Synera

What is Synera used for?

• Synera is used to numb an area of the skin before a procedure.

Before taking Synera, tell your doctor:

• If you are allergic to Synera; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had methemoglobinemia.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Synera with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Synera?

• Tell all of your health care providers that you take Synera. This includes your doctors, nurses, pharmacists, and dentists.
• Do not scratch or rub the skin while it is numb. Do not let it get very hot or very cold.
• Do not put Synera on the treatment area after the treatment is done.
• Do not put on open sores or broken skin.
• Do not put on cuts, scrapes, or damaged skin.
• Use care when using on a large part of the skin. Talk with the doctor.
• Do not use longer than you have been told by the doctor.
• Be careful about getting vaccines while you are getting Synera.
• A severe blood problem called methemoglobinemia has happened with drugs like this one. The risk may be raised in people who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. The risk may also be raised while taking certain other drugs and in infants younger than 6 months of age. Tell your doctor if you have ever had methemoglobinemia.
• The patch may have metal. Take off the patch before an MRI.
• This medicine may cause harm if chewed or swallowed. If Synera has been put in the mouth, call a doctor or poison control center right away.
• If you are 65 or older, use Synera with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Synera while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Synera best taken?

Use Synera as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine is used on the skin.
• Avoid getting Synera in the eyes or on the lips.
• If you get Synera in any of these areas, rinse well with water.
• Take off Synera right away if it burns.
• Do not cut or tear the patch.
• Do not touch the drug in the middle of the patch. Touch only the sticky edges of the patch.
• Do not put the patch on the lips or near the eyes.
• Wash your hands after use.
• Do not get the patch wet. Keep it dry. Do not cover the small holes on the outside of the patch.
• After you take off the patch, press the sticky side of the used patch onto the foil pouch.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Synera that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath. This effect is rare but may be deadly if it happens.
• Skin irritation.
• Burning.
• Feeling hot or cold.
• Trouble breathing, slow breathing, or shallow breathing.
• Very bad numbness and tingling.
• Feeling lightheaded, sleepy, confused, or having blurred eyesight.
• Seizures.
• Mood changes.
• Feeling nervous and excitable.
• Dizziness or passing out.
• Slow heartbeat.
• Twitching.
• Shakiness.
• Upset stomach or throwing up.
• Ringing in ears.
• Change in eyesight.

What are some other side effects of Synera?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pale skin, redness, or swelling where Synera is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Synera?

• Store in the pouch that comes with Synera to help keep away from children.
• Throw away all patches in a sealed container away from children and pets.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Synera, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Synera or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Synera. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.