PACKAGE LEAFLET: INFORMATION FOR THE USER

IMIGRAN® 10 mg NASAL SPRAY, SOLUTION

IMIGRAN® 20 mg NASAL SPRAY, SOLUTIONSumatriptanRead all of this leaflet carefully before you start taking this medicine because it contains important information for you.• Keepthisleaflet.Youmayneedtoreaditagain.• Ifyouhaveanyfurtherquestions,askyourdoctororpharmacist.• Thismedicinehasbeenprescribedforyouonly.Donotpassitontoothers.Itmayharmthem,even

iftheirsignsofillnessarethesameasyours.• Ifyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffects

notlistedinthisleaflet.Seesection4.

What is in this leaflet1. What Imigran is and what it is used for2. What you need to know before you use Imigran Nasal Spray3. How to use Imigran Nasal Spray4. Possible side effects5. How to store Imigran Nasal Spray6. Contents of the pack and other information

1. What Imigran is and what it is used for

Imigran contains the active substance sumatriptanwhichbelongstoagroupofmedicinescalledtriptans(also known as 5-HT1 receptor agonists).Eachpre-filledImigran10mg/Imigran20mgNasalSpraydevicecontains10 mg/20mgsumatriptanrespectivelyin0.1mlofaqueoussolution.

Imigran Nasal Spray is used to treat migraine headaches with or without warning signs (aura).

Migrainesymptomsmaybecausedbythetemporarywideningofbloodvesselsinthehead.ImigranNasalSprayisbelievedtoreducethewideningofthesebloodvessels.Thisinturnhelpstotakeawaytheheadacheandrelieveothersymptomsofamigraineattack,suchasfeelingorbeingsick(nauseaorvomiting)andsensitivitytolightandsound.

2. What you need to know before you use Imigran Nasal Spray

Do not use Imigran:• If you are allergictosumatriptan,oranyoftheotheringredients(listedinSection6).• If you have a heart problemsuchasnarrowingofthearteries(Ischaemic heart disease)orchest

pains(angina),orhavealreadyhadaheartattack.

• If you have circulation problems in your legsthatcausecramp-likepainswhenyouwalk(peripheral vascular disease).

• If you have had a strokeoramini-stroke(also called a transient ischaemic attack or TIA).• If you have high blood pressure.YoumaybeabletouseImigranifyourhighbloodpressureismild

andisbeingtreated.• If you have severe liver disease.• With other migraine medicines, includingthosewhichcontainergotamine,orsimilarmedicines

suchasmethysergideoranytriptan/5-HT1receptoragonist(medicineswhicharealsousedfortreatingmigraine).

• With anti-depressants called MAOIs (monoamine oxidase inhibitors),orifyouhavetakenthesemedicinesinthelast2weeks.

• Forthetreatmentofmigraineswithaccompanying;weaknessofonesideofthebody(hemiplegicmigraines),speakingdifficulties,vertigo,ringinginears(basilarmigraines)orweaknessintheeyemuscles(ophthalmoplegicmigraines).

Ifanyoftheseapplytoyou:➔ Tell your doctor, and don’t use Imigran Nasal Spray.

Warnings and precautionsTalktoyourdoctororpharmacistbeforeusingImigran

If you feel pain or tightness in your chest after you use ImigranTheseeffectsmaybeintensebuttheyusuallypassquickly.Iftheydon’tpassquickly,ortheybecomesevere:➔ Get medical help immediately. Section4ofthisleaflethasmoreinformationaboutthesepossible

sideeffects.

If you have any extra risk factors• If you are a heavy smoker, orareusingnicotine replacement therapy,andespecially• If you are a man aged over 40, or• If you are a woman who has been through the menopause.Inveryrarecases,peoplehavedevelopedseriousheartconditionsafterusingImigran,eventhoughtheyhadnosignsofheartdiseasebefore.Ifanyofthepointsaboveappliestoyouitcouldmeanyouhaveagreaterriskofdevelopingheartdisease-so:➔ Tell your doctor so that your heart function can be checked beforeImigranisprescribedforyou.

If you are taking anti-depressants called SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors)➔ Tell your doctor or pharmacist before you use Imigran.AlsoseeOther medicines and Imigran,

below.

If you are allergic to antibiotics called sulphonamides Ifso,youmayalsobeallergictoImigran.Ifyouknowyouareallergictoanantibioticbutyouarenotsurewhetheritisasulphonamide:➔ Tell your doctor or pharmacist before using Imigran

If you use Imigran frequentlyUsingImigrantoooftenmaymakeyourheadachesworse.➔Tell your doctor if this applies to you. HeorshemayrecommendyoustopusingImigran.If you have a history of fits (seizures)Orifyouhaveotherconditionswhichmightmakeitmorelikelythatyou’llhaveafit–forexample,aheadinjuryoralcoholism:➔ Tell your doctor so that you can be supervised more closely.

If you have had high blood pressure Imigran may not be suitable for you➔Tell your doctor or pharmacist before using Imigran.

If you have liver or kidney disease➔Tell your doctor so that you can be supervised more closely.

Other medicines and ImigranTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Thisincludesanyherbalproductsormedicinesyou’veboughtwithoutaprescription.

SomemedicinesmustnotbetakenwithImigranandothersmaycauseadverseeffectsifthey’retakenwithImigran.You must tell your doctor if you are taking:• ergotamine alsousedtotreatmigraine, orsimilarmedicinessuchasmethysergide(seesection2

DonotuseImigran).Don’tuseImigranatthesametimeasthesemedicines.Stoptakingthesemedicinesatleast24hoursbeforeusingImigran.Don’ttakeanymedicineswhichcontainergotamineorcompoundssimilartoergotamineagainforatleast6hoursafterusingImigran.

• other triptans/5-HT1 receptor agonists (suchas naratriptan,rizatriptan,zolmitriptan), alsousedtotreatmigraine, (seesection2DonotuseImigran).Don’tuseImigranatthesametimeasthesemedicines.Stoptakingthesemedicinesatleast24hoursbeforeusingImigran.Don’ttakeanothertriptan/5-HT1receptoragonistagainforatleast24hoursafterusingImigran.

• SSRIs(Selective Serotonin Reuptake Inhibitors)orSNRIs(Serotonin Noradrenaline Reuptake Inhibitors)usedtotreatdepression.UsingImigranwiththesemedicinescancauseserotoninsyndrome(acollectionofsymptomswhichcanincluderestlessness,confusion,sweating,hallucinations,increasedreflexes,musclespasms,shivering,increasedheartbeatandshaking). Tellyourdoctorimmediatelyifyouareaffectedinthisway.

• MAOIs (monoamine oxidase inhibitors)usedtotreatdepression. Don’tuseImigranifyouhavetakentheseinthelast2weeks.

• St John’s Wort (Hypericum perforatum).TakingherbalremediesthatcontainStJohn’sWortwhileyouareusingImigranmaymakesideeffectsmorelikely.

Pregnancy and breast-feeding• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a

baby, ask your doctor or pharmacist for advice before taking this medicine.ThereisonlylimitedinformationaboutthesafetyofImigranforpregnantwomen,thoughuptillnowthereisnoevidenceofanyincreasedriskofbirthdefects.YourdoctorwilldiscusswithyouwhetherornotyoushoulduseImigranwhileyouarepregnant.

• Don’t breast-feed your baby for 12 hours after using Imigran.Ifyouexpressanybreastmilkduringthistime,discardthemilkanddon’tgiveittoyourbaby.

Driving and using machinesEitherthesymptomsofmigraineoryourmedicinemaymakeyoudrowsy.If you are affected, don’t drive or operate machinery.

3. How to use Imigran Nasal Spray

Alwaysusethismedicineexactlyasyourdoctororpharmacisthastoldyou.Checkwithyourdoctororpharmacistifyouarenotsure.

There’s a step-by-step guidetousingthesprayattheendofthisleaflet(seeSection6).

When to use Imigran:• It’s best to use Imigran as soon as you feel a migraine coming on,althoughitcanbeusedatany

timeduringanattack.• Don’t use Imigran to try to prevent an attack. Only use Imigran after your migraine headache

begins.

How much to use:

Adults aged 18 to 65• The usual dose for adults aged 18 to 65 isoneImigran20 mgsprayintojustonenostril.

ButoneImigran10 mgsprayintoonenostrilisenoughforsomepeople.• Donotusemorethantwospraysofthe20mgnasalsprayorfourspraysofthe10mgnasalspray

(takenin2x20mgdoses)in24hours,providedthatthereisaminimumintervalof2hoursbetweenthetwodoses.

Adolescents aged 12 to 17• The usual dose for adolescents aged 12 to 17isoneImigran10 mg sprayintoonenostril.Do notusemorethantwo10mgspraysin24hours,providedthatthereisaminimumintervalof 2hoursbetweenthetwodoses.

Children under 12• Imigran Nasal Spray is not recommendedforchildrenunder12yearsold.

Older people (aged over 65)• Imigran Nasal Spray is not recommended forpeopleagedover65.If your symptoms start to come back• YoucanuseasecondImigransprayafter2hours,butplease note:➔Adolescents: Do not use more than two sprays of the 10 mg nasal spray in 24 hours.➔Adults: Do not use more than two sprays of the 20 mg nasal spray or four sprays of the 10 mg

nasal spray (taken in 2 x 20mg doses) in 24 hours.

If the first spray has no effect• Don’t use a second spray,oranyotherImigranpreparationforthesameattack.

IfImigrandoesn’tgiveyouanyrelief:➔ Ask your doctor or pharmacist for advice.

If you use more Imigran than you should• Adolescents: Do not use more than two sprays of the 10 mg nasal spray in 24 hours.• Adults: Do not use more than two sprays of the 20 mg nasal spray or four sprays of the 10 mg

nasal spray (taken in 2 x 20mg doses) in 24 hours.UsingtoomuchImigrancouldmakeyouill.Ifyouhaveusedmorethanyoushould:➔ Contact your doctor for advice.

If you have any further question on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.Somesymptomsmaybecausedbythemigraineitself.

Adverseeventsreportedinadultshavealsobeenobservedinadolescents.Theseincludeveryrarereportsofheartattacks.

Allergic reaction: get doctor’s help straight awayThefollowingsideeffectshaveoccurredinaverysmallnumberofpeoplebuttheirexactfrequencyisnotknown.• The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips;

complete collapse. IfyougetanyofthesesymptomssoonafterusingImigran:➔ Don’t use any more.Contact a doctor straight away.

Very common side effects (affectmorethan1 in 10people)• Unpleasanttaste.

Common side effects (affectupto1 in 10 people)• Pain,heaviness,pressure,tightnessorpaininthechest,throatorotherpartsofthebody,orfeelings

ofunusualsensations,includingnumbness,tinglingandwarmthorcold.Theseeffectsmaybeintensebutgenerallypassquickly.

If these effects continue or become severe (especiallythechestpain):➔ Get medical help urgently.Inaverysmallnumberofpeoplethesesymptomscanbecausedbya

heartattack.

Othercommonsideeffectsinclude:• Irritationorburningsensationinthenoseorthroat;nosebleeds.• Feelingsick(nausea)orbeingsick(vomiting),althoughthismaybeduetothemigraineitself.• Tirednessordrowsiness.• Dizziness,feelingweak,orgettinghotflushes.• Temporaryincreaseinbloodpressure.• Shortnessofbreath• Achingmuscles.

Very rare side effects (affectupto1 in 10,000people)• Liverfunctionchanges.Ifyouhaveabloodtesttocheckyourliverfunction,tellyourdoctoror

nursethatyouareusingImigran.

Some patients may have the following side effects but it is not known how often they occur• Seizures/fits,tremors,musclespasm,neckstiffness.• Visualdisturbancessuchasflickering,reducedvision,doublevision,lossofvision,andinsomecases

evenpermanentdefects(althoughthesemaybeduetothemigraineattackitself).• Heartproblems,whereyourheartbeatmaygofaster,slowerorchangerhythm,chestpains(angina)

orheartattack.• Pale,blue-tingedskinand/orpaininyourfingers,toes,ears,noseorjawin

responsetocoldorstress(Raynaud’s phenomenon).• Feelingfaint(bloodpressuremaygodown).

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IMIGRAN® 10 mg NASAL SPRAY, SOLUTION

IMIGRAN® 20 mg NASAL SPRAY, SOLUTION

IMIGRAN® 10 mg

NASAL SPRAY, SOLUTION

IMIGRAN® 20 mg

NASAL SPRAY, SOLUTION

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6. Put the nozzle of the nasal spray into the other nostril,asfarasfeelscomfortable-about1cmor1/2inch(pictureB)Breathe out gently through your mouth.Holdyourheaduprightandcloseyourmouth.

7. Start to breathe in gently through your nose.Asyoubreathein:Press the blue plunger firmly with your thumb.Theplungermayfeelabitstiffandyoumayfeelitclick.Keepbreathinginwhilespraying(pictureC).

8. Remove the sprayandremoveyourfingerfromthesideofyournose.Keep your head upright for 10-20 seconds, breathinggentlyinthroughyournoseandoutthroughyourmouth.Thishelpsthemedicinestayinyournose.Yournosemayfeelwetinsideandyoumaynoticeaslighttasteafterusingthespray-thisisnormalandwillsoonpass.

9. Your nasal spray is now empty.Throwitawaysafelyandhygienically.

• Paininthelowerleftsideofthestomachandbloodydiarrhoea(ischaemic colitis).• Diarrhoea• Paininthejoints• Feelinganxious• Excessivesweating.

Reporting of side effectsIfyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviaHPRAPharmacovigilance,EarlsfortTerrace,IRL-Dublin2;Tel:+35316764971;Fax+35316762517.Websitewww.hpra.ie;email:medsafety@hpra.ie.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.

5. How to store Imigran Nasal Spray

Keepthismedicineoutofthesightandreachofchildren.

KeepImigranNasalSprayinthesealedblisterintheboxtoprotectitfromlight.

Donotstoreabove30°Canddonotfreeze.

DonotusethismedicineaftertheexpirydatewhichisstatedonthecartonafterEXP.Theexpirydatereferstothelastdayofthatmonth.

Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrowawaymedicinesyounolongeruse.Thesemeasureswillhelptoprotecttheenvironment.

6. Contents of the pack and other information

What Imigran Nasal Spray contains

The active substanceissumatriptanEachImigran10mgNasalSpraynasalapplicatorcontains10 mgofsumatriptanin0.1mlofsolution.EachImigran20mgNasalSpraynasalapplicatorcontains20 mgofsumatriptanin0.1mlofsolution.The other ingredientsarepotassiumdihydrogenphosphate,disodiumphosphateanhydrous,sulphuricacid,sodiumhydroxideandpurifiedwater.

What Imigran Nasal Spray looks like and contents of the packThismedicineisprovidedinapre-fillednasalspraydeviceandcontainssumatriptanin0.1 mlofayellow-colouredsolution.

ImigranNasalSprayispackedinaboxcontainingthenasalspraysindividuallysealedinblisters.Theyareavailableinpacksof1,2,4,6,12or18pre-fillednasalspraydevices,althoughnotallpacksizesmaybeavailableinyourcountry.EachnasalspraycontainsonedoseofImigran.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation HolderGlaxoSmithKline(Ireland)Ltd.StonemasonsWayRathfarnhamDublin16

ManufacturerGlaxoSmithKlineManufacturingS.p.A.StradaProvincialeAsolana9043056SanPolodiTorrileParmaItaly

This leaflet was last revised in February 2015 IMIGRANandtheImigranlogoareregisteredtrademarksoftheGSKgroupofcompanies.

©2015GSKgroupofcompanies.Allrightsreserved.

Other sources of information

Thispackageleafletisavailableinformatsthataresuitablefortheblindorpartiallysighted.Suchformatsareavailableonrequest

Ifyouneedmorehelporadviceonmigrainepleasecontactthefollowingnationalorganisation(s):MigraineAssociationofIreland,Unit14,Block5,PortTunnelBusinessPark,Clonshaugh,Dublin17.Telephone(01)8941280or(01)8941281

Step-by-step guide to using your Imigran Nasal Spray

Don’t open a blister until you are ready to use a spray.Eachsprayissealedinablistertokeepitcleanandsafe.Ifyoucarryaspraywithoutablister,orinanopenblister,itmaynotworkproperlywhenyouneedit.Each spray contains just one dose of Imigran. Don’tpresstheplungertoosoonoryouwilllosethedose

ImigranNasalSprayhasthreeparts:

The nozzleThepartthatyouputintoyournostril.Thespraycomesoutofatinyholeinthetop.

The finger-gripHoldthiswhenyouusethespray

The blue plungerPressthistospraythewholedoseintoyournostrilinonego.Thisonlyworksonce-don’t press the plunger until you have put the nozzle into your nostril oryouwilllosethedose.

How to use the nasal spray

1. Remove the nasal sprayfromtheblisterpackagingjustbeforeyouwanttouseit.2. Getintoacomfortableposition.Youmayprefertositdown.3. Blow your noseifitfeelsblocked,orifyouhaveacold.4. Hold the nasal spraygentlywithyourfingersandthumbasshowninpictureA.

Don’t press the blue plunger yet.

5. Block one nostrilbypressingafingerfirmlyonthesideofyournose.Itdoesn’tmatterwhichnostrilyouchoose.

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