INTRODUCTION

SUPATRET 0.04% AQUEOUS GEL contains Tretinoin, which belongs to the group of medicines called Retinoids. It is used to treat acne. It can also be used to treat wrinkles, skin spots and rough skin. Acne is defined as a skin disease involving inflammation of the sebaceous follicles of the face and upper body, characterized by lesions on the face, back, upper chest and shoulders.

Before using SUPATRET 0.04% AQUEOUS GEL, inform your doctor if you have any sunburn, sun sensitivity or any other skin problems. SUPATRET 0.04% AQUEOUS GEL should be used in pregnancy only if specifically directed by your doctor. SUPATRET 0.04% AQUEOUS GEL should be used with caution in breastfeeding women.

The safety and effectiveness of SUPATRET 0.04% AQUEOUS GEL in children (aged less than 12 years) have not been established, so consult your doctor before using it. The most common side effect of using SUPATRET 0.04% AQUEOUS GEL is skin irritation like redness, burning, stinging, dryness and peeling. Contact your doctor if any of the side effects worsen.

USES OF SUPATRET 0.04% AQUEOUS GEL

• It is used to treat acne, wrinkles, skin spots and rough skin.

HOW SUPATRET 0.04% AQUEOUS GEL WORKS

SUPATRET 0.04% AQUEOUS GEL works by modifying the abnormal cavity formation that comes from the excessive conversion of cytoplasm to keratin (a strong protein that is the main substance that forms hair, skin, etc.) of epithelial cells, promoting detachment of tough cells and enhancing shedding.

DIRECTIONS FOR USE

Apply SUPATRET 0.04% AQUEOUS GEL as advised by your physician. It is for external use only. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

SIDE EFFECTS OF SUPATRET 0.04% AQUEOUS GEL

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before using SUPATRET 0.04% AQUEOUS GEL, inform your doctor if you are taking any of the following medicines:

• other medicines used to treat acne (Ex. benzoyl peroxide, resorcinol, salicylic acid)
• medicated or abrasive soaps and cleansers
• medicines containing high concentrations of alcohol, astringents or spices

B. Drug-Food interactions:

Avoid contact of the skin with the lime peel during treatment with SUPATRET 0.04% AQUEOUS GEL.

Overdosage:

If you or anyone else accidentally applied too much of SUPATRET 0.04% AQUEOUS GEL, contact your doctor immediately. Symptoms of overdose include irritation or increased irritation of your skin.

SYNOPSIS

MORE INFORMATION

• Keep SUPATRET 0.04% AQUEOUS GEL out of reach of children
• Store below 25°C

FAQs ABOUT SUPATRET 0.04% AQUEOUS GEL

What if I accidentally swallow SUPATRET 0.04% AQUEOUS GEL?

SUPATRET 0.04% AQUEOUS GEL may be harmful if swallowed. If you accidentally swallow it, call your doctor or poison control centre right away.

What precautions should I take while using SUPATRET 0.04% AQUEOUS GEL?

Do not use SUPATRET 0.04% AQUEOUS GEL on sunburned skin, cuts, scrapes, eczema or damaged skin. Practice good skin care and avoid exposure to sunlight as you may get sunburned more easily. Use sunscreen and wear clothing and eyewear to protect your skin from the sun. Some weather conditions may irritate your skin. Talk with your doctor in such a case.

Can I use makeup during treatment with SUPATRET 0.04% AQUEOUS GEL?

You may use make-up during treatment with SUPATRET 0.04% AQUEOUS GEL unless your doctor has told you otherwise. Before using SUPATRET 0.04% AQUEOUS GEL, clean the area of treatment where you have applied makeup.

What if I forget to use a dose of SUPATRET 0.04% AQUEOUS GEL?

If you forget to use a dose of SUPATRET 0.04% AQUEOUS GEL, apply it as soon as you remember. However, omit the missed dose if it is almost time for the next dose. Do not apply SUPATRET 0.04% AQUEOUS GEL twice to make up for a forgotten dose.

Can I use other skin preparations with SUPATRET 0.04% AQUEOUS GEL?

Do not use any other skin preparations with SUPATRET 0.04% AQUEOUS GEL without asking your doctor. Avoid preparations that may dry or irritate your skin, like those containing astringents, alcohol, spices or lime or certain medicated soaps, shampoos, etc. Do not allow anyone else to use this medication. Do not use other medicines containing retinoids which are not recommended by your doctor, as it might cause unnecessary redness or peeling.

REFERENCES

1. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Acne Vulgaris. Pharmacotherapy Handbook. Ninth edition. Page- 135.

2. Athina L. Yoham; Damian Casadesus. Tretinoin. StatPearls [Internet]. StatPearls Publishing. March 2022. [Accessed on 24th June 2022] https://www.ncbi.nlm.nih.gov/books/NBK557478/#:~:text=Mechanism%20of%20Action,-The%20exact%20mechanism&text=Tretinoin's%20effectiveness%20as%20an%20acne,cell%20detachment%20and%20enhances%20shedding

3. Ortho-McNeil Pharmaceutical, Inc. U.S. Food & Drug Administration. [Revised in June 2022] [Accessed on 24th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf

4. DPT Laboratories. U.S. Food & Drug Administration. [Revised in January 2012] [Accessed on 24th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202567Orig1s000lbl.pdf

5. Memorial Sloan Kettering Cancer Center. Tretinoin. [Revised in June 2022] [Accessed on 24th June 2022] https://www.mskcc.org/pdf/cancer-care/patient-education/tretinoin-topical-01