lidocaine/prilocaine cream - topical, EMLA (cont.)
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 immediately if you develop blistering of the skin where the medication is applied.Remove the cream and tell your doctor immediately if any of these rare but very serious side effects occur: slow/shallow breathing, pale/bluish skin around the mouth/lips, dizziness, 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.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 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 immediately 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.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
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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