Download PATIENT INFORMATION MIRENA

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