Lidocaine / Prilocaine 2.5%-2.5% Cream - 30g Tube

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does NOT assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LIDOCAINE/PRILOCAINE CREAM - TOPICAL

(LYE-doe-kane/PRILL-oh-cane)

COMMON BRAND NAME(S): EMLA

USES: This medication contains 2 amide-type local anesthetics, lidocaine and prilocaine. It is used on normal, unbroken skin or on the outer genital area to prevent pain before certain procedures such as inserting a needle, skin grafts, or skin laser surgery. It works by temporarily numbing the skin and surrounding area. Do not use this product in the ears. If this product alone cannot completely numb the area being treated, it may be used to numb the area before a lidocaine injection is given to provide enough pain relief for certain procedures (e.g., removal of genital warts).

HOW TO USE: This medicine comes with a Patient Information Leaflet. Read it carefully for instructions on how to use this product. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Use this medication only on normal skin and the genital area. Do not apply to broken/irritated skin or open wounds unless directed by your doctor. Wash your hands before using this product. Apply this product to the area at the proper time as directed. The length of time for the medication to stay on the skin depends on the type of procedure you are having. It is usually applied at least 1 hour before needle sticks and 2 hours before minor skin procedures. It may be applied by a health care professional before certain genital procedures. In this case, it is recommended that you remain lying down so the medication will stay in place. To apply, squeeze out the prescribed amount of cream directly onto the skin. You can also squeeze it onto a measuring guide to make sure you get the right dose and then apply it to the area. Do not rub in. Cover with an airtight dressing/bandage as directed by your doctor. Allow the cream to remain in place, usually in a thick layer, as directed by your doctor. Remove the dressing and cream and clean the area thoroughly, usually shortly before the procedure or as directed by your doctor. Dosage and length of application time are based on your age and medical condition and the procedure you are having. In children, dosage may also be based on weight. Do not use larger amounts than prescribed. Do not use on large areas of skin, apply heat, or leave it in place longer than directed or serious side effects may occur. If you are applying this product on a child, make sure the medication stays in place and that your child does not put the medication or dressing/bandage in his/her mouth. You may want to use a second covering to prevent the child from touching the cream. Wash hands immediately after use unless you are treating an area on the hands. Avoid getting the product in your eyes, nose, ears, or mouth. If this medication gets in the eyes, rinse the affected eye immediately and completely with water or saline. Numbness in the eye can lead to injury because you cannot feel particles in the eye or other dangers. Therefore, protect the eye until feeling returns. The area may be numb for several hours after the procedure. Protect the area from injury. Be careful not to bump, rub, or scratch the area or expose it to heat/cold until feeling returns.

SIDE EFFECTS: Redness, swelling, tingling/burning, or lightening of the skin may occur. If any of these 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. Notify your doctor right away if you develop blistering of the skin where the medication is applied. Remove the cream and get medical help right away if any of these rare but very serious side effects occur: slow/shallow breathing, pale/bluish skin around the mouth/lips, dizziness, fainting, fast/slow/irregular heartbeat, mental/mood changes (e.g., confusion, nervousness), seizures, severe drowsiness. 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 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.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to lidocaine or prilocaine; or to any other amide anesthetics (e.g., bupivacaine); 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain blood disorder (methemoglobinemia). Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood disorder (G6PD deficiency, especially in children), heart disease (e.g., irregular heartbeat), kidney disease, liver disease. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the dizziness effect. Caution is advised when using this drug in children, especially if your child is younger than 3 months or small for their age. These children are at greater risk for a certain rare blood problem (methemoglobinemia). Contact the doctor right away in the unlikely event your child has symptoms such as pale/bluish skin around the mouth/lips or fast heartbeat. The risk for serious side effects (including methemoglobinemia) is increased if this medication is applied over too large an area at one time in young children. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Lidocaine passes into breast milk. It is unknown if prilocaine 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: drugs that may rarely cause a certain blood disorder called methemoglobinemia (e.g., acetaminophen, benzocaine, phenobarbital, antimalarials such as chloroquine/primaquine/quinine, nitrates such as nitroglycerin, certain antibiotics such as sulfonamides/nitrofurantoin/dapsone), heart rhythm medications (e.g., amiodarone, bretylium, mexiletine, phenytoin, sotalol). 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.

OVERDOSE: This medicine may be harmful if swallowed. 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. Symptoms of overdose may include: seizures, loss of consciousness.

NOTES: Do not share this medication with others. In children younger than 3 months old, laboratory tests (e.g., methemoglobin levels) should be performed periodically to check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, contact your doctor to establish a new dosing schedule.

STORAGE: Store with the cap tightly closed at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. 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.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.