New FDA-Approved Labeling for Petros Pharmaceuticals’ STENDRA (avanafil) Now Includes Efficacy Data Regarding Use in Men Who Have Undergone Radical Prostatectomy - Seite 2

STENDRA Important Risk Information

STENDRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Do not take STENDRA if you:

• take medicines called nitrates, which are used to treat chest pain (angina)
• use street drugs called "poppers," such as amyl nitrite and butyl nitrite
• take medicines called guanylate cyclase stimulators, which include Adempas^® (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
• are allergic to avanafil or any of the ingredients in STENDRA

Stop sexual activity and get medical help right away if you have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Discuss your health with your healthcare provider to ensure you are healthy enough for sex.

STENDRA can cause serious side effects.

Uncommonly reported side effects include:

• An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away.
• Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes.
• Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness.

Before you take STENDRA, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure;
• have had heart surgery within the last 6 months;
• have had a stroke;
• have low blood pressure, or high blood pressure that is not controlled;
• have a deformed penis shape
• have had an erection that lasted for more than 4 hours;
• have problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia;
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease;
• have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION);
• have had a sudden decrease or loss of hearing;
• have bleeding problems;
• have or have had stomach ulcers;
• have liver problems;
• have kidney problems or are having kidney dialysis.

Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.