Onzetra XSail 11mg/Nosepiece, 16 Inhalations

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.

SUMATRIPTAN POWDER - NASAL

(SOO-ma-TRIP-tan)

COMMON BRAND NAME(S): Onzetra Xsail

USES: Sumatriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (such as nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Sumatriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that narrows blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain. Sumatriptan does not prevent future migraines or lessen how often you get migraine attacks.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using sumatriptan and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Use this medication at the first sign of a migraine as directed by your doctor, usually 1 nosepiece in each nostril. Follow the illustrated directions for the proper use of this medication. Remember to blow with your mouth into the device to deliver medication into your nose. If your symptoms do not get better, do not use more doses of this medication before talking to your doctor. If your symptoms are only partly better, or if your headache comes back, you may use another dose at least 2 hours after the first dose. The dosage is based on your medical condition and response to treatment. Do not use more than 44 milligrams/4 nosepieces in a 24-hour period. If you have a higher risk for heart problems (see Precautions section), your doctor may do a heart exam before you start using sumatriptan. He/she may also direct you to use your first dose of this medication in the office/clinic to watch for serious side effects (such as chest pain). Talk to your doctor for details. If you are using drugs for migraine attacks on 10 or more days each month, the drugs may actually make your headaches worse (medication overuse headache). Do not use medications more often or for longer than directed. Tell your doctor if you need to use this medication more often, or if the medication is not working as well, or if your headaches get worse.

SIDE EFFECTS: Unusual taste, runny nose, or irritation/numbness/tingling of the nose or throat may occur after using this medication. Flushing, feelings of tingling/numbness/prickling/heat, tiredness, weakness, drowsiness, or dizziness may also occur. If any of these effects last or get worse, 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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet, hearing changes, mental/mood changes. Sumatriptan can commonly cause chest/jaw/neck tightness, pain, or pressure that is usually not serious. However, these side effects are like symptoms of a heart attack, which may include chest/jaw/left arm pain, shortness of breath, or unusual sweating. Get medical help right away if these or other serious side effects occur, including: fast/irregular heartbeat, fainting, severe stomach/abdominal pain, bloody diarrhea, seizures, signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion). This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. 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: Before using sumatriptan, tell your doctor or pharmacist if you are allergic to it; 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: blood circulation problems (for example, in your legs, arms, hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizures, stroke or \"mini-stroke\" (transient ischemic attack). Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, smoker, postmenopausal (women), age more than 40 years (men). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). The risk of heart disease, liver disease, and high blood pressure increases with age. Older adults may be more sensitive to the side effects of this drug, especially increased blood pressure and heart problems. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.

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. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop using this medication. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/\"ecstasy,\" St. John\'s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. If you also take any ergotamine medication (such as dihydroergotamine) or other \"triptan\" drugs (such as zolmitriptan, rizatriptan), you will need to separate your sumatriptan dose from your dose of these other medications to lessen the chance of serious side effects. Ask your doctor how long you should wait between your doses of these drugs.

OVERDOSE: If someone has overdosed and has 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.

NOTES: Do not share this medication with others. Certain foods, beverages, or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as lifestyle patterns such as irregular eating/sleeping habits or stress may bring on a migraine headache. Avoiding these \"triggers\" may help lessen migraine attacks. Consult your doctor for more details. Lab and/or medical tests (such as blood pressure) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: Not applicable. See How to Use section.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep the nosepieces in the pouch until ready to use. Once opened, discard any unused nosepieces after 1 hour. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised October 2018. Copyright(c) 2018 First Databank, Inc.