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Tri-Luma Cream 30gm

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This is a summary of the most important information about TRI-LUMA. For details, talk to your healthcare professional.

What is TRI-LUMA Cream?

TRI-LUMA (try-LOOM-ah) Cream is a medicine with three active components. You put TRILUMA Cream on your
face to treat a skin condition called melasma. Melasma consists of dark (hyperpigmented) spots on facial skin,
especially on the cheeks and forehead. This condition usually happens with hormone changes.
TRI-LUMA Cream is for SHORT-TERM (up to 8 weeks) treatment of moderate to severe melasma of the face.
It is NOT FOR LONG-TERM (more than 8 weeks) or maintenance (continuous) treatment of melasma. Milder
forms of melasma may not need treatment with medicine. Melasma can also be managed by staying out of the
sun or by stopping the use of birth control methods that involve hormones.
In studies, after 8 weeks of treatment with TRI-LUMA Cream, most patients had at least some improvement.
Some had their dark spots clear up completely (38% in one study and 13% in another). In most patients treated
with TRI-LUMA Cream, their melasma came back after treatment. If the underlying causes of melasma, such as
the use of certain birth control pills or too much exposure to sunlight, are not removed, melasma will come back
when you stop treatment. TRI-LUMA Cream may improve your melasma, but it is NOT a cure.

Who should not use TRI-LUMA Cream?

Do not use TRI-LUMA if you are allergic to the medicine or any of its ingredients. See the end of this leaflet for a
list of ingredients.

What should I tell my doctor before taking TRI-LUMA?

If you are pregnant, think you are pregnant, plan to be pregnant or are nursing an infant, tell your doctor.
Your doctor will decide with you whether the benefits in using TRI-LUMA Cream will be greater than the risks. If
possible, delay treatment with TRI-LUMA Cream until after the baby is born.
Tell your doctor about all the other medicines and skin products you use, including prescription and nonprescription
medicines, cosmetics, and supplements. They may make your skin more sensitive to sunlight.

How should I use TRI-LUMA cream?

TRI-LUMA Cream should be used as instructed by your doctor.
To help you use the medicine correctly, follow these steps:

Gently wash your face with a mild cleanser. Don’t use a wash cloth to apply the cleanser, just your fingers.
Rinse and pat your skin dry.
Apply TRI-LUMA Cream at night, at least 30 minutes before bedtime.
Put a small amount (pea sized or inch or less) of TRI-LUMA Cream on your fingertip. Apply a thin coat
onto the discolored spot(s). Include about inch of normal skin surrounding the affected area. After you
have used the medicine for a while, you may find that you need slightly less to do the job.
Rub the medicine lightly and uniformly into your skin. The medicine should become invisible almost at once.
If you can still see it, you are using too much.
Keep the medicine away from the corners of your nose, your mouth, eyes and open wounds. Spread it away
from those areas when applying it.
Do not use more TRI-LUMA Cream or apply it more often than recommended by your doctor. Too much
TRI-LUMA Cream may irritate your skin, waste medicine, and won’t give you faster or better results.
Do not cover the treated area with anything after applying TRI-LUMA Cream.
If your skin gets too irritated, stop using TRI-LUMA Cream, and let your doctor know.
To help avoid skin dryness, you may use a moisturizer in the morning after you wash your face.
You may also use a moisturizer and cosmetics during the day.

Use a sunscreen of at least SPF 30 and a wide-brimmed hat over the treated areas. It requires only a small
amount of sunlight to worsen melasma. Melasma can get worse even if you don’t get sunburn.

Only your doctor knows which other medicines may be helpful during treatment, and will tell you about them if
needed. Do not use other medicines unless your doctor approves them.
If you get sunburned, stop using TRI-LUMA Cream until your skin is healed.
After stopping TRI-LUMA treatment, continue to protect your skin from sunlight.

What should I avoid while using TRI-LUMA Cream?

Sunlight or ultraviolet light. Too much natural sunlight or artificial sunlight from a sunlamp can cause sunburn.
Dark skin patches may become darker when the skin is exposed to sunlight. You don’t have to have a sunburn
to make your melasma worse.

TRI-LUMA can make your skin more likely to get sunburn or develop other unwanted effects from the sun.
Protect your skin from natural sunlight as much as possible to help prevent further darkening of existing dark
patches and formation of new ones. Staying out of the sun is especially important for women who take birth
control pills or hormone replacement therapy, and for people who have had dark patches in the past.
Use an effective sunscreen any time you are outside, even on hazy days. The sunscreen should have SPF (sun
protection factor) of 30 or more. Use sunscreen year-round on areas of the skin that are regularly exposed to
sunlight, such as your face and hands. If possible, protect the treated area from sunlight exposure.

If you spend a lot of time outside, be especially careful of sunlight. Ask your doctor what SPF level will give you
the needed high level of protection. If you will be outside, wear protective clothing, including a hat.
Do not use sunlamps while you use TRI-LUMA Cream. Heat, wind, and cold. Heat and cold tend to dry or irritate
normal skin. Skin treated with TRI-LUMA Cream may be more likely to react to heat and cold. Your doctor can
recommend ways to manage your melasma under these conditions.

Other skin products and medicines. Avoid products that may dry or irritate your skin. These may include
soaps and cleaners that are rough or cause drying; certain astringents, such as alcohol-containing products,
soaps and toiletries containing alcohol, spices, or lime; or certain medicated soaps, shampoos, and hair
permanent products. Do not use any other medicines with TRI-LUMA Cream unless you have consulted your
doctor. The medicines and product you have used in the past may cause redness or peeling when used with
TRI-LUMA.

What are the possible side effects of TRI-LUMA Cream?

A very few patients may get severe allergic reactions from TRI-LUMA. This includes people allergic to
sulfites. They may have trouble breathing or severe asthma attacks, which can be life-threatening.
While you use TRI-LUMA Cream, your skin may develop mild to moderate redness, peeling, burning, dryness, or
itching.

TRI-LUMA Cream contains a corticosteroid medicine as one of its active components. The following side effects
have been reported with application of corticosteroid medicines to the skin: itching, irritation, dryness, infection of
the hair follicles, acne, change in skin color, inflammation around the mouth, allergic skin reaction, skin infection,
skin thinning, stretch marks, and sweat problems.

Stop using TRI-LUMA Cream and contact your doctor if you have

severe or continued irritation, blistering, oozing, scaling, or crusting
severe burning or swelling of your skin
irritation of your eyes, nose, and mouth

Some patients using TRI-LUMA Cream develop dark spots on their skin (hyperpigmentation), tingling, increased
skin sensitivity, rash, acne, skin redness caused by a condition called rosacea, skin bumps, blisters, or tiny red
lines or blood vessels showing through the skin (telangiectasia).
If you are concerned about how your skin is reacting to the medicine, call your doctor.

General information about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not
use TRI-LUMA for a condition for which it was not prescribed. Do not give TRI-LUMA to other people, even if
they have the same symptoms you have. It may harm them.

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