PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

IMPORTANT: PLEASE READPART III: CONSUMER INFORMATIONPr IMITREX DF ®(sumatriptan succinate tablets USP)This leaflet is part III of a three-part "ProductMonograph" published when IMITREX DF ® Tabletswas approved for sale in Canada and is designedspecifically for Consumers. Please read this leafletcarefully before you take IMITREX DF ® Tablets. Thisprovides a summary of the information available onyour medicine. This leaflet will not tell you everythingabout IMITREX DF ® 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 IMITREX DF ®(sumatriptan succinate) Tablets. They can be obtainedonly by prescription from your doctor. The decision touse IMITREX DF ® 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 IMITREX DF ® Tablets areappropriate for you.What the medication is used for:IMITREX DF ® Tablets are intended to relieve yourmigraine headache and other associated symptoms of amigraine attack. IMITREX DF ® Tablets should notbe used continuously to prevent or reduce thenumber of attacks you experience. Use IMITREXDF ® 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. IMITREXDF ® narrows these vessels and relieves the symptoms ofmigraine headache.When it should not be used:Do not use IMITREX DF ® Tablets if:• you are allergic to sumatriptan or to any of theingredients in IMITREX DF ® 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 diseaseIMITREX DF ® 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 IMITREX DF ®Tablets.What dosage forms it comes in:IMITREX DF ® Tablets are available as pink 100 mg or white50 mg film-coated tablets in blister packs containing 6 tablets.WARNINGS AND PRECAUTIONSBEFORE you use IMITREX DF ® 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