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Consult your health care provider before using any drug.
Read the Patient Information
about LEVITRA before you start taking it and again each time you get
a refill. There may be new information. You may also find it helpful
to share this information with your partner. This leaflet does not
take the place of talking with your doctor. You and your doctor
should talk about LEVITRA when you start taking it and at regular
checkups. If you do not understand the information, or have
questions, talk with your doctor or pharmacist.
information should you know about LEVITRA?
LEVITRA can cause your
blood pressure to drop suddenly to an unsafe level if it is taken
with certain other medicines. With a
sudden drop in blood pressure, you could get dizzy, faint, or have a
heart attack or stroke.
Do not take LEVITRA if
- take any medicines called "nitrates."
- use recreational drugs called "poppers" like
amyl nitrate and butyl nitrate.
- take medicines called alpha-blockers.
(See "Who Should Not Take
Tell all your healthcare
providers that you take LEVITRA. If you
need emergency medical care for a heart problem, it will be
important for your health care provider to know when you last took
What is LEVITRA?
LEVITRA is a prescription
medicine taken by mouth for the treatment of erectile dysfunction
(ED) in men.
ED is a condition where the
penis does not harden and expand when a man is sexually excited, or
when he cannot keep an erection. A man who has trouble getting or
keeping an erection should see his doctor for help if the condition
bothers him. LEVITRA may help a man with ED get and keep an erection
when he is sexually excited.
LEVITRA does not:
- cure ED
- increase a man's sexual desire
- protect a man or his partner from sexually
transmitted diseases, including HIV. Speak to your doctor about
ways to guard against sexually transmitted diseases.
- serve as a male form of birth control
LEVITRA is only for men with
ED. LEVITRA is not for women or children. LEVITRA must be used only
under a doctor's care.
How does LEVITRA work?
When a man is sexually
stimulated, his body's normal physical response is to increase blood
flow to his penis. This results in an erection. LEVITRA helps
increase blood flow to the penis and may help men with ED get and
keep an erection satisfactory for sexual activity. Once a man has
completed sexual activity, blood flow to his penis decreases, and
his erection goes away.
Who can take LEVITRA?
Talk to your doctor to
decide if LEVITRA is right for you.
LEVITRA has been shown to be
effective in men over the age of 18 years who have erectile
dysfunction, including men with diabetes or who have undergone
Who should not take
Do not take LEVITRA if
- take any medicines called "nitrates"
(See "What important information should you know about LEVITRA?").
Nitrates are commonly used to treat angina. Angina is a symptom of
heart disease and can cause pain in your chest, jaw, or down your
Medicines called nitrates include nitroglycerin that is found in
tablets, sprays, ointments, pastes, or patches. Nitrates can also
be found in other medicines such as isosorbide dinitrate or
isosorbide mononitrate. Some recreational drugs called "poppers"
also contain nitrates, such as amyl nitrate and butyl nitrate. Do
not use LEVITRA if you are using these drugs. Ask your doctor or
pharmacist if you are not sure if any of your medicines are
- take medicines called "alpha-blockers."
Alpha-blockers are sometimes prescribed for prostate problems or
high blood pressure. If LEVITRA is taken with alpha-blockers, your
blood pressure could suddenly drop to an unsafe level. You could
get dizzy and faint.
- you have been told by your healthcare
provider to not have sexual activity because of health problems.
Sexual activity can put an extra strain on your heart, especially
if your heart is already weak from a heart attack or heart
- are allergic to LEVITRA or any of its
ingredients. The active ingredient in
LEVITRA is called vardenafil. See the end of this leaflet for a
complete list of ingredients.
What should you discuss
with your doctor before taking LEVITRA?
Before taking LEVITRA,
tell your doctor about all your medical problems, including if you:
- have heart problems
such as angina, heart failure, irregular heartbeats, or have had a
heart attack. Ask your doctor if it is safe for you to have sexual
- have low blood pressure or
have high blood pressure that is not controlled
- have had a stroke
- or any family members have a rare heart
condition known as prolongation of the QT interval (long QT
- have liver problems
- have kidney problems and require dialysis
- have retinitis pigmentosa,
a rare genetic (runs in families) eye disease
- have stomach ulcers
- have a bleeding problem
- have a deformed penis shape
or Peyronie's disease
- have had an erection that lasted more than 4
- have blood cell problems
such as sickle cell anemia, multiple myeloma, or leukemia
Can other medications
Tell your doctor about all
the medicines you take including prescription and non-prescription
medicines, vitamins, and herbal supplements. LEVITRA and other
medicines may affect each other. Always check with your doctor
before starting or stopping any medicines. Especially tell your
doctor if you take any of the following:
- medicines called nitrates (See "What important
information should you know about LEVITRA?")
- medicines called alpha-blockers. These include
Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin
mesylate), Minipress® (prazosin HCl) or Uroxatral® (alfuzosin HCl).
- medicines that treat abnormal heartbeat. These
include quinidine, procainamide, amiodarone and sotalol.
- ritonavir (Norvir®) or indinavir sulfate (Crixivan®)
- ketoconazole or itraconazole (such as Nizoral®
- other medicines or treatments for ED
How should you take
Take LEVITRA exactly as your
doctor prescribes. LEVITRA comes in different doses (2.5 mg, 5 mg,
10 mg, and 20 mg). For most men, the recommended starting dose is 10
mg. Take LEVITRA no more than once a day. Doses should be
taken at least 24 hours apart. Some men can only take a low dose of
LEVITRA because of medical conditions or medicines they take. Your
doctor will prescribe the dose that is right for you.
- If you are older than 65 or have liver
problems, your doctor may start you on a lower dose of LEVITRA.
- If you are taking certain other medicines your
doctor may prescribe a lower starting dose and limit you to one
dose of LEVITRA in a 72-hour (3 days) period.
Take 1 LEVITRA tablet about
1 hour (60 minutes) before sexual activity. Some form of sexual
stimulation is needed for an erection to happen with LEVITRA.
LEVITRA may be taken with or without meals.
Do not change your dose of
LEVITRA without talking to your doctor. Your doctor may lower your
dose or raise your dose, depending on how your body reacts to
If you take too much
LEVITRA, call your doctor or emergency room right away.
What are the possible
side effects of LEVITRA?
The most common side effects
with LEVITRA are headache, flushing, stuffy or runny nose,
indigestion, upset stomach, or dizziness. These side effects usually
go away after a few hours. Call your doctor if you get a side effect
that bothers you or one that will not go away.
LEVITRA may uncommonly
- an erection that won't go away (priapism).
If you get an erection that lasts more than 4 hours, get medical
help right away. Priapism must be treated as soon as possible or
lasting damage can happen to your penis including the inability to
- vision changes,
such as seeing a blue tinge to objects or having difficulty
telling the difference between the colors blue and green.
These are not all the side
effects of LEVITRA. For more information, ask your doctor or
How should LEVITRA be
- Store LEVITRA at room temperature between 59°
and 86° F (15° to 30° C).
- Keep LEVITRA and all medicines out of the
reach of children.
Medicines are sometimes
prescribed for conditions other than those described in patient
information leaflets. Do not use LEVITRA for a condition for which
it was not prescribed. Do not give LEVITRA to other people, even if
they have the same symptoms that you have. It may harm them.
This leaflet summarizes the
most important information about LEVITRA. If you would like more
information, talk with your healthcare provider. You can ask your
doctor or pharmacist for information about LEVITRA that is written
for health professionals.
For more information you can
www.LEVITRA.com , or call 1-866-LEVITRA.
What are the
ingredients of LEVITRA?
microcrystalline cellulose, crospovidone, colloidal silicon dioxide,
magnesium stearate, hypromellose, polyethylene glycol, titanium
dioxide, yellow ferric oxide, and red ferric oxide.
Norvir (ritonavir) is a
trademark of Abbott Laboratories
Crixivan (indinavir sulfate) is a trademark of Merck & Co., Inc.
Nizoral (ketoconazole) is a trademark of Johnson & Johnson
Sporanox (itraconazole) is a trademark of Johnson & Johnson
Hytrin (terazosin HCl) is a trademark of Abbott Laboratories
Flomax (tamsulosin HCl) is a trademark of Yamanouchi Pharmaceutical
Cardura (doxazosin) is a trademark of Pfizer Inc.
Minipress (prazosin HCl) is a trademark of Pfizer Inc.
Uroxatral (alfuzosin HCl) is a trademark of Sanofi-Synthelabo