INTRODUCTION

FLONIDA 5% contains Fluorouracil which belongs to the group of medicines called Anti-cancer agents. It is used on the skin to treat multiple actinic (solar) keratosis and some simple skin cancers. Actinic keratosis is a rough, scaly patch on the skin that develop from years of sun exposure. It is often found on the face, lips, ears, forearms, scalp, neck or back of the hands.

Before using FLONIDA 5% inform your doctor if you have partial or complete DPD (dihydropyrimidine dehydrogenase enzyme) deficiency. FLONIDA 5% is not recommended for use in pregnant and breastfeeding women as it may pass through breast milk. FLONIDA 5% is not recommended for use in children and adolescents (under 18 years of age) and it should be used with caution in elderly patients (aged 65 years or above). Contact your doctor before using it.

The most common side effects of using FLONIDA 5% are allergic reactions (allergic contact dermatitis) such as pain, itching or burning sensation, irritation, redness and swelling of small blood vessels, and darkening or scarring of the skin. Consult your doctor if any of the symptom worsens.

USES OF FLONIDA 5%

• Treats multiple actinic (solar) keratosis and some simple skin cancers

HOW FLONIDA 5% WORKS

FLONIDA 5% works by interfering with the growth of genetic material (DNA and RNA) of the cancer cells. As a result, it slows the growth of cancer cells and eventually kills them.

DIRECTIONS FOR USE

Apply FLONIDA 5% as directed by your physician. It is for external use only. Apply a thin layer of this medicine to the affected area. Avoid applying the medicine around your eyes and mouth. Your doctor will decide the correct dose and duration for you depending upon your age and severity of the condition.

SIDE EFFECTS OF FLONIDA 5%

HOW TO MANAGE SIDE EFFECTS

Itching, burning or irritation of skin:

Avoid hot showers because hot water can irritate the skin further. Do not scratch the affected area. Use sunscreen and protective clothing when going outdoors. Regularly use unscented moisturizers to soothe and hydrate the affected area after the advice of the doctor. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before using FLONIDA 5%, inform your doctor if you are taking any of the following medicines:

• antiviral medicines such as brivudine, and sorivudine (used to treat chickenpox or shingles)

Overdosage:

If you or anyone else accidentally use too much of FLONIDA 5% or if you or a child accidentally swallow the medicine, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep FLONIDA 5% out of reach of children
• Store FLONIDA 5% at room temperature

FAQs ABOUT FLONIDA 5%

Is FLONIDA 5% safe?

Yes, FLONIDA 5% is safe if used in the dose and duration as advised by your doctor. Use it exactly as directed by the doctor to get the most benefit. Follow your doctor's instructions carefully and let your doctor know if any of the side effect bother you.

Can I use FLONIDA 5% during pregnancy?

No, FLONIDA 5% is not recommended for use in pregnant women. Inform your doctor immediately if you become pregnant or think you may be pregnant while using this medicine.

What should I do if I forget to use FLONIDA 5%?

If you forget to use a dose of FLONIDA 5%, use it as soon as you remember. However, omit the missed dose if it is almost time for the next one. Do not use it two times to make up for the forgotten dose.

What is FLONIDA 5% used for?

FLONIDA 5% is used on the skin to treat multiple actinic (solar) keratosis and some simple skin cancers. Actinic keratosis is a rough, scaly patch on the skin that develop from years of sun exposure. It is often found on the face, lips, ears, forearms, scalp, neck or back of the hands.

Is FLONIDA 5% safe to use in children?

FLONIDA 5% is generally not recommended for use in children and adolescents (under 18 years of age). Consult child’s doctor for advice to decide the alternative drug therapy for your child.

REFERENCES

1. KD. Tripathi. Chemotherapy of Neoplastic diseases. Essentials of medical pharmacology. Seventh edition. 2013. Page – 864.

2. William Philip Werschler. Considerations for Use of Fluorouracil Cream 0.5% for the Treatment of Actinic Keratosis in Elderly Patients. NIH. National Library of Medicine, National center for Biotechnology Information. PMC PubMed Central. July 2008. [Accessed on 10th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2989823/

3. Sanofi. An Open-Label 18-Month Safety Study of Fluorouracil Cream 0.5% for the Treatment of Actinic Keratoses. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in April 2008] [Accessed on 10th June 2022] https://clinicaltrials.gov/ct2/show/NCT00377273

4. Mylan Products Ltd. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 10th June 2022] https://www.medicines.org.uk/emc/files/pil.9260.pdf

5. Almirall Hermal GmbH. Fluorouracil. [Revised in February 2022] [Accessed on 10th June 2022] https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=258bb79a-56b3-4f46-ade6-7331ec031074