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Product description Safety information Side Effects

Drug Name

Revatio (sildenafil)

Drug Uses

Revatio (sildenafil) relaxes muscles and increases blood flow to particular areas of the body.
Revatio may also be used for other purposes not listed in this medication guide.

How to use

Revatio is usually taken three times daily, approximately 4 to 6 hours apart. It can be taken with or without food.

Drug Class and Mechanism

Revatio (sildenafil) is a phosphodiesterase inhibitor. It works by relaxing blood vessels in the lungs, which decreases blood pressure.

Missed Dose

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take extra medicine to make up the missed dose.

Storage

Store this medication at room temperature and keep it out of the reach of children.

Warnings/Precautions

Do not take Revatio if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Revatio with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.
Before taking Revatio, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease or heart rhythm problems;
• a recent history (in the past 6 months) of a heart attack, stroke, or heart rhythm disorder;
• congestive heart failure;
• high or low blood pressure;
• coronary artery disease;
• liver disease;
• kidney disease;
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• a bleeding disorder such as hemophilia;
• a stomach ulcer;
• retinitis pigmentosa (an inherited condition of the eye);
• a physical deformity of the penis (such as Peyronie's disease); or
• if you have been told you should not have sexual intercourse for health reasons.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Revatio.

Revatio can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking Revatio, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether Revatio is the actual cause of vision loss.
Do not use Revatio without telling your doctor if you are pregnant or plan to become pregnant during treatment. It is not known if Revatio passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Possible Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of Revatio.

Stop using Revatio and call your doctor at once if you have any of these serious side effects:

• sudden vision loss;
• ringing in your ears, or sudden hearing loss;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• irregular heartbeat;
• swelling in your hands, ankles, or feet;
• shortness of breath;
• vision changes;
• feeling light-headed, fainting; or
• penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

• warmth or redness in your face, neck, or chest;
• stuffy nose;
• headache;
• upset stomach; or
• back pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.