o New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

Transcription

1 MEDICATION GUIDE FLUOXETINE CAPSULES, USP (fl xʹ e teen) 10 mg and 20 mg Read the Medicatin Guide that cmes with fluxetine capsules befre yu start taking it and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r treatment. Talk with yur healthcare prvider if there is smething yu d nt understand r yu want t learn mre abut. Fluxetine capsules are in a class f drugs called selective sertnin reuptake inhibitrs (SSRIs), which are ften used fr the treatment f depressin and anxiety disrders. Althugh fluxetine capsules are nt a treatment fr depressin, it cntains fluxetine hydrchlride, the same active ingredient in sme antidepressants. What is the mst imprtant infrmatin I shuld knw abut fluxetine capsules? Fluxetine capsules and ther antidepressant medicines may cause serius side effects including: 1. Suicidal thughts r actins: Fluxetine capsules and ther antidepressant medicines may increase suicidal thughts r actins in sme children, teenagers, r yung adults within the first few mnths f treatment r when the dse is changed. Depressin r ther serius mental illnesses are the mst imprtant causes f suicidal thughts r actins. Watch fr these changes and call yur healthcare prvider right away if yu ntice: New r sudden changes in md, behavir, actins, thughts, r feelings, especially if severe. Pay particular attentin t such changes when fluxetine capsules are started r when the dse is changed. Keep all fllw-up visits with yur healthcare prvider and call between visits if yu are wrried abut symptms. Call yur healthcare prvider right away if yu have any f the fllwing symptms, r call 911 if an emergency, especially if they are new, wrse, r wrry yu: attempts t cmmit suicide acting n dangerus impulses acting aggressive r vilent thughts abut suicide r dying new r wrse depressin new r wrse anxiety r panic attacks feeling agitated, restless, angry r irritable truble sleeping an increase in activity r talking mre than what is nrmal fr yu ther unusual changes in behavir r md Call yur healthcare prvider right away if yu have any f the fllwing symptms, r call 911 if an emergency. Fluxetine capsules may be assciated with these serius side effects: 2. Sertnin Syndrme. This cnditin can be life-threatening and may include: agitatin, hallucinatins, cma r ther changes in mental status

2 crdinatin prblems r muscle twitching (veractive reflexes) racing heartbeat, high r lw bld pressure sweating r fever nausea, vmiting, r diarrhea muscle rigidity dizziness flushing tremr seizures 3. Severe allergic reactins: truble breathing swelling f the face, tngue, eyes r muth rash, itchy welts (hives) r blisters, alne r with fever r jint pain 4. Manic episdes: greatly increased energy severe truble sleeping racing thughts reckless behavir unusually grand ideas excessive happiness r irritability talking mre r faster than usual 5. Seizures r cnvulsins 6. Changes in appetite r weight. Children and adlescents shuld have height and weight mnitred during treatment. 7. Abnrmal bleeding: Fluxetine capsules and ther antidepressant medicines may increase yur risk f bleeding r bruising, especially if yu take the bld thinner warfarin (Cumadin *, Jantven * ), a nnsteridal anti-inflammatry drug (NSAID s, like ibuprfen r naprxen), r aspirin. 8. Visual Prblems eye pain changes in visin swelling r redness in r arund the eye Only sme peple are at risk fr these prblems. Yu may want t underg an eye examinatin t see if yu are at risk and receive preventative treatment if yu are. 9. Lw salt (sdium) levels in the bld. Elderly peple may be at greater risk fr this. Symptms may include: headache weakness r feeling unsteady cnfusin, prblems cncentrating r thinking r memry prblems D nt stp fluxetine capsules withut first talking t yur healthcare prvider. Stpping fluxetine capsules t quickly may cause serius symptms including:

3 anxiety, irritability, high r lw md, feeling restless r changes in sleep habits headache, sweating, nausea, dizziness electric shck-like sensatins, shaking, cnfusin What are fluxetine capsules? Fluxetine capsules are a prescriptin medicine used t treat premenstrual dysphric disrder (PMDD). It is nt knwn if fluxetine capsules are safe and effective in children. Talk with yur healthcare prvider if yu d nt think that yur cnditin is getting better with fluxetine capsules treatment. Wh shuld nt take fluxetine capsules? D nt take fluxetine capsules if yu: take a Mnamine Oxidase Inhibitr (MAOI). Ask yur healthcare prvider r pharmacist if yu are nt sure if yu take an MAOI, including the antibitic linezlid. D nt take an MAOI within 5 weeks f stpping fluxetine capsules unless directed t d s by yur healthcare prvider. D nt start fluxetine capsules if yu stpped taking an MAOI in the last 2 weeks unless directed t d s by yur healthcare prvider. Wmen wh take fluxetine capsules clse in time t an MAOI may have serius r even lifethreatening side effects. Get medical help right away if yu have any f these symptms: high fever uncntrlled muscle spasms stiff muscles rapid changes in heart rate r bld pressure cnfusin lss f cnsciusness (pass ut) take Mellaril * (thiridazine). D nt take Mellaril * within 5 weeks f stpping fluxetine capsules because this can cause serius heart rhythm prblems r sudden death. take the antipsychtic medicine pimzide (Orap * ) because this can cause serius heart prblems. What shuld I tell my healthcare prvider befre taking fluxetine capsules? Ask if yu are nt sure. Befre starting fluxetine capsules, tell yur healthcare prvider if yu: Are taking certain drugs r treatments such as: Triptans used t treat migraine headache Medicines used t treat md, anxiety, psychtic r thught disrders, including tricyclics, lithium, buspirne, SSRIs, SNRIs, MAOIs r antipsychtics Tramadl and fentanyl Over-the-cunter supplements such as tryptphan r St. Jhn s Wrt Electrcnvulsive therapy (ECT) have liver prblems have kidney prblems have heart prblems have r had seizures r cnvulsins have biplar disrder r mania have lw sdium levels in yur bld have a histry f a strke

4 have high bld pressure have r had bleeding prblems are pregnant r plan t becme pregnant. It is nt knwn if fluxetine capsules will harm yur unbrn baby. are breastfeeding r plan t breastfeed. Sme fluxetine may pass int yur breast milk. Talk t yur healthcare prvider abut the best way t feed yur baby while taking fluxetine capsules. Tell yur healthcare prvider abut all the medicines that yu take, including prescriptin and nnprescriptin medicines, vitamins, and herbal supplements. Fluxetine capsules and sme medicines may interact with each ther, may nt wrk as well, r may cause serius side effects. Yur healthcare prvider r pharmacist can tell yu if it is safe t take fluxetine capsules with yur ther medicines. D nt start r stp any medicine while taking fluxetine capsules withut talking t yur healthcare prvider first. If yu take fluxetine capsules, yu shuld nt take any ther medicines that cntain fluxetine hydrchlride: Symbyax * Przac * Przac * Weekly Hw shuld I take fluxetine capsules? What shuld I avid while taking fluxetine capsules? Fluxetine capsules can cause sleepiness r may affect yur ability t make decisins, think clearly, r react quickly. Yu shuld nt drive, perate heavy machinery, r d ther dangerus activities until yu knw hw fluxetine capsules affects yu. D nt drink alchl while using fluxetine capsules. What are the pssible side effects f fluxetine capsules? Fluxetine capsules may cause serius side effects, including: Take fluxetine capsules exactly as prescribed. Yur healthcare prvider may need t change the dse f fluxetine until it is the right dse fr yu. Talk t yur healthcare prvider if yur symptms d nt get better. Fluxetine capsules may be taken with r withut fd. If yu take t much fluxetine, call yur healthcare prvider r g t the nearest hspital emergency rm right away. See What is the mst imprtant infrmatin I shuld knw abut fluxetine capsules? Prblems with bld sugar cntrl. Wmen wh have diabetes and take fluxetine capsules may have prblems with lw bld sugar while taking fluxetine capsules. High bld sugar can happen when fluxetine capsules are stpped. Yur healthcare prvider may need t change the dse f yur diabetes medicines when yu start r stp taking fluxetine capsules. Feeling anxius r truble sleeping The mst cmmn side effects f fluxetine capsules include: headache weakness (asthenia) pain accidental injury truble sleeping (insmnia) dizziness feeling anxius r nervus thinking differently

5 infectin flu symptms nausea diarrhea sexual prblems runny r stuffy nse (rhinitis) sre thrat (pharyngitis) Tell yur healthcare prvider if yu have any side effect that bthers yu r that des nt g away. These are nt all the pssible side effects f fluxetine capsules. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre fluxetine capsules? Stre at 20 t 25 C (68 t 77 F). Prtect frm light. Keep fluxetine capsules and all medicines ut f the reach f children. General infrmatin abut fluxetine capsules Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use fluxetine capsules fr a cnditin fr which it was nt prescribed. D nt give fluxetine capsules t ther peple, even if they have the same cnditin. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut fluxetine capsules. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu may ask yur healthcare prvider r pharmacist fr infrmatin abut fluxetine capsules that is written fr healthcare prfessinals. Fr mre infrmatin abut fluxetine capsules call Mylan Pharmaceuticals Inc. at ( INFO- RX). What are the ingredients in fluxetine capsules? Active ingredient: fluxetine hydrchlride, USP Inactive ingredients: cllidal silicn dixide, magnesium stearate, pregelatinized starch (crn), and sdium lauryl sulfate. In additin, each f the empty gelatin capsules cntain the fllwing: 10 mg - FD&C Blue N. 1, FD&C Green N. 3, FD&C Yellw N. 6, gelatin, and titanium dixide 20 mg - FD&C Red N. 40, gelatin, and titanium dixide. The imprinting ink cntains the fllwing: black irn xide, D&C Yellw N. 10 Aluminum Lake, FD&C Blue N. 1 Aluminum Lake, FD&C Blue N. 2 Aluminum Lake, FD&C Red N. 40 Aluminum Lake, prpylene glycl and shellac glaze. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. * The brands listed are trademarks f their respective wners. Mylan Pharmaceuticals Inc. Mrgantwn, WV U.S.A. REVISED MARCH 2016 FLUXPD:R6