The following wording is contained in a separate leaflet provided for patients.

Please read this leaflet carefully before you administer IMITREX Nasal Spray. This leaflet provides a summary of the information available about your medicine. Please do not throw away this leaflet until you have finished your medicine. You may need to read this leaflet again. This leaflet does not contain all the information on IMITREX Nasal Spray. For further information or advice, ask your doctor or pharmacist.

The name of your medicine is IMITREX (sumatriptan) Nasal Spray. It can be obtained only by prescription from your doctor. The decision to use IMITREX Nasal Spray is one that you and your doctor should make jointly, taking into account your individual preferences and medical circumstances. If you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40), you should tell your doctor, who should evaluate you for heart disease in order to determine if IMITREX is appropriate for you. Although the vast majority of those who have taken IMITREX have not experienced any significant side effects, some individuals have experienced serious heart problems and, rarely, considering the extensive use of IMITREX worldwide, deaths have been reported. In all but a few instances, however, serious problems occurred in people with known heart disease and it was not clear whether IMITREX was a contributory factor in these deaths.

IMITREX Nasal Spray is intended to relieve your migraine, but not to prevent or reduce the number of attacks you experience. Use IMITREX Nasal Spray only to treat an actual migraine attack.

If the answer to any of the following questions is YES or if you do not know the answer, then please discuss it with your doctor before you use IMITREX Nasal Spray.

· Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you using inadequate contraception? Are you breastfeeding?

· Do you have any chest pain, heart disease, shortness of breath, or irregular heartbeats? Have you had a heart attack?

· Do you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40)?

· Have you had a stroke, transient ischemic attacks (TIAs), or Raynaud syndrome?

· Do you have high blood pressure?

· Have you ever had to stop taking this or any other medicine because of an allergy or other problems?

· Are you taking any other migraine medicines, including other 5-HT₁ agonists or any other medicines containing ergotamine, dihydroergotamine, or methysergide?

· Are you taking any medicines for depression (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors [SSRIs])?

· Have you had, or do you have, any disease of the liver or kidney?

· Have you had, or do you have, epilepsy or seizures?

· Is this headache different from your usual migraine attacks?

Remember, if you answered YES to any of the above questions, then discuss it with your doctor.

Do not use IMITREX Nasal Spray if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception, unless you have discussed this with your doctor.

Before using IMITREX Nasal Spray, see the enclosed instruction pamphlet. For adults, the usual dose is a single nasal spray administered into 1 nostril. If your headache comes back, a second nasal spray may be administered anytime after 2 hours of administering the first spray. For any attack where you have no response to the first nasal spray, do not take a second nasal spray without first consulting with your doctor. Do not administer more than a total of 40 mg of IMITREX Nasal Spray in any 24-hour period. The effects of long-term repeated use of IMITREX Nasal Spray on the surfaces of the nose and throat have not been specifically studied. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

· Some patients experience pain or tightness in the chest or throat when using IMITREX Nasal Spray. If this happens to you, then discuss it with your doctor before using any more IMITREX Nasal Spray. If the chest pain is severe or does not go away, call your doctor immediately.

· If you have sudden and/or severe abdominal pain following IMITREX Nasal Spray, call your doctor immediately.

· Shortness of breath; wheeziness; heart throbbing; swelling of eyelids, face, or lips; or a skin rash, skin lumps, or hives happens rarely. If it happens to you, then tell your doctor immediately. Do not take any more IMITREX Nasal Spray unless your doctor tells you to do so.

· Some people may have feelings of tingling, heat, flushing (redness of face lasting a short time), heaviness or pressure after treatment with IMITREX Nasal Spray. A few people may feel drowsy, dizzy, tired, sick, or may experience nasal irritation. Tell your doctor of these symptoms at your next visit.

· If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately.

If you have taken more medicine than you have been told, contact either your doctor, hospital emergency department, or nearest poison control center immediately.

Keep your medicine in a safe place where children cannot reach it. It may be harmful to children. Store your medicine away from heat and light. Do not store at temperatures above 86°F (30°C), or below 36°F (2°C). If your medicine has expired (the expiration date is printed on the treatment pack), throw it away as instructed. If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to. Throw away your medicine as instructed.

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