INTRODUCTION

MELALITE FORTE CREAM contains Hydroquinone which belongs to the group of medicines called Demelanizing agents. It is used to lighten the areas of darkened skin such as chloasma (brown patches appear on the face due to hormonal changes during pregnancy), melasma (skin problem caused by brown to gray-brown patches on the face due to sun exposure), freckles (small brown spots on skin often in areas that gets exposed to sun), age spots and acne scars.

Skin darkening is called as epidermal hyper-pigmentation and it is caused by deposit of too much melanin in the skin.

Before using MELALITE FORTE CREAM, inform your doctor if you have any inflammatory skin conditions, skin cancer or taking any other medicines that cause sensitivity to light (Ex. chlorpromazine, doxycycline and amiodarone).

This medicine is not recommended for use if you are regularly exposed to sunlight for long hours. Your doctor may advise you to use sunscreen products in addition to MELALITE FORTE CREAM to prevent pigmentation on the skin.

MELALITE FORTE CREAM is not recommended for use in pregnant and breastfeeding women. Also, it is not recommended for use in children (less than 12 years of age). The most common side effects of using MELALITE FORTE CREAM are irritation, pain or swelling at the site of application, redness and skin dryness. Consult your doctor if any of the side effect gets worse or bothers you.

USES OF MELALITE FORTE CREAM

• Used to lighten the areas of darkened skin such as chloasma, melasma, freckles, age spots and acne scars
   

HOW MELALITE FORTE CREAM WORKS

MELALITE FORTE CREAM is used as a de-pigmentation agent on the skin to suppress the activity of cells called melanocytes. Melanocytes are responsible for producing melanin, which leads to the darkening of the skin. MELALITE FORTE CREAM suppresses the overactivity of these cells by blocking the melanin production cycle, thus leads to fading of the brownish spots.

DIRECTIONS FOR USE

Apply MELALITE FORTE CREAM as advised by your physician. It is for external use only. This medicine is applied using fingertips and rubbed evenly onto the affected area. Wash your hands immediately after applying MELALITE FORTE CREAM. Avoid contact with eyes and avoid exposure to sun immediately after application of this medicine. Your doctor will decide the frequency of application and duration of MELALITE FORTE CREAM for you depending upon your age and skin condition.

SIDE EFFECTS OF MELALITE FORTE CREAM

HOW TO MANAGE SIDE EFFECTS

Skin redness or itching:

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Avoid sun exposure or UV rays as it may sensitize your skin. Use sunscreen and protective clothing when going outdoor. Regularly moisturize your skin after consulting the doctor. Consult your doctor if the symptom does not improve.

Skin dryness:

Drink lot of fluids. Apply moisturizer several times a day after consulting your doctor. Do not take bath for long time (not more than 5-10 minutes) and use warm water for bathing. Choose fabric clothes to wear. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions:

Before applying MELALITE FORTE CREAM, inform your doctor if you are taking any of the following medicines:

• chlorpromazine (used to treat symptoms of schizophrenia)
• doxycycline (used to treat bacterial infections)
• amiodarone (used to treat irregular heartbeat)

Overdosage:

It is unlikely to overdose with topical application of MELALITE FORTE CREAM and in rare cases you may experience redness and burning sensation at the site of application. In case of accidental ingestion of MELALITE FORTE CREAM, consult your doctor or visit the nearby hospital immediately, since MELALITE FORTE CREAM is reported to be poisonous and may cause convulsions and haemolytic anaemia if ingested in large amount.

SYNOPSIS

MORE INFORMATION

• Keep MELALITE FORTE CREAM out of reach of children
• Store at room temperature

FAQs ABOUT MELALITE FORTE CREAM

What is MELALITE FORTE CREAM used for?

MELALITE FORTE CREAM is used to lighten the areas of darkened skin such as chloasma (brown patches appear on the face due to hormonal changes during pregnancy), melasma (skin problem caused by brown to gray-brown patches on the face due to sun exposure), freckles (small brown spots on skin often in areas that gets exposed to sun), age spots and acne scars.

What are the common side effects of MELALITE FORTE CREAM?

The most common side effects of using MELALITE FORTE CREAM are irritation, pain or swelling at the site of application, redness (erythema), burning and stinging sensation, red itchy rash on skin (allergic contact dermatitis) and skin dryness. Consult your doctor if any of the side effect worsens.

Can MELALITE FORTE CREAM be used in children?

No, MELALITE FORTE CREAM is not recommended for use in children (less than 12 years of age). Consult child’s doctor for advice to select a suitable alternative therapy for your child to treat the specific condition.

Does MELALITE FORTE CREAM cause skin redness or itching?

MELALITE FORTE CREAM may cause skin redness or itching in some individuals. To manage this effect, avoid taking hot showers because hot water can irritate your skin further. Do not scratch the affected area. Avoid sun exposure or UV rays as it may sensitize your skin. Use sunscreen and protective clothing when going outdoor. Regularly moisturize your skin after consulting the doctor. Consult your doctor if the symptom does not improve.

How to apply MELALITE FORTE CREAM?

Apply MELALITE FORTE CREAM as advised by your physician. It is for external use only.  This medicine is applied using fingertips and rubbed evenly onto the affected area. Wash your hands immediately after applying MELALITE FORTE CREAM. Avoid contact with eyes and avoid exposure to sun immediately after application of this medicine. Your doctor may advise you to use sunscreen products in addition to MELALITE FORTE CREAM to prevent pigmentation on the skin.  

REFERENCES

1. KD. Tripathi. Drugs Acting on Skin and Mucous Membranes. Essentials of Pharmacology. Seventh 7th edition. 2013. Page – 886.

2. Xing, X., Chen, L., Xu, Z., Jin, S., Zhang, C. and Xiang, L., 2020. The efficacy and safety of topical tranexamic acid (liposomal or lotion with microneedling) versus conventional hydroquinone in the treatment of melasma. Journal of Cosmetic Dermatology [Revised in October 2020] [Accessed on 14th July 2022] https://onlinelibrary.wiley.com/doi/abs/10.1111/jocd.13810

3. Janney, M.S., Subramaniyan, R., Dabas, R., Lal, S., Das, N.M. and Godara, S.K., 2019. A randomized controlled study comparing the efficacy of topical 5% tranexamic acid solution versus 3% hydroquinone cream in melasma. NIH National Library of Medicine, National centre for biotechnology information. Pubmed.gov. [Revised in March 2019] [Accessed on 14th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6484568/

4. Schwartz, C., Jan, A. and Zito, P.M. Hydroquinone. NIH National Library of Medicine, National centre for biotechnology information. Pubmed.gov. [Revised in May 2022] [Accessed on 14th July 2022] https://www.ncbi.nlm.nih.gov/books/NBK539693/

5. Omengue, A.M., Sobngwi, E., Dehayem, M., Balt, E.V., Boli, A.M., Choukem, S.P., Gautier, J.F. and Mbanya, J.C. Effect of Body Lotions on Capillary Blood Glucose Measurement–Interference of Hydroquinone-containing Body Lotion with Capillary Glucose Measurement. NIH National Library of Medicine, National centre for biotechnology information. Pubmed.gov. April 2018 [Accessed on 14th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5954594/

6. Kauh, Y.C. and Zachian, T.F., Melasma. Rhemaderm. [Accessed on 14th July 2022] https://link.springer.com/chapter/10.1007/978-1-4615-4857-7_72

7. Sanchez, J.L. and Vazquez, M. A hydroquinone solution in the treatment of melasma. International Journal of Dermatology [Revised in January 1982] [Accessed on 14th July 2022] https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-4362.1982.tb00496.x

8. New GPC, Inc. DailyMed. National Library of Medicine; National Institute of Health [Revised in October 2010] [Accessed on 14th July 2022] https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2e53471e-ad03-4d6b-9384-4af374bb5f74

9. Axia Medical Solutions, LLC. Balancer-Hydroquinone cream. [Accessed on 14th July 2022] https://fda.report/DailyMed/7271877f-2ed5-4e58-84a1-dce3844a0bc5/#warnings