Refissa

Refissa

tretinoin/emollient base

This medication is used to improve the appearance of the skin by reducing fine lines and wrinkles, reducing roughness, and improving skin color. It should be used with a skin care and sunlight-avoidance program that includes moisturizer and daily use of an effective sunscreen (minimum SPF 15). Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells. Tretinoin does not repair sun-damaged skin or reverse aging due to sun exposure.

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About Refissa

This medication is used to improve the appearance of the skin by reducing fine lines and wrinkles, reducing roughness, and improving skin color. It should be used with a skin care and sunlight-avoidance program that includes moisturizer and daily use of an effective sunscreen (minimum SPF 15).

Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells. Tretinoin does not repair sun-damaged skin or reverse aging due to sun exposure.

Read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. Ask your doctor or pharmacist if you have any questions.

Gently clean your face with a mild or soapless cleanser and pat skin dry. Wait 20-30 minutes before applying this medication. Apply a pea-sized amount of cream, using just enough to cover your entire face lightly, usually once a day before bedtime or as directed by your doctor. Be careful to avoid your eyes, nostrils and mouth. Do not wash your face or apply another skin care product for at least 1 hour after using this product.

Do not use more of this medication than prescribed or use it more often. It will not give you faster or better results, but will increase the risk of developing redness, peeling and pain. Do not use on cut, scraped, sunburned, or eczema-affected skin.

Avoid getting this medication in your eyes. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes.

Effects of this medication will appear slowly, with most improvement seen in the first 6 months of use.

If used for acne, your condition may worsen at first, then improve.

A brief sensation of warmth or stinging may occur immediately after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2-4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes).

If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Your doctor may want you to decrease how often you use tretinoin, change the strength, or have you stop using it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Notify your doctor if you experience: blistering, crusting, severe burning/swelling of the skin, eye redness and watering (conjunctivitis), eyelid swelling, darkening or lightening of skin color.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use sunscreen daily and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Wait until your skin has completely recovered from a sunburn before using tretinoin.

Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product.

If you have recently used products containing sulfur, resorcinol or salicylic acid, use tretinoin with caution. Wait until the effects of such products on the skin have decreased before using tretinoin.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage at 59-86 degrees F (15-30 degrees C) is permitted. Do not freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

See also Precautions section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotions), medicated or abrasive soaps and cleansers, products containing alpha hydroxy acid, products containing glycolic acid, products containing sulfur, resorcinol or salicylic acid, soaps and cosmetics with a strong drying effect, other drugs that may increase your sensitivity to sunlight (including fluoroquinolones such as ciprofloxacin, tetracyclines, thiazide water pills such as hydrochlorothiazide, sulfa drugs such as sulfamethoxazole, phenothiazines such as chlorpromazine).

Benzoyl peroxide should not be applied at the same time as this medication.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medicine may be harmful if swallowed. Symptoms of overdose may include excessive redness, peeling, and discomfort.

Missed Doses:

If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until morning, wait until your next dose is scheduled.

Notes:

Cosmetics may be used 1 hour after applying tretinoin. Be sure to clean skin well before applying the medication. Daily moisturizer should be used to protect your skin from dryness.

Do not share this medication with others.

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