Stendra 200mg Tablets – 30 Count Bottle

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

AVANAFIL – ORAL

(a-VAN-a-fil)

COMMON BRAND NAME(S): Stendra

USES: Avanafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, avanafil 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). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity. 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 avanafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually as needed. Take avanafil about 30 minutes before sexual activity. Do not take more than once daily. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if your condition does not improve.

SIDE EFFECTS: Headache, flushing, or dizziness may occur. If any of these effects persist or worsen, 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 your doctor has prescribed this medication because he or she 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 in one or both eyes (NAION) may occur. This effect may or may not be caused by avanafil. If this serious problem occurs, stop taking avanafil 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 avanafil 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.

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. 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 avanafil, 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, a severe loss of body water (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. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. 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. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.

DRUG INTERACTIONS: 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. A product that may interact with this drug is: riociguat. Avanafil 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 avanafil 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. Your doctor may start treatment with a lower dose of avanafil to minimize your risk of low blood pressure. Other medications can affect the removal of avanafil from your body, which may affect how avanafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as indinavir, ritonavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), nefazodone, rifampin, among others. Do not take this medication with any other product that contains avanafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil, vardenafil).

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: Not applicable.