REPORTING SUSPECTED SIDE EFFECTSYou can report any suspected adverse reactionsassociated with the use of health products to the CanadaVigilance Program by one of the following 3 ways:• Report online at www.healthcanada.gc.ca/medeffect• Call toll-free at 1-866-234-2345• Complete a Canada Vigilance Reporting Form and:- Fax toll-free to 1-866-678-6789, or- Mail to: Canada Vigilance ProgramHealth CanadaPostal Locator 0701COttawa, ON K1A 0K9Postage paid labels, Canada Vigilance Reporting Formand the adverse reaction reporting guidelines areavailable on the MedEffect Canada Web site atwww.healthcanada.gc.ca/medeffect.NOTE: Should you require information related to themanagement of side effects, contact your healthprofessional. The Canada Vigilance Program does notprovide medical advice.IMPORTANT: PLEASE READMORE INFORMATIONThis document plus the full product monograph,prepared for health professionals can be found at:http://www.gsk.ca or by contacting the sponsor,<strong>GlaxoSmithKline</strong> Inc.7333 Mississauga RoadMississauga, OntarioL5N 6L41-800-387-7374This leaflet was prepared by <strong>GlaxoSmithKline</strong> Inc.Last revised: October 21, 2014© 2014 <strong>GlaxoSmithKline</strong>, All Rights Reserved® <strong>IMITREX</strong> <strong>DF</strong> is a registered trademark, used under licenseby <strong>GlaxoSmithKline</strong> Inc.October 21, 2014Page 46 of 58
IMPORTANT: PLEASE READPART III: CONSUMER INFORMATIONPr <strong>IMITREX</strong> ®(sumatriptan succinate injection)Subcutaneous Injection and AutoinjectorThis leaflet is part III of a three-part "ProductMonograph" published when <strong>IMITREX</strong> ® Injection wasapproved for sale in Canada and is designed specificallyfor Consumers. Please read this leaflet carefully beforeyou take <strong>IMITREX</strong> ® Injection. This provides asummary of the information available on your medicine.This leaflet will not tell you everything about<strong>IMITREX</strong> ® Injection. Please do not throw away thisleaflet until you have finished your medicine. You mayneed to read it again. Contact your doctor or pharmacistif you have any questions about the drug.ABOUT THIS MEDICATIONThe name of your medicine is <strong>IMITREX</strong> ® (sumatriptansuccinate) Injection. It can be obtained only byprescription from your doctor. The decision to use<strong>IMITREX</strong> ® Injection is one that you and your doctorshould make jointly, taking into account your individualpreferences and medical circumstances. If you have riskfactors for heart disease (such as high blood pressure,high cholesterol, obesity, diabetes, smoking, strongfamily history of heart disease, or you arepostmenopausal or a male over 40), you should tell yourdoctor, who should evaluate you for heart disease inorder to determine if <strong>IMITREX</strong> ® Injection isappropriate for you.What the medication is used for:<strong>IMITREX</strong> ® Injection is intended to relieve yourmigraine headache and other associated symptoms of amigraine attack. <strong>IMITREX</strong> ® Injection should not beused continuously to prevent or reduce the numberof attacks you experience. Use <strong>IMITREX</strong> ® Injectiononly to treat an actual migraine headache attack.What it does:Migraine headache is believed to be caused by awidening of the blood vessels in the head. <strong>IMITREX</strong> ®narrows these vessels and relieves the symptoms ofmigraine headache.When it should not be used:Do not use <strong>IMITREX</strong> ® Injection if:• you are allergic to sumatriptan or to any of theingredients in <strong>IMITREX</strong> ® Injection. (See “Whatthe 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 severe liver disease<strong>IMITREX</strong> ® Injection should not be used for the treatment ofother types of headaches that are different from migraine attacks<strong>IMITREX</strong> ® Injection should not be given intravenously, butonly into the tissues just below the skin (on the outside of thethigh or in the upper arm).What the medicinal ingredient is:sumatriptan succinateWhat the nonmedicinal ingredients are:sodium chloride solutionThere is no gluten, lactose, sulfite or tartazine in <strong>IMITREX</strong> ®Injection.What dosage forms it comes in:<strong>IMITREX</strong> ® Injection (6 mg; total volume = 0.5 mL) is availablein pre-filled syringes placed in a tamper-evidentcarrying/disposal case. Two pre-filled syringes plus an<strong>IMITREX</strong> STATdose Pen ® autoinjector are packed in an<strong>IMITREX</strong> STATdose System ® autoinjector kit. A refill pack isavailable containing 2 pre-filled syringes in a carton.WARNINGS AND PRECAUTIONSBEFORE you use <strong>IMITREX</strong> ® Injection 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 headacheOctober 21, 2014Page 47 of 58
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