Vardenafil tablet (Levitra®)

What is this medicine?

VARDENAFIL is a medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Levitra® may help a man with ED get and keep an erection when he is sexually excited. Levitra® must be used only under a doctor's care. It is not for women or children.

What should my health care professional know before I receive this medicine?

They need to know if you have any of the following conditions:

• heart problems
• low blood pressure or incontrolled high blood pressure
• have had a stroke
• any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)
• liver or kidney problems
• severe vision loss
• retinitis pigmentosa, a rare genetic (runs in families) eye disease
• stomach ulcers
• bleeding problem
• deformed penis shape or Peyronie’s disease
• take any medicines called “alpha blockers” (alpha blockers are sometimes prescribed for prostate problems or high blood pressure)
• have blood cell problems, such as sickle cell anemia, multiple myeloma, or leukemia

How should this medicine be used?

Take vardenafil tablets by mouth with or without food. Follow the directions on the prescription label. The dose is usually taken about 1 hour before sexual activity. Swallow the tablets with a drink of water. Do not take double or extra doses.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This doesn't apply. Levitra is taken when needed.

What may interact with this medicine?

Do not take this medicine with the following:

• nitrates
• alpha-blockers
• recreational drugs that contain nitrates called "poppers"

This medicine may also interact with the followig:

• arsenic trioxide
• bosentan
• certain antibiotics such as clarithromycin, erythromycin, sparfloxacin, troleandomycin
• certain medicines used for seizures such as carbamazepine, phenytoin, and phenobarbital
• certain medicines for the treatment of HIV infection or AIDS
• certain medicines to control the heart rhythm (e.g., amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, procainamide, propafenone, sotalol)
• chloroquine
• cisapride
• diltiazem
• grapefruit juice
• medicines for fungal infections (fluconazole, itraconazole, ketoconazole, voriconazole)
• methadone
• nicardipine
• pentamidine
• pimozide
• rifabutin, rifampin, or rifapentine
• some medicines for treating depression or mood problems (amoxapine, maprotiline, fluoxetine, fluvoxamine, nefazodone, pimozide, phenothiazines, tricyclic antidepressants)
• verapamil

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while taking this medicine?

If you notice any changes in your vision while taking this drug, notify your prescriber or health care professional as soon as possible. Stop using vardenafil right away if you have a loss of sight in one or both eyes. Contact your healthcare provider immediately.

Contact your physician immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated immediately to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after vardenafil use, you should refrain from further activity and should discuss the episode with your prescriber or health care professional as soon as possible.

Do not change the dose of your medication. Please call your prescriber or health care professional to determine if your dose needs to be reevaluated.

Using vardenafil does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

What side effects may I notice from this medicine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• back pain
• changes in hearing such as loss of hearing or ringing in ears
• changes in vision such as loss of vision, blurred vision, eyes being more sensitive to light, or trouble telling the difference between blue and green objects or objects having a blue color tinge to them
• chest pain or palpitations
• difficulty breathing, shortness of breath
• dizziness
• eyelid swelling
• muscle aches
• prolonged erection (lasting longer than 4 hours)
• skin rash, itching
• seizures

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• flushing
• headache
• indigestion
• nausea
• stuffy nose

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.