patients taking bicalutamide develop lung inflammation known as interstitial lung disease.

Rare serious adverse effects (may affect up to 1 in 1,000 people):

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

Other adverse effects:

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

Very common adverse effects (may affect more than 1 in 10 people):

• Breast tenderness or increased breast size.
• Decreased sex drive, erection problems, impotence.
• Hot flushes.

Common adverse effects (may affect up to 1 in 100 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 be altered depending on liver function.
• Decrease in red blood cells, which may cause paleness and lead to weakness or difficulty breathing.

Uncommon adverse 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.
• Hair loss.
• Need to urinate during the night, blood in the urine.
• Abdominal pain, chest pain, headache, back pain, neck pain.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Vomiting.
• Dry skin.

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

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

Adverse effects not known:

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse 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 container.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This 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 components are: lactose monohydrate, povidone K-30, sodium starch glycolate (potato starch) and magnesium stearate in the tablet core; hypromellose, titanium dioxide (E-171) and macrogol 400 in the film coating.

Appearance of the product and contents of the pack

Bicalutamide Kern Pharma is presented as white, round, biconvex, film-coated tablets. Each pack contains 30 film-coated tablets packed 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 most recent revision of this leaflet: December 2014.

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