INTRODUCTION

PICON contains Pimecrolimus which belongs to the group of medicines called immunosuppressants. It is used to treat signs and symptoms of mild or moderate atopic dermatitis (eczema) in adults and in children (aged 2 years or above), who have failed to respond adequately to other topical prescription medicines or emollients, and in whom those treatments are not advisable. Atopic dermatitis is an auto-immune inflammatory skin disease that causes severe itching (especially at night), dryness and red to brownish-gray patches, especially on the hands, feet, neck, upper chest and other parts of the body.

Pimecrolimus is a calcineurin inhibitor which acts by blocking the release of various inflammatory cytokines and mediators responsible for causing inflammation in the skin. When PICON is used to treat early signs and symptoms of eczema, it can prevent the progression of disease (severe flare-ups). It is only meant to treat atopic dermatitis and cannot be used for other skin conditions. Do not apply this medicine on the skin affected by viral infection such as chicken pox or cold sores.

During treatment with PICON, avoid excessive exposure to sunlight, sun lamps and tanning beds. Always wear only loose-fitting clothing and use appropriate sunscreen products while going outdoors and minimize the amount of time you spend in the sun. While undergoing therapy with this medicine, avoid smoking or going near naked flames, because of risk of severe burns. All the fabrics (such as clothing, bedding, dressings etc.) that have been in contact with this medicine can burn more easily.

The most common side effects of applying this medicine are application site reactions such as itching, irritation, burning sensation or a feeling of warmth. These side effects are usually mild and will last only for a short time. Before using this medicine inform your doctor if you have any skin infection. PICON is not recommended for use in pregnant or breastfeeding women and in children under 2 years of age. Consult your doctor before taking. Stop the treatment and consult your doctor if you have not seen any improvement or if your condition gets worse after 6 weeks of therapy.

USES OF PICON

• Treats mild or moderate atopic dermatitis

HOW PICON WORKS

PICON works by blocking the release of various inflammatory cytokines and mediators responsible for causing inflammation and immune reactions. Following topical application, pimecrolimus binds to macrophilin-12 and inhibits the activity of a protein called calcineurin, leading to the inhibition of T cell activation and cytokines production in the affected cells.

DIRECTIONS FOR USE

Wash your hands before and after application. Apply a thin layer of PICON on the affected area of the skin and rub it gently. It can be applied on the skin areas including the head, face and neck and in the folds of the skin. Do not cover the treated skin with bandages, wraps or dressings. It is for external use only.  

Avoid contact of this medicine with your eyes, ears, nose, mouth or other mucous membrane. If accidentally, contact happens, wipe off or rinse it off thoroughly with water. Do not swallow the medicine. Do not apply this medicine on the areas of the skin affected by viral infection such as chicken pox or cold sores. Avoid swimming or bathing after application.

Your doctor will decide the correct dose and duration for you depending upon your age, body weight and health condition. Continue to apply this medicine, as long as your doctor tells you to do so, to obtain better results. Stop the treatment and consult your doctor if you have not seen any improvement or if your condition gets worse after 6 weeks of therapy.

SIDE EFFECTS OF PICON

HOW TO MANAGE SIDE EFFECTS

Skin itching or irritation:

Avoid hot showers because hot water can irritate the skin. Do not rub or scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use moisturizers to soothe and hydrate the affected area. If it does not get better, speak to a doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking:

• vaccinations
• ultraviolet light treatments (such as UV-A, PUV-A and UV-B)
• systemic immunosuppressive medicines (e.g. cyclosporin or azathioprine)

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT PICON

Is PICON a steroid medicine?

No. It does not contain any steroids.

Is PICON safe during pregnancy?

No. It is generally not recommended for use in pregnant women unless clearly necessary. Consult your doctor before application.

Can [GBBNKEYWORD] be used on the face?

Yes. It can be applied on the skin areas including the head, face and neck and in the folds of the skin. However, consult your doctor before application.

REFERENCES

1. Craig Burkhart, Dean Morrell and Lowell Goldsmith. Dermatological Pharmacology. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1822.

2. Gerald G. Briggs and Roger K. Freeman. P. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 3144-3146.

3. Emer, Jason, M.D. Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on August 2010] [Accessed 30th December 2020]  https://clinicaltrials.gov/ct2/show/NCT01177566

4. Thomas Luger, Mark Boguniewicz, Warner Carr, Michael Cork, Mette Deleuran, Lawrence Eichenfield, Philippe Eigenmann, Regina Fölster-Holst, Carlo Gelmetti, Harald Gollnick, Eckard Hamelmann, Adelaide A Hebert, Antonella Muraro, Arnold P Oranje, Amy S Paller, Carle Paul, Luis Puig, Johannes Ring, Elaine Siegfried, Jonathan M Spergel, Georg Stingl, Alain Taieb, Antonio Torrelo, Thomas Werfel and Ulrich Wahn. Pimecrolimus in atopic dermatitis: Consensus on safety and the need to allow use in infants. NCBI; PMC US National Library of Medicine, National Institute of Health. April 2015. [Accessed 30th December 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4657476/

5. Meda Pharma GmBH & Co. KG. and MEDA Manufacturing. Electronic Medicines Compendium (EMC); [Revised on June 2019] [Accessed 30th December 2020]  https://www.medicines.org.uk/emc/files/pil.4966.pdf

6. Contract Pharmaceutical Limited. U.S. Food & Drug Administration. [Revised on March 2014] [Accessed 30th December 2020]. https://www.fda.gov/media/73430/download