Suicidal thoughts or actions:

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1 MEDICATION GUIDE Venlafaxine (VEN la fax een) Hydrchlride Extended-release Capsules USP Read the Medicatin Guide that cmes with venlafaxine hydrchlride extended-release capsulesbefre yu start taking them 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 want t learn mre abut. What is the mst imprtant infrmatin I shuld knw abut venlafaxine hydrchlride extended-release capsules? Venlafaxine hydrchlride extended-release capsulesand ther antidepressant medicines may cause serius side effects, including: 1. Suicidal thughts r actins: Venlafaxine hydrchlride extended-release 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 venlafaxine hydrchlride extended-release capsulesare 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 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.

2 Call yur healthcare prvider right away if yu have any f the fllwing symptms, r call 911 if an emergency. Venlafaxine hydrchlride extended-release capsules may be assciated with these serius side effects: Sertnin Syndrme This cnditin can be life-threatening and may include: agitatin, hallucinatins, cma r ther changes in mental status crdinatin prblems r muscle twitching (veractive reflexes) racing heartbeat, high r lw bld pressure sweating r fever nausea, vmiting, r diarrhea muscle rigidity Changes in bld pressure. Venlafaxine hydrchlride extended-release capsules may: increase yur bld pressure. Cntrl high bld pressure befre starting treatment and mnitr bld pressure regularly Enlarged pupils (mydriasis). Anxiety and insmnia. Changes in appetite r weight. Manic/hypmanic episdes: greatly increased energy severe truble sleeping racing thughts reckless behavir unusually grand ideas excessive happiness r irritability talking mre r faster than usual 8. 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 9. Seizures r cnvulsins. 10. Abnrmal bleeding: Venlafaxine hydrchlride extended-release capsulesand ther antidepressant medicines may increase yur risk f bleeding r bruising, especially if yu take the bld thinner warfarin (Cumadin, Jantven ), a nn-steridal anti-inflammatry drug (NSAIDs, like ibuprfen r naprxen), r aspirin. 11. Elevated chlesterl. 12.

3 Lung disease and pneumnia: Venlafaxine hydrchlride extended-release capsulesmay cause rare lung prblems. Symptms include: wrsening shrtness f breath cugh chest discmfrt 13. 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. D nt stp venlafaxine hydrchlride extended-release capsules withut first talking t yur healthcare prvider. Stpping venlafaxine hydrchlride extended-release capsulest quickly r changing frm anther antidepressant t quickly may cause serius symptms including: anxiety, irritability feeling tired, restless r prblems sleeping headache, sweating, dizziness electric shck-like sensatins, shaking, cnfusin, nightmares vmiting, nausea, diarrhea What are venlafaxine hydrchlride extended-release capsules? Venlafaxine hydrchlride extended-release capsulesare a prescriptin medicine used t treat depressin. It is imprtant t talk with yur healthcare prvider abut the risks f treating depressin and als the risks f nt treating it. Yu shuld discuss all treatment chices with yur healthcare prvider. Venlafaxine hydrchlrideextended-release capsulesare als used t treat: Panic Disrder (PD) Talk t yur healthcare prvider if yu d nt think that yur cnditin is getting better with venlafaxinehydrchlride extended-release capsuletreatment. Wh shuld nt take venlafaxine hydrchlride extended-release capsules? D nt take venlafaxine hydrchlride extended-release capsulesif yu: are allergic t venlafaxine hydrchlride extended-release capsulesr any f the ingredients in venlafaxine hydrchlride extended-release capsules. See the end f this Medicatin Guide fr a cmplete list f ingredients in venlafaxine hydrchlride extended-release capsules. have uncntrlled angle-clsure glaucma 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 7 days f stpping venlafaxine hydrchlride extended-release capsules unless directed t d s by yur physician. D nt start venlafaxine hydrchlride extended-release capsules if yu stpped taking an MAOI in the last 2 weeks unless directed t d s by yur physician.

4 Peple wh take venlafaxine hydrchlride extended-release capsules clse in time t an MAOI may have serius r even life-threatening 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) What shuld I tell my healthcare prvider befre taking venlafaxine hydrchlride extended-release capsules? Ask if yu are nt sure. Befre starting venlafaxine hydrchlride extended-release capsules, tell yur healthcare prvider if yu: Are taking certain drugs such as: Medicines used t treat migraine headaches such as: triptans Medicines used t treat md, anxiety, psychtic r thught disrders, such as: tricyclic antidepressants lithium SSRIs SNRIs antipsychtic drugs Medicines used t treat pain such as: tramadl Medicines used t thin yur bld such as: warfarin Medicines used t treat heartburn such as: Cimetidine Over-the-cunter medicines r supplements such as: Aspirin r ther NSAIDs Tryptphan St. Jhn s Wrt

5 have heart prblems have diabetes have liver prblems have kidney prblems have thyrid prblems have r had seizures r cnvulsins have biplar disrder r mania have lw sdium levels in yur bld have high bld pressure have high chlesterl have r had bleeding prblems are pregnant r plan t becme pregnant. It is nt knwn if venlafaxine hydrchlride extended-release capsules will harm yur unbrn baby. Talk t yur healthcareprvider abut the benefits and risks f treating depressin during pregnancy are breast-feeding r plan t breast-feed. Sme venlafaxine hydrchlride may pass int yur breast milk. Talk t yur healthcare prvider abut the best way t feed yur baby while taking venlafaxine hydrchlride extended-release capsules. Tell yur healthcare prvider abut all the medicines that yu take, including prescriptin and nnprescriptin medicines, vitamins, and herbal supplements. Venlafaxine hydrchlride extended-release 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 venlafaxine hydrchlride extendedrelease capsules with yur ther medicines. D nt start r stp any medicine while taking venlafaxine hydrchlride extended-release capsules withut talking t yur healthcare prvider first. If yu take venlafaxine hydrchlride extended-release capsules, yu shuld nt take any ther medicines that cntain (venlafaxine) including: venlafaxine HCl. Hw shuld I take venlafaxine hydrchlride extended-release capsules? Take venlafaxine hydrchlride extended-release capsules exactly as prescribed. Yur healthcare prvider may need t change the dse f venlafaxine hydrchlride extended-release capsules until it is the right dse fr yu. Venlafaxine hydrchlride extended-release capsules are t be taken with fd. If yu miss a dse f venlafaxine hydrchlride extended-release capsules, take the missed dse as sn as yu remember. If it is almst time fr the next dse, skip the missed dse and take yur next dse at the regular time. D nt take tw dses f venlafaxine hydrchlride extended-release capsules at the same time. If yu take t many venlafaxine hydrchlride extended-release capsules, call yur healthcare prvider r pisn cntrl center right away, r get emergency treatment. When switching frm anther antidepressant t venlafaxine hydrchlride extended-release capsules yur dctr may want t lwer the dse f the initial antidepressant first t avid side effects What shuld I avid while taking venlafaxine hydrchlride extended-release capsules? Venlafaxine hydrchlride extended-release 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

6 activities until yu knw hw venlafaxine hydrchlride extended-release capsules affect yu. D nt drink alchl while using venlafaxine hydrchlride extended-release capsules. What are the pssible side effects f venlafaxine hydrchlride extended-release capsules? Venlafaxine hydrchlride extended-release capsules may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut venlafaxine hydrchlride extendedrelease capsules? Increased chlesterl- have yur chlesterl checked regularly Newbrns whse mthers take venlafaxine hydrchlride extended-release capsules in the third trimester may have prblems right after birth including: prblems feeding and breathing seizures shaking, jitteriness r cnstant crying Angle-clsure glaucma Cmmn pssible side effects in peple wh take venlafaxine hydrchlride extended-release capsules include: unusual dreams sexual prblems lss f appetite, cnstipatin, diarrhea, nausea r vmiting, r dry muth feeling tired, fatigued r verly sleepy change in sleep habits, prblems sleeping yawning tremr r shaking dizziness, blurred visin sweating feeling anxius, nervus r jittery headache increase in heart rate 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 venlafaxine hydrchlride extended-release capsules. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT FDA Hw shuld I stre venlafaxine hydrchlride extended-release capsules? Stre venlafaxine hydrchlride extended-release capsules at rm temperature between 68 F and 77 F (20 C t 25 C). Keep venlafaxine hydrchlride extended-release capsules in a dry place. Keep venlafaxine hydrchlride extended-release capsules and all medicines ut f the reach f children. General infrmatin abut venlafaxine hydrchlride extended-release capsules

7 Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use venlafaxine hydrchlride extended-release capsules fr a cnditin fr which they were nt prescribed. D nt give venlafaxine hydrchlride extended-release capsules t ther peple, even if they have the same cnditin. They may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut venlafaxine hydrchlride extended-release capsules. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu may ask yur healthcare prvider r pharmacist fr infrmatin abut venlafaxine hydrchlride extended-release capsules that is written fr healthcare prfessinals. Fr mre infrmatin abut venlafaxine hydrchlride extended-release capsules call What are the ingredients in venlafaxine hydrchlride extended-release capsules USP? Active ingredient: venlafaxine hydrchlride, USP. Inactive ingredients: black irn xide, dibutyl sebacate, ethylcellulse, gelatin, plyethylene glycl, pvidne, prpylene glycl, shellac, sugar spheres (which cntain sucrse and crn starch), sunset yellw FCF FD&C yellw 6, talc, and titanium dixide. The 37.5 mg capsules als cntain D&C yellw 10 and ptassium hydrxide, the 75 mg capsules als cntain D&C yellw 10 and may cntain ptassium hydrxide, and the 150 mg capsules als cntain ptassium hydrxide. All brand names listed are the registered trademarks f their respective wners and are nt trademarks f Teva Pharmaceuticals USA, Inc. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin fr all antidepressants. Manufactured Fr: TEVA PHARMACEUTICALS USA, INC. Nrth Wales, PA Rev. D 12/2014

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