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Cialis

GENERIC NAME(S): TADALAFIL

Uses

Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction -ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.

Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia -BPH ). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder .

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

How to use Cialis

Read the Patient Information Leaflet provided by your pharmacist before you start taking tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth. with or without food, as directed by your doctor. Do not take tadalafil more often than once daily.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To treat the symptoms of BPH. take this medication as directed by your doctor, usually once a day. If you are also taking finasteride with this medication to treat symptoms of BPH, talk with your doctor about how long you should continue taking this medication.

To treat erectile dysfunction -ED, there are 2 ways that tadalafil may be prescribed. Your doctor will determine which is the best way for you to take tadalafil. Follow your doctor's directions exactly since your dosage depends on how you are taking it. The first way is to take it as needed, usually at least 30 minutes before sexual activity. Tadalafil's effect on sexual ability may last up to 36 hours.

The second way to treat ED is to take tadalafil regularly, once a day every day. If you take it this way, you may attempt sexual activity at any time between your doses.

If you are taking tadalafil to treat both ED and BPH, take it as directed by your doctor, usually once a day. You may attempt sexual activity at any time between your doses.

If you are taking tadalafil once daily for BPH, or for ED, or for both, take it regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Headache. stomach upset, back pain. muscle pain. stuffy nose, flushing, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Sexual activity may put extra strain on your heart. especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex. stop and get medical help right away: severe dizziness, fainting. chest/jaw/left arm pain, nausea .

Rarely, sudden decreased vision. including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking tadalafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease. diabetes. high cholesterol. certain other eye problems ("crowded disk"), high blood pressure. if you are over 50, or if you smoke.

Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking tadalafil and get medical help right away if these effects occur.

In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction. including: rash, itching /swelling (especially of the face/tongue /throat), severe dizziness, trouble breathing .

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking tadalafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure, a severe loss of body water (dehydration), penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This brand of the drug is not usually used in women. During pregnancy, tadalafil should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: riociguat.

Tadalafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use tadalafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite.

If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of tadalafil or adjust your alpha blocker medication to minimize your risk of low blood pressure.

Other medications can affect the removal of tadalafil from your body, which may affect how tadalafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as fosamprenavir, ritonavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), rifampin, among others.

Do not take this medication with any other product that contains tadalafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil).

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

If you are taking this medication on a regular schedule and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.

Images

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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See additional information.

CIALIS for ED+BPH (erectile dysfunction + symptoms of benign prostatic hyperplasia)

2 conditions, 1 medication

Only CIALIS for daily use (5 mg) is approved to treat ED and the frustrating urinary symptoms of BPH

If you're one of the many men with ED and symptoms of BPH, like needing to go frequently, day or night, CIALIS for daily use (5 mg) may treat both conditions.

Getting started with CIALIS for daily use (5 mg)

Take CIALIS for daily use (5 mg) once a day, every day at about the same time CIALIS may be taken with or without meals Do not drink alcohol in excess with CIALIS Avoid skipping doses and do not split tablets, as you may not receive an adequate dose If you miss a dose, take it when you remember, but do not take CIALIS more than once each day

You may see symptom improvement in as early as 2 weeks after beginning treatment, although it could take about 4 weeks

CIALIS for daily use (5 mg) is the recommended dose to treat both ED and the symptoms of BPH. The recommended starting dose of CIALIS for daily use for the treatment of ED is 2.5 mg.

The most important information
to know about CIALIS

Do not take CIALIS if you:Take medicines called“nitrates” A type of medicine commonly used to treat heart problems. These medicines relax and widen blood vessels. This allows more blood to flow to the heart, which makes the heart work less hard. Some recreational drugs called "poppers," like amyl nitrite and butyl nitrite, also contain nitrates. such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, as the combination may cause an unsafe drop in blood pressure; or use recreational
drugs called “poppers” A slang term for various chemical compounds, including amyl nitrite and butyl nitrite, that are used for recreational purposes. The chemical compound is inhaled to increase sexual desire. like amyl nitrite and butyl nitrite Take medicines called“guanylate cyclase stimulators” Medications used to treat pulmonary hypertension. such as riociguat (Adempas ® ),* a medicine used to treat pulmonary hypertension, as the combination may cause an unsafe drop in blood pressure Are allergic to CIALIS or ADCIRCA ® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as: RashHives Swelling of the lips, tongue, or throat Difficulty breathing or swallowing

After taking a single tablet, some of the active ingredient of CIALIS remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if it is already weak from a heart attack or heart disease.

*The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

Remembering to take CIALIS

Make it part of your routine Take CIALIS for daily use with your favorite morning beverage or evening meal

Keep track of your doseDo not take CIALIS more than one time each day

Don’t wait until the last minute to get a refill Sign up for refill notices if your local pharmacy offers a prescription reminder program

Side effects with CIALIS

The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon but serious side effects include: An erection that won't go away. If you get an erection that lasts more than 4 hours, seek immediate medical help to avoid long-term injury In rare instances, men taking prescription ED tablets, including CIALIS, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It's not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS, and call a healthcare provider right away

These are not all the possible side effects of CIALIS.

Call your healthcare provider if you experience any side effects that bother you or don't go away. And please see Important Safety Information and full Patient Information for additional information.

Indications: CIALIS is approved to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. Taking CIALIS with finasteride when starting BPH treatment has been studied for 26 weeks. CIALIS is not for women or children.

IMPORTANT SAFETY INFORMATION FOR CIALIS

What Is The Most Important Information I Should Know About CIALIS?

Do not take CIALIS if you:take medicines called “nitrates” such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure; or use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. take medicines called guanylate cyclase stimulators such as riociguat (Adempas ® ),* a medicine used to treat pulmonary hypertension as the combination may cause an unsafe drop in blood pressure. are allergic to CIALIS or ADCIRCA ® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing.

After taking a single tablet, some of the active ingredient of CIALIS remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if it is already weak from a heart attack or heart disease.

What Should I Tell My Healthcare Provider Before Taking CIALIS?

CIALIS is not right for everyone. Only your healthcare provider and you can decide if CIALIS is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. Do not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking CIALIS, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or heart attack pulmonary hypertensionlow blood pressure or high blood pressure that is not controlled strokeliver or kidney problems or require dialysisretinitis pigmentosa. a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAIONstomach ulcers or a bleeding problema deformed penis shape or Peyronie’s disease an erection that lasted more than 4 hoursblood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Can Other Medicines Affect CIALIS?

Tell your healthcare provider about all the medicines you take, especially: medicines called "nitrates" which are often prescribed for chest pain medicines called guanylate cyclase stimulators, such as riociguat (Adempas ® ), used to treat pulmonary arterial hypertension and chronic-thromboembolic hypertension alpha-blockers often prescribed for prostate problems blood pressure medications medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (ED) CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take both CIALIS and ADCIRCA. Do not take sildenafil citrate (Revatio ® )* with CIALIS.

How Should I Take CIALIS?

CIALIS should not be taken more than one time each day. If you miss a dose, you may take it when you remember but do not take more than one dose per day. Take CIALIS exactly as your healthcare provider prescribes it.

What Should I Avoid While Taking CIALIS?

Do not use other ED medicines or ED treatments. Do not drink too much alcohol (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What Are The Possible Side Effects Of CIALIS?

The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon but serious side effects include:
An erection that won’t go away: If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

In rare instances, men taking prescription ED tablets, including CIALIS, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It’s not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS and call a healthcare provider right away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 .

CIALIS does not:
Cure ED, increase a man's sexual desire, protect a man or his partner from sexually transmitted diseases, including HIV or serve as a male form of birth control.

CIALIS is available by prescription only.

*The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

TD CON ISI 16SEP2015

What is Cialis (tadalafil)?

Cialis (tadalafil) relaxes muscles and increases blood flow to particular areas of the body.
Cialis (tadalafil) is used to treat erectile dysfunction (impotence).
Cialis (tadalafil) may also be used for purposes other than those listed in this medication guide.

What should I discuss with my doctor before taking Cialis (tadalafil)?

Do not take Cialis (tadalafil) if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

A small number of patients have had a sudden loss of eyesight after taking tadalafil. This type of vision loss is caused by decreased blood flow to the optic nerve of the eye. It is not clear whether tadalafil is the actual cause of such vision loss. Sudden vision loss with tadalafil use has occurred most often in people with heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

Before taking Cialis (tadalafil), tell your doctor if you have:
heart disease or heart rhythm problems;
a recent history of heart attack (within the past 90 days);
a recent history of stroke or congestive heart failure (within the past 6 months);
angina (chest pain);
high or low blood pressure;
liver disease;
kidney disease (or if you are on dialysis);
a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
a bleeding disorder such as hemophilia;
a stomach ulcer;
retinitis pigmentosa (an inherited condition of the eye);
a physical deformity of the penis (such as Peyronie's disease); or
if you have been told you should not have sexual intercourse for health reasons.

If you have any of these conditions, you may not be able to use tadalafil or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B: Although tadalafil is not for use in women, this medication is not expected to be harmful to an unborn baby. Do not use tadalafil without telling your doctor if you are pregnant or plan to become pregnant during treatment.
Although Cialis (tadalafil) is not for use in women, it is not known if tadalafil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
You may need a lower dose of this medication if you are older than 65. Follow your doctor's instructions.

How should I take Cialis (tadalafil)?

Take each dose with a full glass of water.
Avoid taking High-fat food before taking Viagra as it may cause the medicine to take more time to start working.
Tadalafil is usually taken only when needed, 30 - 60 minutes before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.
Do not take tadalafil more than once a day. Allow 24 hours to pass between doses.
Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since tadalafil is used as needed, you are not likely to be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a tadalafil overdose may include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

What should I avoid while taking tadalafil?

Avoid drinking alcohol, which can increase some of the side effects of tadalafil.
Grapefruit and grapefruit juice may interact with tadalafil. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Do not use any other drug to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), unless your doctor tells you to.

What are the possible side effects of tadalafil?

If you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw during sexual activity, stop and call your doctor right away. You could be having a serious side effect of tadalafil.
Stop using tadalafil and get emergency medical help if you have sudden vision loss.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tadalafil and call your doctor at once if you have any of these serious side effects:
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
irregular heartbeat;
swelling in your hands, ankles, or feet;
shortness of breath;
vision changes;
feeling light-headed, fainting; or
penis erection that is painful or lasts 4 hours or longer.
Continue taking tadalafil and talk with your doctor if you have any of these less serious side effects:
warmth or redness in your face, neck, or chest;
stuffy nose;
headache;
upset stomach; or
back pain.
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.
What drug(s) may interact with Cialis (tadalafil)?

Do not take tadalafil if you are taking the following medications:
nitroglycerin-type drugs for the heart or chest pain such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, even if these are only taken occasionally

Cialis (tadalafil) may also interact with the following medications:
alpha blockers, such as alfuzosin (UroXatral), doxazosin (Cardura), prazosin (Minipress), or terazosin (Hytrin), used to treat high blood pressure or an enlarged prostate.
bosentan
certain antibiotics such as clarithromycin, erythromycin, troleandomycin
certain drugs used for seizures such as carbamazepine, phenytoin, and phenobarbital
cimetidine
cisapride
diltiazem
grapefruit juice
medicines for fungal infections (fluconazole, itraconazole, ketoconazole, voriconazole)
mibefradil
nicardipine
certain medicines for the treatment of HIV infection or AIDS
quinidine
rifabutin, rifampin or rifapentine
some drugs for treating depression, anxiety or other mood problems (examples: fluoxetine, fluvoxamine, nefazodone)
verapamil

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