PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

IMPORTANT: PLEASE READPART III: CONSUMER INFORMATIONPr IMITREX ®(sumatriptan nasal spray)This leaflet is part III of a three-part "ProductMonograph" published when IMITREX ® Nasal Spraywas approved for sale in Canada and is designedspecifically for Consumers. Please read this leafletcarefully before you use IMITREX ® Nasal Spray. Thisprovides a summary of the information available onyour medicine. This leaflet will not tell you everythingabout IMITREX ® Nasal Spray. Please do not throwaway this leaflet until you have finished your medicine.You may need to read it again. Contact your doctor orpharmacist if you have any questions about the drug.ABOUT THIS MEDICATIONThe name of your medicine is IMITREX ® (sumatriptan)Nasal Spray. It can be obtained only by prescriptionfrom your doctor. The decision to use IMITREX ® NasalSpray is one that you and your doctor should makejointly, taking into account your individual preferencesand medical circumstances. If you have risk factors forheart disease (such as high blood pressure, highcholesterol, obesity, diabetes, smoking, strong familyhistory of heart disease, or you are postmenopausal or amale over 40), you should tell your doctor, who shouldevaluate you for heart disease in order to determine ifIMITREX ® Nasal Spray is appropriate for you.What the medication is used for:IMITREX ® Nasal Spray is intended to relieve yourmigraine headache and other associated symptoms of amigraine attack. IMITREX ® Nasal Spray should notbe used continuously to prevent or reduce thenumber of attacks you experience. Use IMITREX ®Nasal Spray only to treat an actual migraineheadache attack.What it does:Migraine headache is believed to be caused by awidening of the blood vessels in the head. IMITREX ®narrows these vessels and relieves the symptoms ofmigraine headache.When it should not be used:Do not use IMITREX ® Nasal Spray if:• you are allergic to sumatriptan or to any of theingredients in IMITREX ® Nasal Spray. (See“What the nonmedicinal ingredients are:”).• you have a history, or any symptoms or signs of aheart condition• you have high blood pressure• you are taking or have recently taken (within 2 weeks) amonoamine oxidase inhibitor (MAOI)• you are taking or have recently taken (within 24 hours) anergotamine containing medication or its derivatives, oranother triptan used to treat migraine• you have any degree of liver diseaseIMITREX ® Nasal Spray should not be used for the treatment ofother types of headaches that are different from migraine attacks.What the medicinal ingredient is:sumatriptanWhat the nonmedicinal ingredients are:anhydrous dibasic sodium phosphate, monobasic potassiumphosphate, purified water, sodium hydroxide and sulphuric acid.There is no gluten, lactose, sulfite or tartazine in IMITREX ®Nasal Spray.What dosage forms it comes in:IMITREX ® Nasal Spray 5 mg and 20 mg are each supplied inboxes of 2 nasal spray devices (1 X 2 devices). Each unit dosespray supplies 5 and 20 mg, respectively.WARNINGS AND PRECAUTIONSBEFORE you use IMITREX ® Nasal Spray talk to your doctor orpharmacist if:• you are pregnant, think you might be pregnant, you aretrying to become pregnant, you are using inadequatecontraception, or you are breast feeding• you have any chest pain, heart disease, shortness ofbreath, or irregular heartbeats, you have had a heartattack, or you have angina• you have risk factors for heart disease (such as highblood pressure, high cholesterol, obesity, diabetes,smoking, strong family history of heart disease, or areyou postmenopausal or a male over 40)• you have ever had to stop taking this or any othermedication because of an allergy or other problems, or youare allergic to sulpha-containing drugs• you are taking any medications, including migrainemedications such as other triptans, 5-HT 1 agonists or thosecontaining ergotamine, dihydroergotamine, or methysergide• you have ever experienced difficulty moving one side ofyour body when you have a headache• you have ever had a stroke, transient ischemic attacks(TIAs), or Raynaud’s Syndrome• you are under 18 years of age• you are over 65 years of ageOctober 21, 2014Page 54 of 58