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PENCIAL 50 mg FILM-COATED TABLETS

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About the medicine

How to use PENCIAL 50 mg FILM-COATED TABLETS

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/

Online doctors for PENCIAL 50 mg FILM-COATED TABLETS

Discuss questions about PENCIAL 50 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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€80
5.0 (21)
Doctor

Giorgi Eremeishvili

Urology 22 years exp.

Giorgi Eremeishvili is a top-category urologist, a Candidate of Medical Sciences, and a licensed physician in Spain. He provides expert assistance in the diagnosis and treatment of a wide range of urological conditions in both men and women, employing a comprehensive approach and evidence-based principles.

Key areas of expertise:

  • Erectile dysfunction, decreased libido, premature ejaculation.
  • Male infertility: comprehensive diagnosis and modern treatment methods.
  • Prostate gland diseases: acute and chronic prostatitis, prostatic adenoma (benign prostatic hyperplasia), prostate cancer.
  • Inflammatory diseases of the genitourinary system: acute and chronic cystitis, pyelonephritis, epididymitis, orchitis, urethritis.
  • Sexually transmitted infections (STIs): chlamydia, ureaplasmosis, mycoplasmosis, gardnerellosis, candidiasis, herpetic infections, HPV, CMV, trichomoniasis, and others.
  • Urination disorders: urinary retention, frequent urination, urinary incontinence, overactive bladder, neurogenic bladder.
  • Neoplasms: cysts, tumors of the kidneys, bladder, testicles, prostate gland (including prostate cancer).
  • Surgical interventions: determining indications and selecting optimal minimally invasive methods.

Dr. Eremeishvili applies an integrated approach to each case. This includes thorough preoperative preparation, postoperative observation, and regular dynamic follow-up during the treatment process to achieve the best possible outcomes. All diagnostic and therapeutic recommendations are based on current evidence-based medicine and comply with the recommendations of the European Association of Urology, guaranteeing high-quality and effective care.

If you are seeking qualified assistance in diagnosing or treating urological conditions, book an online consultation with Dr. Giorgi Eremeishvili. Get expert support, accurate diagnosis, and a personalized treatment plan from the comfort of your home.

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€60
5.0 (29)
Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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€60
5.0 (29)
Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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€60

Frequently Asked Questions

Is a prescription required for PENCIAL 50 mg FILM-COATED TABLETS?
PENCIAL 50 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in PENCIAL 50 mg FILM-COATED TABLETS?
The active ingredient in PENCIAL 50 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
How much does PENCIAL 50 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for PENCIAL 50 mg FILM-COATED TABLETS is around 42.37 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures PENCIAL 50 mg FILM-COATED TABLETS?
PENCIAL 50 mg FILM-COATED TABLETS is manufactured by Biowise Pharmaceuticals, S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of PENCIAL 50 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether PENCIAL 50 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to PENCIAL 50 mg FILM-COATED TABLETS?
Other medicines with the same active substance (bicalutamide) include BICALUTAMIDE ACCORD 50 mg FILM-COATED TABLETS, BICALUTAMIDE ALMUS 50 mg FILM-COATED TABLETS, BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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