Information for LEVITRA® (vardenafil HCl) Tablets
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®
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 LEVITRA®")
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 LEVITRA®.
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.
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
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
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 prostatectomy.
should not take LEVITRA? Do
not take LEVITRA® if you:
take any medicines called "nitrates"
(See "What is the most important information I should
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
arm. 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 nitrates.
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
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 disease.
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.
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 activity.
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 syndrome)
have liver problems
have kidney problems and require
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
have had an erection that lasted
more than 4 hours
have blood cell problems such as
sickle cell anemia, multiple myeloma, or leukemia
other medications affect LEVITRA®?
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
is the most important information I should know about
medicines called alpha blockers.
These include Hytrin® (terazosin), Flomax®
(tamsulosin), Cardura® (doxazosin), Minipress®
(prazosin) or Uroxatral® (alfuzosin).
medicines that treat abnormal heartbeat.
These include quinidine, procainamide, amiodarone
and sotalol. ritonavir (Norvir®) or indinavir
ketoconazole or itraconazole (such
as Nizoral® or Sporanox®)
other medicines or treatments for
should you take LEVITRA®?
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 LEVITRA®.
If you take too much LEVITRA®, call
your doctor or emergency room right away.
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.
may uncommonly cause: 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 have erections. 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 pharmacist.
How should LEVITRA® be stored?
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. General Information about LEVITRA®.
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.
are the ingredients of LEVITRA®?
Active Ingredient: vardenafil hydrochloride Inactive
Ingredients: microcrystalline cellulose, crospovidone,
colloidal silicon dioxide, magnesium stearate, hypromellose,
polyethylene glycol, titanium dioxide, yellow ferric
oxide, and red ferric oxide.