INTRODUCTION

ELIDEL 1% contains Pimecrolimus which belongs to the group of medicines called Immunosuppressants. It is used to manage atopic dermatitis (eczema). Eczema is an inflammatory condition of the skin characterized by red and itchy rashes. Allergies are the main common cause of eczema. Symptoms include dry skin, severe itching, redness of hands, feet, ankles, wrist and neck, etc.

ELIDEL 1% is not recommended for use in other skin conditions and skin affected by an active viral infection such as cold sores (herpes simplex) or chicken pox. Avoid exposure to sunlight while using ELIDEL 1%. This medicine is generally not recommended for use among pregnant and breastfeeding women.

The most common side effects of using ELIDEL 1% are feeling of warmth and burning sensation at the application site, irritation, itching, and reddening of the skin where the cream has been applied and skin infections (such as folliculitis). Consult your doctor if any of the side effect worsens.

USES OF ELIDEL 1%

• Manages atopic dermatitis (eczema)

HOW ELIDEL 1% WORKS

ELIDEL 1% is a calcineurin inhibitor. It works by blocking calcineurin (a protein in our bodies that helps to activate our immune system). By blocking the immune response it lessens the inflammation which is caused by eczema.

DIRECTIONS FOR USE

Always apply ELIDEL 1% as directed by your physician. It is for external use only. Wash and dry your hands before applying. Apply a thin layer of ELIDEL 1% to the affected area and rub it gently and fully. Avoid applying this medicine around nose, eyes or mouth. Do not cover the manageed areas of skin with dressings, bandages, and wraps. Also, do not bath or shower right after applying the cream as this could wash your cream off. Your doctor will decide the duration of management depending on severity of the condition.

SIDE EFFECTS OF ELIDEL 1%

HOW TO MANAGE SIDE EFFECTS

Itchy skin:

Avoid hot showers as 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 consulting the doctor. Consult your doctor if the itching worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before applying ELIDEL 1%, inform your doctor if you are taking or applying any of the following medicines:

• medicines used as immunomodulators (Ex. azathioprine or cyclosporin)
• erythromycin (used for bacterial infections)
• itraconazole, ketoconazole, fluconazole (used for fungal infections)
• calcium channel blockers such as diltiazem, nifedipine (used for high blood pressure)
• cimetidine (used to manage gastric ulcers)

Overdosage:

If you or anyone else applied too much of ELIDEL 1% or accidentally swallowed the medicine, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep ELIDEL 1% out of the sight and reach of children.
• Store ELIDEL 1% below 25°C.

FAQs ABOUT ELIDEL 1%

What is ELIDEL 1% used for?

ELIDEL 1% is used to manage atopic dermatitis (eczema) of the skin, in cases where corticosteroids cannot be used. Eczema is an inflammatory condition of the skin characterized by red and itchy rashes. Allergies are the main common cause of eczema. Symptoms include dry skin, severe itching, redness of hands, feet, ankles, wrist, and neck, etc.

Can I consume alcohol while using ELIDEL 1%?

Avoid consumption of alcohol while applying ELIDEL 1% as it may cause flushing, rash, burning or itching sensation or swelling. Consult your doctor before using it.

Is ELIDEL 1% safe to use in breast-feeding women?

ELIDEL 1% is generally not recommended for use in breastfeeding women as it is not known whether it may pass through breast milk. Consult your doctor before using it.

When to avoid using ELIDEL 1%?

ELIDEL 1% is not recommended for use if your skin is affected by an active viral infection such as cold sores (herpes simplex) or chickenpox. Also, not recommended for use in patients who are allergic to pimecrolimus.

What common side effects are seen with ELIDEL 1%?

The most common side effects of using ELIDEL 1% are feeling of warmth and burning sensation at the application site, irritation, itching and reddening of the skin where the cream has been applied and skin infections (such as folliculitis). Consult your doctor if any of the side effect worsens.

REFERENCES

1. Matthew J. Sewell, Craig N. Burkhart, and Dean S. Morrell. Dermatological Pharmacology. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018. Page – 1271-1296.

2. Grace K. Kim, and James Del Rosso. Uses of Pimecrolimus Cream. The Journal of Clinical and Aesthetic Dermatology. February 2013 [Accessed on 8th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3579486/

3. Novartis Pharmaceuticals. Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in March 2011] [Accessed on 8th June 2022] https://clinicaltrials.gov/ct2/show/NCT00124709

4. Mylan Products Ltd. Electronic Medicines Compendium (EMC). [Revised in January 2022]. [Accessed on 8th June 2022] https://www.medicines.org.uk/emc/files/pil.4966.pdf

5. Biocon Biologics India Limited. Pimecrolimus solution 1% w/v (Picon lotion). Biocon.com. [Revised in August 2019]. [Accessed on 8th June 2022] https://www.biocon.com/docs/domestic-marketpi/immuno/PICON%20LOTION%20PI.pdf