LIDOCAINE/TETRACAINE PATCH - TOPICAL

PHONETIC PRONUNCIATION: (LYE-doe-kane/TET-ra-kane)

COMMON BRAND NAME(S): Synera

GENERIC NAME(S): lidocaine/tetracaine

Uses

USES: This product contains 2 local anesthetics: lidocaine and tetracaine. It is used on the skin to prevent pain before certain procedures (such as inserting a needle for drawing blood, removing a small piece of skin for testing). It works by briefly numbing the skin and surrounding area.

How to use LIDOCAINE/TETRACAINE PATCH - TOPICAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Do not open the foil pouch that contains the patch until you are ready to apply the patch. Make sure the skin is clean and dry before applying the patch. The patch should only be applied to normal, unbroken skin. Do not apply the patch to skin that is cut, scratched, swollen, or red. Do not cut or tear the patch or get the patch wet. Peel away the protective liner and place the patch on the procedure site as directed by your doctor, usually 20 to 30 minutes before the procedure. Do not touch the middle part of the patch that contains the medication. Firmly press down on the edges of the patch to make sure it does not fall off. Wash your hands after applying the patch. If the patch is near or on your hand, make sure not to get the patch wet. Do not cover the small holes on the outside of the patch. You may feel a warm feeling on the area where the patch is applied. However, if the area starts hurting or burning, then you should remove the patch and tell your doctor. Do not apply the patch on your lips or near or in your eyes. If this occurs, rinse the area with plenty of water and protect the area until the numbness goes away. Remove the patch as directed, usually shortly before the procedure. You should not leave the patch on for more than 30 minutes. Leaving the patch in place for longer than directed will increase the risk of side effects. Also, using more than 1 patch at a time or using patches one after the other may increase the risk of side effects. After removing the patch, stick the patch onto the foil pouch or fold the patch in half with the sticky sides together and discard out of reach of children and pets. Do not reuse the patch. Wash your hands after removing the patch unless you are treating an area on the hands. The skin where the patch was placed will feel numb so be careful not to injure the area (such as by rubbing or scratching it) or let the skin touch hot or cold things. This patch may be harmful if placed in the mouth or swallowed. If you are applying this product on a child, make sure the patch stays in place and that your child does not put the patch in his/her mouth.

Side Effects

SIDE EFFECTS: Redness, swelling, 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. Tell your doctor right away if you have any serious side effects, including: blistering of the skin. Remove the patch and get medical help right away if you have any very serious side effects, including: dizziness, drowsiness, slow/shallow breathing, slow/irregular heartbeat, mental/mood changes (such as confusion, nervousness), shaking, seizures, vision changes (such as double/blurred vision), ringing in the ears, fainting. A very serious allergic reaction to this drug is rare. However, get medical help right away 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

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to lidocaine or tetracaine; or to other local anesthetics (such as prilocaine); or to PABA, 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: certain blood disorders (methemoglobinemia, G6PD deficiency), a certain hereditary disorder (pseudocholinesterase deficiency), liver disease, heart disease (such as irregular heartbeat). If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be at greater risk for side effects while using this product. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Lidocaine may pass into breast milk. It is unknown if tetracaine passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Tell your doctor or pharmacist if you are using other local anesthetic products (such as prilocaine or other products containing lidocaine or tetracaine) at the same time as this medication because your risk of serious side effects may increase.

Overdose

OVERDOSE: This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For 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, fainting, slow/irregular heartbeat, slow/shallow breathing.

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SYNERA PATCH

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SYNERA PATCH

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Disclaimer

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.

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