National Geographic : 2004 May
Patient Information LEVITRA® (Luh-VEE-Trah) (vardenafil HCI) Tablets 086690341P 8/03 Read the Patient Informationabout LEVITRAbefore you start taking It and again each time you get a refill.There may be new information. Youmay also findit helpfulto share this information withyour partner. This leafletdoes not take the placeoftalkingwithyour doctor. Youand your doctor should talkabout LEVITRA when you start taking it and at regular checkups. Ifyou do not understand the information, or have questions, talk withyour doctor or pharmacist. WHATIMPORTANT INFORMATION SHOULDYOUKNOWABOUTLEVITRA? LEVITRA can cause your blood pressure to drop suddenly to an unsafe level If It Is taken with certain other medicines. Witha sudden drop in blood pressure, youcouldget dizzy,faint, or havea heart attackor stroke. Do nottakeLEITRA if you: * takeanymedicinescalled"nitrates." * use recreationaldrugscalled"poppers"likeamylnitrateand butylnitrate. * takemedicinescalledalpha-blockers. (See "Who Should NotTake LEVITRA?") Tell all your healthcare providers that you take LEVITRA.If you need emergency medical care for a heart problem,it willbe important for your healthcare provider to know when you last took LEVITRA. WHATISLEVITRA? LEVITRAis a prescription medicine taken by mouth for the treatment oferectile dysfunction (ED)inmen. EDis a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. LEVITRAmay help a man with EDget and keep an erection when he is sexually excited. LEVITRAdoes not * cureED * Increasea man'ssexualdesire * protecta manor hispartnerfromsexuallytransmitteddiseases,includingHIV. Speakto your doctoraboutwaysto guardagainstsexuallytransmitteddiseases. * serveasa maleform of birth control LEVITRAis only for menwith ED.LEVITRAis not for womenor children. LEVITRAmust beusedonlyundera doctor's care. HOWDOESLEVITRAWORK? When a man is sexually stimulated, his body's normal physical response is to increase blood flow to his penis. This results in an erection. LEVITRAhelps Increase blood flow to the penis and may help men withEDget and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity,blood flow to his penis decreases, and his erection goes away. WHOCANTAKELEVITRA? Talkto your doctor to decide if LEVITRAis right for you. LEVITRAhas been shown to be effectivein men over the age of18 years who have erectile dysfunction, including men with diabetes or who have undergone prostatectomy. WHOSHOULDNOTTAKELEVITRA? Do nottake LEVITRA Ifyoe: *take any medicines called "nitrates" (See "What important information should you know about LEVITRA?").Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm. Medicines called nitrates include nitroglycerin that is foundIntablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called "poppers" also contain nitrates, such as amyl nitrate and butyl nitrate. Donot use LEVITRAIfyou are using these drugs. Askyour doctor or pharmadst ifyou are not sure if any of your medicines are nitrates. Stake medicines called "alpha-blockers." Alpha-blockersare sometimes prescribed for prostate problems or high blood pressure. If LEVITRAis taken withalpha-lockers, your blood pressure could suddenly drop to an unsafe level.Youcould get dizzyand faint. * youhave been told byyour healthcare provider to not have sexual activity because of health problems. Sexualactivitycanput an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. "are allergic to LEVITRAor any of Its Ingredients. Theactive ingredient in LEVITRAis called vardenafil.See the end of this leafletfor a complete 1st of ingredients. WHATSHOULDYOUDISCUSSWITHYOURDOCTORBEFORETAKING LEVITRA? Beforetaking LEVITRA,tell your doctor about all your medical problems, IncludingI you: * have heartproblems such as angina, heart failure,irregular heartbeats, or have had a heart attack. Askyour doctor ifit is safe for you to have sexual activity. * have lowblood pressure or havehigh blood pressure that is not controlled * have had a stroke * or any familymembers have a rare heart condition knownas prolongation ofthe OTinterval(longOTsyndrome) Shaveliver problems * have kidney problems and require dialysis * have retinite pigmentosa, a raregenetic(runs infamilies) eye disease * hae stomach ulcers * have a bleeding problem * have a deformed penis shape or Peyronie's disease * have had an erection that lasted more than 4 hours * have blood cell problems such as sicklecellanemia, multiplemyeloma,or leukemia CANOTHERMEDICATIONS AFFECTLEVITRA? Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. LEVITRAand other medicines may affect each other. Alwayscheck withyour doctor before starting or stopping any medicines. Especiallytell your doctor ifyou take any of the following: * medicines callednitrates(See"Whatimportantinformationshouldyouknow aboutLEVITRA?") * medicinescalledalpha-blockers. TheseincludeHytrinr (terazosin HCI), Flomax (tamsulosinHCI),Cardura®(doxazosinmesylate),Minipress® (prazosinHCI)or Uroxatra (alfuzosinHCI). * medicinesthattreatabnormalheartbeatTheseincludequinidine,procainamide, amiodarone andsotalol. * ritonavir(Norvir®)orindinavirsulfate(Crixivan) * ketoconazole or itraconazole(suchasNizoral®or Sporanox®) *erythromycin Othermedicines ortreatmentsforED HOWSHOULDYOUTAKELEVITRA? TakeLEVITRAexactlyas your doctor prescribes. LEVITRAcomes indifferent doses (2.5 mg, 5 mg, 10 mg, and 20mg). Formost men, therecommended startingdose is 10 mg. TakeLEVITRAno more than once a day. Doses should be takenat least24 hours apart. Some mencan onlytakea lowdose of LEVITRAbecause of medical conditions or medicines theytake. Your doctor willprescribe the dose that is rightfor you. SIfyou areolderthan 65 or have liverproblems, your doctor maystart youon a lowerdose of LEVITRA. *If youare takingcertainothermedicinesyourdoctormayprescribea lower startingdoseandlimityoutoone dose of LEVITRAina 72-hour(3 days)period. Take1 LEVITRAtabletabout 1 hour (60 minutes) before sexualactivity.Some formof sexualstimulationis neededforan erectionto happenwithLEVITRA. LEVITRAmaybe takenwithor withoutmeals. Donot changeyourdose of LEVITRAwithout takllingto your doctor. Yourdoctor may loweryour dose or raiseyourdose, dependingon how yourbodyreactsto LEVITRA. If youtaketoo much LEVITRA, callyourdoctoror emergencyroomrightaway. WHATARETHEPOSSIBLESIDEEFFECTSOFLEVITRA? Themost common side effectswithLEVITRAare headache,flushing,stuffyor runnynose, indigestion,upset stomach, ordizziness.Thesesideeffectsusually go awayaftera fewhours. Callyourdoctor ifyou get a side effectthatbothers you or onethat willnotgo away. LEVITRAmay uncommonly cause: Sanerection that won't go away (priapitm). Ifyou get an erectionthat lasts morethan4 hours, get medicalhelp rightaway.Priapism must be treated as soon as possible or lastingdamage canhappen to your penis Includingthe inabilityto haveerections. *vision changes, such as seeing a bluetinge to objects or havingdifficulty tellingthedifferencebetweenthecolors blueand green. Theseare not all theside effectsof LEVITRA.Formore information,ask your doctor or pharmacist. HOWSHOULDLEVITRABESTORED? * Store LEVITRA at room temperature between59" and 86" F(15" to 30° C). * KeepLEVITRA and all medicines out ofthe reach of children. GENERALINFORMATION ABOUTLEVITRA. Medicinesare sometimes prescribed forconditions other thanthose described inpatientinformationleaflets.Do notuse LEVITRAfor a condition for whichit was not prescribed. Donot giveLEVITRAto other people,eveniftheyhavethe same symptoms that youhave.It mayharm them. Thisleafletsummarizes themost importantinformationabout LEVITRA.Ifyou wouldlikemoreinformation,talkwithyourhealthcare provider.Youcan ask your doctor or pharmacist for Informationabout LEVITRAthat is writtenfor healthprofessionals. Formore informationyoucan also visitwww.LEVITRAcom, or cal1-866-LEVITRA. WHATARETHEINGREDIENTS OFLEVITRA? ActiveIngredientvardenafilhydrochloride InactiveIngredients: microcrystalline cellulose,crospovidone, colloidalsilicon dioxide,magnesiumstearate,hypromellose,polyethyleneglycol,titanium dioxide,yellowferricoxide,andredferricoxide. Norvir (ritonavir)isa trademark of AbbottLaboratories Crixivan(indinavir sulfate)is a trademarkof Merck& Co.,Inc. Nzoral(ketoconazole) isa trademark of Johnson& Johnson Sporanox(itraconazole) isa trademark ofJohnson& Johnson Hytrin(terazosinHCI)isatrademarkof AbbottLaboratories Romax(tamsulosinHCI)is atrademark of Yamanouchi Pharmaceutical Co.,Ltd. Cardura(doxazosin mesylate)is atrademarkof PfizerInc. Minipress(prazosinHCI)isatrademarkofPfizerInc. Uroxatral(alfuzosinHCI)is a trademark ofSanofi-Synthelabo Manufactured and Marketedby: SBayer HealthCare BayerPharmaceuticals Corporation 400 MorganLane WestHaven,CT06516 Madein Germany Marketedby: GGlaxoSmithKline GlaxoSmithKline ResearchTrianglePark NC27709 f Only 086690341P 8/03 12030 ©2003 BayerPharmaceuticalsCorporation PrintedInU.S .A.