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LEVITRA (Bayer) is an FDA-approved oral prescription medication for the treatment of erectile dysfunction (ED) in men and is taken only when needed.

Take LEVITRA no more than once a day.

What LEVITRA does:

LEVITRA helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis should decrease and his erection should go away.

LEVITRA has been clinically shown to improve erectile function even in men who had other health factors, like diabetes or prostate surgery.

LEVITRA provided first time success and reliable improvement of erection quality for many men. Men reported having harder erections and improved overall sexual experiences.

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LEVITRA works:

In major clinical trials in the general ED population, LEVITRA improved the quality of erections for a majority of men.

A lot of guys who took LEVITRA were satisfied the first time they tried it.

It's for the guy who needs a little help once in a while and the guy who needs more frequent help.

Do not take LEVITRA if you:

• Take any form of medication known as "nitrates"
  (a type of medicine used to relieve chest pain that can occur as a result of heart disease). Taking LEVITRA in combination with nitrates (such as nitroglycerin, isosorbide mononitrate, and isosorbide dinitrate) may result in serious side effects.
• Take medicines called "alpha-blockers"
  (sometimes prescribed for prostate problems or high blood pressure). Taking LEVITRA with alpha-blockers may drop your blood pressure to an unsafe level.
• Your doctor determines that sexual activity poses a health risk for you.
• You have a known sensitivity or allergy to any component of LEVITRA.

The most common side effects with LEVITRA are:

• Headaches
• Flushing
• Stuffy or runny nose

LEVITRA may uncommonly cause:

• An erection that won't go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections.
• Vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green.

In an extensive clinical trial program that included more than 50 trials and involved more than 4,400 men with erectile dysfunction (ED), the results of one or more of these clinical trials showed:

Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take LEVITRA. Men who use alpha-blockers, sometimes prescribed for high blood pressure or prostate problems, also should not take LEVITRA. Such combinations could cause blood pressure to drop to an unsafe level.

LEVITRA is not for everyone. LEVITRA is for use by prescription only.

Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take LEVITRA. Men who use alpha-blockers, sometimes prescribed for high blood pressure or prostate problems, also should not take LEVITRA. Such combinations could cause blood pressure to drop to an unsafe level.

You should not take LEVITRA if your doctor determines that sexual activity poses a health risk for you. LEVITRA does not protect against sexually transmitted diseases, including HIV.

If you have any concerns about whether you can take LEVITRA, talk to your doctor.

The most commonly reported side effects with LEVITRA are headache, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Call your doctor if you get a side effect that bothers you or one that will not go away. Men who experience an erection for more than four hours should seek immediate medical attention.

LEVITRA may uncommonly cause:

• An erection that won't go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections.
• Vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green.

These are not all the side effects of LEVITRA. For more information, ask your doctor or pharmacist.

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