Leaflet: information for the user

Bicalutamide pensa 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.

Contentsof the leaflet:

1. What isBicalutamide pensaand what it is used for.
2. What you need to know before you start takingBicalutamide pensa.
3. How to takeBicalutamide pensa.
4. Possible side effects.
5. Storage ofBicalutamide pensa.
6. Contents of the pack and additional information.

Bicalutamide 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 used in the treatment of advanced prostate cancer in combination with a medication called a luteinizing hormone-releasing hormone (LHRH) agonist - an additional hormonal treatment - or concurrently with surgical removal of the testicles.

Do not take Bicalutamida pensa

• 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 are used to treat allergies, or cisaprida, which is used to treat heartburn and acid reflux.

Bicalutamida pensa should not be administered to children and adolescents under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamida pensa.

• If you have any liver disorder or disease that may affect 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. Fatal cases (severe liver changes and liver failure) have been reported.

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

• If you are taking any other medication, including those obtained without a prescription. In particular, if you are taking medications that thin the blood or medications to prevent blood clotting.

• If you have diabetes. The combined treatment of bicalutamida with LHRH analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dosage.

• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamida in these cases.

Inform your doctor if you have any heart or blood vessel problems or are being treated for them, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when Bicalutamida pensa is used.

If any of the above situations apply to you, inform your doctor, who will take this into account during your treatment with Bicalutamida pensa.

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

If you are taking Bicalutamida pensa, you and/or your partner should use a contraceptive method while you are on treatment with Bicalutamida pensa and for 130 days after the end of treatment.

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

Children and adolescents

Bicalutamida pensa should not be administered to children and adolescents under 18 years old.

Other medications and Bicalutamida pensa

Inform your doctor or pharmacist if you are using, or have recently used, other medications or may need to take any other medication, including those obtained without a prescription and herbal remedies.

Do not take bicalutamida with the following medications:

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

- Cisaprida (for stomach disturbances).

If you take Bicalutamida pensa with any of the following medications, the effect of this and the other medications may be affected. Consult your doctor before taking any of the following medications with bicalutamida:

- In particular, inform your doctor if you are taking blood-thinning medications such as warfarin.

- 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 (e.g., diltiazem or verapamil. These medications are used to treat high blood pressure or certain heart diseases).

- Cimetidina (used to treat stomach ulcers).

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

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

Please note that these warnings may also apply to medications you have taken in the past,

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication.

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

Bicalutamida pensa may have an effect on male fertility that may be reversible.

Driving and operating machinery:

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

Bicalutamida pensa contains lactose

If your doctor has told you that you have an intolerance to certain sugars, 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.

Usual dose:

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

If you take more Bicalutamida pensa 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 5620420.

If you forget to takeBicalutamida pensa

Do not take a double dose to compensate for the missed doses, simply continue with your usual treatment.

If you interrupt treatment withBicalutamida pensa

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, this medicine may cause side effects,although not everyone will experience them.

If you notice any of the following symptoms, inform your doctor immediately or go to the nearest hospital emergency service. 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 or neck, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.

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

•Urinary blood.

•Abdominal pain.

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

Other possible side effects of this medicine are:

Very common: in more than 1 in 10 patients

• Anemia.

• Dizziness.

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

• Drowsiness.

•Urinary blood.

•Skin rash.

•Weakness, swelling.

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

Common: between 1 and 10 in 100 patients

• Weight gain.

• Somnolence.

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

• Indigestion, flatulence (gas).

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

• Decreased appetite.

• Chest pain.

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

• Erectile dysfunction.

• Decreased libido

• Depression.

Uncommon: between 1 and 10 in 1,000 patients

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

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

Rare: between 1 and 10 in 10,000 patients

•Liver failure. Fatalities have been reported.

•Increased sensitivity to sunlight.

Frequency not known: cannot be estimated from available data

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

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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 shown 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 unused medications at the SIGRE collection point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bicalutamida pensa

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

Appearance of Bicalutamida pensa and content of the packaging

Coated tablets with a film coating. White, round, and biconvex.

Each package contains 30 coated tablets conditioned in a blister.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Tecnimede, S.A.

Quinta da Cerca

Caixaria 2565-187 Dois Portos

Portugal

Last review date of this leaflet: June 2020

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