Pencial 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pencial 50 mg film-coated tablets

Bicalutamide

Read the entire 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, because it may 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 Pencial is and what it is used for.
2. What you need to know before taking Pencial.
3. How to take Pencial.
4. Possible side effects.
5. How to store 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 antiandrogens, 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 androgen levels in the body.

2. What you need to know before taking Pencial

Do not take Pencial:

• If you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6).
• If you are a woman.
• If you are taking terfenadine or astemizole, used to treat allergies, or cisapride, used to treat gastric burning and acid reflux.

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

Warnings and precautions:

Talk to your doctor or pharmacist before taking Pencial:

• If you have any liver disorder or liver disease. This 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 liver function tests. Deaths have been reported (severe liver changes and liver failure).
• If you are taking any other medicine, including those you have purchased without prescription, especially if you are taking oral anticoagulants (to prevent blood clots).
• If you have diabetes. Combined treatment with bicalutamide and LHRH analogues may alter your blood sugar levels. Your doctor should adjust your insulin dose and/or antidiabetic medications.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in such cases.
• If you have a lung inflammation called interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Deaths have been reported.

Inform 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 taking Pencial.

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

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

If you are taking bicalutamide, you and/or your partner must use a contraceptive method while you are receiving 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 medicine must 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 need to take any other medicines.

Do not take bicalutamide 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 these medicines and/or bicalutamide may be affected. Consult your doctor before taking any of the following medicines together with bicalutamide:

• In particular, inform your doctor if you are taking blood-thinning medicines such as warfarin.
• Cyclosporine (used to suppress the immune system to prevent and treat rejection of organ or bone marrow transplants).
• 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 (to treat 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 used in drug addiction treatment), moxifloxacin (an antibiotic), or antipsychotics used for serious mental illnesses).

Taking Pencial with food and drink

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

Pencial may make you feel sleepy, so you should be cautious when driving or operating machinery.

Pencial contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Pencial

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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.

The recommended dose is:

• In adults, the recommended 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 Pencial than you should:

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

In case of overdose or accidental ingestion, contact 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, wait, and take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Pencial:

Do not stop taking the medicine even if you feel well, unless your doctor tells you otherwise.

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

4. Possible adverse effects

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

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

• Severe difficulty breathing, or sudden worsening of breathing problems, possibly with cough or fever. Some patients taking Pencial develop lung inflammation known as 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 adverse effects of this medicine are:

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

• Breast tenderness or increased breast size
• Hot flushes
• Anaemia
• Dizziness
• Abdominal pain, constipation, nausea (feeling sick)
• Blood in the urine
• Skin rash
• Weakness, swelling

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

• Weight gain
• Drowsiness
• Heart attack (fatalities have been reported), heart failure
• Indigestion, flatulence (gas)
• Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching
• Loss of appetite
• Chest pain
• Liver toxicity, elevated transaminase levels (liver enzymes), yellow skin and eyes (jaundice)
• Erectile dysfunction, decreased sexual desire
• Depression

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

• Interstitial lung disease (a type of lung inflammation). Fatalities have been reported
• Allergic reactions (hypersensitivity), skin swelling, hives

Rare adverse 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 electrocardiogram (QT interval prolongation).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible 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 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 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. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pencial

• The active substance is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide.
• The other components are: monohydrate lactose, povidone K-30, sodium carboxymethylstarch from potato, magnesium stearate, Opadry White Y-7-1000.

Appearance of the product and contents of the pack

Pencial is presented as film-coated tablets.

Each pack contains 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Balearic Islands (Spain)

Manufacturer:

TECNIMEDE

Quinta da Cerca – Caixaria

2565-187 DOIS PORTOS

PORTUGAL

Date of the most recent review of this leaflet: February 2024

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