MEDICATION GUIDE VIMOVO (vi-mh-vh) (naprxen and esmeprazle magnesium) Delayed Release Tablets Read this Medicatin Guide befre yu start taking VIMOVO and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking with yur healthcare prvider abut yur medical cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut VIMOVO? VIMOVO, which cntains naprxen [a nnsteridal anti-inflammatry drug (NSAID)] and esmeprazle magnesium, may increase the chance f a heart attack r strke that can lead t death. This chance increases: with lnger use f NSAID medicines in peple wh have heart disease NSAID-cntaining medicines, such as VIMOVO, shuld never be used right befre r after a heart surgery called a crnary artery bypass graft (CABG). NSAID-cntaining medicines, such as VIMOVO, can cause ulcers and bleeding in the stmach and intestines at any time during treatment. Ulcers and bleeding: can happen withut warning symptms may cause death The chance f a persn getting an ulcer r bleeding increases with: taking medicines called sterid hrmnes (crticsterids) and bld thinners (anticagulants) lnger use smking drinking alchl lder age having pr health NSAID medicines shuld nly be used: exactly as prescribed at the lwest dse pssible fr yur treatment fr the shrtest time needed What are Nn-Steridal Anti-Inflammatry Drugs (NSAIDs)? NSAID medicines are used t treat pain and redness, swelling, and heat (inflammatin) frm medical cnditins such as: different types f arthritis menstrual cramps and ther types f shrt-term pain Wh shuld nt take a Nn Steridal Anti Inflammatry Drug (NSAID)? D nt take an NSAID medicine: 35
if yu had an asthma attack, hives, r ther allergic reactin with aspirin r any ther NSAID medicine fr pain right befre r after heart bypass surgery Tell yur healthcare prvider: abut all f yur medical cnditins abut all f the medicines yu take. NSAIDs and sme ther medicines can interact with each ther and cause serius side effects. Keep a list f yur medicines t shw t yur healthcare prvider and pharmacist. if yu are pregnant. NSAID medicines shuld nt be used by pregnant wmen late in their pregnancy. if yu are breastfeeding. Talk t yur healthcare prvider. What are the pssible side effects f Nn Steridal Anti Inflammatry Drugs (NSAIDs)? Serius side effects include: heart attack strke high bld pressure heart failure frm bdy swelling (fluid retentin) kidney prblems including kidney failure bleeding and ulcers in the stmach and intestine lw red bld cells (anemia) life-threatening skin reactins life-threatening allergic reactins liver prblems including liver failure asthma attacks in peple wh have asthma Other side effects include: stmach pain cnstipatin diarrhea gas heartburn nausea vmiting dizziness Get emergency help right away if yu have any f the fllwing symptms: shrtness f breath r slurred speech truble breathing swelling f the face r chest pain thrat weakness in ne part r side f yur bdy Stp yur NSAID medicine and call yur healthcare prvider right away if yu have any f the fllwing symptms: nausea mre tired r weaker there is bld in yur than usual bwel mvement r it is itching black and sticky like tar yur skin r eyes lk skin rash r blisters with yellw fever stmach pain unusual weight gain flu-like symptms swelling f the arms and vmit bld legs, hands and feet 36
These are nt all f the pssible side effects with NSAID medicines. Talk t yur healthcare prvider r pharmacist fr mre infrmatin abut NSAID medicines. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at 1-800-FDA-1088. Other infrmatin abut Nn Steridal Anti Inflammatry Drugs (NSAIDs) Aspirin is an NSAID medicine but it des nt increase the chance f a heart attack. Aspirin can cause bleeding in the brain, stmach, and intestines. Aspirin can als cause ulcers in the stmach and intestines. Sme f these NSAID medicines are sld in lwer dses withut a prescriptin (ver-the-cunter). Talk t yur healthcare prvider befre using ver-the-cunter NSAIDs fr mre than 10 days. NSAID medicines that need a prescriptin Generic Name Celecxib Diclfenac Diflunisal Etdlac Fenprfen Nalfn, Nalfn 200 Flurbiprfen Ansaid TRADENAME Celebrex Cataflam, Vltaren, Arthrtec (cmbined with misprstl) Vltaren Dlbid Ldine, Ldine XL Ibuprfen Mtrin, Tab-Prfen, Vicprfen* (cmbined with hydrcdne), Cmbunx (cmbined with xycdne) Indmethacin Indcin, Indcin SR, Ind-Lemmn, Indmethagan Ketprfen Oruvail Ketrlac Tradl Mefenamic Pnstel Acid Melxicam Mbic Nabumetne Relafen Naprxen Naprsyn, Anaprx, Anaprx DS, EC-Naprsyn, Naprelan, VIMOVO Oxaprzin Daypr Pirxicam Feldene Sulindac Clinril Tlmetin Tlectin, Tlectin DS, Tlectin 600 * Vicprfen cntains the same dse f ibuprfen as ver-the-cunter (OTC) NSAIDs, and is usually used fr less than 10 days t treat pain. The OTC NSAID label warns that lng-term cntinuus use may increase the risk f heart attack r strke. What ther imprtant infrmatin shuld I knw abut VIMOVO? VIMOVO may help yur acid-related symptms, but yu culd still have serius stmach prblems. Talk with yur healthcare prvider. VIMOVO can cause ther serius side effects, including: 37
Diarrhea. VIMOVO may increase yur risk f getting severe diarrhea. This diarrhea may be caused by an infectin (Clstridium difficile) in yur intestines. Call yur healthcare prvider right away if yu have watery stl, stmach pain, and fever that des nt g away. Bne fractures. Peple wh take multiple daily dses f prtn pump inhibitr medicines fr a lng perid f time (a year r lnger) may have an increased risk f fractures f the hip, wrist, r spine. Yu shuld take VIMOVO exactly as prescribed, at the lwest dse pssible fr yur treatment and fr the shrtest time needed. Talk t yur healthcare prvider abut yur risk f bne fracture if yu take VIMOVO. VIMOVO can have ther serius side effects. See What is the mst imprtant infrmatin I shuld knw abut VIMOVO? and What are the pssible side effects f VIMOVO? What is VIMOVO? VIMOVO cntains 2 medicines: naprxen, a nn-steridal anti-inflammatry drug (NSAID) and esmeprazle magnesium, a prtn pump inhibitr (PPI). VIMOVO is a prescriptin medicine used t: relieve signs and symptms f stearthritis, rheumatid arthritis, and ankylsing spndylitis decrease the risk f develping stmach (gastric) ulcers in peple wh are at risk f develping gastric ulcers with NSAIDs It is nt knwn if VIMOVO is safe r effective in children under the age f 18. Wh shuld nt take VIMOVO? D nt take VIMOVO: If yu had an asthma attack, hives, r ther allergic reactin after taking aspirin r ther NSAID medicine. If yu are allergic t any f the ingredients in VIMOVO. See the end f this leaflet fr a cmplete list f ingredients in VIMOVO. If yu are allergic t any ther Prtn Pump Inhibitr (PPI) medicine. Fr pain right befre r after heart bypass surgery If yu are in the late stages f pregnancy (third trimester) What shuld I tell my healthcare prvider befre taking VIMOVO? Befre yu take VIMOVO, tell yur healthcare prvider abut all yur medical cnditins, including if yu: have been tld that yu have lw magnesium levels in yur bld have liver r kidney prblems have ulcerative clitis r Crhn s disease (inflammatry bwel disease r IBD) have any ther medical cnditins are pregnant r plan t becme pregnant. See What is the mst imprtant infrmatin I shuld knw abut VIMOVO? are breastfeeding r plan t breastfeed. VIMOVO can pass int yur milk and may harm yur baby. Yu shuld nt breastfeed while taking VIMOVO. Talk t yur healthcare prvider abut the best way t feed yur baby if yu take VIMOVO. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal 38
supplements. Since VIMOVO cntains naprxen, talk t yur healthcare prvider befre taking any ther NSAID-cntaining prducts. Taking VIMOVO with ther medicines can cause serius side effects. VIMOVO may affect the way ther medicines wrk, and ther medicines may affect hw VIMOVO wrks. Especially tell yur healthcare prvider if yu take: sterid hrmnes (crticsterids) St. Jhn s Wrt rifampin (Rifater, Rifamate, Rimactane, Rifadin) a medicine fr high bld pressure r heart prblems aspirin chlestyramine (Questran, Questran Light, Lchlest, Lchlest Light, Prevalite) cyclsprine (Gengraf, Neral, Sandimmune) r tacrlimus (Prgraf) a water pill (diuretic) lithium carbnate methtrexate a bld thinner medicine an antidepressant medicine atazanavir (Reyataz) ketcnazle (Nizral) prducts that cntain irn digxin (Lanxin) erltinib (Tarceva) clpidgrel (Plavix) Ask yur healthcare prvider r pharmacist fr a list f these medicines if yu are nt sure. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider r pharmacist when yu get a new medicine. Hw shuld I take VIMOVO? Take VIMOVO exactly as yur healthcare prvider tells yu t take it. Yur healthcare prvider may tell yu t take Vitamin D and Calcium supplements during treatment with VIMOVO. Yur healthcare prvider will tell yu hw many VIMOVO t take and when t take them. D nt change yur dse r stp VIMOVO withut first talking t yur healthcare prvider. Take VIMOVO at least 30 minutes befre a meal. Swallw VIMOVO tablets whle with liquid. D nt split, chew, crush r disslve the VIMOVO tablet. Tell yur healthcare prvider if yu cannt swallw the tablet whle. Yu may need a different medicine. Yu may use antacids while taking VIMOVO. If yu frget t take a dse f VIMOVO, take it as sn as yu remember. If it is almst time fr yur next dse, d nt take the missed dse. Take the next dse n time. D nt take 2 dses at ne time t make up fr a missed dse. 39
If yu take t much VIMOVO, tell yur healthcare prvider r g t the clsest hspital emergency rm right away. Symptms that yu have taken t much VIMOVO may include: feeling weak and tired dizziness vmiting feeling sleepy bleeding upper stmach-area mvements f a bdy pain r discmfrt part that yu cannt heartburn, cntrl indigestin, r nausea crdinatin prblems a change in breathing and decreased mvement r yu stp breathing If yu take mre VIMOVO than yur healthcare prvider prescribes, call yur Pisn Cntrl Center at 1-800-222-1222. Yur healthcare prvider may d certain tests frm time t time t check yu fr side effect f VIMOVO. What shuld I avid while taking VIMOVO? VIMOVO can cause drwsiness, dizziness, r depressin. Yu shuld nt drive r d ther activities that require yu t be alert until yu knw hw VIMOVO affects yu. What are the pssible side effects f VIMOVO? VIMOVO may cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut VIMOVO? High bld pressure. Heart prblems such as cngestive heart failure. Tell yur healthcare prvider abut any swelling f yur bdy, hands r feet, sudden weight gain r truble breathing. Active bleeding. Tell yur healthcare prvider if yu have signs f active bleeding including: passing black sticky bwel mvements (stls) having bldy diarrhea vmiting r cughing up bld r dark particles that lk like cffee grunds Serius allergic reactins. Tell yur healthcare prvider r get medical help right away if yu develp sudden wheezing, swelling f yur lips, tngue, thrat r bdy, rash, fainting r prblems breathing r swallwing (severe allergic reactin). Serius skin reactins. Tell yur healthcare prvider r get medical help right away if yu develp: reddening f yur skin with blisters r peeling blisters and bleeding f yur lips, eye lids, muth, nse, and genitals. Liver prblems. Tell yur healthcare prvider if yu develp: 40
yellwing f the skin r the whites f yur nausea eyes right upper stmach area dark urine (abdmen) pain feel tired flu-like symptms Chrnic (lasting a lng time) inflammatin f the stmach lining (Atrphic Gastritis). Using VIMOVO fr a lng perid f time may increase the risk f inflammatin t yur stmach lining. Yu may r may nt have symptms. Tell yur dctr if yu have stmach pain, nausea, vmiting, r weight lss. Lw magnesium levels in yur bdy. This prblem can be serius. Lw magnesium can happen in sme peple wh take a prtn pump inhibitr medicine fr at least 3 mnths. If lw magnesium levels happen, it is usually after a year f treatment. Yu may r may nt have symptms f lw magnesium. Tell yur dctr right away if yu have any f these symptms: seizures dizziness abnrmal r fast heart beat jitteriness jerking mvements r shaking (tremrs) muscle weakness spasms f the hands and feet cramps r muscle aches spasm f the vice bx Yur dctr may check the level f magnesium in yur bdy befre yu start taking VIMOVO, during treatment, r if yu will be taking VIMOVO fr a lng perid f time. The mst cmmn side effects f VIMOVO include: inflammatin f the lining f the stmach, with r withut lss f the prtective layer f the stmach (ersive gastritis) indigestin diarrhea stmach ulcers upper stmach-area (abdminal) pain nausea 41
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 VIMOVO. 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 1-800-FDA-1088. Hw shuld I stre VIMOVO? Stre VIMOVO at rm temperature between 68 F t 77 F (20 C t 25 C) Keep VIMOVO in the riginal cntainer and keep the bttle tightly clsed. Keep VIMOVO dry. Keep VIMOVO and all medicines ut f the reach f children. General infrmatin abut VIMOVO Medicines are smetimes prescribed fr purpses ther than thse listed in this Medicatin Guide. D nt use VIMOVO fr a cnditin fr which it was nt prescribed. D nt give VIMOVO t ther peple, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut VIMOVO. If yu wuld like mre infrmatin, ask yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin that is written fr healthcare prfessinals. Fr mre infrmatin, call 1-866-479-6742 r g t www.vimovo.cm What are the ingredients in VIMOVO? Active ingredients: naprxen and esmeprazle magnesium Inactive ingredients: carnauba wax, cllidal silicn dixide, crscarmellse sdium, irn xide yellw, glyceryl mnstearate, hyprmellse, irn xide black, magnesium stearate, methacrylic acid cplymer dispersin, methylparaben, plysrbate 80, plydextrse, plyethylene glycl, pvidne, prpylene glycl, prpylparaben, titanium dixide, and triethyl citrate. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Distributed by: Hrizn Pharma USA, Inc., Deerfield, IL 60015 Revised 02/2014 VIMOVO is a trademark f the AstraZeneca grup f cmpanies. The VIMOVO trademark has been licensed t Hrizn Pharma fr use in the US. Other trademarks are the prperty f AstraZeneca respective cmpanies. 42