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DIANE35
BerlexCanada
CyproteroneAcetateEthinylEstradiol
AcneTherapy

ActionAndClinicalPharmacology:Diane35isacombination

antiandrogenestrogenforuseinthetreatmentofandrogen
dependentdermatologicalconditionsinfemales.
Cyproteroneisasteroidcompoundwithpotentantiandrogenic,
progestogenicandantigonadotrophicactivity.Itexertsits
antiandrogeniceffectbyblockingandrogenreceptors.Italso
reducesandrogensynthesisbyanegativefeedbackeffectonthe
hypothalamopituitaryovariansystems.Theestrogencomponent
(ethinylestradiol)ofDiane35increaseslevelsofsexhormone
bindingglobulin(SHBG)andthusreducesthefreecirculating
plasmalevelsofandrogens.Cyproteronehasnotendencytoreduce
SHBGlevels.
Ifusedaloneinwomen,cyproteroneleadstomenstrualcycle
disturbanceswhichareavoidedwhencombinedwithethinyl
estradiol.WhenDiane35isadministeredinacyclicmannerithas
theaddedeffectofpreventingovulationandpossibleconception.
ThecomponentsofDiane35arerapidlyabsorbedafteroral
administration.Duetothelongterminalhalflifeofcyproterone,a
4foldincreaseinplasmalevelsoccursafter6to12daysofdaily
dosing.Longtermtherapy(36months)withDiane35didnothave
asignificantinfluenceonlipidmetabolism.Atrendtoincreased
plasmacholesterolandtriglyceridelevelswasobserved.Therewas
aslightdecreaseinlowdensitylipoprotein(LDL)witha
simultaneousincreaseinhighdensitylipoprotein(HDL).
IndicationsAndClinicalUses:Forthetreatmentofwomenwithsevere

acne,unresponsivetooralantibioticandotheravailabletreatments,
withassociatedsymptomsofandrogenization,includingseborrhea
andmildhirsutism.
Note:Diane35shouldnotbeprescribedsolelyforitscontraceptive
properties.However,whentakenasrecommended(seeDosage),
Diane35willprovidereliablecontraceptioninpatientstreatedfor
theaboveclinicalconditions.Ifpatientcomplianceisuncertainand
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contraceptionisnecessary,thenasupplementarynonhormonal
contraceptivemethodshouldbeconsidered.
Diane35hasmanypropertiesincommonwith
estrogen/progestogencombinationoralcontraceptivesandthesame
Contraindications,WarningsandPrecautionsapplicabletothisclass
ofdrugsshouldbeconsidered.
Estrogenand/orprogestogenshouldnotbetakenduringtreatment
withDiane35.
ContraIndications:Thrombophlebitis,thromboembolicdisorders,ora

historyoftheseconditionscerebrovasculardisordersmyocardial
infarctionorcoronaryarterydiseaseactiveliverdiseaseorhepatic
adenomasorcarcinomashistoryofcholestaticjaundiceknownor
suspectedcarcinomaofthebreastknownorsuspectedestrogen
dependentneoplasiaundiagnosedabnormalvaginalbleedingany
ocularlesionarisingfromophthalmicvasculardisease,suchas
partialorcompletelossofvisionordefectinvisualfieldswhen
pregnancyissuspectedordiagnosedpreviousorexistingliver
tumorsseverediabeteswithvascularchangesahistoryof
otosclerosiswithdeteriorationduringpregnancy.
tag_WarningWarnings
Manufacturers'WarningsInClinicalStates:PredisposingFactorsFor

CoronaryArteryDiseases:Inwomenwithpredisposingfactorsfor
coronaryarterydisease(suchascigarettesmoking,hypertension,
hypercholesterolemia,obesity,diabetesandincreasingage),theuse
ofestrogen/progestogencombinationshavebeenreportedasan
additionalriskfactor.
Aftertheageof35years,estrogen/progestogencombinations
shouldbeconsideredonlyinexceptionalcircumstancesandwhen
therisk/benefitratiohasbeencarefullyweighedbyboththepatient
andthephysician.
Cigarettesmokingincreasestheriskofseriousadverseeffectson
theheartandbloodvesselsfromtheuseofthisclassofmedication.
Thisriskincreaseswithageandheavysmoking(15ormore
cigarettesperday)andismoremarkedinwomenover35yearsof
age.Womenwhousesuchmedicationshouldnotsmoke.
Estrogen/progestogencombinationsmaycauseanincreasein
plasmalipoproteinsandshouldbeadministeredwithcautionto
womenknowntohavepreexistenthyperlipoproteinemia.Lipid
profilesshouldbedeterminedregularlyinthesepatients.
Thecombinationofobesity,hypertensionanddiabetesis
particularlyhazardoustowomenwhoaretakingthisclassof
medication.Shouldthistriadofconditionsdevelop,thepatient
shouldbeplacedonanalternateformoftherapy.
Discontinuemedicationattheearliestmanifestationof:A.
Thromboembolicandcardiovasculardisorderssuchas:
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thrombophlebitis,pulmonaryembolism,cerebrovasculardisorders,
myocardialischemia,mesentericthrombosisandretinalthrombosis.
Theuseofestrogen/progestogencombinationproductsshouldbe
avoidedinconditionswhichpredisposetovenousstasisandto
vascularthrombosis,e.g.,immobilizationafteraccidentsor
confinementtobedduringlongtermillness.Undersuchconditions,
othernonhormonalmethodsoftreatmentshouldbeconsidered.For
usewhensurgeryiscontemplated,seePrecautions.
B.Visualdefects,partialorcomplete.
C.Papilledema,orophthalmicvascularlesions.
D.Severeheadacheofunknownetiology,orworseningofpre
existingmigraineheadache.
E.Onsetofjaundiceorhepatitis.
F.Itchingofthewholebody.
Pregnancy:Fetalabnormalitieshavebeenreportedtooccurinthe
offspringofwomenwhohavetakenestrogen/progestogen
combinationsinearlypregnancy.Ruleoutpregnancyassoonasitis
suspected.
Lactation:Theuseofestrogen/progestogencombinationsduringthe
periodamotherisbreastfeedingherinfantmaynotbeadvisable.
Thehormonalcomponentsareexcretedinbreastmilkandmay
reduceitsquantityandquality.Thelongtermeffectsonthe
developingchildarenotknown.
Thisdrugmaycausefluidretention.Conditionssuchasepilepsy,
asthma,andcardiacorrenaldysfunctionrequirecarefulobservation.
Recognizedfirstlinetestsofgenotoxicitygavenegativeresults
whenconductedwithcyproterone.However,furthertestsshowed
thatcyproteronewascapableofproducingadductswithDNA(and
anincreaseinDNArepairactivity)inlivercellsfromratsand
monkeysandalsoinfreshlyisolatedhumanhepatocytes.This
DNAadductformationoccurredatexposuresthatmightbe
expectedtooccurintherecommendeddoseregimensfor
cyproterone.Oneinvivoconsequenceofcyproteronetreatmentwas
theincreasedincidenceoffocal,possiblypreneoplastic,liver
lesionsinwhichcellularenzymeswerealteredinfemalerats.
Therelevanceofthesefindingsdoesnotappeartobeclinically
significantbasedontheresultsofamulticentreinternationalliver
tumorcasecontrolstudywhichdemonstratedthatthereisno
evidenceofanincreasedriskofhepatocellularcarcinomaassociated
withcontraceptivesteroidscontainingcyproteroneacetate,even
afterlongtermuse.
Precautions:PhysicalExaminationandFollowup:Before
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estrogen/progestogencombinationsareused,athoroughhistoryand
physicalexaminationshouldbemadeincludingabloodpressure
determination.Breasts,liver,extremities,abdomenandpelvic
organsshouldbeexamined.APapanicolaousmearshouldbetaken
ifthepatienthasbeensexuallyactiveandaurinalysisshouldbe
done.
Thefirstfollowupexaminationshouldbedone3monthsafterthe
initialprescription.Thereafter,examinationsshouldbeconductedat
regularintervalsduringlongtermtreatmentandmorefrequentlyfor
thosepatientsatgreaterriskforadverseeffects.Ateachannual
visit,examinationshouldincludethoseproceduresoutlinedabove
thatweredoneattheinitialvisit.
HepaticFunction:Patientswhohavehadjaundiceshouldbegiven
estrogen/progestogencombinationswithgreatcareandunderclose
observation.
Ifthereisaclearcuthistoryofcholestaticjaundice,especiallyifit
occurredduringpregnancy,othermethodsoftreatmentshouldbe
prescribed.Thedevelopmentofseveregeneralizedpruritusor
icterusrequiresthatthemedicationbewithdrawnuntiltheproblem
isresolved.Ifthejaundiceshouldprovetobecholestaticintype,
therapyshouldnotberesumed.Inpatientstaking
estrogen/progestogencombinations,changesinthecompositionof
thebilemayoccurandanincreasedincidenceofgallstoneshasbeen
reported.Hepaticnodules(adenomaandfocalnodularhyperplasia)
havebeenreported,particularlyinlongtermusersof
estrogen/progestogencombinations.Althoughtheselesionsare
uncommon,theyhavecausedfatalintraabdominalhemorrhageand
shouldbeconsideredinwomenpresentingwithanabdominalmass,
acuteabdominalpain,orevidenceofintraabdominalbleeding.
Hypertension:Patientswithessentialhypertensionwhoseblood
pressureiswellcontrolledmaybegiventhedrugbutonlyunder
closesupervision.Ifasignificantelevationofbloodpressurein
previouslynormotensiveorhypertensivesubjectsoccursatanytime
duringtheadministrationofthedrug,cessationofmedicationis
necessary.
MigraineandHeadache:Theonsetorexacerbationofmigraineor
thedevelopmentofheadacheofanewpatternwhichisrecurrent,
persistent,orsevere,requiresdiscontinuationofmedicationand
evaluationofthecause.
Diabetes:Diabeticpatients,orthosewithafamilyhistoryof
diabetes,shouldbeobservedcloselytodetectanyalterationsin
carbohydratemetabolism.Patientspredisposedtodiabeteswhocan
bekeptunderclosesupervisionmaybegivenestrogen/progestogen
combinationsunderstrictmedicalsupervision.Youngdiabetic
patientswhosediseaseisofrecentorigin,wellcontrolled,andnot
associatedwithhypertensionorothersignsofvasculardiseasesuch
asocularfundalchanges,shouldbecloselyobserved.
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MetabolicandEndocrineDiseases:Inmetabolicorendocrine
diseasesandwhenmetabolismofcalciumandphosphorusis
abnormal,carefulclinicalevaluationshouldprecedemedicationand
aregularfollowupisrecommended.
OcularDisease:Progressiveastigmaticerror,possiblyleadingto
keratoconus,hasbeennotedinsomemyopicwomenreceiving
drugsoftheestrogen/progestogenclass.Inwomenwhodeveloped
myopiaatornearpuberty,andinwhommyopiastabilizedinadult
life,estrogen/progestogencombinationsaftersome6monthsofuse
haveincreasedtherefractiveerror2to3fold.Womenwitha
familyhistoryofmyopicastigmatismorkeratoconuswhoareusing
suchtherapymayexperiencerapidadvancementoftheocular
disorder.
Contactlenswearerswhodevelopvisualchangesorchangesinlens
toleranceshouldbeassessedbyanophthalmologistandtemporary
orpermanentcessationofwearconsidered.
ConnectiveTissueDisease:Theuseofestrogen/progestogen
combinationsinsomewomenhasbeenassociatedwithpositive
lupuserythematouscelltestsandwithclinicallupuserythematosus.
Insomeinstancesexacerbationofrheumatoidarthritisandsynovitis
hasbeenobserved.
Breasts:Althoughestrogen/progestogencombinationusehasnot
beenshowntoincreasetheriskofdevelopingbreastcancer,
particularattentionshouldbepaidtowomenwhohavean
immediatefamilyhistoryofthisdiseaseandarethereforemore
pronetoitsdevelopment.Carefulmonitoringismandatorybecause,
ifabreastcancershoulddevelop,estrogencontainingdrugsmay
causearapidprogressionifthemalignancyishormonedependent.
Specialjudgmentshouldbeusedinprescribingsuchmedications
forwomenwithfibrocysticdiseaseofthebreast.
Womenreceivingsuchmedicationsshouldbeinstructedinself
examinationoftheirbreasts.Theirphysiciansshouldbenotified
wheneveranymassesaredetected.
VaginalBleeding:Persistentirregularvaginalbleedingrequires
specialdiagnosticjudgmenttoexcludethepossibilityofpregnancy
orneoplasm.
Fibroids:Patientswithfibroids(leiomyomata)shouldbecarefully
observed.Suddenenlargement,painortendernessrequire
discontinuanceofmedication.
Age:Ingeneral,womeninthelaterreproductiveyearsgradually
assumeanincreasingriskofcirculatoryandmetabolic
complicationswhichbecomesmoreprominentat35yearsofage.In
viewofthis,closerobservation,shorterdurationof
estrogen/progestogencombinationuseandavoidanceofcigarette
smokingisadvisable.Alternatively,adoptionofothermeansof
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therapyshouldbeconsideredforthisagegroup.
Estrogen/progestogencombinationsmaymasktheonsetof
climacteric.
EmotionalDisorders:Patientswithahistoryofemotional
disturbances,especiallythedepressivetype,aremorepronetohave
arecurrenceofdepressionwhiletakingestrogen/progestogen
combinations.Incasesofaseriousrecurrence,atrialofanalternate
methodoftherapyshouldbemadewhichmayhelptoclarifythe
possiblerelationship.
LaboratoryTests:Resultsoflaboratorytestsshouldbeinterpretedin
lightofthefactthatthepatientistakingestrogen/progestogen
therapy.Thelaboratorytestslistedbelowaremodified.
A.Liverfunctiontests:Aspartateserumtransaminase(AST):
variouslyreportedelevations.Alkalinephosphataseandgamma
glutaminetransaminase(GGT):slightlyelevated.
B.Coagulationtests:Minimalelevationoftestvaluesreportedfor
suchparametersasFactorsVII,VIII,IXandX.
C.Thyroidfunctiontests:Proteinbindingofthyroxineisincreased
asindicatedbyincreasedtotalserumthyroxineconcentrationsand
decreasedT3resinuptake.
D.Lipoproteins:Smallchangesofunprovenclinicalsignificance
mayoccurinlipoproteincholesterolfractions.
E.Gonadotropins:LHandFSHlevelsaresuppressedbytheuseof
estrogen/progestogentherapy.Wait2weeksafterdiscontinuingthe
useofestrogen/progestogentherapybeforemeasurementsaremade.
TissueSpecimens:Pathologistsshouldbeadvisedof
estrogen/progestogentherapywhenspecimensobtainedfrom
surgicalproceduresaresubmittedforexamination.
ReturntoFertility:Afterdiscontinuingtherapy,thepatientshould
delaypregnancyuntilatleast1normalmenstrualcyclehas
occurred.Thepatientshouldbeinstructedtouseanonhormonal
methodofcontraceptionduringthistimeperiod.
Amenorrhea:Womenhavingahistoryofoligomenorrhea,
secondaryamenorrhea,orirregularcyclesmayremainanovulatory
orbecomeamenorrheicfollowingestrogen/progestogen
combinationtherapy.Amenorrhea,especiallyifassociatedwith
breastsecretion,thatcontinuesfor6monthsormoreafter
withdrawal,warrantsacarefulassessmentofhypothalamicpituitary
function.
ThromboembolicComplicationsPostsurgery:Retrospective
studieshavereportedanincreasedriskofpostsurgery
thromboemboliccomplicationsinestrogen/progestogen
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combinationusers.Iffeasible,suchdrugsshouldbediscontinuedat
least1monthpriortoelectivemajorsurgery.Medicationshouldnot
beresumeduntilatleast2weeksafterhospitaldischargefollowing
surgery.
DrugInteractions:Concurrentuseofthefollowingdrugsmayresultin

reducedefficacyofDiane35andincreasedincidenceof
breakthroughbleeding:ampicillin,analgesics,antihistamines,
antimigrainepreparations,chloramphenicol,griseofulvin,isoniazid,
neomycin,nitrofurantoin,penicillinV,phenylbutazone,
sulfonamidesandtetracycline.
Concurrentuseofanticoagulantswithestrogen/progestogen
combinationsmayreducetheanticoagulanteffect.Effectivenessof
thefollowingdrugsmaybealteredwhenusedconcurrently:
antihypertensives,benzodiazepines(thosethatundergooxidative
degradation)betaadrenergicblockers,caffeine,corticosteroids,
hypoglycemics,phenothiazines,theophyllines,tricyclic
antidepressantsandvitamins.
Concurrentuseofthefollowingdrugsmayreducetheefficacyof
Diane35becauseofacceleratedestrogenmetabolismcausedbythe
inductionofhepaticenzymes:carbamazepine,phenobarbital,
phenytoin,primidoneandrifampin.
Diabeticsusingestrogen/progestogencombinationsmayrequire
adjustmentoftheirantidiabeticmedication.
ConcurrentadministrationofvitaminC(ascorbicacid)with
estrogen/progestogencombinationshasbeenreportedtoresultina
significantriseinplasmaethinylestradiollevels.
Pregnancy:Ruleoutpregnancybeforetreatmentisbegun.Because
oftheantiandrogenicactionofDiane35,feminizationofmale
fetuseshasoccurredinanimalstudiesandmaypossiblyoccurin
humans.
AdverseReactions:General:Anincreasedriskofthefollowingserious

adversereactionshasbeenassociatedwiththeuseof
estrogen/progestogencombinations:thrombophlebitisarterial
thromboembolismpulmonaryembolismmesentericthrombosis
neuroocularlesions,e.g.,retinalthrombosisandopticneuritis
myocardialinfarctioncerebralthrombosiscerebralhemorrhage
hypertensionlivertumorsgallbladderdiseaseandcongenital
anomalies.
Thefollowingadversereactionsalsohavebeenreportedinpatients
receivingestrogen/progestogencombinationoralcontraceptives:
nauseaandvomiting,usuallythemostcommonadversereaction
occurringinapproximately10%orlessofpatientsduringthefirst
cycle.Otherreactions,asageneralrule,areseenlessfrequentlyor
onlyoccasionally:gastrointestinalsymptoms(suchasabdominal
crampsandbloating)breakthroughbleedingspottingchangein
menstrualflowdysmenorrheaamenorrheaduringandafter
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treatmenttemporaryinfertilityafterdiscontinuanceoftreatment
edemachloasmaormelasmawhichmaypersistbreastchanges:
tenderness,enlargement,andsecretionchangeinweight(increase
ordecrease)changeincervicalerosionandsecretionendocervical
hyperplasiapossiblediminutioninlactationwhengiven
immediatelypostpartumcholestaticjaundicemigraineincreasein
sizeofuterineleiomyomatarash(allergic)mentaldepression
reducedtolerancetocarbohydratesvaginalcandidiasis
premenstruallikesyndromeintolerancetocontactlenseschangein
cornealcurvature(steepening)cataractsopticneuritisretinal
thrombosischangesinlibidochoreachangesinappetitecystitis
likesyndromerhinitisheadachenervousnessdizzinesshirsutism
lossofscalphairerythemamultiformeerythemanodosum
hemorrhagiceruptionvaginitisporphyriaimpairedrenalfunction
Raynaud'sphenomenonauditorydisturbanceshemolyticuremic
syndromeandpancreatitis.
ProductspecificAdverseReactions:Diane35wasgenerallywell
toleratedinstudiesinvolving1563womenwhoweretreatedfor
periodsof6to36cycles.Themostfrequentlyreportedcomplaint
wasdysmenorrhea(10.2%)whichdecreasedovertimeinamanner
characteristicoftreatmentwithestrogen/progestogencombinations.
Othereffectsreportedwerealsosimilarinnatureandfrequencyto
thosereportedwithestrogen/progestogencombinations.
SeriouspostmarketingadversereactionsreportedwithDiane35
includedeepvenousthrombosis,venousthrombosiswithpulmonary
embolism,arterialemboliinvolvingtheextremitiesandthespleen,
cerebralischemicvascularaccident,cerebralvenousthrombosis,
sinusthrombosis,retinalveinthrombosis,hypertensivecrisis,
migraine,pancreatitis,focalnodularhyperplasiaoftheliver,
subcapsularliverhematoma,liveradenoma,hepatocellular
carcinoma,primarybileductcarcinoma,hepatitis,liverdystrophy,
cholangitis,pseudomembranouscolitis,cholestasis,abdominalpain,
epilepticseizures,cerebraltumorsymptoms,acutebrachiofacial
paresis,acutehydrocephalus,manicsyndrome,hyperpathia,
anaphylactoidreactions,ascites,diabetesmellitus,acuteleukemia
andbreastcancer.
Thefollowingnonseriousadversereactions,listedaccordingto
bodysystem,havebeenreportedpostmarketing:Cardiovascular:
headaches,migraine,superficialphlebitis,palpitations,flushing.
Gastrointestinal:focalnodularhyperplasia,livertumor,hepatitis,
jaundice,hepatomegalywithoutabnormallivertests,nausea,
diarrhea,flatulence,stomatitis,salivaryglandswelling.
Genitourinary:menstrualdisorder,ovariancyst,myoma,cervix
dysplasia,vaginitis,urinarytractinfection,prematurebirth,
abortion,missedabortionandplacentainsufficiency.
Metabolism:abnormalliverenzymes,hyperthyroidism,
hyperprolactinemia.
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Nervoussystem:depression,decreasedlibido,nervousness,
insomnia,somnolence,confusion,hypesthesia,paresthesia,seizures
(inpatientswithahistoryofepilepsy),visualdisturbances,
symptomsofconjunctivalirritation,hearingdisorder.
Skin:alopecia,acne,chloasma,exanthema,erythemanodosum,
striae,neurodermitis,skinallergy,urticaria,facialedema,pruritus,
photosensitivity,pigmentation,dryskin,Herpeszoster,cellulitis,
s.c.lumps,eczema,livedo,bluespots.
SymptomsAndTreatmentOfOverdose:SymptomsandTreatment:

TherehavebeennoreportsofoverdosewithDiane35.Thereareno
specificantidotesandtreatmentshouldbesymptomatic,basedon
theknowledgeofthepharmacologicalactionoftheconstituents.
tag_DosageDosage
DosageAndAdministration:Diane35shouldnotbeprescribedsolely

foritscontraceptiveproperties.Ifpatientcomplianceisuncertain
andcontraceptionisnecessary,thenasupplementarynonhormonal
contraceptivemethodshouldbeconsidered.
Diane35issuppliedinblisterpackunitsconsistingof21tablets
eachtabletcontainingcyproteroneacetate2mgandethinyl
estradiol0.035mg.Eachcycleconsistsof21daysonmedication
anda7dayintervalwithoutmedication(3weekson,1weekoff).
FirstTreatmentCourse:Thepatientisinstructedtotake1tablet
dailyfor21consecutivedaysbeginningonday1ofhermenstrual
cycle.(Forthefirstcycleonlythefirstdayofmenstrualflowis
consideredDay1.)Thetabletsarethendiscontinuedfor7days(1
week).Withdrawalbleedingshouldusuallyoccurduringtheperiod
thatthepatientisoffthetablets.Thefirstcyclewillbesomewhat
shorterthanusual,whereasallfollowingcycleswilllast4weeks.
SubsequentCourses:Thepatientbeginshernextandallsubsequent
21daycourseoftablets(followingthesame21dayson,7daysoff)
onthesamedayoftheweekthatshebeganherfirstcourse.She
beginstakinghertablets7daysafterdiscontinuation,regardlessof
whetherornotwithdrawalbleedingisstillinprogress.
Treatmentshouldbecontinuedforseveralmonths,since
improvementmaynotbeobservedwith4or5cycles.Itis
recommendedtocontinuetreatmentwithDiane35foratleast
another3to4cyclesaftersignshavesubsided.
Pregnancyshouldberuledoutbeforecontinuingtreatmentwith
Diane35inpatientswhohavemissedamenstrualperiod.If
pregnancyissuspected,medicationshouldbediscontinued.
SpecialNotesonAdministration:ItisrecommendedthatDiane35
tabletsbetakenatthesametimeeachday.Irregulartablettaking,
vomitingorintestinalaffectionswithdiarrhea,veryrareindividual
metabolicdisturbancesorprolongedsimultaneoususeofcertain
medicalpreparationscanaffectthecontraceptiveaction(see
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Precautions,DrugInteractions).
Ifspottingorbreakthroughbleedingoccursduringthe3weeksin
whichDiane35isbeingtaken,thepatientisinstructedtocontinue
takingthemedication.Thistypeofbleedingusuallyistransientand
withoutsignificance.However,ifthebleedingispersistentor
prolonged,thepatientisadvisedtoconsultherphysician.
Inexceptionalcases,menstruationmayfailtooccurduringthe7
daytabletfreeinterval.Thepatientisadvisednottoresumetablet
takingandtoconsultherphysician.
Althoughtheoccurrenceofpregnancyishighlyunlikelyifthe
tabletsaretakenaccordingtodirections,thepossibilityof
pregnancyshouldberuledoutbeforecontinuingtreatmentwith
Diane35inpatientswhohavemissedaperiodofwithdrawal
bleeding.Thepatientshouldconsultherphysicianand,inthe
meantime,asupplementarynonhormonalmethodofcontraception
shouldbeemployed.
Ifthepatientforgetstotakeatabletattheusualtime,thetabletmay
betakenwithinthenext12hours.Ifmorethan12hourshave
elapsedfromthetimeofusualadministration,thepatientmust
discardthemissedtabletandcontinuetotaketheremainingtablets
inthepackattheusualtimeinordertoavoidapremature
withdrawalbleedingduringthiscycle.Asupplementary
nonhormonalmethodofcontraceptionmustbeemployeduntilthe
packisemptytopreventpregnancywhichwouldnecessitate
immediatediscontinuationofDiane35treatment.
UseoftheBlisterPack:Thepatientshouldbeinstructedtotakethe
firsttabletfromtheblisterpackoutofthesectionmarkedwiththe
correspondingdayoftheweek(forexample"MO"forMonday),
andswallowitwholewithsomeliquid.Thepatientshouldbe
instructedtotakethetabletatthesametimeeachday.

AvailabilityAndStorage:Eachbeige,round,biconvex,sugarcoated

tabletcontains:cyproteroneacetate2mgandethinylestradiol0.035
mg.Nonmedicinalingredients:cornstarch,lactose,magnesium
stearate,povidoneandtalctabletcoating:calciumcarbonate,ferric
oxideyellow,glycerol,polyethyleneglycol,povidone,sucrose,talc,
titaniumdioxideandwax.Blisterpackunitsof21.Storeatroom
temperature(15to25C).

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