INDICATIONS

Levitra Jelly 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.

INSTRUCTIONS  

Use Levitra Jelly as directed by your doctor.

• Take Levitra Jelly by mouth with or without food.
• Take Levitra Jelly about 1 hour before sexual activity.
• Do not take Levitra Jelly 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 Jelly.
• If you miss a dose of Levitra Jelly 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.

DOSAGE

For most patients, the recommended starting dose of Levitra Jelly 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 Jelly 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 Jelly.
• 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 Jelly in a 72-hour (3 days) period.

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

STORAGE

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

MORE INFO:

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.

SAFETY INFORMATION

Do NOT use Levitra Jelly if:

• you are allergic to any ingredient in Levitra Jelly
• 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 Jelly. 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 Jelly. 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 Jelly effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levitra Jelly 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 Jelly may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Levitra Jelly with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• Levitra Jelly 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 Jelly 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 Jelly 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 Jelly 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 Jelly 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 Jelly 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 Jelly. 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 Jelly with caution in the elderly; they may be more sensitive to its effects.
• Levitra Jelly is not recommended for use in children younger 18 years.

SIDE EFFECTS

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.