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Patient Information
(vardenafil HCl) Tablets
Take LEVITRA exactly as your doctor prescribes. LEVITRA comes in different doses (2.5 mg, 5 mg, 10 mg, and
Read the Patient Information about LEVITRA before you start taking it and again each time you get a refill. There may 20 mg). For most men, the recommended starting dose is 10 mg. Take LEVITRA no more than once a day.
be new information. You may also find it helpful to share this information with your partner. This leaflet does not take Doses should be taken at least 24 hours apart. Some men can only take a low dose of LEVITRA because of medical the place of talking with your doctor. You and your doctor should talk about LEVITRA when you start taking it and at conditions or medicines they take. Your doctor will prescribe the dose that is right for you. regular checkups. If you do not understand the information, or have questions, talk with your doctor or pharmacist.
• If you are older than 65 or have liver problems, your doctor may start you on a lower dose of LEVITRA.
• If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, your WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT LEVITRA?
doctor may start you on a lower dose of LEVITRA.
LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other
• If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.
dose of LEVITRA in a 72-hour (3 days) period.
Take 1 LEVITRA tablet about 1 hour (60 minutes) before sexual activity. Some form of sexual stimulation is needed Do not take LEVITRA if you:
for an erection to happen with LEVITRA. LEVITRA may be taken with or without meals. • take any medicines called “nitrates.”
Do not change your dose of LEVITRA without talking to your doctor. Your doctor may lower your dose or raise • use recreational drugs called “poppers” like amyl nitrate and butyl nitrate.
your dose, depending on how your body reacts to LEVITRA.
If you take too much LEVITRA, call your doctor or emergency room right away.
Tell all your healthcare providers that you take LEVITRA. If you need emergency medical care for a heart
problem, it will be important for your healthcare provider to know when you last took LEVITRA.
The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose, indigestion, upset
stomach, or dizziness. These side effects usually go away after a few hours. Call your doctor if you get a side LEVITRA is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. effect that bothers you or one that will not go away.
ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he LEVITRA may uncommonly cause:
cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if • an erection that won’t go away (priapism).If you get an erection that lasts more than 4 hours, get medical help
the condition bothers him. LEVITRA may help a man with ED get and keep an erection when he is sexually excited. right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis including LEVITRA does not:
color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between
• protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your doctor about In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including LEVITRA) reported a ways to guard against sexually transmitted diseases. sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are • serve as a male form of birth control related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination LEVITRA is only for men with ED. LEVITRA is not for women or children. LEVITRA must be used only under a of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including LEVITRA, HOW DOES LEVITRA WORK?
Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis.
people taking PDE5 inhibitors, including LEVITRA. It is not possible to determine whether these events are related This results in an erection. LEVITRA helps increase blood flow to the penis and may help men with ED get and directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors.
keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis If you experience these symptoms, stop taking LEVITRA and contact a doctor right away.
decreases, and his erection goes away.
These are not all the side effects of LEVITRA. For more information, ask your doctor or pharmacist.
Talk to your doctor to decide if LEVITRA is right for you. • Store LEVITRA at room temperature between 59° and 86° F (15° to 30° C).
LEVITRA has been shown to be effective in men over the age of 18 years who have erectile dysfunction, including • Keep LEVITRA and all medicines out of the reach of children.
men with diabetes or who have undergone prostatectomy.
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do Do not take LEVITRA if you:
not use LEVITRA for a condition for which it was not prescribed. Do not give LEVITRA to other people, even if • take any medicines called “nitrates” (See “What important information should you know about LEVITRA?”).
they have the same symptoms that you have. It may harm them. Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your This leaflet summarizes the most important information about LEVITRA. If you would like more information, talk with your healthcare provider. You can ask your doctor or pharmacist for information about LEVITRA that is written Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches.
Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some For more information you can also visit www.LEVITRA.com, or call 1-866-LEVITRA.
recreational drugs called “poppers” also contain nitrates, such as amyl nitrate and butyl nitrate. Do not use LEVITRA WHAT ARE THE INGREDIENTS OF LEVITRA?
if you are using these drugs. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates.
Active Ingredient: vardenafil hydrochloride
you have been told by your healthcare provider to not have sexual activity because of health problems.
Inactive Ingredients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate,
Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.
are allergic to LEVITRA or any of its ingredients. The active ingredient in LEVITRA is called vardenafil. See the
Norvir (ritonavir) is a trademark of Abbott Laboratories end of this leaflet for a complete list of ingredients.
Crixivan (indinavir sulfate) is a trademark of Merck & Co., Inc.
Invirase or Fortavase (saquinavir mesylate) is a trademark of Roche Laboratories Inc. WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING LEVITRA?
Reyataz (atazanavir sulfate) is a trademark of Bristol-Myers Squibb Company Before taking LEVITRA, tell your doctor about all your medical problems, including if you:
Nizoral (ketoconazole) is a trademark of Johnson & Johnson • have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your
Sporanox (itraconazole) is a trademark of Johnson & Johnson doctor if it is safe for you to have sexual activity. Hytrin (terazosin HCl) is a trademark of Abbott Laboratories • have low blood pressure or have high blood pressure that is not controlled
Flomax (tamsulosin HCl) is a trademark of Yamanouchi Pharmaceutical Co., Ltd.
have had a stroke
Cardura (doxazosin mesylate) is a trademark of Pfizer Inc.
have had a seizure
Minipress (prazosin HCl) is a trademark of Pfizer Inc.
or any family members have a rare heart condition known as prolongation of the QT interval (long QT
Uroxatral (alfuzosin HCl) is a trademark of Sanofi-Synthelabo • have liver problems
have kidney problems and require dialysis
have retinitis pigmentosa, a rare genetic (runs in families) eye disease
have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic
neuropathy (NAION)
have 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 sickle cell anemia, multiple myeloma, or leukemia
Bayer HealthCare Pharmaceuticals Inc.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. LEVITRA and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following: • medicines called nitrates (See “What important information should you know about LEVITRA?”)• medicines called alpha-blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl) or Uroxatral® (alfuzosin HCl). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to fainting. You shouldcontact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed byanother healthcare provider. LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and • medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone and sotalol.
• ritonavir (Norvir®) or indinavir sulfate (Crixivan®) saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®) • ketoconazole or itraconazole (such as Nizoral® or Sporanox®)• erythromycin or clarithromycin 2008 Bayer HealthCare Pharmaceuticals Inc.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch <http://www.fda.gov/medwatch>, or call 1-800-FDA-1088.

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