BICALUTAMIDE PENSA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Pensa 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 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 leaflet. See section 4.

Contents of the pack:

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

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

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

This medicine is used in the treatment of advanced prostate cancer in combination with a medicine called luteinizing hormone-releasing hormone (LHRH) analogue - an additional hormonal treatment - or together with surgical removal of the testicles.

2. What you need to know before you take Bicalutamida Pensa

Do not take Bicalutamida Pensa

• 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 Pensa should not be given to children and adolescents under 18 years.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Bicalutamida Pensa.

• 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. Fatal cases have been reported.
• If you are taking any other medicines, including those obtained without a prescription. In particular, if you are taking medicines that thin the blood or medicines to prevent blood clots.
• If you have diabetes. Combination treatment with bicalutamide and 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.

Tell your doctor if you have any heart or blood vessel problems or are being treated for them, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when taking Bicalutamida Pensa.

If any of the above applies to you, inform your doctor. He will take this into account during your treatment with Bicalutamida Pensa.

If you are admitted to hospital, inform the medical staff that you are taking Bicalutamida Pensa 50 mg film-coated tablets.

If you are taking Bicalutamida Pensa, you and/or your partner must use a contraceptive method while you are being treated with Bicalutamida Pensa and for 130 days after the end of treatment.

Ask your doctor if you have any questions about contraceptive methods.

Children and adolescents

Bicalutamida Pensa should not be given to children and adolescents under 18 years.

Other medicines and Bicalutamida Pensa

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription and herbal 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 Pensa with any of the following medicines, the effect of this and the other medicines may be affected. Consult your doctor before taking any of the following medicines with bicalutamide:

• In particular, tell your doctor if you are taking blood-thinning medicines such as warfarin.
• 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 (e.g. diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart diseases).
• Cimetidine (for stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

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

Please note that these warnings may also apply to medicines that you have taken some time ago.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Bicalutamida Pensa must not be taken by women, including pregnant or breast-feeding women.

Bicalutamida Pensa may have an effect on male fertility, which may be reversible.

Driving and using machines:

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

Bicalutamida Pensa 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 Pensa

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

• The recommended dose for adults is one tablet 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 Pensa 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. Telephone 91 5620420.

If you forget to take Bicalutamida Pensa

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 Pensa

Do not stop taking this medicine unless your doctor tells you to. If you feel well, do not stop taking Bicalutamida Pensa.

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

4. Possible side effects

Like all medicines, this medicine 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.

• 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 breathing or swallowing.
• Difficulty breathing or sudden worsening of difficulty breathing, 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 include:

Very common: more than 1 in 10 patients

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Hot flushes.
• 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: less than 1 in 10 patients but more than 1 in 100 patients

• Weight gain.
• Somnolence.
• Heart attack (fatal cases have been reported), heart failure.
• Indigestion, flatulence (wind).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Loss of appetite.
• Chest pain.
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes).
• Impotence.
• Decreased libido.
• Depression.

Uncommon: less than 1 in 100 patients but more than 1 in 1,000 patients

• Interstitial lung disease (a lung disease). Fatal cases have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

Rare: less than 1 in 1,000 patients but more than 1 in 10,000 patients

• Liver failure. Fatal cases have been reported.
• Increased sensitivity to sunlight.

Frequency not known: cannot be estimated from the available data

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

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamida Pensa

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 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 other information

What Bicalutamida Pensa contains

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other ingredients are: Core: lactose monohydrate, povidone K-30, sodium starch glycollate (from potato), magnesium stearate. Coating: hypromellose, macrogol, titanium dioxide.

Appearance of Bicalutamida Pensa and contents of the pack

Film-coated tablets, white, round and biconvex.

Each pack contains 30 film-coated tablets in blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Tecnimede, S.A.

Quinta da Cerca

Caixaria 2565-187 Dois Portos

Portugal

Date of last revision of this leaflet: June 2020

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