National Geographic : 2004 Feb
Patient Information LEVITRA® (Luh-VEE-Trah) (vardenafil HCI) Tablets 086690341P 8/03 Readthe Patient Informationabout LEVITRAbeforeyoustart takingitand again each time you get a refill.Theremay be new information.Youmay also findit helpfulto share this informationwithyour partner. Thisleafletdoes not takethe placeoftalkingwithyour doctor. Youandyour doctor should talkabout LEVITRA when you start takingit and at regular checkups. Ifyoudo not understand the information, or havequestions, talkwithyour doctor or pharmacist. WHATIMPORTANT INFORMATION SHOULDYOUKNOWABOUTLEVITRA? LEVITRAcancause yourbloodpressure to dropsuddenly to an unsafe level if it is taken with certain other medicines. Witha sudden drop in blood pressure, you could get dizzy,faint, or havea heart attack or stroke. Do nottake LEVITRA if you: * take any medicines called "nitrates." * use recreational drugs called "poppers" likeamylnitrate andbutylnitrate. *take medicines called alpha-blockers. (See "Who Should NotTakeLEVITRA?") 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 forthe 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 ifthe condition bothers him.LEVITRAmay help a man withEDget and keep an erection when he is sexually excited. LEVITRAdoes not: * cure ED * increase a man's sexual desire * protect a man or his partner from sexuallytransmitted diseases, includingHIV. Speak to your doctor about waysto guard against sexuallytransmitted diseases. * serve as a male form of birthcontrol LEVITRAis onlyfor men withED. LEVITRAis not for women or children. LEVITRAmust be used onlyunder a doctor's care. HOWDOESLEVITRAWORK? When a man is sexually stimulated, his body's normal physical response is to increase blood flowto his penis. This results in an erection. LEVITRAhelps increase blood flowto the penis and may help men withEDget and keep an erection satisfactory for sexual activity.Once a man has completed sexual activity,blood flowto his penis decreases, and his erection goes away. WHOCANTAKELEVITRA? Talkto your doctor to decide if LEVITRAis rightfor you. LEVITRAhas been shown to be effectivein menover the age of18 years who have erectile dysfunction, including men withdiabetes or who have undergone prostatectomy. WHOSHOULDNOTTAKELEVITRA? Do nottake LEVITRA if you: Stakeany medicines called "nitrates" (See "What important information should you knowabout LEVITRA?").Nitrates are commonly used to treat angina. Anginais a symptom of heart disease and can cause pain inyour chest, jaw,or down your arm. Medicines callednitrates includenitroglycerinthat is found intablets, 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 amylnitrate and butyl nitrate. Donot use LEVITRAif you are using these drugs. Askyour doctor or pharmacist if you are not sure if any ofyour medicines are nitrates. Stakemedicines called "alpha-blockers." Alpha-blockers are sometimes prescribed for prostate problems or highblood pressure. IfLEVITRAistaken withalpha-blockers, your blood pressure couldsuddenly drop to an unsafe level.Youcould get dizzyand faint. *you havebeen toldby yourhealthcare providerto nothave sexual activity because ofhealth problems. Sexual activitycan put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. *are allergic to LEVITRA or any of its ingredients. The active ingredient in LEVITRAis calledvardenafil.See the end of this leafletfor a complete list of ingredients. WHATSHOULDYOUDISCUSSWITHYOURDOCTORBEFORETAKING LEVITRA? BeforetakingLEVITRA,tell yourdoctorabout all yourmedical problems, includingifyou: *haveheart problems such as angina, heart failure,irregularheartbeats, or have had a heartattack. Askyour doctor ifit is safe foryouto havesexualactivity. * have lowbloodpressure or have highblood pressure that isnot controlled * have had a stroke * or anyfamilymembers havea rare heart condition knownas prolongation of the OTinterval(longQTsyndrome) * have liver problems * have kidneyproblems and require dialysis * have retinitis pigmentosa, a raregenetic (runs infamilies) eyedisease * havestomach ulcers Shavea bleeding problem * havea deformed penis shape or Peyronie's disease Shavehad an erection that lasted morethan 4 hours * have bloodcell problems such as sicklecell anemia, multiplemyeloma, or leukemia CANOTHERMEDICATIONS AFFECTLEVITRA? Tell your doctor about allthe medicines you take includingprescription and non-prescription medicines, vitamins, and herbalsupplements. LEVITRAand other medicines may affecteach other. Alwayscheck withyour doctor before starting or stopping any medicines. Especiallytell your doctor ifyou take any ofthe following: * medicinescallednitrates(See"Whatimportantinformationshouldyouknow aboutLEVITRA?") * medicinescalledalpha-blockers.TheseincludeHytrin (terazosinHCI), Flomax®(tamsulosin HCI),Cardura®(doxazosinmesylate),Minipress® (prazosinHCI)or Uroxatral®(alfuzosinHCI). * medicines thattreatabnormalheartbeat.Theseincludequinidine,procainamide, amiodaroneandsotalol. * ritonavir(Norvir®)or indinavirsulfate(Crixivan®) * ketoconazole or itraconazole(suchasNizoral®orSporanox®) * erythromycin * othermedicinesor treatmentsfor ED HOWSHOULDYOUTAKELEVITRA? TakeLEVITRAexactlyas your doctor prescribes. LEVITRAcomes indifferent doses (2.5 mg, 5 mg, 10 mg, and 20 mg). Formost men, the recommended starting dose is 10 mg. TakeLEVITRAno more than once a day. Doses should betaken at least 24 hours apart. Some men can onlytake a lowdose of LEVITRAbecause of medicalconditions or medicines they take. Yourdoctor willprescribe the dose that is rightfor you. * Ifyou are older than 65 or have liverproblems, your doctor may start you on a lower dose of LEVITRA. * Ifyou are takingcertainother medicines your doctor may prescribe a lower startingdose and limityouto one dose of LEVITRA in a 72-hour (3days) period. Take1 LEVITRAtablet about 1 hour (60 minutes) before sexual activity.Some form of sexual stimulation is needed foran erection to happen withLEVITRA. LEVITRAmay be taken withor without meals. Donot change your dose ofLEVITRAwithout talkingto your doctor. Yourdoctor may loweryour dose or raiseyour dose, depending on how your body reacts to LEVITRA. Ifyou take too much LEVITRA, callyour doctor or emergency room rightaway. WHATARETHEPOSSIBLESIDEEFFECTSOFLEVITRA? The most common side effects withLEVITRAare headache, flushing, stuffy or runny nose, indigestion, upset stomach, or dizziness. These side effects usually go away after a fewhours. Callyour doctor ifyouget a side effectthat bothers you or one that willnot go away. LEVITRA mayuncommonlycause: * an erection that won't go away(priapism). Ifyou get an erection that lasts more than 4 hours, get medical helpright away. Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inabilityto have erections. *vision changes, such as seeing a blue tinge to objects or having difficulty tellingthe difference between the colors blue and green. These are not all the side effects of LEVITRA.For more information, ask your doctor or pharmacist. HOWSHOULDLEVITRABESTORED? * Store LEVITRAat room temperature between 59 ° and 86° F (15° to 30° C). * KeepLEVITRA and all medicines outof the reach ofchildren. GENERAL INFORMATION ABOUTLEVITRA. Medicines are sometimes prescribed for conditions otherthan those described in patient information leaflets.Donot use LEVITRAfor a condition for which it was not prescribed. Donot giveLEVITRAto other people, even ifthey have the same symptoms that you have. It may harm them. Thisleafletsummarizes the most important information about LEVITRA.Ifyou would likemore information, talkwithyour healthcare provider. Youcan ask your doctor or pharmacist for information about LEVITRAthat is written for healthprofessionals. Formoreinformationyoucan alsovisitwww.LEVITRAcom, or call1-866-LEVITRA. WHATARETHEINGREDIENTS OFLEVITRA? ActiveIngredient:vardenafilhydrochloride InactiveIngredients: microcrystalline cellulose, crospovidone, colloidalsilicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide,yellowferricoxide,and redferricoxide. Norvir(ritonavir)isa trademark of Abbott Laboratories Crixivan(indinavirsulfate) is a trademark of Merck& Co.,Inc. Nizoral(ketoconazole) is a trademark ofJohnson &Johnson Sporanox (itraconazole) isa trademark ofJohnson & Johnson Hytrin(terazosin HCI)isa trademark of Abbott Laboratories Flomax(tamsulosin HCI)isa trademark ofYamanouchiPharmaceutical Co.,Ltd. Cardura (doxazosin mesylate) is a trademark of PfizerInc. Minipress (prazosin HCI)isa trademark of PfizerInc. Uroxatral(alfuzosin HCI)is a trademark ofSanofi-Synthelabo Manufacturedand Marketedby: SER Bayer HealthCare Bayer Pharmaceuticals Corporation 400 MorganLane West Haven,CT06516 MadeinGermany Marketedby: G GlaxoSmith Kline GlaxoSmithKline ResearchTriangle Park NC27709 It Only 086690341P 8/03 12030 ©2003BayerPharmaceuticals Corporation Printed inU.S .A .