BREVINOR TABLETS

Main information

  • Trade name:
  • BREVINOR TABLETS
  • Dosage:
  • 5/0.036mg Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BREVINOR TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0936/018/001
  • Authorization date:
  • 07-03-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0936/018/001

CaseNo:2027670

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PharmaciaIrelandLimited

9Riverwalk,NationalDigitalPark,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Brevinor500micrograms/35microgramsTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom07/03/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Brevinor500micrograms/35microgramsTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains500microgramsNorethisteroneand35microgramsEthinylestradiol.

Excipients:alsoincludesLactosemonohydrate42.21mgpertablet.

Forafulllistofexcipeints,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

Blue,round,flattabletwithbevelededges,approximately3/16”diameter,inscribed‘Searle’ononesideand‘BX’on

theother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Hormonalcontraception

4.2Posologyandmethodofadministration

BeforestartingBrevinor,athoroughgeneralmedicalandgynaecologicalexamination(includingthebreastsanda

cytologicalsmearofthecervix)shouldbecarriedoutandthefamilymedicalhistorycarefullynoted.Disturbancesof

theclottingmechanismsshouldberuledoutifanymembersofthefamilyhavesufferedfromthromboembolicdisease

(e.g.deepveinthrombosis,stroke,myocardialinfarction)atayoungage.

Pregnancymustbeexcludedideallybyapregnancytest.

Asaprecaution,throughexaminationsshouldbeconductedatapproximatelysix-monthintervalsduringuseoftablets.

FirstCycle

Tablet-takingformthefirstpackofBrevinorisstartedonthe1 st

dayofthemenstrualcycle,i.e.thefirstdayofthe

menstrualbleeding.Additionalcontraceptiveprecautionsshouldbetakenforthefirst7daysofthefirstpack.Patients

unabletostarttakingBrevinortabletsonthefirstdayofthemenstrualcyclemaystarttreatmentonanydayuptoand

includingthe5thdayofthemenstrualcycle.Itisalsorecommendedthatanothermethodofcontraceptionisusedfor

thefirst7daysoftablet-takinginthosepatientsdelayingtherapyuptoDay5.Onetabletistobetakenataroundthe

sametimeofdayoneachof21consecutivedaysfollowedbyatablet-freeintervalof7days,duringwhicha

withdrawalbleedingoccurs.

Subsequentcycles

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weekasthefirstpack.

Changingfromanotheroralcontraceptive

ThefirsttabletofBrevinorshouldbetakenonthefirstdayofbleedingthatoccursaftertheintakeofthelastactive

tabletofthepatient’spreviousoralcontraceptive.

Irregulartablettaking

IfthewomanforgetstotakeaBrevinortabletthenitmustbetakenwithin12hoursoftheusualtimefortakingit.Ifa

missedtabletisnottakenwithin12hoursthenitshouldbetakenwhenrememberedandtheremainingtabletstakenas

usualwithextranon-hormonalcontraceptivemeasures(exceptrhythmortemperaturemethod)usedforthenext7

days.Ifthesesevendaysextendbeyondtheendofthepackthenthenextpackoftabletsshouldbecommencedatonce

withnotablet-freeinterval.Inthissituation,awithdrawalbleedshouldnotbeexpecteduntiltheendofthesecond

pack.Ifthepatientdoesnothaveawithdrawalbleedduringthetablet-freeintervalfollowingtheendofthesecond

pack,thepossibilityofpregnancymustbeexcludedbeforeresumingwiththenextpack.

Postpartum

Normally,afteradelivery,Brevinorshouldbestartedafterthefirstnormalmenstrualcycle.

Ifimmediatereliablecontraceptionisrequiredformedialreasons,medicationwithBrevinorshouldbeinitiatedafter

Day7andbeforeDay12postpartum.

Postmiscarriage

Followingamiscarriageoralcontraceptioncanbestartedimmediately(Day2butnolaterthanDay5)forimmediate

cover.

Whenoralcontraceptivesareadministeredintheimmediatepostpartum/postmiscarriageperiod,theincreasedriskof

thromboembolicdiseasemustbeconsidered.

Absenceofwithdrawalbleeding

If,inexceptionalcases,withdrawalbleedingfailstooccur,pregnancymustberuledoutbeforetheuseofBrevinoris

continued.

Procedureintheeventofirregularbleeding

Breakthroughbleedingandspottingaresometimesencountered,primarilyduringthefirstthreemonthsofuse,and

usuallyceasespontaneously.Thewoman,thereforeshouldcontinuetouseBrevinorevenifirregularbleedingoccurs.

Shouldbreak-throughbleedingpersistorrecur,appropriatediagnosticmeasurestoexcludeanorganiccauseshouldbe

taken.

Thisalsoappliesinthecaseofspottingwhichoccursatirregularintervalsinseveralconsecutivecyclesorwhich

occursforthefirsttimeafterlonguseofBrevinor.

Gastro-intestinalupset

Vomitingordiarrhoeamayreducetheefficacyororalcontraceptivesbypreventingfullabsorption.Tablettakingfrom

thecurrentpackshouldbecontinued.Additionalnon-hormonalmethodsofcontraception(excepttherhythmor

temperaturemethods)shouldbeusedduringthegastro-intestinalupsetandfor7daysfollowingtheupset.Ifthese7

daysoverruntheendofthepack,thenextpackshouldbestartedwithoutabreak.Inthissituation,awithdrawalbleed

shouldnotbeexpecteduntiltheendofthesecondpack.Ifthepatientdoesnothaveawithdrawalbleedduringthe

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resumingwiththenextpack.Othermethodsofcontraceptionshouldbeconsideredifthegastro-intestinaldisorder(s)

islikelytobeprolonged.

4.3Contraindications

Confirmedorsuspectedpregnancyandinnursingmothers.

Acuteorchronicliverdisease,jaundiceorpersistentpruritisduringapreviouspregnancy,Dubin-Johnson

syndromeandRotorsyndrome.

Presenceorhistoryofthrombophlebitisorthromboembolicdisorders,cardiovasculardisease,myocardial

infarction,coronaryarterydiseaseorcongenitalhyperlipidema.

Sickle-cellanaemia.

Currentorpreviousknownorsuspectedsteroid-dependentneoplasiae.g.previousorexistinglivertumours

cancerofthebreast,endometriumorreproductivetract.

Severediabetesmellituswithvascularchanges.

Disordersoflipidmetabolism(See4.4Specialwarningsandprecautionsforuse).

Pemphigoidgestationis.

Deteriorationofotosclerosisduringpregnancy.

Undiagnosedvaginalbleeding.

HypersensitivitytoanyofthecomponentsofBrevinor.

4.4Specialwarningsandprecautionsforuse

Theuseofanycombinedoralcontraceptivecarriesanincreasedriskofvenousthromboembolism(VTE)compared

withnouse.TheexcessriskofVTEishighestduringthefirstyearawomanusesacombinedoralcontraceptive.This

increasedriskislessthantheriskofVTEassociatedwithpregnancy,whichisestimatedas60casesper100,000

pregnanies.VTEisfatalin1-2%ofcases.

ItisnotknownhowBrevinorinfluencestheriskofVTEcomparedwithothercombinedoralcontraceptives.

ReasonsforimmediatediscontinuationofmedicationwithBrevinor:

Suspectedorconfirmedsymptomsorsignsofthrombophlebitisorthromboembolicevents(e.g.unusualpainsinor

swellingofthelegs).

Pulmonaryembolicdiseaseand/orafeelingofpainandtightnessinthechest(stabbingpainsonbreathingor

coughingfornoapparentreason).

Occurrenceforthefirsttime,orexacerbationormigrainousheadachesoranincreasedfrequencyorunusually

severeheadaches.

Suddendisturbancesofvisionorhearingorotherperceptualdisorders.

Fourweeksbeforeelectivesurgeryandduringimmobilisatione.g.afteraccidents,surgery.Itwouldbereasonable

toresumeBrevinortwoweeksaftersurgeryprovidingthewomanisambulant.However,everywomanshouldbe

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additionalriskfactorsandthechanceofunwantedconception.

Onsetofjaundice,hepatitis,itchingofthewholebody.

Increasesinepilepticseizures.

Significantriseinbloodpressure.

Onsetofseveredepression.

10.Severeupperabdominalpainorliverenlargement.

11.Pregnancy.

Patientswiththefollowingconditionsshouldonlyusetheoralcontraceptivepillafterdetailingdiscussionwith

theirGeneralPractitioner.Patientswiththeseconditionsrequirestrictmedicalsupervisionduring

medication.

Diabetesmellitusorimpairedcarbohydratetolerance.

Hypertension.

Varicoseveins.

Otosclerosis.

Multiplesclerosis.

Epilepsy.

Porphyria.

Tetany.

Sydenham’schorea.

10.Cardiacorrenaldysfunction.

11.Familyhistoryofbreastcancerorpasthistoryofbreastnodules.

12.Fibrocysticdiseaseofthebreast.

13.Asthma.

14.Historyofclinicaldepression.

15.Systemiclupuserythematosus.

16.Uterinemyoma.

17.Migraine.

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19.Womenwhowearcontactlenses.

Deteriorationinanyoftheaboveconditionsmayindicatethatuseoftheoralcontraceptiveshouldbe

discontinued.

Accordingtothepresentstateofknowledge,anassociationbetweentheuseofhormonalcontraceptivesandan

increasedriskofvenousandarterialthromboembolicdiseasesuchasmyocardialinfarction,pulmonaryembolism,

thrombophlebitis,strokeorretinalthrombosis,cannotberuledout.Thephysicianshouldbealerttotheearliest

manifestationsofthesedisorders.ShouldanyoftheseoccurorbesuspectedBrevinorshouldbediscontinued

immediately.

Therelativeriskofarterialthromboses(e.g.stroke,myocardialinfarction)isincreasedbythepresenceofother

predisposingfactorssuchas:

Cigarettesmoking.

Hypercholesterolaemia.

Obesity.

Diabetes.

Historyofpre-eclamptictoxaemia.

Increasingage.

Aftertheageof35years,thephysicianandpatientsshouldcarefullyreassesstherisk/benefitratioofusingcombined

oralcontraceptivesasopposedtoalternativemethodsofcontraception.

Changesinserumtriglycerides,cholesterolandlipoproteinlevelshavebeenreportedinusersoforalcontraceptives.

Oralcontraceptivesmaycauseadecreaseinglucosetolerance.

Anincreaseinbloodpressurehasbeenreportedinwomentakingoralcontraceptives.Elevatedbloodpressureusually

returnstonormalafterdiscontinuationoforalcontraceptives.

Womenwithahistoryofoligomenorrheaorsecondaryamenorrhoeaoryoungwomenwithoutregularcyclesmayhave

atendencytoremainanovulatoryortobecomeamenorrhoeicafterdiscontinuationoforalcontraceptives.Womenwith

thesepre-existingproblemsshouldbeadvisedofthispossibilityandencouragedtouseothercontraceptivemethods.

Numerousepidemiologicalstudieshavebeenreportedontherisksofovarian,endometrial,cervicalandbreastcancer

inwomenusingcombinedoralcontraceptives.Theevidenceisclearthatcombinedoralcontraceptivesoffer

substantialprotectionagainstbothovarianandendometrialcancer.

Inrarecasesbenignand,inevenrarercases,malignantlivertumoursleadinginisolatedcasestolife-threateningintra-

abdominalhaemorrhagehavebeenobservedaftertheuseofhormonalsubstancessuchasthosecontainedinBrevinor.

Ifsevereupperabdominalcomplaints,liverenlargementorsignsorintra-abdominalhaemorrhageoccur,thepossibility

ofalivertumourshouldbeincludedinthedifferentialdiagnosis.

Earlierstudiesreportedanincreasedriskofsurgicallyconfirmedgallbladderdiseaseinusersofoestrogensandoral

contraceptives.However,morerecentstudieshaveshownthattherelativeriskofthedevelopinggallbladderdisease

maybeminimal.

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Studiesinanimalshaveindicatedthatadministrationofveryhighdosesofoestrogensand/orprogestogenswillinduce

neoplastictumoursinsomeanimalspecies.

Theresultsofrecentstudiesinhumanbeingssuggestthatthereisasmallbutstatisticallyincreasedincidenceof

endometrialcarcinomaandofbreastcancerinwomenwhohavebeentreatedwithoestrogens.Allwomeninparticular

thoseover35yearsshouldhaveregularbreastexaminationswhileonthepill.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Hepaticenzymeinducerssuchasbarbiturates,primidone,hydantoins,phenylbutazone,rifampicin,carbamazepineand

griseofulvincanimpairtheefficacyofBrevinor.Forwomenreceivinglong-termtherapywithhepaticenzyme

inducers,anothermethodofcontraceptionshouldbeused.Theuseofampicillinandotherantibioticsmayalsoreduce

theefficacyofBrevinor,possiblybyalteringtheintestinalfloraandindividualpregnancieshavebeenreported.St.

John'sWortshouldnotbetakenconcomitantlywithBrevinorasitcouldleadtoalossofcontraceptiveeffect.

Womenreceivingshortcoursesofenzymeinducersorbroadspectrumantibioticsshouldtakeadditional,non-hormonal

(exceptrhythmortemperaturemethod)contraceptiveprecautionsduringthetimeofconcurrentmedicationandfor7

daysafterwards.Ifthese7daysoverruntheendofthepack,thenextpackshouldbestartedwithoutabreak.Inthis

situation,awithdrawalbleedshouldnotbeexpecteduntiltheendofthesecondpack.Ifthepatientdoesnothavea

withdrawalbleedduringthetablet-freeintervalfollowingtheendofthesecondpack,thepossibilityofpregnancymust

beruledoutbeforeresumingthenextpack.Withrifampicin,additionalcontraceptiveprecautionsshouldbecontinued

for4weeksaftertreatmentstops,evenifonlyashortcoursewasadministered.

Therequirementfororalantidiabeticsorinsulincanchangeasaresultoftheeffectonglucosetolerance.

Theuseoforalcontraceptivesmayinfluencetheresultsofcertainlaboratorytestsincludingbiochemicalparametersof

liver,thyroid,adrenalandrenalfunction,plasmalevelsorcarrierproteinsandlipid/lipoproteinfractions,parametersof

carbohydratemetabolismandparametersofcoagulationandfibrinolysis.Laboratorystaffshouldthereforebe

informedaboutoralcontraceptiveusewhenlaboratorytestsarerequested.

4.6Pregnancyandlactation

IfpregnancyoccursduringmedicationwithBrevinor,thepreparationshouldbewithdrawnimmediately.

Anincreasedriskofcongenitalabnormalities,includingheartdefectsandlimbdefects,hasbeenreportedfollowingthe

useofsexhormones,includingoralcontraceptivesinpregnancy.ItisadvisabletodiscontinueBrevinorthreemonths

beforeaplannedpregnancy.

TheuseofBrevinorduringlactationmayleadtoareductioninthevolumeofmilkproducedandtoachangeinits

composition.Minuteamountsoftheactivesubstancesareexcretedwiththemilk.AstheeffectofBrevinorhasnot

beendetermindinbreast-fedinfants,itisrecommendedthatpatientswhoarebreastfeedingshouldnottakethis

product.

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

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Casesofheadaches(includingmigranes),gastricupsetsincludingdyspepsia,nauseaandvomiting,breasttenderness,

changesinbodyweight,fluidretention,bloating,thrombophlebitis,changesinlibido,breakthroughbleeding,failureof

withdrawalbleedingtooccur,depressivemoods,candidiasis,rash,urticaria,pruritis,erythemanodosum,erythema

multiforme,acne,hirsutismandalopeciacanoccur.

Inpredisposedwomen,useofBrevinorcansometimescausechloasma,whichisexacerbatedbyexposuretosunlight.

Individualcasesofpoortoleranceofcontactlenseshavebeenreportedwithuseoforalcontraceptives.Contactlens

wearerswhodevelopchangesinlenstoleranceshouldbeassessedbyanophthalmologist.

RefertoSection4.4Specialwarningsandspecialprecautionsforuseforadditionalinformation.

4.9Overdose

Overdosagemaycausenausea,vomitingandwithdrawalbleedinginfemales.Seriousilleffectshavenotbeenreported

followinglargedosesoforalcontraceptivesinchildren.Ingeneral,treatmentofoverdoseisnotnecessary;however,

treatmentmaybesymptomatic,ifappropriate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ThemodeofactionofBrevinorissimilartothatofotherprogestogen/oestrogenoralcontraceptivesandincludesthe

inhibitionofovulation,thethickeningofcervicalmucussoastoconstituteabarriertospermandtherenderingofthe

endometriumunreceptivetoimplantation.Suchactivityisexertedthroughacombinedeffectononeormoreofthe

following:hypothalamus,anteriorpituitary,ovary,endometriumandcervicalmucus.

5.2Pharmacokineticproperties

Followingoraladministration,theabsolutebioavailabilityofnorethisteroneisabout65%.Thetimetopeakplasma

concentrationrangesfrom0.5to4hours,beingmoredelayedasthedoseincreases.Thereisextensivefirst-pass

metabolism.Intheplasma,about80%isboundtosexhormonesbindingglobulinandalbumin.Theeliminationhalf-

lifeiaabout5-14hours.

Afteroraladministrationtheabsolutebioavailabilityofethinyloestradiolisabout40%.Peakplasmaconcentrationis

reachedin1to2hours.Proteinbinding,primarilytoalbumin,isabout98%.Thereisextensivefirst-passmetabolism

andextensiveenterohepaticcirculation.Theeliminationhalf-lifeis6to20hours.

5.3Preclinicalsafetydata

Studiesinanimalshaveindicatedthatadministrationofveryhighdosesofoestrogenand/orprogestogenswillinduce

neoplastictumoursinsomeanimalspecies.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CornStarch

Povidone

MagnesiumStearate

Lactosemonohydrate

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6.2Incompatibilities

Notapplicable

6.3ShelfLife

5years

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

PVC/Foillaminateblisterenclosedinacardboardouter.Eachpackcontains21tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PharmaciaIrelandLimited

9Riverwalk

NationalDigitalPark

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA936/18/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 07March1997

Dateoflastrenewal: 07March2007

10DATEOFREVISIONOFTHETEXT

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