When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to sumatriptan. Tell your doctor if you have heart disease or blood circulation problems, including heart rhythm problems, ischemic bowel disease, or a history of heart disease, heart attack, angina, stroke, or transient ischemic attack (TIA).

How to Use This Medicine:
Device Assisted Patch

• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to.
• This medicine is contained in a skin patch. The patch uses electricity to deliver the medicine through your skin.
• The patches come in sealed pouches. Do not use this medicine if the pouch seal is broken or if the patch is cut, damaged, or changed in any way.
• Choose a skin area for the patch. The patch should be applied clean, dry skin on your upper arm or thigh. Choose a place that does not have much hair and does not have a scar, tattoo, cut, burn, scratch, or other irritation. The patch should not be placed on skin that has been red or irritated in the past 3 days.
• Wash your hands with soap and water before and after applying a patch.
• When you are ready to apply the patch, pull the 2 foil tabs. Rub each foil packet. Trace around the green arrow 3 times.
• Unfold the orange flap. Lift open the package. Slowly peel the patch from the silver liner. Make sure the medicine pads are securely attached.
• Apply the patch to your skin. Push the activation button. A red LED (light emitting diode) should turn on. The red light should blink and then turn solid red.
• If the light does not stay solid red or turns off in the first 10 minutes, that means the patch is not working. Take the patch off and dispose of it. Start over with a new patch.
• You might feel a little burning or tingling when the patch first starts working.
• The patch must be applied and activated within 15 minutes after you remove the foil tabs.
• You can tape the patch to your skin with medical tape if it starts to peel off.
• Wear the patch for 4 hours or until the light turns off. Remove the patch slowly to avoid skin irritation. Clean the area gently with a mild soap and water to remove any medicine left on the skin.
• Keep the patch dry. Do not bathe, shower, or swim while you are wearing a patch.
• Remove the patch and call your doctor right away if you feel moderate to severe pain at the patch site. This is to avoid serious burns and possible scars at the patch site.
• If your headache comes back or gets worse, you may apply a second patch to your other arm or thigh. However, you must wait at least 2 hours after the first patch was activated.
• Do not use more than 2 patches within 24 hours.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.
• Fold the used patch in half with the sticky sides together. Throw any used patch away so that children or pets cannot get to it. You will also need to throw away old patches after the expiration date has passed. This patch contains lithium-manganese dioxide batteries. Talk to your doctor or pharmacist about how to follow state and local laws when you throw away the patch.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have taken another triptan or ergot medicine in the past 24 hours (including almotriptan, dihydroergotamine, eletriptan, ergotamine, frovatriptan, methysergide, naratriptan, rizatriptan, or zolmitriptan).
• Do not use this medicine if you have used an MAO inhibitor in the past 2 weeks.
• Some foods and medicines can affect how sumatriptan works. Tell your doctor if you are using medicine for depression.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, diabetes, epilepsy, high blood pressure, or high cholesterol. Tell your doctor if you smoke or have a family history of heart disease. Tell your doctor if you have a history of stomach or bowel bleeding, Raynaud disease, or other types of blood flow problems.
• Do not breastfeed for 12 hours after you use this medicine.
• This medicine may cause the following problems:
  
  • Skin problems where the patch was placed
  • Higher risk for heart rhythm problems, heart attack, or stroke
  • Tightness or discomfort in your chest, neck, throat, or jaw
  • Serotonin syndrome (more likely if used with medicine to treat depression)
• This patch contains metal parts. You must take it off before you have an MRI. Apply the patch carefully if you have a medical device on or in your body (such as a heart pacemaker, body-worn insulin pump, or implantable deep brain stimulator).
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your headaches may become worse if you use headache medicine for 10 or more days per month.
• Call your doctor if your symptoms do not improve or if they get worse.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, sweating, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Chest pain, especially if it spreads to your arms, jaw, back, or neck, trouble breathing, unusual sweating, faintness
• Color changes and cold feeling in your toes or fingers
• Fast, slow, pounding, or uneven heartbeat
• Numbness, tingling, cramps, coldness, or unexplained pain
• Numb, cold feeling and color changes in your fingers or toes
• Seizures
• Severe stomach pain, bloody diarrhea, vomiting, nausea, fever
• Tightness or discomfort in your chest, neck, or jaw
• Vision changes that are not part of a usual migraine

If you notice these less serious side effects, talk with your doctor:

• Mild redness, pain, itching, tingling, or change in skin color where the patch is put on your skin

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088