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Healthcare providers should inform patientstheir familiesand their caregivers about the benefits and risks associated with treatment with SARAFEM and should counsel them in its appropriate useHealthcare providers should instruct patientstheir familiesand their caregivers to read the Medication Guide and should assist them in understanding its contentsPatients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Neonates exposed to fluoxetine and other SSRIs or serotonin and norepinephrine reuptake inhibitorsSNRIslate in the third trimester have developed complications requiring prolonged hospitalizationrespiratory supportand tube feedingSuch complications can arise immediately upon deliveryReported clinical findings have included respiratory distresscyanosisapneaseizurestemperature instabilityfeeding difficultyvomitinghypoglycemiahypotoniahypertoniahyperreflexiatremorjitterinessirritabilityand constant cryingThese features are consistent with either a direct toxic effect of SSRIs and SNRIs orpossiblya drug discontinuation syndromeIt should be noted thatin some casesthe clinical picture is consistent with serotonin syndromesee WARNINGS AND PRECAUTIONS

Report any new or worsening symptoms to your doctorsuch asmood or behavior changesanxietypanic attackstrouble sleepingor if you feel impulsiveirritableagitatedhostileaggressiverestlesshyperactivementally or physicallymore depressedor have thoughts about suicide or hurting yourself.

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