Vardenafil is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Vardenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It works by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Vardenafil does not cure erectile dysfunction or increase sexual desire. Vardenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

How should this medication be used?

Vardenafil comes as a tablet to take by mouth. It is usually taken as needed, with or without food, 60 minutes before sexual activity. Vardenafil usually should not be taken more often than once every 24 hours. If you have certain health conditions or are taking certain medications, your doctor may tell you to take vardenafil less often. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vardenafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on an average dose of vardenafil and increase or decrease your dose depending on your response to the medication. Tell your doctor if vardenafil is not working well or if you are experiencing side effects.

What side effects can this medication cause?
Vardenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• upset stomach
• heartburn
• dizziness
• flushing
• stuffy or runny nose
• flu-like symptoms

Some side effects can be serious. If you experience any of the following symptoms , call your doctor immediately:

• erection that lasts longer than 4 hours
• sudden severe loss of vision (see below for more information)
• blurred vision
• changes in color vision (seeing blue tinge on objects, difficulty telling the difference between blue and green, or difficulty seeing at night)
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• fainting
• hives
• rash

Vardenafil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Some patients experienced a sudden loss of some or all of their vision after they took vardenafil or other medications that are similar to vardenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking vardenafil, call your doctor immediately. Do not take any more doses of vardenafil or similar medications such as sildenafil or tadalafil until you talk to your doctor.

What special precautions should I follow?
Before taking vardenafil,

• tell your doctor and pharmacist if you are allergic to vardenafil or any other medications.
• do not take vardenafil if you are taking or have recently taken nitrates such as isosorbide dinitrate (Isordil), isosorbide mononitrate (Imdur, ISMO), and nitroglycerin (Nitro-BID, Nitro-Dur, Nitroquick, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure if any of your medications contain nitrates.
• do not take street drugs containing nitrates such as amyl nitrate and butyl nitrate ('poppers') while taking vardenafil.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and terazosin (Hytrin); amiodarone (Cordarone); antifungals such as fluconazole (Diflucan), griseofulvin (Fulvicin, Grifulvin, Gris-PEG), itraconazole (Sporanox), and ketoconazole (Nizoral); aprepitant (Emend);carbamazepine (Carbatrol, Epitol, Tegretol);clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dexamethasone (Decadron, Dexpak);diltiazem (Cardizem, Dilacor, Tiazac); disopyramide (Norpace); efavirenz (Sustiva); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); isoniazid (INH, Nydrazid); lovastatin (Altocor, Mevacor);medications for high blood pressure or irregular heartbeat; metronidazole (Flagyl); nevirapine (Viramune); other medications or treatments for erectile dysfunction; nefazodone (Serzone); paroxetine (Paxil); phenobarbital; phenytoin (Dilantin, Phenytek);procainamide (Procanbid, Pronestyl); quinidine (Quinidex); rifabutin (Mycobutin);rifampin (Rifadin, Rimactane, in Rifamate); sertraline (Zoloft); sotalol (Betapace); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Brands used here are for information purposes only. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort..
• tell your doctor if you smoke and if you have ever had an erection that lasted more than 4 hours. Also tell your doctor if you have or have ever had a condition that affects the shape of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease; diabetes; high cholesterol; high or low blood pressure; irregular heartbeat; a heart attack; angina (chest pain); a stroke; ulcers in the stomach or intestine; a bleeding disorder; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); and liver, kidney, or heart disease. Also tell your doctor if you or any of your family members have or have ever had long QT syndrome (a heart condition) or retinitis pigmentosus (an eye disease) or if you have ever had severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see. Tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons.
• you should know that vardenafil is only for use in males. Women should not take vardenafil, especially if they are or could become pregnant or are breast-feeding. If a pregnant woman takes vardenafil, she should call her doctor.
• if you are having surgery, including dental surgery or any dental procedure, tell the doctor or dentist that you are taking vardenafil.
• you should know that sexual activity may be a strain on your heart, especially if you have heart disease. If you have chest pain during sexual activity, call your doctor immediately and avoid sexual activity until your doctor tells you otherwise.
• tell all your health care providers that you are taking vardenafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took vardenafil.

What special dietary precautions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medicine.

Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What storage conditions are needed for this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of overdose?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• back or muscle pain
• blurred vision

What other information should I know?
Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Supply

Each film coated tablet containing Vardenafil 20 mg is available in a blister pack of 10 tablets.