PATIENT INFORMATION LEAFLET

Pencial 50 mg film-coated tablets

Bicalutamide

Read this leaflet carefully before you start taking this medicine, as 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, pharmacist or nurse.

- 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, 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

1. What Pencial is and what it is used for.

2. What you need to know before you start taking Pencial.

3. How to take Pencial.

4. Possible side effects.

5. Storage of Pencial.

6. Contents of the pack and additional information.

Pencial belongs to a group of medications called antiandrogens, 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 Pencial:

• If you are allergic to bicalutamide or any of the other components of this medication (listed in section 6).
• If you are a woman.
• If you are taking terfenadine or astemizol, which are used to treat allergies, or cisaprida, which is used to treat heartburn and acid reflux.

Bicalutamide should not be administered to children and adolescents under 18 years of age.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Pencial:

• 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. Severe liver changes and liver failure have been reported.
• If you are taking any other medication, including those you have purchased, particularly if you are taking oral anticoagulants (to prevent blood clots).
• If you have diabetes. The combined treatment of bicalutamide 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. You should exercise caution, as there is no experience with the use of bicalutamide in these cases.
• If you have a lung inflammation called interstitial lung disease. Symptoms of this condition may include severe difficulty breathing with cough or fever. Fatalities have been reported.

Inform your doctor if you have any of the following symptoms:

Any heart or blood vessel disorder, including arrhythmia problems, or if you are being treated with medications for these conditions. The risk of arrhythmia problems may increase when using Pencial.

Notify hospital staff that you are taking Pencial.

Only stop taking the tablets if your doctor instructs you to do so.

If you are taking bicalutamide, you and/or your partner should use a contraceptive method while you are on treatment with bicalutamide and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.

Children and adolescents:

This medication should not be administered to children or adolescents under 18 years of age.

Other medications and Pencial:

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

Do not take bicalutamide with the following medications:

• Terfenadine or astemizol (for hay fever or allergy).
• Cisaprida (for stomach disturbances).

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

• Particularly, 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 (a 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 conditions).
• Cimetidine (used to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Pencial may interfere 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., de-addiction medication), moxifloxacino (an antibiotic), or antipsychotics used to treat severe mental illnesses).

Taking Pencial with food and drinks:

Take a bicalutamide tablet, preferably at the same time every day, with or without food.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pencial is contraindicated in women. Women should not take this medication, including pregnant women or breastfeeding mothers.

Pencial may have a reversible effect on male fertility.

Driving and operating machinery:

Pencial may cause drowsiness, so you should be careful when driving or operating machinery.

Pencial contains lactose:.

If your doctor has told you 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 or pharmacist. 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.

The recommended dose is:

• For adults, the recommended dose is 1 tablet per day.

• Swallow the tablet whole with the help of water.

• Try to take the tablet at the same time every day.

If you take more Pencial than you should:

If you ingest a dose higher than the normal 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 take Pencial:

If you forget to take your daily dose, omit the missed dose, wait, and take the next one at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pencial

Do not stop taking the 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.

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

• Severe breathing difficulties, or sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking Pencial develop a lung inflammation called pulmonary disease.
• Severe skin itching (with blisters) or swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Blood in the urine
• 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 side effects(may affect more than 1 in 10 patients):

• Breast tenderness or enlargement
• Hot flushes
• Anemia

• Dizziness
• Abdominal pain, constipation, nausea (urge to vomit)
• Blood in the urine
• Skin rash
• Weakness, swelling

Common side effects(may affect up to 1 in 10 patients):

• Weight gain
• Drowsiness
• Myocardial infarction (fatalities have been reported), heart failure
• Indigestion, flatulence (gas)
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching
• Loss of appetite
• Chest pain
• Liver toxicity, elevated levels of transaminases (liver enzymes), yellow discoloration of the skin and eyes (jaundice)
• Impotence, decreased libido
• Depression

Uncommon side effects(may affect up to 1 in 100 patients):

• Allergic reactions (hypersensitivity), swelling of the skin, urticaria

Rare side effects(may affect up to 1 in 1,000 patients):

• Liver failure. Fatalities have been reported
• Increased sensitivity to sunlight

Frequency not known: cannot be estimated from available data

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use www.notificaram.es. By reporting side effects, 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.

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 trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment.

Composition of Pencial

- The active ingredient is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide

- The other components are: Lactose monohydrate, povidone K-30, sodium carboxymethylcellulose from potato, magnesium stearate, opadry white Y-7-1000

Appearance of the product and contents of the packaging

Pencial is presented in the form of film-coated tablets.

Each package contains 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Islas Baleares (Spain)

Responsible for manufacturing:

TECNIMEDE

Quinta da Cerca – Caixaria

2565-187 DOIS PORTOS

PORTUGAL

Last review date of this leaflet: February 2024

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