When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to vardenafil.

How to Use This Medicine:
Tablet, Dissolving Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine about 60 minutes before you have sex. Do not take it more than once per day. Always allow at least 24 hours between doses.
• Disintegrating tablet: Do not open the blister pack until you are ready to take the tablet. Make sure your hands are dry and peel back the foil to remove the tablet. Do not push the tablet through the foil. Place the tablet on your tongue and let it melt. Do not take the medicine with liquid. Do not break, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you also use riociguat or a nitrate medicine.
• Some foods and medicines can affect how vardenafil works. Tell your doctor if you are using any of the following:
  
  • Atazanavir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, ritonavir, saquinavir
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine to treat high blood pressure or prostate problems (including alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you have kidney disease, liver disease, heart or blood vessel disease, angina, high or low blood pressure, heart failure, vision or eye problems, heart rhythm problems (including QT prolongation), or a history of stroke or heart attack. Tell your doctor if you have sickle cell anemia, leukemia, multiple myeloma, phenylketonuria (PKU), or fructose intolerance.
• This medicine may cause the following problems:
  
  • Low blood pressure (especially if taken with other medicines that lower blood pressure)
  • Painful or prolonged erection
  • Vision or hearing problems
  • Heart problems
• This medicine will not protect you from sexually transmitted diseases (including HIV or AIDS).
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread to your jaw or arm, trouble breathing, nausea, unusual sweating
• Fast, pounding, or uneven heartbeat
• Lightheadedness, fainting
• Painful erection or an erection that lasts longer than 4 hours
• Sudden vision loss, changes in vision or in how you see colors (especially blue or green)
• Sudden hearing loss, ringing in your ears, dizziness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Stuffy or runny nose
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088