Microsoft word - 07 oct 23 viagra 0220-6.0.doc

PATIENT SUMMARY OF INFORMATION ABOUT

This summary contains important information about VIAGRA®. It is not meant to take the
place of your doctor’s instructions. Read this information carefully before you start taking
VIAGRA. Ask your doctor or pharmacist if you do not understand any of this information or if
you want to know more about VIAGRA.
This medicine can help many men when it is used as prescribed by their doctors. However,
VIAGRA is not for everyone. It is intended for use only by men who have a condition called
erectile dysfunction. VIAGRA 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 VIAGRA
with any nitrate medicine your blood pressure could suddenly drop to an unsafe or life
threatening level.
• WHAT IS VIAGRA?
VIAGRA 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. VIAGRA helps a man with erectile
dysfunction get an erection only when he is sexually excited.
• HOW SEX AFFECTS THE BODY
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.
• HOW VIAGRA WORKS
VIAGRA enables many men with erectile dysfunction to respond to sexual stimulation. When a
man is sexually excited, VIAGRA helps the penis fill with enough blood to cause an erection.
After sex is over, the erection goes away.
• VIAGRA 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 VIAGRA. If you take VIAGRA 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:
nitroglycerin (sprays, ointments, skin patches or pastes, and tablets that are swallowed or dissolved in the mouth) isosorbide mononitrate and isosorbide dinitrate (tablets that are swallowed, chewed, or dissolved in the mouth) 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.
VIAGRA is only for patients with erectile dysfunction. VIAGRA is not for newborns, children,
or women. Do not let anyone else take your VIAGRA. VIAGRA must be used only under a
doctor’s supervision.
• WHAT VIAGRA DOES NOT DO
VIAGRA does not cure erectile dysfunction. It is a treatment for erectile dysfunction. VIAGRA does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS. VIAGRA is not a hormone or an aphrodisiac.
• WHAT TO TELL YOUR DOCTOR BEFORE YOU BEGIN VIAGRA
Only your doctor can decide if VIAGRA is right for you. VIAGRA 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 VIAGRA alone or with your other
medicines. Your doctor should determine if your heart is healthy enough to handle the extra
strain of having sex.
have ever had any heart problems (e.g., angina, chest pain, heart failure, irregular heart beats, heart attack or narrowing of the aortic valve) have a rare inherited eye disease called retinitis pigmentosa have ever had any blood problems, including sickle cell anemia or leukemia are allergic to sildenafil or any of the other ingredients of VIAGRA tablets have a deformed penis, Peyronie’s disease, or ever had an erection that lasted more than 4 hours have stomach ulcers or any types of bleeding problems
• VIAGRA AND OTHER MEDICINES
Some medicines can change the way VIAGRA 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:
• Remember, VIAGRA should never be used with medicines that contain nitrates (see • If you are taking medicines called alpha-blockers for the treatment of high blood pressure or prostate problems, your blood pressure could suddenly drop. You could get dizzy or faint. • If you are taking a protease inhibitor, your dose may be adjusted (please see Finding • VIAGRA should not be used with any other medical treatments that cause erections. These treatments include pills, medicines that are injected or inserted into the penis, implants or vacuum pumps.
• FINDING THE RIGHT DOSE FOR YOU
VIAGRA 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.
Do not take more VIAGRA than your doctor prescribes. If you think you need a larger dose of VIAGRA, check with your doctor. VIAGRA should not be taken more than once a day. Your doctor may prescribe a lower dose of VIAGRA in certain circumstances. For example: 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 VIAGRA. 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 If you have prostate problems or high blood pressure for which you take medicines called alpha blockers, your doctor may start you on a lower dose of
• HOW TO TAKE VIAGRA
Take VIAGRA about one hour before you plan to have sex. Beginning in about 30 minutes and
for up to 4 hours, VIAGRA can help you get an erection if you are sexually excited. If you take
VIAGRA after a high-fat meal (such as a cheeseburger and french fries), the medicine may take
a little longer to start working. VIAGRA can help you get an erection when you are sexually
excited. You will not get an erection just by taking the pill.
• POSSIBLE SIDE EFFECTS
Like all medicines, VIAGRA 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 VIAGRA 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
VIAGRA) 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 VIAGRA, 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).
Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been
rarely reported in people taking PDE5 inhibitors, including VIAGRA. It is not possible to
determine whether these events are related directly to the PDE5 inhibitors, to other diseases or
medications, to other factors, or to a combination of factors. If you experience these symptoms,
stop taking VIAGRA and contact a doctor right away.
Heart attack, stroke, irregular heart beats, and death have been reported rarely in men taking
VIAGRA. 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 VIAGRA.
VIAGRA 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.
• ACCIDENTAL OVERDOSE
In case of accidental overdose, call your doctor right away.
• STORING VIAGRA
Keep VIAGRA out of the reach of children. Keep VIAGRA 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 VIAGRA
VIAGRA 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. If you have any questions or want
more information about VIAGRA, talk with your doctor or pharmacist, visit www.viagra.com, or
call 1-888-4VIAGRA.
October 2007

Source: http://www.lavc.edu/myweb/RASKOFSA/HS_Assignments/HSA_3_Solutions/M5A_Sol_Viagra_ppi.pdf