INTRODUCTION

BICALPRO 150MG TABLET contains Bicalutamide which belongs to a group of medicines called Anti-androgens. It is used in the treatment of prostate cancer in adult male patients. Prostate cancer is a type of slow growing cancer that occurs in the cells of the prostate gland (a small walnut-shaped gland that provides nourishment to sperm in males) that grows out of control and spread to other parts of the body.

Prostate cancer is characterized by symptoms such as troubled urination, blood in urine, urge to urinate frequently at night, blood in semen, bone pain, losing weight without trying, pain while sitting and erectile dysfunction. During treatment with BICALPRO 150MG TABLET, your doctor may perform blood tests to check for any changes to your blood.

Avoid direct exposure to excessive sunlight or UV light while you are taking BICALPRO 150MG TABLET. Before taking BICALPRO 150MG TABLET, inform your doctor if you have any liver or heart problems or diabetes. BICALPRO 150MG TABLET is not recommended for use in women, including pregnant women or mothers who are breast-feeding their babies.

BICALPRO 150MG TABLET is also not recommended for use in children and adolescents (less than 18 years of age). The most common side effects of taking BICALPRO 150MG TABLET are skin rash, breast swelling or tenderness, weakness, loss of appetite, dizziness, sleepiness, nausea, etc. Call your doctor if any of the symptoms gets worse over time.

USES OF BICALPRO 150MG TABLET

• Treats prostate cancer in adult male patients

HOW BICALPRO 150MG TABLET WORKS

BICALPRO 150MG TABLET inhibits cell growth and prevents spread of cancer cells from the prostate gland to other parts of the body by selectively blocking proteins responsible for growth and development of prostate gland (androgen receptors) which reduces the effect of androgen (male sex hormone) in the prostate gland.

DIRECTIONS FOR USE

Take BICALPRO 150MG TABLET as advised by your physician. Swallow with a glass of water and do not chew or crush it. Your doctor will decide the correct dose and duration of BICALPRO 150MG TABLET treatment for you depending upon your age, body weight and disease condition. Do not stop taking BICALPRO 150MG TABLET unless your doctor advises you to stop.

SIDE EFFECTS OF BICALPRO 150MG TABLET

HOW TO MANAGE SIDE EFFECTS

Dizziness:

When you feel dizzy, lie or sit down immediately. Lie-down in a dark and quite place with eyes closed. Vehicle driving should be avoided if you experience frequent dizziness without warning. If symptom persists, contact your doctor.

Nausea and vomiting:

Try to take BICALPRO 150MG TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating oily or spicy food. Drink ice cold drinks. Try to avoid sugary snacks and drinks. Avoid drinking too much liquid along with your meals, drink slowly in between meals. If symptom persists, contact your doctor.

Constipation:

Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals, drink plenty of water and exercise regularly. If this does not help, inform your doctor for receiving alternate treatments for constipation.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug Interactions:

Before taking BICALPRO 150MG TABLET, inform your doctor, if you are taking any of the following medicines:

• cisapride (used for stomach disorders)
• terfenadine, astemizole (medicines used for hay fever or allergy)
• medicines used to treat heart rhythm problems (Ex. quinidine, procainamide, amiodarone and sotalol)
• methadone (medicine used for pain relief and drug addiction detoxification)
• moxifloxacin (an antibiotic used in infections)
• medicines used for serious mental illnesses (Ex. clozapine, cariprazine)
• medicines used to prevent blood clots (Ex. warfarin, heparin)
• ciclosporin (medicine used to suppress your immune system to prevent and treat rejection of a transplanted organ or bone marrow)
• certain medicines used to treat high blood pressure or other heart conditions (Ex. amlodipine, nifedipine)
• cimetidine (used to treat stomach ulcers)
• ketoconazole (used to treat fungal infections of the skin and nails)
• medicines used in certain cancer treatments (Ex. buserelin, leuprorelin, triptorelin)

Overdosage:

If you or anyone else accidentally take too much of BICALPRO 150MG TABLET, contact your doctor immediately or go to a hospital straight away.

SYNOPSIS

MORE INFORMATION

• Keep BICALPRO 150MG TABLET out of reach of children
• Store BICALPRO 150MG TABLET between 20-25°C

FAQs ABOUT BICALPRO 150MG TABLET

Can BICALPRO 150MG TABLET affect male fertility?

Yes. BICALPRO 150MG TABLET may have an effect on male fertility which could be reversible. Patients and their partners should use birth control while taking BICALPRO 150MG TABLET and for 130 days after stopping the treatment. Consult your doctor for further queries.

What if I miss a dose of BICALPRO 150MG TABLET?

If you miss a dose of BICALPRO 150MG TABLET, take it as soon as you remember. However, skip that dose if it's almost time for the next one. Do not take BICALPRO 150MG TABLET two times to make up for the missed dose.

Can I go out in the sun while taking BICALPRO 150MG TABLET?

Avoid direct exposure to excessive sunlight or UV light while you are taking BICALPRO 150MG TABLET as it can increase you skin’s sensitivity to sunlight. Discuss with your doctor how you can protect your skin from the sun during treatment with BICALPRO 150MG TABLET.

Can BICALPRO 150MG TABLET be taken in pregnancy?

BICALPRO 150MG TABLET is strictly for use in men and is not recommended for use in women, including pregnant women. If you are pregnant, think you may be pregnant or are planning for a child, consult your doctor before taking it.

Can BICALPRO 150MG TABLET be taken by a diabetes patient?

BICALPRO 150MG TABLET should be used with caution in patients with diabetes (high blood sugar levels). Consult your doctor before taking it. Your doctor may advise you to check your blood sugar level before and during BICALPRO 150MG TABLET treatment.

REFERENCES

1. KD. Tripathi. Androgens and Related Drugs, Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Eighth edition. 2019. Page – 326.

2. AstraZeneca. Casodex 150-mg Compassionate Use Trial for Subjects with Prostate Cancer. NIH U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in June 2008] [Accessed on 2nd May 2022]. https://clinicaltrials.gov/ct2/show/NCT00636259

3. Jesco Pfitzenmaier and Jens E. Altwein. Hormonal Therapy in the Elderly Prostate Cancer Patient. NIH National Library of Medicine. National center for biotechnology information. PubMed Central. April 2009. [Accessed on 2nd May 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2689585/

4. Zhao J, Stockwell T, Roemer A, Chikritzhs T. Is alcohol consumption a risk factor for prostate cancer? A systematic review and meta-analysis. NIH National Library of Medicine. National center for biotechnology information. Pubmed.gov. November 2016. [Accessed on 2nd May 2022]. https://pubmed.ncbi.nlm.nih.gov/27842506/

5. Accord Healthcare Limited. Electronic medicines compendium (EMC). [Revised in January 2021] [Accessed on 2nd May 2022]. https://www.medicines.org.uk/emc/files/pil.9687.pdf

6. Accord Healthcare Limited. Electronic medicines compendium (EMC). [Revised in February 2020] [Accessed on 2nd May 2022]. https://www.medicines.org.uk/emc/files/pil.6038.pdf

7. Corden Pharma GmbH. U.S. Food and Drug Administration (USFDA). [Revised in October 2017] [Accessed on 2nd May 2022]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Prostate Specific Antigen (Free) PSA
• Prostate Specific Antigen (Total) PSA
• Liver function tests
• Complete Blood Count