28. Sargent J, Kirchner JR, Davis R, Kirkhart B. Oral sumatriptan is effective andwell tolerated for the acute treatment of migraine: results of a multicenter study.Neurology 1995; 45(8 Suppl 7):S10-S14.29. Sutherland JM, Eadie MJ. Cluster headache. Res Clin Stud Headache 1970; 3:92-125.30. The Multinational Oral Sumatriptan and Cafergot Comparative Study Group. Arandomized, double-blind comparison of sumatriptan and Cafergot in the acutetreatment of migraine. Eur Neurol 1991; 31(5):314-322.31. The Oral Sumatriptan Dose-Defining Study Group. Sumatriptan-an oral dosedefiningstudy. Eur Neurol 1991; 31(5):300-305.32. The Oral Sumatriptan International Multiple-Dose Study Group. Evaluation of amultiple-dose regimen of oral sumatriptan for the acute treatment of migraine. EurNeurol 1991; 31(5):306-313.33. The Subcutaneous Sumatriptan International Study Group. Treatment of migraineattacks with sumatriptan. N Engl J Med 1991; 325(5):316-321.34. The Sumatriptan Auto-Injector Study Group. Self-treatment of acute migrainewith subcutaneous sumatriptan using an auto-injector device. Eur Neurol 1991;31(5):323-331.35. Visser WH, de Vriend RH, Jaspers MW, Ferrari MD. Sumatriptan in clinicalpractice: a 2-year review of 453 migraine patients. Neurology 1996; 47(1):46-51.October 21, 2014Page 42 of 58
IMPORTANT: PLEASE READPART III: CONSUMER INFORMATIONPr <strong>IMITREX</strong> <strong>DF</strong> ®(sumatriptan succinate tablets USP)This leaflet is part III of a three-part "ProductMonograph" published when <strong>IMITREX</strong> <strong>DF</strong> ® Tabletswas approved for sale in Canada and is designedspecifically for Consumers. Please read this leafletcarefully before you take <strong>IMITREX</strong> <strong>DF</strong> ® Tablets. Thisprovides a summary of the information available onyour medicine. This leaflet will not tell you everythingabout <strong>IMITREX</strong> <strong>DF</strong> ® Tablets. 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 <strong>IMITREX</strong> <strong>DF</strong> ®(sumatriptan succinate) Tablets. They can be obtainedonly by prescription from your doctor. The decision touse <strong>IMITREX</strong> <strong>DF</strong> ® Tablets is one that you and yourdoctor should make jointly, taking into account yourindividual preferences and medical circumstances. Ifyou have risk factors for heart disease (such as highblood pressure, high cholesterol, obesity, diabetes,smoking, strong family history of heart disease, or youare postmenopausal or a male over 40), you should tellyour doctor, who should evaluate you for heart diseasein order to determine if <strong>IMITREX</strong> <strong>DF</strong> ® Tablets areappropriate for you.What the medication is used for:<strong>IMITREX</strong> <strong>DF</strong> ® Tablets are intended to relieve yourmigraine headache and other associated symptoms of amigraine attack. <strong>IMITREX</strong> <strong>DF</strong> ® Tablets should notbe used continuously to prevent or reduce thenumber of attacks you experience. Use <strong>IMITREX</strong><strong>DF</strong> ® Tablets 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. <strong>IMITREX</strong><strong>DF</strong> ® narrows these vessels and relieves the symptoms ofmigraine headache.When it should not be used:Do not use <strong>IMITREX</strong> <strong>DF</strong> ® Tablets if:• you are allergic to sumatriptan or to any of theingredients in <strong>IMITREX</strong> <strong>DF</strong> ® Tablets. (See“What the nonmedicinal ingredients are:”)• you have a history, or any symptoms or signs of a heartcondition• 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 disease<strong>IMITREX</strong> <strong>DF</strong> ® Tablets should not be used for the treatmentof other types of headaches that are different from migraineattacks.What the medicinal ingredient is:sumatriptan succinateWhat the nonmedicinal ingredients are:croscarmellose sodium, dibasic calcium phosphate anhydrous,iron oxide red (100 mg only), magnesium stearate,methylhydroxypropyl cellulose, microcrystalline cellulose,sodium bicarbonate, titanium dioxide, and triacetin.There is no gluten, lactose, sulfite or tartazine in <strong>IMITREX</strong> <strong>DF</strong> ®Tablets.What dosage forms it comes in:<strong>IMITREX</strong> <strong>DF</strong> ® Tablets are available as pink 100 mg or white50 mg film-coated tablets in blister packs containing 6 tablets.WARNINGS AND PRECAUTIONSBEFORE you use <strong>IMITREX</strong> <strong>DF</strong> ® Tablets 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 43 of 58
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