Uses of Vardenafil Tablets:

• It is used to treat erectile dysfunction (ED).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Vardenafil Tablets?

• If you have an allergy to vardenafil or any other part of this medicine (vardenafil tablets).
• If you are allergic to this medicine (vardenafil tablets); any part of this medicine (vardenafil tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have certain hereditary eye problems like retinitis pigmentosa.
• If you have been told that you are not healthy enough to have sex.
• If you have any of these health problems: Chest pain (includes chest pain during sex), heart disease, heart failure, or high or low blood pressure.
• If you have ever had a long QT on ECG.
• If you have had any of these health problems in the last 6 months: An abnormal heartbeat, heart attack, or stroke.
• If you use drugs called "poppers" like amyl nitrite and butyl nitrite.
• If you are taking any of these drugs: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, riociguat, or ritonavir.
• If you are taking another drug that has the same drug in it.
• If you are taking or will be taking another drug like this one.
• If you are taking any of these drugs: Atazanavir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, ritonavir, saquinavir, or drugs to treat a heartbeat that is not normal.

This is not a list of all drugs or health problems that interact with this medicine (vardenafil tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (vardenafil tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Vardenafil Tablets?

• Tell all of your health care providers that you take this medicine (vardenafil tablets). This includes your doctors, nurses, pharmacists, and dentists.
• There is more than 1 brand of this medicine (vardenafil tablets). One brand cannot safely be used for the other. The doctor will tell you about any needed change.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (vardenafil tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you are taking another drug like this one that is used to treat erectile dysfunction (ED) or high pressure in the lungs.
• Talk with your doctor before you drink alcohol.
• Avoid grapefruit and grapefruit juice.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• A very bad eye problem has rarely happened with this medicine (vardenafil tablets). This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
• If you are 65 or older, use this medicine (vardenafil tablets) with care. You could have more side effects.
• This medicine is not approved for use in children. Talk with the doctor.
• This medicine is not approved for use in women. If you are a woman using this medicine (vardenafil tablets), talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

How is this medicine (Vardenafil Tablets) best taken?

Use this medicine (vardenafil tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take 60 minutes before sex.
• Read the package insert for more details.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Change in eyesight.
• Loss of eyesight.
• Change in hearing.
• Hearing loss.
• Ringing in ears.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

What are some other side effects of Vardenafil Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Flushing.
• Headache.
• Stuffy nose.
• Runny nose.
• Upset stomach.
• Back pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Vardenafil Tablets?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (vardenafil tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.