LEVITRA ®

FDA approval of Levitra was based on four multi-center, double-blind, randomized, placebo controlled, fixed-dose, parallel design trials. The studies enrolled a total of 2431 men with an average age of 57 years. The doses investigated were 5 mg, 10 mg, and 20 mg. An efficacy assessment was based on the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) corresponding to vaginal penetration achievement (SEP2), and the ability to maintain an erection for intercourse (SEP3).

Results demonstrated clinically meaningful and statistically significant improvements in the EF Domain, SEP2, and SEP3 scores compared to placebo. The mean baseline EF Domain score in these trials was 11.8.

In a major North American fixed dose trial, 762 subjects were evaluated. The mean baseline EF Domain scores were 13, 13, 13, 14 for the Levitra 5 mg, 10 mg, 20 mg and placebo groups, respectively. There was significant improvement at three months with Levitra (EF Domain scores of 18, 21, 21, for the 5 mg, 10 mg and 20 mg dose groups, respectively) compared to the placebo group (EF Domain score of 15). The European trial of 803 subjects confirmed these results. In the North American trial, Levitra significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo at 3 months. The European trial confirmed these results. Mechanism of Action
Levitra is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Erection of the penis is initiated by the relaxation of smooth muscle in the corpus cavernosum, one of a pair of sponge-like regions in the penis. When aroused, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP triggers smooth muscle relaxation, increasing blood flow into the penis, resulting in erection.

Do not take Levitra if you:
Take any medicines called "nitrates" . 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 found in tablets, 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. Do not use Levitra if you are using these drugs. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates.

Take medicines called "alpha blockers". Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If Levitra is taken with alpha blockers, your blood pressure could suddenly drop to an unsafe level. You could get dizzy and faint.

You have been told by your healthcare provider to not have sexual activity because of health problems. Sexual activity can 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 on Levitra is called vardenafil. See the end of this leaflet for a complete list of ingredients.

The first sign of overdose is backache. Be also careful taking Levitra with some other drugs, for example nitrates and alpha-blockers, and recreational drugs that contain nitrates called "poppers". In this case you'd better consult a doctor. Inform him about your past problems with heart rhythm, high or low blood pressure, a stomach ulcer, a bleeding disorder such as hemophilia, kidney disease and others. Your doctor will decide whether you can take Levitra and those drugs simultaneously. Levitra is not recommended for patients whose sexual activity is limited because of the diseases of the cardiovascular system. Levitra can decrease blood flow to the nerves of the eye, as a result a man can loose his vision. It can be observed on one or both eyes. But on practice such cases took place when people do not follow the instructions how to take medicine correctly. It is not possible to find out whether these actions are connected directly to these medicines or to other factors. There is no clinical facts to prove that Levitra is an aphrodisiac. It is forbidden to use Levitra in complex with other medicine for treatment erectile dysfunction.

Do not be confused if after taking Levitra you still do not have erection. The medication can help achieve it when sexual stimulation occurs. An erection will not occur just by taking a pill.

One more specific feature of Levitra is that it does not depend on the reception of alcohol. So you can easilly continue your romantic evening having sex even after a few glasses of champagne. Be sure, there is no risk and side effects. Today Levitra is unique available medicine in the form of pills in the world which posses the real efficiency in treatment erectile dysfunction. Effectiveness of other advertised pills, as a rule, is fictition.

Who should not take LEVITRA?
Do not take LEVITRA if you take any medicines called "nitrates" 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 found in tablets, 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. Do not use LEVITRA if you are using these drugs. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates.

Do not take LEVITRA if you take medicines called "alpha-blockers." Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If LEVITRA is taken with alpha-blockers, your blood pressure could suddenly drop to an unsafe level. You could get dizzy and faint.

Do not take LEVITRA if you have been told by your healthcare provider to not have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

Adverse events associated with the use of Levitra may include (but are not limited to) the following:

• Headache
• Flushing
• Rhinitis
• Dyspepsia
• Accidental Injury
• Sinusitis
• Flu Syndrome
• Dizziness
• Nausea

Rarely, a sudden loss of eyesight in one or both eyes (NAION) may occur. This may or may not be due to vardenafil. If this serious problem occurs, seek immediate medical attention. You have a slightly greater chance of developing this serious eye problem if you have heart disease, diabetes, high cholesterol, certain eye problems ("crowded disk"), high blood pressure, are over 50 years of age, or if you smoke.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur:

• fast/slow/irregular heartbeat
• seizures
• short-term memory loss

Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and seek immediate medical attention:

• severe dizziness
• fainting
• chest pain

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

Rarely, vardenafil may cause sudden hearing problems, or ringing in the ears. Stop taking this medication and tell your doctor immediately if these effects occur.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing