Description

Product Overview

What SILDENAFIL is and what it is used for

SILDENAFIL is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. SILDENAFIL helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).
SILDENAFIL is not for use in women or children.
It is not known if SILDENAFIL is safe and effective in women or children under 18 years of age.

What you need to know before you take Sildenafil

•SILDENAFIL can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.
•Do not take SILDENAFIL if you take any other medicines called “nitrates.”
•Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.
•Tell all your healthcare providers that you take SILDENAFIL. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took SILDENAFIL.
•Stop sexual activity and get medical help right away if you get 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. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.
•SILDENAFIL does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.

Who should not take SILDENAFIL?

Do not take SILDENAFIL if you:
•take medicines called “nitrates” (such as nitroglycerin)
•use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitrate
•are allergic to Sildenafil, as contained in Sildenafil Citrate, See the end of this leaflet for a complete list of ingredients in SILDENAFIL.

What should I tell my healthcare provider before taking SILDENAFIL?
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 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 take1, 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 alpha blockers such as terazosin Hcl
•Tamsulosin Hcl
•Doxazosin mesylate
•Prazosin Hcl
•Alfuzosin Hcl
•Dutasteride and tamsulosin Hcl, or 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, indinavir sulfate, saquinavir or atazanavir sulfate.
•Some types of oral antifungal medicines, such as ketoconazole, and itraconazole.
•Some types of antibiotics, such as clarithromycin, telithromycin, or erythromycin.
•Other medicines that treat high blood pressure.
•Other medicines or treatments for ED

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.

How to take Sildenafil

•Take SILDENAFIL exactly as your healthcare provider tells you to take it.
•Your healthcare provider will tell you how much SILDENAFIL to take and when to take it.
•Your healthcare provider may change your dose if needed.
•Take SILDENAFIL about 1 hour before sexual activity. You may take SILDENAFIL between 30 minutes to 4 hours before sexual activity if needed.
•SILDENAFIL can be taken with or without food.
•If you take SILDENAFIL after a high fat meal (such as a cheeseburger and french fries), SILDENAFIL may take a little longer to start working
•Do not take SILDENAFIL more than 1 time a day.

If you accidentally take too much SILDENAFIL Call your doctor or go to the nearest hospital emergency room right away.

Possible Side Effects

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. Stop taking SILDENAFIL 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 and contact a doctor right away.

The most common side effects of SILDENAFIL 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. Most, but not all, of these men had heart problems before taking SILDENAFIL. It is not known if SILDENAFIL 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. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.

How to Store Sildenafil

•Store SILDENAFIL at room temperature between 68°F to 77°F (20°C to 25°C).
•Keep SILDENAFIL and all medicines out of the reach of children.