Lidocaine, Tetracaine Medicated topical patch

What is this medicine?

LIDOCAINE; TETRACAINE (LYE doe kane; TET ra kane) causes loss of feeling in the skin and surrounding tissues. It is used to numb the skin before a procedure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease

• pseudocholinesterase deficiency

• skin infection or problem

• an unusual or allergic reaction to lidocaine, tetracaine, other anesthetics, para-aminobenzoic acid (PABA), parabens, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not remove the patch from the packaging until you are ready to use. Place the patch on the area of skin as directed by your doctor or healthcare professional. Do not apply to skin that is cut, scratched, or red. Remove the patch carefully from the foil pouch, only touching the sticky edges. Place the patch on your skin. Save the foil pouch. Do not leave on the skin for longer than 30 minutes. Do not get water on the patch. To remove the patch, pull it off your skin, only touching the sticky edges. Press the sticky side of the used patch onto the foil pouch. Discard it in an area out of reach of children and pets. Wash your hands after applying the patch and after removing the patch from your skin.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

• medicines to control heart rhythm like mexiletine, tocainide

• other products that may contain anesthetic medicine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

After use of this medicine, you will be numb for some time. Be careful to avoid injury while the area is numb and you are not aware of pain. Do not scratch, rub, or expose the skin to hot or cold while you are numb.

Do not touch this medicine to the eye. It may cause irritation and injury. If this medicine does touch the eye, wash the eye out with water or saline for eyes. Then protect the eye until feeling returns.

Do not cut the patch or remove the top cover as this could cause the patch to overheat and burn the skin. Do not cover the holes on the top side of the patch as this could cause the patch not to heat.

If you are going to have a magnetic resonance imaging (MRI) procedure, tell your MRI technician if you have this patch on your body. It must be removed before a MRI.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blister, pain where applied

• breathing problems

• changes in vision

• chills, fever

• confused, excitable, nervous, restless

• dizzy, drowsy

• headache

• irregular heartbeat

• nausea, vomiting

• seizures

• tremors

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• red or pale color skin, swelling or tingling at the application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Throw away used patches out of the reach of children. Chewing on or eating a new or used patch may cause harm to children or pets.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.