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What is the most important information I should know about tadalafil?
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A small number of patients have lost eyesight in one eye after
taking tadalafil. This type of vision loss is called non-arteritic
anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss
of eyesight because blood flow is blocked to the optic nerve. It is not
clear at this time if tadalafil causes NAION. NAION also happens in
patients who do not take this medicine. People who have a higher chance
for NAION include those who: |
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have high blood pressure; |
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have certain eye problems. |
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Stop using tadalafil if you have any loss in your eyesight and seek
medical help right away. |
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Do not take tadalafil if you are taking any of the following
medicines: |
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a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur,
Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide
dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur,
ISMO, Monoket), and others; |
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nitrates are also found in some recreational drugs such as amyl
nitrate or nitrite ("poppers"); or |
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an alpha blocker (other than tamsulosin (Flomax) 0.4 mg once a day)
such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress),
terazosin (Hytrin), alfuzosin (Uroxatral), and others. |
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Taking tadalafil with any of these medications may cause very low
blood pressure, possibly resulting in dizziness, fainting, stroke, or
heart attack. |
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Contact your doctor or seek emergency medical attention for any
erection that lasts longer than 4 hours. A sustained erection can damage
the penis. |
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• |
Refrain from further sexual activity and notify your doctor it you
develop dizziness, nausea, or angina (pain, tightness, discomfort,
numbness, or tingling in the chest, arms, neck, or jaw) during sexual
activity. |
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• |
Tadalafil is usually taken when needed before sexual activity. The
effects of tadalafil may last for up to 36 hours or more. Your doctor
will determine how often you can take tadalafil. Do not take tadalafil
more often than is directed by your doctor. |
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Tadalafil relaxes muscles within the penis. This allows increased
blood flow into the penis, necessary to achieve and maintain an erection. |
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Tadalafil is used to treat erectile dysfunction (impotence). |
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Tadalafil may also be used for purposes other than those listed in
this medication guide. |
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What should I discuss with my healthcare provider before taking
tadalafil?
|
|
• |
A small number of patients have lost eyesight in one eye after
taking tadalafil. This type of vision loss is called non-arteritic
anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss
of eyesight because blood flow is blocked to the optic nerve. It is not
clear at this time if tadalafil causes NAION. NAION also happens in
patients who do not take this medicine. People who have a higher chance
for NAION include those who: |
| |
· |
have high blood pressure; |
| |
· |
have certain eye problems. |
|
• |
Stop using tadalafil if you have any loss in your eyesight and seek
medical help right away. |
|
• |
Do not take tadalafil if you are taking any of the following
medicines: |
| |
· |
a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur,
Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide
dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur,
ISMO, Monoket), and others; |
| |
· |
nitrates are also found in some recreational drugs such as amyl
nitrate or nitrite ("poppers"); or |
| |
· |
an alpha blocker (other than tamsulosin (Flomax) 0.4 mg once a day)
such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress),
terazosin (Hytrin), alfuzosin (Uroxatral), and others. |
|
• |
Taking tadalafil with any of these medications may cause very low
blood pressure, possibly resulting in dizziness, fainting, stroke, or
heart attack. |
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Before taking tadalafil, tell your doctor if you |
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have heart problems such as angina, heart failure, irregular
heartbeats, or have had a heart attack; |
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have low blood pressure or high blood pressure that is not
controlled; |
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have ever had blood cell problems such as sickle cell anemia,
multiple myeloma, or leukemia; |
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have a bleeding disorder; |
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have retinitis pigmentosa (an inherited condition of the eye); |
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have a physical deformity of the penis such as Peyronie's disease; |
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had an erection that lasted longer than 4 hours. |
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You may not be able to take tadalafil, or you may require a dosage
adjustment or special monitoring during treatment if you have any of the
conditions listed above. |
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Although tadalafil is not indicated for use by women, it is in the
FDA pregnancy category B. This means that tadalafil is not expected to
be harmful to an unborn baby. Tadalafil should not be taken by women. |
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It is not known whether tadalafil passes into breast milk. Tadalafil
should not be taken by women. |
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If you are over 65 years of age, you may be more likely to
experience side effects from tadalafil. Your doctor may prescribe a
lower dose of this medication. |
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How should I take tadalafil?
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Take tadalafil exactly as directed by your doctor. If you do not
understand these directions, ask your pharmacist, nurse, or doctor to
explain them to you. |
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Take each dose with a full glass of water. |
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• |
Tadalafil is usually taken when needed before sexual activity. The
effects of tadalafil may last for up to 36 hours or more. Your doctor
will determine how often you can take tadalafil. Do not take tadalafil
more often than is directed by your doctor. |
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Tadalafil can help achieve an erection when sexual stimulation
occurs. An erection will not occur just by taking a pill. |
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Tadalafil can be taken with or without food. |
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Tadalafil should not be taken with excessive amounts of alcohol (e.g.
5 or more drinks). Excessive alcohol may increase the risk of headache,
dizziness, increased heart rate, or low blood pressure when tadalafil is
taken. |
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If you develop dizziness, nausea, or angina (pain, tightness,
discomfort, numbness, or tingling in the chest, arms, neck, or jaw)
during sexual activity, refrain from further sexual activity and notify
your doctor. |
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• |
Contact your doctor or seek emergency medical attention for any
erection that lasts longer than 4 hours. A sustained erection can damage
the penis. |
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Grapefruit and grapefruit juice may interact with tadalafil. The
interaction could lead to potentially adverse effects. You should
discuss the use of grapefruit and grapefruit juice with your doctor. Do
not increase or decrease the amount of grapefruit products in your diet
without first talking to your doctor. |
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Store this medication at room temperature away from moisture and
heat. |
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What happens if I miss a dose?
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Tadalafil is used as needed, so you are not likely to miss a dose. |
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What happens if I overdose?
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Seek emergency medical attention if an overdose is suspected. |
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Symptoms of a tadalafil overdose are not known. |
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What should I avoid while taking tadalafil?
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Do not take any other drug used to treat impotence, such as
sildenafil (Viagra), vardenafil (Levitra), alprostadil (Caverject, Muse,
Edex) or yohimbine (Yocon, Yodoxin, others), without first talking to
your doctor. |
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Tadalafil should not be taken with excessive amounts of alcohol (e.g.
5 or more drinks). Excessive alcohol may increase the risk of headache,
dizziness, increased heart rate, or low blood pressure when tadalafil is
taken. |
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• |
Grapefruit and grapefruit juice may interact with tadalafil. The
interaction could lead to potentially adverse effects. You should
discuss the use of grapefruit and grapefruit juice with your doctor. Do
not increase or decrease the amount of grapefruit products in your diet
without first talking to your doctor. |
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What are the possible side effects of tadalafil?
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If you experience any of the following serious side effects, stop
taking tadalafil and seek emergency medical attention or contact your
doctor immediately: |
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an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives); |
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chest pain or irregular heartbeats; |
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dizziness, nausea, or angina (pain, tightness, discomfort, numbness,
or tingling in the chest, arms, neck, or jaw); |
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swelling of the ankles or legs; |
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prolonged or severe dizziness; or |
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a prolonged (lasting longer than 4 hours) or painful erection. |
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Other, less serious side effects may be more likely to occur.
Continue to take tadalafil and talk to your doctor if you experience |
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stuffy or runny nose; or |
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temporary blue tint in vision or difficulty telling the difference
between the colors blue and green (uncommon). |
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Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome. |
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What other drugs will affect tadalafil?
|
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• |
Do not take tadalafil if you are taking any of the following
medicines: |
| |
· |
a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur,
Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide
dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur,
ISMO, Monoket), and others; |
| |
· |
nitrates are also found in some recreational drugs such as amyl
nitrate or nitrite ("poppers"); or |
| |
· |
an alpha blocker (other than tamsulosin (Flomax) 0.4 mg once a day)
such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress),
terazosin (Hytrin), alfuzosin (Uroxatral), and others. |
|
• |
Taking tadalafil with any of these medications may cause very low
blood pressure, possibly resulting in dizziness, fainting, stroke, or
heart attack. |
|
• |
Before taking tadalafil, tell your doctor if you are taking any of
the following medications: |
| |
· |
any other drug used to treat impotence, such as sildenafil (Viagra),
vardenafil (Levitra), alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon,
Yodoxin, others); |
| |
· |
the antibiotic erythromycin (E-Mycin, Eryc, Ery-Tab, others); |
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an antifungal medication such as itraconazole (Sporanox) or
ketoconazole (Nizoral); or |
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HIV medications such as indinavir (Crixivan), ritonavir (Norvir),
and others. |
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You may not be able to take tadalafil, or you may require a dosage
adjustment or special monitoring during treatment if you are taking any
of the medicines listed above. |
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Drugs other than those listed here may also interact with tadalafil
or affect your condition. Talk to your doctor or pharmacist before
taking any prescription or over-the-counter medicines, including
vitamins, minerals, and herbal products. |
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Where can I get more information?
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Your pharmacist has additional information about tadalafil written
for health professionals that you may read. |
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Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed. |
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Every effort has been made to ensure that the information provided
by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete,
but no guarantee is made to that effect. Drug information contained
herein may be time sensitive. Multum information has been compiled for
use by healthcare practitioners and consumers in the United States and
therefore Multum does not warrant that uses outside of the United States
are appropriate, unless specifically indicated otherwise. Multum's drug
information does not endorse drugs, diagnose patients or recommend
therapy. Multum's drug information is an informational resource designed
to assist licensed healthcare practitioners in caring for their patients
and/ or to serve consumers viewing this service as a supplement to, and
not a substitute for, the expertise, skill, knowledge and judgment of
healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug
or drug combination is safe, effective or appropriate for any given
patient. Multum does not assume any responsibility for any aspect of
healthcare administered with the aid of information Multum provides. The
information contained herein is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions,
or adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist. |
Copyright 1996-2005 Cerner Multum, Inc. Version: 2.01. Revision date: 7/
11/ 05. |