Uses

Vardenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, vardenafil works by increasing blood flow to the penis to help a man get and keep an erection.

This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking vardenafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication as directed by your doctor, usually as needed. Take vardenafil, with or without food, about 1 hour before sexual activity. Do not take more than once daily. Doses should be taken at least 24 hours apart.

Dry your hands before handling this medication. Remove the dose from the blister package right before use. Place the tablet on your tongue and allow it to dissolve completely. Do not crush or split the tablet. This medication should not be taken with liquid.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Vardenafil disintegrating tablets are absorbed differently in the body than vardenafil film-coated tablets. Do not switch from one to the other without consulting your doctor.

Tell your doctor if your condition does not improve.

Side Effects

Headache, flushing, or dizziness may occur. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away:

• severe dizziness
• fainting
• chest/jaw/left arm pain
• nausea

Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking vardenafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.

Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking vardenafil and get medical help right away if these effects occur.

In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.

Get medical help right away if you have any very serious side effects, including:

• seizures
• temporary memory loss

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking vardenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure)
• stroke in the past 6 months
• kidney disease (dialysis)
• liver disease
• high or low blood pressure
• dehydration
• penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease)
• history of painful/prolonged erection (priapism)
• conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma)
• eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION)
• bleeding disorders
• active stomach ulcers

This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not usually used in women. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.

Drug Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• riociguat
• vericiguat

Vardenafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use vardenafil with any of the following:

• certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide)
• recreational drugs called "poppers" containing amyl or butyl nitrite

If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. To manage this drug interaction, you should not start vardenafil treatment with the disintegrating tablet. Your doctor will start treatment with a lower dose of the regular vardenafil tablets first to minimize your risk of low blood pressure, and then may direct you to switch to vardenafil disintegrating tablets later.

Other medications can affect the removal of vardenafil from your body, which may affect how vardenafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as indinavir), ritonavir, among others.

Do not take this medication with any other product that contains vardenafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil).

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: back/muscle pain, abnormal vision.

Notes

Do not share this medication with others.

Missed Dose

Not applicable.

Storage

Store this medication in the original packaging at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.