PENCIAL 50 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pencial 50 mg film-coated tablets

Bicalutamide

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

Contents of the pack and other information

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

1. What Pencial is and what it is used for

Pencial belongs to a group of medicines called 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 conditions, along with other treatments, such as drugs that reduce androgen levels in the body.

2. What you need to know before you take Pencial

Do not take Pencial:

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

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

Warnings and precautions:

Tell your doctor or pharmacist before you start taking Pencial:

• If you have any liver problems. This 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 regularly check your liver function. Serious liver damage and liver failure have been reported.
• If you are taking any other medicines, including those you have bought, especially if you are taking oral anticoagulants (to prevent blood clots).
• If you have diabetes. The combined treatment of bicalutamide with LHRH analogues may affect your blood sugar levels. Your doctor will need to adjust your insulin and/or anti-diabetic medication.
• If you have severe kidney problems. Caution is needed, as there is no experience with the use of bicalutamide in these cases.
• If you have a lung disease called interstitial lung disease. Symptoms of this may include severe difficulty breathing with cough or fever. Serious cases have been reported.

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

Any heart or blood vessel condition, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when using Pencial.

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

Only stop taking the tablets if your doctor tells you to.

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

Children and adolescents

This medicine should not be given to children or adolescents under 18 years of age.

Other medicines and Pencial

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

Do not take bicalutamide with the following medicines:

• Terfenadine or astemizol (for hay fever or allergy).
• Cisapride (for stomach problems).

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

• In particular, tell your doctor if you are taking medicines that thin the blood, 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 anesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart conditions).
• Cimetidine (for stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Pencial 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., drugs for addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Taking Pencial with food and drink

Take one bicalutamide tablet, preferably at the same time each day, with or without food.

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and using machines

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

Pencial contains lactose.

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

3. How to take Pencial

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Remember to take your medicine.

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

The recommended dose is:

• For adults, the recommended dose is one tablet per day.
• Swallow the tablet whole with water.
• Try to take the tablet at the same time each day.

If you take more Pencial than you should:

If you take more than the prescribed dose, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420.

If you forget to take Pencial

If you forget to take your daily dose, skip the missed dose and wait for the next scheduled dose. Do not take a double dose to make up for the missed dose.

If you stop taking Pencial

Do not stop taking the medicine unless your doctor tells you to.

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.

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

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

• Breast tenderness or enlargement
• Hot flushes
• Anemia

• Dizziness
• Abdominal pain, constipation, nausea (feeling sick)
• Blood in the urine
• Rash
• Weakness, swelling

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

• Weight gain
• Drowsiness
• Heart attack (including fatal cases), heart failure
• Indigestion, flatulence (gas)
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite
• Chest pain
• Liver toxicity, elevated liver enzymes, yellowing of the skin and eyes (jaundice)
• Erectile dysfunction, decreased sex drive
• Depression

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

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

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

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

Frequency not known: cannot be estimated from the available data

• Changes in the electrocardiogram (QT interval prolongation).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Pencial

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

No special storage conditions are required.

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 Pencial contains

• The active substance is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide.
• The other ingredients are: lactose monohydrate, povidone K-30, sodium starch glycolate, magnesium stearate, opadry white Y-7-1000.

Appearance and packaging

Pencial is available as film-coated tablets.

Each pack contains 30 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Islas Baleares (Spain)

Manufacturer:

TECNIMEDE

Quinta da Cerca – Caixaria

2565-187 DOIS PORTOS

PORTUGAL

Date of last revision of this leaflet: February 2024

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