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, peripheral vascular disease, or a history of heart attack, angina, stroke, or transient ischemic attack (TIA).

How to Use This Medicine:
Powder, Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed. Use sumatriptan only when you have a migraine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• Spray: Use 1 spray of medicine for 1 dose, unless your doctor tells you to use more.
• Powder:
  
  • This medicine is given through a nosepiece with the Xsail™ breath-powered delivery device. You will throw away each nosepiece after you use it, but you will keep the device to use again.
  • Your healthcare provider will teach you how to use the nosepiece and device.
  • Follow the directions to put the nosepiece into the device until you hear it click.
  • Press the white button all the way down one time, and then release it. This will open the capsule that contains the medicine powder.
  • Insert the nosepiece into your nose, and then rotate the device around to your mouth.
  • Blow into the mouthpiece for 2 or 3 seconds. Your breath will blow the powder up into your nose.
  • Press the clear tab and take the nosepiece out of the device.
  • Repeat the same steps with another nosepiece in your other nostril.
• If your headache improves but then comes back, you may use a second dose. Wait at least 2 hours before you take the second dose. Call your doctor if your headache does not improve at all after the first dose.
• Talk with your doctor if you need to treat more than 4 headaches in any 30-day period.
• Keep the bottle tightly closed when not using it. Store at room temperature, away from heat and direct light. Do not store in the refrigerator or freezer.

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 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 you have a family history of heart disease.
• Do not breastfeed for 12 hours after you use this medicine.
• This medicine may cause the following problems:
  
  • Higher risk for heart rhythm problems, heart attack, or stroke
  • Tightness or discomfort in your chest, neck, or jaw
  • Spasms in the blood vessels, including Raynaud syndrome
  • Serotonin syndrome (more likely if used with medicine to treat depression)
  • High blood pressure
• This medicine may make you dizzy or drowsy. Do not drive or do anything 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
• 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, pounding, or uneven heartbeat
• Numbness, tingling, cramps, unexplained pain in your legs or feet
• Severe stomach pain, bloody diarrhea, nausea, or vomiting
• Sudden severe headache (other than the one being treated)
• Vision changes that are not part of a usual migraine

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

• Bad or unusual taste in your mouth
• Burning or tingling in your nose
• Drowsiness, tiredness, dizziness

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