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PATIENT SUMMARY OF INFORMATION ABOUT
This medicine can help many men when it is used as prescribed by their doctors. However, SILDENAFIL is not for everyone. It is intended for use only by men who have a condition called erectile dysfunction. SILDENAFIL must never be used by men who are taking medicines that contain nitrates of any kind, at any time. This includes nitroglycerin. If you take SILDENAFIL with any nitrate medicine your blood pressure could suddenly drop to an unsafe or life threatening level.
SILDENAFIL is a pill used to treat erectile dysfunction (impotence) in men. It can help many men who have erectile dysfunction get and keep an erection when they become sexually excited (stimulated). You will not get an erection just by taking this medicine. SILDENAFIL helps a man with erectile dysfunction get an erection only when he is sexually excited.
When a man is sexually excited, the penis rapidly fills with more blood than usual. The penis then expands and hardens. This is called an erection. After the man is done having sex, this extra blood flows out of the penis back into the body. The erection goes away. If an erection lasts for a long time (more than 6 hours), it can permanently damage your penis. You should call a doctor immediately if you ever have a prolonged erection that lasts more than 4 hours. Some conditions and medicines interfere with this natural erection process. The penis cannot fill with enough blood. The man cannot have an erection. This is called erectile dysfunction if it becomes a frequent problem. During sex, your heart works harder. Therefore sexual activity may not be advisable for people who have heart problems. Before you start any treatment for erectile dysfunction, ask your doctor if your heart is healthy enough to handle the extra strain of having sex. If you have chest pains, dizziness or nausea during sex, stop having sex and immediately tell your doctor you have had this problem.
SILDENAFIL enables many men with erectile dysfunction to respond to sexual stimulation. When a man is sexually excited, SILDENAFIL helps the penis fill with enough blood to cause an erection. After sex is over, the erection goes away.
SILDENAFIL Is Not for Everyone As noted above (How Sex Affects the Body), ask your doctor if your heart is healthy enough for sexual activity. If you take any medicines that contain nitrates – either regularly or as needed – you should never take SILDENAFIL. If you take SILDENAFIL with any nitrate medicine or recreational drug containing nitrates, your blood pressure could suddenly drop to an unsafe level. You could get dizzy, faint, or even have a heart attack or stroke. Nitrates are found in many prescription medicines that are used to treat angina (chest pain due to heart disease) such as:
Nitrates are also found in recreational drugs such as amyl nitrate or nitrite (“poppers”). If you are not sure if any of your medicines contain nitrates, or if you do not understand what nitrates are, ask your doctor or pharmacist. SILDENAFIL is only for patients with erectile dysfunction. SILDENAFIL is not for newborns, children, or women. Do not let anyone else take your SILDENAFIL. SILDENAFIL must be used only under a doctor’s supervision.
What To Tell Your Doctor Before You Begin SILDENAFIL Only your doctor can decide if SILDENAFIL is right for you. SILDENAFIL can cause mild, temporary lowering of your blood pressure. You will need to have a thorough medical exam to diagnose your erectile dysfunction and to find out if you can safely take SILDENAFIL alone or with your other medicines. Your doctor should determine if your heart is healthy enough to handle the extra strain of having sex. Be sure to tell your doctor if you:
SILDENAFIL and Other Medicines Some medicines can change the way SILDENAFIL works. Tell your doctor about any medicines you are taking. Do not start or stop taking any medicines before checking with your doctor or pharmacist. This includes prescription and nonprescription medicines or remedies:
Finding the Right Dose for You SILDENAFIL comes in different doses (25 mg, 50 mg and 100 mg). If you do not get the results you expect, talk with your doctor. You and your doctor can determine the dose that works best for you.
If you are older than age 65, or have serious liver or kidney problems, your doctor may start you at the lowest dose (25 mg) of SILDENAFIL. If you are taking protease inhibitors, such as for the treatment of HIV, your doctor may recommend a 25 mg dose and may limit you to a maximum single dose of 25 mg of SILDENAFIL in a 48 hour period. If you are taking alpha-blocker therapy, you should not take a dose of greater than 25 mg of SILDENAFIL at the same time (within 4 hours) as your dose of alpha-blocker.
Take SILDENAFIL about one hour before you plan to have sex. Beginning in about 30 minutes and for up to 4 hours, SILDENAFIL can help you get an erection if you are sexually excited. If you take SILDENAFIL after a high-fat meal (such as a cheeseburger and french fries), the medicine may take a little longer to start working. SILDENAFIL can help you get an erection when you are sexually excited. You will not get an erection just by taking the pill.
Like all medicines, SILDENAFIL can cause some side effects. These effects are usually mild to moderate and usually don’t last longer than a few hours. Some of these side effects are more likely to occur with higher doses. The most common side effects of SILDENAFIL are headache, flushing of the face, and upset stomach. Less common side effects that may occur are temporary changes in color vision (such as trouble telling the difference between blue and green objects or having a blue color tinge to them), eyes being more sensitive to light, or blurred vision. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including SILDENAFIL) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including SILDENAFIL, and call a doctor right away. In rare instances, men have reported an erection that lasts many hours. You should call a doctor immediately if you ever have an erection that lasts more than 4 hours. If not treated right away, permanent damage to your penis could occur (see How Sex Affects the Body). Heart attack, stroke, irregular heart beats, and death have been reported rarely in men taking SILDENAFIL. Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to SILDENAFIL. SILDENAFIL may cause other side effects besides those listed on this sheet. If you want more information or develop any side effects or symptoms you are concerned about, call your doctor.
In case of accidental overdose, call your doctor right away.
Keep SILDENAFIL out of the reach of children. Keep SILDENAFIL in its original container. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
For More Information on SILDENAFIL SILDENAFIL is a prescription medicine used to treat erectile dysfunction. Only your doctor can decide if it is right for you. This sheet is only a summary.
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This summary contains important information about SILDENAFIL.
It is not meant to take the place of your doctor’s instructions. Read this information carefully before you start taking SILDENAFIL. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about SILDENAFIL.
