PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

IMPORTANT: PLEASE READPART III: CONSUMER INFORMATIONPr IMITREX ®(sumatriptan succinate injection)Subcutaneous Injection and AutoinjectorThis leaflet is part III of a three-part "ProductMonograph" published when IMITREX ® Injection wasapproved for sale in Canada and is designed specificallyfor Consumers. Please read this leaflet carefully beforeyou take IMITREX ® Injection. This provides asummary of the information available on your medicine.This leaflet will not tell you everything aboutIMITREX ® 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 IMITREX ® (sumatriptansuccinate) Injection. It can be obtained only byprescription from your doctor. The decision to useIMITREX ® 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 IMITREX ® Injection isappropriate for you.What the medication is used for:IMITREX ® Injection is intended to relieve yourmigraine headache and other associated symptoms of amigraine attack. IMITREX ® Injection should not beused continuously to prevent or reduce the numberof attacks you experience. Use IMITREX ® 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. IMITREX ®narrows these vessels and relieves the symptoms ofmigraine headache.When it should not be used:Do not use IMITREX ® Injection if:• you are allergic to sumatriptan or to any of theingredients in IMITREX ® 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 diseaseIMITREX ® Injection should not be used for the treatment ofother types of headaches that are different from migraine attacksIMITREX ® 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 IMITREX ®Injection.What dosage forms it comes in:IMITREX ® 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 anIMITREX STATdose Pen ® autoinjector are packed in anIMITREX STATdose System ® autoinjector kit. A refill pack isavailable containing 2 pre-filled syringes in a carton.WARNINGS AND PRECAUTIONSBEFORE you use IMITREX ® 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