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

IMITREX® (sumatriptan nasal spray)
(sumatriptan) Nasal Spray

Read this leaflet carefully before you start to take IMITREX Nasal Spray. Keep the leaflet for reference because it gives you a summary of important information about IMITREX Nasal Spray (sumatriptan nasal spray) .

Read the leaflet that comes with each refill of your prescription because there may be new information.

This leaflet does not have all the information about IMITREX Nasal Spray (sumatriptan nasal spray) . Ask your healthcare provider for more information or advice.

What is IMITREX Nasal Spray (sumatriptan nasal spray) ?

IMITREX Nasal Spray (sumatriptan nasal spray) is a kind of medicine called a triptan. You should take it only if you have a prescription.

IMITREX Nasal Spray (sumatriptan nasal spray) is used to relieve your migraine. It is not used to prevent attacks or reduce the number of attacks you have. Use IMITREX Nasal Spray (sumatriptan nasal spray) only to treat an actual migraine attack.

The decision to use IMITREX Nasal Spray (sumatriptan nasal spray) is one that you and your healthcare provider should make together, based on your personal needs and health.

Talk with your healthcare provider before taking IMITREX Nasal Spray (sumatriptan nasal spray)

1. Risk factors for heart disease to tell your healthcare provider:

Tell your healthcare provider if you have risk factors for heart disease such as:

• high blood pressure
• high cholesterol
• being overweight
• diabetes
• smoking
• strong family history of heart disease
• you are postmenopausal
• you are a male over 40 years of age

If you do have risk factors for heart disease, your healthcare provider should check you for heart disease to see if IMITREX is right for you.

Although most of the people who have taken IMITREX have not had any serious side effects, some have had serious heart problems. Deaths have been reported, but these were rare considering the extensive worldwide use of IMITREX. Usually, serious problems happened in people with known heart disease. It was not clear whether IMITREX had anything to do with these deaths.

2. Important questions to ask yourself before you take IMITREX Nasal Spray (sumatriptan nasal spray) :

If the answer to any of the following questions is YES or if you do not know the answer, then please talk with your healthcare provider before you take IMITREX Nasal Spray (sumatriptan nasal spray) .

• Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you not using adequate 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 (see list above)?
• Have you had a stroke, a mini-stroke (also called a transient ischemic attack or TIA), 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 triptans? Are you taking any medicines containing ergotamine, dihydroergotamine, or methysergide?
• Are you taking any medicine for depression or other health problems such as a monoamine oxidase inhibitor, selective serotonin reuptake inhibitor (SSRI), or serotonin norepinephrine reuptake inhibitor (SNRI)? Common SSRIs are citalopram HBr (CELEXA®), escitalopram oxalate (LEXAPRO®), paroxetine (PAXIL®), fluoxetine (PROZAC®/SARAFEM®), olanzapine/fluoxetine (SYMBYAX®), sertraline (ZOLOFT®), and fluvoxamine. Common SNRIs are duloxetine (CYMBALTA®) and venlafaxine (EFFEXOR®).
• 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 talk with your healthcare provider about it.

Important points about IMITREX Nasal Spray (sumatriptan nasal spray)

1. The use of IMITREX Nasal Spray (sumatriptan nasal spray) during pregnancy:

Do not take IMITREX Nasal Spray (sumatriptan 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 talked with your healthcare provider about this.

2.  How to take IMITREX Nasal Spray (sumatriptan nasal spray) :

Before taking IMITREX Nasal Spray (sumatriptan nasal spray) , see the enclosed instructions leaflet.

For adults, the usual dose is a single nasal spray in 1 nostril. If your headache comes back, you can take a second nasal spray anytime after 2 hours after you took 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 talking with your healthcare provider. Do not take more than a total of 40 mg of IMITREX Nasal Spray (sumatriptan nasal spray) in any 24-hour period. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

The effects of long-term repeated use of IMITREX Nasal Spray (sumatriptan nasal spray) on the surfaces of the nose and throat have not been specifically studied.

3. What to do if you take an overdose:

If you have taken more medicine than has been prescribed for you, contact either your healthcare provider, hospital emergency department, or nearest poison control center right away.

4. How to store your medicine:

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).

The expiration date of your medicine is printed on the packaging. If your medicine has expired, throw it away.

If your healthcare provider decides to stop your treatment, do not keep any leftover medicine unless your healthcare provider tells you to.

Some possible side effects of IMITREX Nasal Spray (sumatriptan nasal spray)

• Some patients feel pain or tightness in the chest or throat when using IMITREX Nasal Spray (sumatriptan nasal spray) . If this happens to you, tell your healthcare provider before taking any more IMITREX Nasal Spray (sumatriptan nasal spray) . If the chest pain, tightness, or pressure is severe or does not go away, call your healthcare provider right away.
• Call your healthcare provider right away if you have sudden and/or severe abdominal pain after you take IMITREX Nasal Spray (sumatriptan nasal spray) .
• Some people may have a reaction called serotonin syndrome when they take certain kinds of medicines for depression called SSRIs or SNRIs while they are taking IMITREX Nasal Spray (sumatriptan nasal spray) . Symptoms may include confusion, hallucinations, fast heartbeat, feeling faint, fever, sweating, muscle spasm, difficulty walking, and/or diarrhea. Call your healthcare provider right away if you have any of these symptoms after taking IMITREX Nasal Spray (sumatriptan nasal spray) .
• 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 healthcare provider right away. Do not take any more IMITREX Nasal Spray (sumatriptan nasal spray) unless your healthcare provider tells you to.
• Some people may feel tingling, heat, flushing (redness of face lasting a short time), heaviness, or pressure after taking IMITREX Nasal Spray (sumatriptan nasal spray) . A few people may feel drowsy, dizzy, tired, sick, or may experience nasal irritation. If you have any of these symptoms, tell your healthcare provider 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 healthcare provider right away

Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.