Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
inmostcases.Mostlikely,theseactionsworktogetherto preventpregnancy. Mirenacancauseyourmenstrual bleedingtobelessbythinningtheliningoftheuterus. FDA-Approved Patient Information PATIENT INFORMATION MIRENA® (Mur-ā-nah) (levonorgestrel-releasing intrauterine system) Mirena does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs). ReadthisPatientInformationcarefullybeforeyoudecide ifMirenaisrightforyou.Thisinformationdoesnottake the place of talking with your gynecologist or other healthcareproviderwhospecializesinwomen’shealth.If youhaveanyquestionsaboutMirena,askyourhealthcare provider.Youshouldalsolearnaboutotherbirthcontrol methodstochoosetheonethatisbestforyou. How well does Mirena work for contraception? Thefollowingchartshowsthechanceofgettingpregnant forwomenwhousedifferentmethodsofbirthcontrol. Each box on the chart contains a list of birth control methodsthataresimilarineffectiveness.Themosteffectivemethodsareintheboxatthetopofthechart. Mirena,anintrauterinedevice,isintheboxatthetopof thechart.Theboxonthebottomofthechartshowsthe chanceofgettingpregnantforwomenwhodonotuse birthcontrolandaretryingtogetpregnant. What is Mirena? •Mirenaisahormone-releasingsystemplacedinyour uterustopreventpregnancyforupto5years. •Mirenacanalsolessenmenstrualbloodlossinwomen whohaveheavymenstrualflowandwhoalsowantto useabirthcontrolmethodthatisplacedintheuterus topreventpregnancy. •Mirenaisrecommendedforwomenwhohavehadat leastonechild. MirenaisT-shaped.Itismadeofflexibleplasticand contains aprogestin hormonecalledlevonorgestrelthat isoftenusedinbirthcontrolpills.Mirenadoesnotcontain estrogen.Mirenareleasesthehormoneintotheuterus. Onlysmallamountsofthehormoneenteryourblood. Two threads are attached to the stem of Mirena. The threadsaretheonlypartofMirenayoucanfeelwhen Mirenaisinyouruterus. Fewerthan1 pregnancyper 100women inoneyear Fewer Pregnancies Birthcontrolpills Skinpatch Vaginalring withhormones 10–20pregnancies per100women inoneyear Mirena is small... Implants Injections Intrauterinedevices Sterilization Condoms Diaphragm Nosexduringthe mostfertiledaysof themonthlycycle Spermicide Withdrawal and flexible What if I need birth control for more than 5 years? Mirenamustberemovedafter5years.Yourhealthcare providercaninsertanewMirenaduringthesameoffice visitifyouchoosetocontinueusingMirena. 85ormore pregnanciesper More 100womenin Pregnancies oneyear What if I change my mind about birth control and want to become pregnant in less than 5 years? YourhealthcareprovidercanremoveMirenaatanytime. YoumaybecomepregnantassoonasMirenaisremoved. About8outof10womenwhowanttobecomepregnant willbecomepregnantsometimeinthefirstyearafter Mirenaisremoved. Nobirthcontrol How well does Mirena work for heavy menstrual bleeding? In the clinical trial performed in women with heavy menstrualbleedingandtreatedwithMirena,almost9out of10weretreatedsuccessfullyandtheirbloodlosswas reducedbymorethanhalf. How does Mirena work? ItisnotknownexactlyhowMirenaworks.Mirenamay workinseveralways.Itmaythickenyourcervicalmucus, thintheliningofyouruterus,inhibitspermmovement andreducespermsurvival.Mirenamaystopreleaseof youreggfromyourovary,butthisisnotthewayitworks Who might use Mirena? YoumightchooseMirenaifyou: •Wantbirthcontrolthatprovidesalowchanceofgetting pregnant(lessthan1in100) 1 Should I check that Mirena is in the proper position? Yes,youshouldcheckthatMirenaisinproperpositionby feelingtheremovalthreads.Youshoulddothisaftereach menstrualperiod.First,washyourhandswithsoapand water.Feelforthethreadsatthetopofyourvaginawith your clean fingers. The threads are the only part of MirenayoushouldfeelwhenMirenaisinyouruterus.Be carefulnottopullonthethreads.Ifyoufeelmorethan justthethreads,Mirenaisnotintherightpositionand may not prevent pregnancy. Call your healthcare provider to have it removed. If you cannot feel the threadsatall,askyourhealthcareprovidertocheckthat Mirenaisstillintherightplace.Ineithercase,usea non-hormonalbirthcontrolmethod(suchascondoms orspermicide)untilotherwiseadvisedbyyourhealthcare provider. •Wantbirthcontrolthatisreversible •Wantabirthcontrolmethodthatdoesnotrequiretaking itdaily •Havehadatleastonechild •Wanttreatmentforheavyperiodsandwanttousea birthcontrolmethodthatisplacedintheuterusto preventpregnancy. Who should not use Mirena? DonotuseMirenaifyou: •Mightbepregnant •Havehadaseriouspelvicinfectioncalledpelvicinflammatory disease (PID) unless you have had a normal pregnancyaftertheinfectionwentaway •Haveanuntreatedpelvicinfectionnow •Havehadaseriouspelvicinfectioninthepast3months afterapregnancy •Cangetinfectionseasily.Forexample,ifyouhave: •Morethanonesexualpartneroryourpartnerhasmore thanonepartner •Problemswithyourimmunesystem •Intravenousdrugabuse. •Haveorsuspectyoumighthavecanceroftheuterusor cervix •Havebleedingfromthevaginathathasnotbeenexplained •Haveliverdiseaseorlivertumor •Havebreastcancernoworinthepastorsuspectyou havebreastcancer •Haveanintrauterinedeviceinyouruterusalready •Haveaconditionoftheuterusthatchangestheshape oftheuterinecavity,suchaslargefibroidtumors •Areallergictolevonorgestrel,silicone,orpolyethylene. How soon after placement of Mirena should I return to my healthcare provider? Callyourhealthcareproviderifyouhaveanyquestionsor concerns (see “When should I call my healthcare provider”). Otherwise, you should return to your healthcare providerforafollow-upvisit4to12weeks afterMirenaisplacedtomakesurethatMirenaisinthe rightposition. Can I use tampons with Mirena? TamponsmaybeusedwithMirena. What if I become pregnant while using Mirena? Callyourhealthcareproviderrightawayifyouthinkyou arepregnant.IfyougetpregnantwhileusingMirena,you may have an ectopic pregnancy. This means that the pregnancyisnotintheuterus.Unusualvaginalbleeding orabdominalpainmaybeasignofectopicpregnancy. Ectopicpregnancyisamedicalemergencythatoften requires surgery.Ectopicpregnancycancauseinternal bleeding,infertility,andevendeath. TherearealsorisksifyougetpregnantwhileusingMirena andthepregnancyisintheuterus.Severeinfection, miscarriage,prematuredelivery,andevendeathcanoccur withpregnanciesthatcontinuewithanintrauterine device(IUD). Becauseofthis,yourhealthcareprovider maytrytoremoveMirena,eventhoughremovingitmay causeamiscarriage.IfMirenacannotberemoved,talk withyourhealthcareprovideraboutthebenefitsand risksofcontinuingthepregnancy. If you continue your pregnancy, see your healthcare providerregularly.Callyourhealthcareproviderright awayifyougetflu-likesymptoms,fever,chills,cramping, pain,bleeding,vaginaldischarge,orfluidleakingfrom yourvagina.Thesemaybesignsofinfection. ItisnotknownifMirenacancauselong-termeffectson thefetusifitstaysinplaceduringapregnancy. Before having Mirena placed, tell your healthcare provider if you: •Havehadaheartattack •Havehadastroke •Werebornwithheartdiseaseorhaveproblemswith yourheartvalves •Haveproblemswithbloodclottingortakemedicineto reduceclotting •Havehighbloodpressure •Recentlyhadababyorifyouarebreastfeeding •Havediabetes(highbloodsugar) •Usecorticosteroidmedicationsonalong-termbasis •Haveseveremigraineheadaches. How is Mirena placed? First,yourhealthcareproviderwillexamineyourpelvisto findtheexactpositionofyouruterus.Yourhealthcare providerwillthencleanyourvaginaandcervixwithan antisepticsolution,andslideathinplastictubecontaining Mirenaintoyouruterus.Yourhealthcareproviderwill thenremovetheplastictube,andleaveMirenainyour uterus.Yourhealthcareproviderwillcutthethreadsto therightlength.Placementtakesonlyafewminutes duringanofficevisit. Youmayexperiencepain,bleedingordizzinessduringand afterplacement.Ifthesesymptomsdonotpass30minutes after placement, Mirena may not have been placed correctly.Yourhealthcareproviderwillexamineyoutosee ifMirenaneedstoberemovedorreplaced. How will Mirena change my periods? Forthefirst3to6months,yourmonthlyperiodmay becomeirregularandthenumberofbleedingdaysmay increaseatfirst. Youmayalsohavefrequentspottingor lightbleeding.Afewwomenhaveheavybleedingduring thistime.Afteryourbodyadjusts,thenumberofbleeding daysislikelytolessen,andyoumayevenfindthatyour periodsstopaltogether. Insomewomenwithheavybleeding,thetotalblood losspercycleprogressively decreaseswithcontinued use.Thenumberofspottingandbleedingdaysmay 2 donothaveaperiodfor6weeksduringMirenause, callyourhealthcareprovider.WhenMirenaisremoved, yourmenstrualperiodswillcomeback. •Changes in bleeding. Youmayhavebleedingandspotting betweenmenstrualperiods,especiallyduringthefirst3 to6months.Sometimesthebleedingisheavierthan usualatfirst.However,thebleedingusually becomes lighter than usual and may be irregular. Call your healthcareproviderifthebleedingremainsheavierthan usualorifthebleedingbecomesheavyafterithasbeen lightforawhile. •Cyst on the ovary. About12outof100womenusing Mirenadevelopacystontheovary.Thesecystsusually disappearontheirowninamonthortwo.However, cystscancausepainandsometimescystswillneed surgery. Thisisnotacompletelistofpossiblesideeffectswith Mirena. For more information, ask your healthcare provider. Callyourdoctorformedicaladviceaboutsideeffects. Youmayreportsideeffectstothemanufacturerat 1-888-842-2937, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. initiallyincreasebutthentypicallydecreasesinthemonths thatfollow. Is it safe to breast-feed while using Mirena? YoumayuseMirenawhenyouarebreastfeedingifmore thansixweekshavepassedsinceyouhadyourbaby.If youarebreastfeeding,Mirenaisnotlikelytoaffectthe qualityoramountofyourbreastmilkorthehealthof yournursingbaby.However,isolatedcasesofdecreased milk production have been reported among women usingprogestin-onlybirthcontrolpills. Will Mirena interfere with sexual intercourse? YouandyourpartnershouldnotfeelMirenaduringintercourse.Mirenaisplacedintheuterus,notinthevagina. Sometimesmalepartnersfeelthethreads. What are the possible side effects of using Mirena? Mirenacancauseserioussideeffectsincluding: •Pelvic inflammatory disease (PID). SomeIUDusersget aseriouspelvicinfectioncalledpelvicinflammatory disease.PIDisusuallysexuallytransmitted.Youhave ahigherchanceofgettingPIDifyouoryourpartner havesexwithotherpartners.PIDcancauseserious problemssuchasinfertility,ectopicpregnancyorpelvic painthatdoesnotgoaway.PIDisusuallytreated withantibiotics.MoreseriouscasesofPIDmayrequire surgery.Ahysterectomy(removaloftheuterus)is sometimes needed.Inrarecases,infectionsthatstart asPIDcanevencausedeath. •Tellyourhealthcareproviderrightawayifyouhaveany ofthesesignsofPID:long-lastingorheavybleeding, unusual vaginal discharge, low abdominal (stomach area)pain,painfulsex,chills,orfever. •Life-threatening infection. Life-threateninginfectioncan occurwithinthefirstfewdaysafterMirenaisplaced. Callyourhealthcareproviderifyoudevelopseverepain withinafewhoursafterMirenaisplaced. •Embedment. Mirena maybecomeattachedtotheuterine wall.Thisiscalledembedment.Ifembedmenthappens, Mirenamaynolongerpreventpregnancyandyoumay needsurgerytohaveitremoved. •Perforation. Mirenamaygothroughtheuterus.Thisis calledperforation.Ifyouruterusisperforated,Mirena maynolongerpreventpregnancy.Itmaymoveoutside theuterusandcancauseinternalscarring,infection,or damagetootherorgans,andyoumayneedsurgeryto haveMirenaremoved. After Mirena has been placed, when should I call my healthcare provider? Callyourhealthcareproviderifyouhaveanyconcerns aboutMirena.Besuretocallifyou: •Thinkyouarepregnant. •Havepelvicpainorpainduringsex. •Haveunusualvaginaldischargeorgenitalsores. •Haveunexplainedfever. •Might be exposed to sexually transmitted diseases (STDs). •CannotfeelMirena‘sthreads. •Developverysevereormigraineheadaches. •Haveyellowingoftheskinorwhitesoftheeyes.These maybesignsofliverproblems. •Haveastrokeorheartattack. •OryourpartnerbecomesHIVpositive. •Haveseverevaginalbleedingorbleedingthatlastsa longtime. General advice about prescription medicines Medicinesaresometimesprescribedforconditionsthat arenotmentioned inpatientinformationleaflets.This leafletsummarizesthemostimportantinformationabout Mirena.Ifyouwouldlikemoreinformation,talkwithyour healthcare provider. You can ask your healthcare providerforinformationaboutMirenathatiswrittenfor healthproviders. CommonsideeffectsofMirenainclude: •Pain,bleedingordizzinessduringandafterplacement.If thesesymptomsdonotstop30minutesafterplacement, Mirena may not have been placed correctly. Your healthcareproviderwillexamineyoutoseeifMirena needstoberemovedorreplaced. •Expulsion. Mirenamaycomeoutbyitself.Thisiscalled expulsion.YoumaybecomepregnantifMirenacomes out. If you notice that Mirena has come out, use a backupbirthcontrolmethodlikecondomsandcallyour healthcareprovider. •Missed menstrual periods. About2outof10women stophavingperiodsafter1yearofMirenause.Ifyou ©2009,BayerHealthCarePharmaceuticalsInc.Allrights reserved. Manufacturedfor: BayerHealthCarePharmaceuticalsInc. Wayne,NJ07470 ThispatientinformationbookletwasupdatedOctober 2009. 3 Fill out the following checklist. Your answers will help you and your healthcare provider decide if Mirena is a good choice for you. Do you have any of these conditions? Yes No Don’tknow— willdiscuss withmy healthcare provider Abnormalitiesoftheuterus ❏ ❏ ❏ Acquiredimmunedeficiency ❏ ❏ ❏ syndrome(AIDS) Anemiaorbloodclottingproblems ❏ ❏ ❏ Bleedingbetweenperiods ❏ ❏ ❏ Canceroftheuterusorcervix ❏ ❏ ❏ Historyofothertypesofcancer ❏ ❏ ❏ Steroidtherapy(forexample,prednisone) ❏ ❏ ❏ Possiblepregnancy ❏ ❏ ❏ Diabetes ❏ ❏ ❏ Ectopicpregnancyinthepast ❏ ❏ ❏ Faintingattacks ❏ ❏ ❏ Genitalsores ❏ ❏ ❏ Heartdisease ❏ ❏ ❏ Heartmurmur ❏ ❏ ❏ Heavymenstrualflow ❏ ❏ ❏ Hepatitisorotherliverdisease ❏ ❏ ❏ Infectionoftheuterusorcervix ❏ ❏ ❏ IUDinplacenoworinthepast ❏ ❏ ❏ IVdrugabusenoworinthepast ❏ ❏ ❏ Leukemia ❏ ❏ ❏ Morethanonesexualpartner ❏ ❏ ❏ Asexualpartnerwhohasmore ❏ ❏ ❏ thanonesexualpartner Pelvicinfection ❏ ❏ ❏ Abortionormiscarriageinthepast2months ❏ ❏ ❏ Pregnancyinthepast2months ❏ ❏ ❏ Severemenstrualcramps ❏ ❏ ❏ Severeheadache ❏ ❏ ❏ Sexuallytransmitteddisease(STD), ❏ ❏ ❏ suchasgonorrheaorchlamydia Stroke ❏ ❏ ❏ AbnormalPapsmear ❏ ❏ ❏ Unexplainedgenitalbleeding ❏ ❏ ❏ Uterineorpelvicsurgery ❏ ❏ ❏ Vaginaldischargeorinfection ❏ ❏ ❏ HIVinfection ❏ ❏ ❏ Breastfeeding ❏ ❏ ❏ Highbloodpressure ❏ ❏ ❏ Manufactured for: Manufacturedfor: BayerHealthCarePharmaceuticalsInc. Bayer HealthCare Pharmaceuticals Inc. Wayne,NJ 07470 Wayne, NJ 07470 ManufacturedinFinland Manufactured in Finland BayerHealthCarePharmaceuticals MirenaHotline-1-866-647-3646 ©2009,BayerHealthCarePharmaceuticalsInc. Allrightsreserved. October2009 BayerHealthCarePharmaceuticalsInc. 6795103 82174622 4