In the U.S.—

• Impotence therapy agent (systemic)

Vardenafil (var-DEN-a-fil ) belongs to a group of medicines that delay the enzymes (proteins in your body) called phosphodiesterases from working too quickly. The penis is one of the areas where these enzymes work. Vardenafil is used to treat men who have erectile dysfunction (also called sexual impotence). Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Vardenafil may help a man get and keep an erection when he is sexually excited. Vardenafil helps to increase the blood flow to the penis and may help men with erectile dysfunction get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Vardenafil does not help to cure erectile dysfunction.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For vardenafil, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to vardenafil. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Vardenafil is not indicated for use in women. Vardenafil has not been studied in pregnant women. However, vardenafil has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether vardenafil passes into breast milk. Vardenafil is not indicated for use in women.

Older adults—Elderly people are especially sensitive to the effects of vardenafil, which may increase their chance of having side effects. Patients 65 years of age and older are started on a lower dose than younger adults. The dose may be increased by a doctor as needed and tolerated.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking vardenafil, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Medicine for irregular heart beats, such as
• Amiodarone (e.g., Cordarone) or
• Procainamide (e.g., Procan SR, Promine, Pronestyl, Pronestyl-SR) or
• Quinidine (e.g., Cardioquin, Quinaglute Dura-tabs, Quinidex Extentabs, Quin-Release) or
• Sotalol (e.g., Betapace, Sotacor)—these medicines should not be used together with vardenafil

• Alpha blockers (medicine for high blood pressure) such as
• Terazosin (e.g., Hytrin)
• Tamsulosin (e.g., Flomax)
• Doxazosin (e.g., Cardura)
• Prazosin (e.g., Minipress)
• Alfuzosin (e.g., Uroxatral)—these medicines should not be used at the same time as vardenafil because they can cause very low blood pressure and serious side effects

• Erythromycin (medicine used to treat infection)—this medicine may cause there to be more vardenafil in your body; your doctor may want to adjust your dose of vardenafil

• Ketoconazole (e.g., Nizoral)
• Itraconazole (e.g., Sporanox)—these medicines may cause there to be more vardenafil in your body; your doctor may want to adjust your dose of vardenafil

• Indinavir (e.g., Crixivan) or
• Ritonavir (e.g., Norvir, Kaletra)—these medicines may cause there to be more vardenafil in your body; your doctor may want to adjust your dose of vardenafil

• Nitrates, such as nitroglycerin (e.g., Nitrostat or Transderm-Nitro)—vardenafil increases the chance of very low blood pressure and using these medicines together is not recommended

• Angina (reoccurring chest pain) or
• Hypotension (low blood pressure) or
• Hypertension (high blood pressure) or
• Stroke (recent history of) or
• Arrhythmia (irregular heartbeat) or
• Heart attack (within the last 6 months) or
• Heart failure or
• Liver disease (severe) or
• Kidney disease (severe) or
• Retinal disorders (rare hereditary eye problem)—vardenafil has not been studied in patients with these medical conditions and should not be used
• Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and should be used with caution in these patients

• Bleeding disorders or
• Stomach ulcers—chance of problems occurring may be increased; it is not known if the medicine is safe for use in these patients

• Heart disease, underlying—chance of low blood pressure occurring is greater; vardenafil should be used carefully in these patients

• Liver disease, moderate—this condition may cause there to be more vardenafil in your body; your doctor may want to start these patients on a lower dose

• Heart blood flow problems—these conditions may cause you to be more sensitive to vardenafil

• Sickle-cell anemia
• Bone marrow cancer
• Leukemia—vardenafil should be used with caution in these patients

• QT prolongation (rare heart condition)—vardenafil may cause this condition to become worse

Special patient directions come with vardenafil. Read the directions carefully before you start using vardenafil and each time you get a refill of your medicine.

This medicine usually begins to work within 60 minutes after taking it. It continues to work for up to 4 hours. Stimulation is required for an erection. If you have any questions about the use and benefits of vardenafil ask your health care professional.

Dosing—

The dose of vardenafil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of vardenafil. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For treatment of erectile dysfunction:
    • Adults up to 65 years of age—10 mg as a single dose no more than once a day, 1 hour before sexual activity. If needed, your doctor may change your dose.
    • Adults 65 years of age and older—5 mg as a single dose no more than once a day, 1 hour before sexual intercourse. If needed, your doctor may change your dose.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Vardenafil has not been studied with other medicines used for treatment of erectile dysfunction. Using them together is not recommended .

Use vardenafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects is increased.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

This medicine does not protect you against sexually transmitted diseases. Use protective measures and ask your doctor if you have any questions about this.

It is important to tell your doctor about any heart problems you may have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Less common
  • Arm, back or jaw pain;  blindness;  blurred vision;  body aches or pain;  chest pain or discomfort;  chest tightness or heaviness;  chills;  cold sweats;  confusion;  congestion ;  cough;  decreased vision ;  difficult or labored breathing;  difficulty swallowing;  dizziness;  dizziness, faintness, or lightheadedness when getting up from lying or sitting position;  dryness or soreness of throat;  eye pain;  fainting;  fast, irregular, pounding, or racing heartbeat or pulse;  fever;  headache;  hives;  hoarseness;  itching;  nausea;  nervousness;  pain or discomfort in arms, jaw, back or neck;  pounding in the ears;  puffiness or swelling of the eyelids or around the eyes, face, lips or tongue;  runny nose ;  shortness of breath;  skin rash;  slow or fast heartbeat;  sweating;  tearing;  tender, swollen glands in neck;  tightness in chest;  trouble in swallowing;  unusual tiredness or weakness;  voice changes;  vomiting;  wheezing 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Feeling of warmth and redness of the face, neck, arms and occasionally, upper chest;  sneezing;  stuffy nose 
  
  

• Less common
  • Abnormal ejaculation;  abnormal vision ;  abdominal pain;  acid or sour stomach;  back pain;  belching;  bloody nose;  burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings;  burning feeling in chest or stomach;  changes in color vision;  changes in vision;  diarrhea;  difficulty in moving;  difficulty seeing at night;  difficulty swallowing;  dim vision;  dry mouth;  eye pain;  excessive muscle tone;  face swelling;  fast heartbeat;  feeling of constant movement of self or surroundings;  general feeling of discomfort or illness;  heartburn;  increased redness of the eye;  increased sensitivity of eyes to sunlight;  indigestion;  itching skin;  joint pain;  lack or loss of strength;  loss of appetite ;  muscle aches and pains;  trouble sleeping;  muscle cramping;  muscle stiffness;  muscle tension or tightness;  neck pain;  pain ;  pain or burning in throat;  sensation of spinning;  shivering;  sleepiness or unusual drowsiness;  sleeplessness;  sore throat;  sores, ulcers, or white spots on lips or tongue or inside the mouth;  stomach discomfort, upset, or pain;  swollen joints;  tenderness in stomach area;  trouble sleeping;  unable to sleep;  watery eyes 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.