aminolevulinic acid solution applicator - topical, Levulan (cont.)

SIDE EFFECTS: Redness, swelling, tingling, stinging/burning, scabs/crusting, or change in skin color may occur at the treatment site. These effects may last for up to 4 weeks after you receive the blue light treatment or after you are exposed to bright light. Decreasing your contact with bright light will reduce these side effects. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.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.Tell your doctor immediately if any of these unlikely but serious side effects occur: open skin sores (ulcers), bleeding.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to porphyrins; or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: porphyria, photosensitivity to the blue light treatment.During pregnancy, this medication should be used only when clearly needed. 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.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other skin care products.Tell your doctor if you use any other medications that may make you more sensitive to sunlight (increase photosensitivity), especially of: tetracycline antibiotics (e.g., doxycycline, tetracycline), sulfa antibiotics (e.g., sulfamethoxazole), phenothiazines (e.g., chlorpromazine), griseofulvin, certain diabetes drugs (sulfonylureas such as glipizide, glyburide), certain "water pills" (thiazide diuretics such as hydrochlorothiazide).This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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