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What is this medicine?

VARDENAFIL is used to treat erection problems in men. Vardenafil works faster than Sildenafil (Viagra®) and it is less likely to have visual disturbance side effect.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
anatomical deformity of the penis, Peyronie’s disease, or ever had an erection that lasted more than 4 hours
bleeding disorder
cancer
diabetes
frequent heartburn or gastroesophageal reflux disease (GERD)
heart disease, angina, high or low blood pressure, a history of heart attack, or other heart problems
high cholesterol
HIV infection
kidney disease
liver disease
sickle cell disease
stroke
stomach or intestinal ulcers
eye or vision problems
an unusual reaction to vardenafil, medicines, foods, dyes, or preservatives

How should this medicine be used?

Take vardenafil tablets by mouth with or without food. 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 does not apply. However, do not take double or extra doses.

What may interact with this medicine?

Do not take vardenafil if you are taking the following medications:
nitroglycerin-type drugs for the heart or chest pain such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, even if these are only taken occasionally. This includes some recreational drugs called ‘poppers’ which also contain amyl nitrate and butyl nitrate.

Vardenafil may also interact with the following medications:
alpha blockers such as alfuzosin (UroXatral®), doxazosin (Cardura®), prazosin (Minipress®), tamsulosin (Flomax®), or terazosin (Hytrin®), used to treat high blood pressure or an enlarged prostate.
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

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

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

This list may not describe all possible side effects.

Where can I keep my medicine?

Keep out of the reach of children.

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

Erectile Dysfunction

Levitra

Levitra is indicated for the treatment of erectile dysfunction. Levitra is a phosphodiesterase inhibitor that works by helping the blood flow into the penis to achieve and maintain an erection.

Use Levitra as directed by your doctor.

  • Take Levitra by mouth with or without food.
  • Take Levitra about 1 hour before sexual activity.
  • Do not take Levitra more often than once daily, or as directed by your doctor.
  • Check with your doctor before you eat grapefruit or drink grapefruit juice while you use Levitra.
  • If you miss a dose of Levitra and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor.

For most patients, the recommended starting dose of Levitra is 10 mg, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day.

Some men can only take a low dose of Levitra because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you.

  • If you are older than 65 or have liver problems, your doctor may start you on a lower dose of Levitra.
  • If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of Levitra.
  • If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of Levitra in a 72-hour (3 days) period.

Ask your health care provider any questions you may have about how to use Levitra.

Store Levitra at 25 degrees C (77 degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F). Keep Levitra out of the reach of children.

Active Ingredient: Vardenafil.

Inactive Ingredients: Microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.

Do NOT use Levitra if:

  • you are allergic to any ingredient in Levitra
  • you have been advised by your doctor to avoid sexual activity because of heart problems
  • you have certain heart problems (eg, severe heart failure, angina), low or high blood pressure, severe liver problems or severe kidney problems that require dialysis
  • you have certain hereditary degenerative eye problems (eg, retinitis pigmentosa)
  • you have had a heart attack, stroke, or life-threatening irregular heartbeat within the past 6 months
  • you have a history of a certain type of irregular heartbeat (eg, congenital QT prolongation) or you take certain antiarrhythmic medicines (eg, quinidine, procainamide, amiodarone, sotalol)
  • you are taking a nitrate (eg, isosorbide, nitroglycerin) in any form (eg, capsule, ointment, patch, tablet), or nitroprusside
  • you use certain recreational drugs called “poppers” (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)
  • you take another PDE5 inhibitor (eg, sildenafil, tadalafil) or another medicine that contains vardenafil.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Levitra. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a deformed penis (eg, cavernosal fibrosis, Peyronie disease), blood cell problems (eg, leukemia, multiple myeloma, sickle cell anemia), or any other condition that may increase the risk of a prolonged erection (priapism)
  • if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
  • if you have a history of certain eye problems (eg, macular degeneration, optic neuropathy, retinitis pigmentosa, sudden vision loss) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
  • if you have a history of liver or kidney problems, dialysis, high or low blood pressure, ulcers, seizures, lung problems (eg, pulmonary veno-occlusive disease), bleeding problems, blood vessel problems, or heart problems (eg, angina, aortic stenosis, heart failure)
  • if you have a history of heart attack, stroke, a certain type of irregular heartbeat (long QT syndrome), or a family history of long QT syndrome.

Some medicines may interact with Levitra. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
  • Certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol) because the risk of irregular heartbeat may be increased
  • Azole antifungals (eg, itraconazole), HIV protease inhibitors (eg, indinavir, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Levitra’s side effects
  • Rifampin because it may decrease Levitra’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levitra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • Levitra may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Levitra with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Levitra may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Patients with heart problems who take Levitra may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion; vision or speech changes; one-sided weakness; or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
  • Levitra may rarely cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
  • Levitra does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
  • Levitra will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
  • Levitra may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
  • Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Levitra. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
  • Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Levitra. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
  • Do not use other medicines or treatments for ED while you are taking Levitra without first checking with your doctor.
  • Use Levitra with caution in the elderly; they may be more sensitive to its effects.
  • Levitra is not recommended for use in children younger 18 years.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Dizziness; flushing; headache; heartburn; nausea; stuffy or runny nose; upset stomach.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast, slow, or irregular heartbeat; memory loss; numbness of an arm or leg; prolonged, painful erection; ringing in the ears; seizures; severe back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes; sudden, severe headache or vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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