Avanafil Tablets

What is this medication?

AVANAFIL (av AN a fil) treats erection dysfunction (ED). It works by increasing blood flow to the penis, which helps to maintain an erection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Stendra

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anatomical deformation of the penis, Peyronie's disease, or history of priapism (painful and prolonged erection)
• Bleeding disorders
• Eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
• Heart disease, angina, a history of heart attack, irregular heart beats, or other heart problems
• High or low blood pressure
• History of blood diseases, like sickle cell anemia or leukemia
• History of stomach bleeding
• Kidney disease
• Liver disease
• Stroke
• An unusual or allergic reaction to avanafil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. The dose is taken 15 to 30 minutes before sexual activity, depending on the dose you are being prescribed. You should not take the dose more than once per day. Do not take your medication more often than directed.

Talk to your care team about the use of this medication in children. This medication is not used in children for this condition.

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. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Itraconazole
• Nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• Riociguat

This medication may also interact with the following:

• Carbamazepine
• Certain medications for high blood pressure
• Certain medications for the treatment of HIV infection or AIDS
• Certain medications used for fungal or yeast infections, like fluconazole, ketoconazole, and voriconazole
• Grapefruit juice
• Macrolide antibiotics like clarithromycin, erythromycin, troleandomycin
• Medications for prostate problems
• Phenobarbital
• Phenytoin
• Rifabutin, rifampin or rifapentine
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider 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 using this medication?

If you notice any changes in your vision while taking this medication, call your care team as soon as possible. Stop using this medication and call your care team right away if you have a loss of sight in one or both eyes.

Contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking this medication, you should refrain from further activity and call your care team as soon as possible.

Do not drink alcohol to excess (examples, 5 glasses of wine or 5 shots of whiskey) when taking this medication. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

Using this medication 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 receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Hearing loss or ringing in ears
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Prolonged or painful erection
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden vision loss in one or both eyes

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

• Back pain
• Facial flushing or redness
• Headache
• Runny or stuffy nose
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 30 degrees C (68 and 86 degrees F). Protect from light. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.