Sildenafil Citrate (generic Viagra®) Tablets

About this medicine

Sildenafil citrate (sildenafil tablets) is used to treat erectile dysfunction (ED). For full prescribing information, view the drug label information.

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Trade names

Viagra® (sildenafil citrate) The list of names may not include all products that are available on the market.

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How to take this medicine

• Take sildenafil tablets exactly as your healthcare provider tells you.
• Your healthcare provider will tell you how much to take and when to take the medication.
• Your healthcare provider may change your dose if needed.
• Take sildenafil tablets about 1 hour before sexual activity. You may take it between 30 minutes to 4 hours before sexual activity if needed.
• Sildenafil tablets can be taken with or without food.
• If you take it after a high fat meal (such as a cheeseburger and french fries), it may take a little longer to start working
• Do not take sildenafil tablets more than 1 time a day.
• If you accidentally take too many sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away.

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Who should not take this medicine?

Do not take sildenafil tablets if you:

• take medicines called nitrates (such as nitroglycerin)
• use street drugs called “poppers” (such as amyl nitrate or amyl nitrite, and butyl nitrate)
• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas®)
• are allergic to sildenafil, as contained in sildenafil tablets and REVATIO®, or any of the ingredients in sildenafil tablets.

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Side effects

Sildenafil tablets 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). It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking sildenafil tablets 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. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away.

The most common side effects of sildenafil tablets are:

• 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

In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. Most, but not all, of these men had heart problems before taking sildenafil tablets. It is not known if sildenafil tablets caused these problems.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of sildenafil tablets. For more information, ask your healthcare provider or pharmacist.

Contact your doctor if you have additional questions about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Storage

• Keep out of the reach of children
• Store at controlled room temperature, between 20°C to 25°C (68°F to 77°F)
• Throw away any unused medicine after the expiration date

Other important information

Medicine may not work

As with almost all medicine, the recommended treatments do not work for every single person. There is a risk the medicine will not work and your ED continues. If after more than 4 weeks your symptoms have not improved, you should consider scheduling an in-person visit with a doctor.

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Inform your healthcare providers

Before you take sildenafil tablets, 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 non-arteritic anterior ischemic optic neuropathy (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. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates
• medicines called guanylate cyclase stimulators, such as riociguat (Adempas)
• 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 tablets 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 tablets contain 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 tablets should not be used with REVATIO® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca® (tadalafil)).

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Telemedicine does not replace your primary care physician. It is important to keep your primary care physician and pharmacist informed of all medications you are taking, including those in your Keeps treatment plan, as they can interact with other medicines you may be taking.