Avanafil Oral tablet
What is this medicine?
AVANAFIL (ah VA Na fil) is used to treat erection problems in men.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:bleeding disorders
eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
anatomical deformation of the penis, Peyronie’s disease, or history of priapism (painful and prolonged erection)
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
an unusual or allergic reaction to avanafil, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine 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 medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. This medicine is not used in children for this condition.
Overdosage: If you think you've 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 medicine?
Do not take this medicine with any of the following medications:
nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
other medicines for erectile dysfunction like sildenafil, tadalafil, vardenafil
This medicine may also interact with the following medications:
certain drugs for high blood pressure
certain drugs for the treatment of HIV infection or AIDS
certain drugs used for fungal or yeast infections, like fluconazole, itraconazole, ketoconazole, and voriconazole
macrolide antibiotics like clarithromycin, erythromycin, troleandomycin
medicines for prostate problems
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 medicine?
If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Stop using this medicine and call your health care provider right away if you have a loss of sight in one or both eyes.
Contact your doctor or health care professional 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 medicine, you should refrain from further activity and call your doctor or health care professional as soon as possible.
Do not drink alcohol to excess (examples, 5 glasses of wine or 5 shots of whiskey) when taking this medicine. 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 medicine 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 medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
changes in hearing
changes in vision
fast, irregular heartbeat
prolonged or painful erection
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
stuffy or runny nose
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 medicine?
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 medicine 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.
March 21, 2017
U.S. FDA-approved Package Insert