IMPORTANT SAFETY INFORMATION

Do not take Sildenafil if you:

• take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
• are allergic to sildenafil, as contained in Sildenafil and REVATIO, or any of the ingredients in Sildenafil

Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate medical help

Sildenafil can cause serious side effects. Rarely 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. If it is not treated right away, priapism can permanently damage your penis
• 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). Stop taking Sildenafil and call your healthcare provider right away if youhave any sudden vision loss
• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Sildenafil and contact a doctor right away

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

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
• have had heart surgery within the last 6 months
• have pulmonary hypertension
• 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 NAION
• have bleeding problems
• have or have had stomach ulcers
• have liver problems
• have kidney problems or are having kidney dialysis
• have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sildenafil may affect the way other medicines work, and other medicines may affect the way Sildenafil works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates
• medicines called guanylate cyclase stimulators such as Adempas (riociguat)
• medicines called alpha-blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Sildenafil with alpha-blockers can lead to a drop in blood pressure or to fainting
• medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase), or atazanavir sulfate (Reyataz)
• some types of oral antifungal medicines, such as ketoconazole (Nizoral) and itraconazole (Sporanox)
• some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
• other medicines that treat high blood pressure
• other medicines or treatments for ED
• Sildenafil contains sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH).
• Sildenafil should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])

Sildenafil does not protect against sexually transmitted diseases, including HIV.

The most common side effects of Sildenafil: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.

INDICATION

Sildenafil is prescription medicine used to treat erectile dysfunction (ED).

Sildenafil is not for women or children.

Please see full prescribing information for Sildenafil (25 mg, 50 mg, 100 mg) tablets.

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event to the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.