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What is CIALIS? CIALIS 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.CIALIS may help a man with ED get and keep an erection when he is sexually excited.(back to questions)

CIALIS 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

CIALIS is only for men with ED.CIALIS is not for women or children.CIALIS must be used only under a doctor's care. (back to questions)

How does CIALIS work? When a man is sexually stimulated, his body's normal physical response is to increase blood flow to his penis.CIALIS 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. Talk to your doctor to decide if CIALIS is right for you.CIALIS 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.(back to questions)

Who should not take CIALIS? Do not take CIALIS if you: · take any medicines called "nitrates".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 CIALIS 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", other than Flomax® 0.Alpha blockers are sometimes prescribed for prostate problems or high blood pressure.If CIALIS is taken with alpha blockers other than Flomax® 0.4 mg daily, your blood pressure could suddenly drop to an unsafe level.You could get dizzy and faint.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 CIALIS or any of its ingredients.The active ingredient in CIALIS is called tadalafil.(back to questions)

What should you discuss with your doctor before taking CIALIS? Before taking CIALIS, 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 · have liver problems

· have kidney problems or require dialysis

· have retinitis pigmentosa, a rare genetic (runs in families) eye disease

· have stomach ulcers

· have a deformed penis shape or Peyronie's disease

· have had an erection that lasted more than 4 hours

· have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia (back to questions)

Can other medications affect CIALIS? Tell your doctor about all the medicines you take including prescription and non prescription medicines, vitamins, and herbal supplements.CIALIS 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.These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl) or Uroxatral® (alfuzosin HCl).Norvir®) or indinavir (Crixivan®) · ketoconazole or itraconazole (such as Nizoral® or Sporanox®) · erythromycin · other medicines or treatments for ED (back to questions)

How should you take CIALIS?CIALIS comes in different doses (5 mg, 10 mg, and 20 mg).For most men, the recommended starting dose is 10 mg.CIALIS should be taken no more than once a day.Some men can only take a low dose of CIALIS because of medical conditions or medicines they take.Your doctor will prescribe the dose that is right for you.If you have kidney problems, your doctor may start you on a lower dose of CIALIS.If you have kidney or liver problems or you are taking certain medications, your doctor may limit your highest dose of CIALIS to 10 mg and may also limit you to one tablet in 48 hours (2 days) or one tablet in 72 hours (3 days).In some patients, the ability to have sexual activity was improved at 30 minutes after taking CIALIS when compared to a sugar pill.The ability to have sexual activity was improved up to 36 hours after taking CIALIS when compared to a sugar pill.You and your doctor should consider this in deciding when you should take CIALIS prior to sexual activity.Some form of sexual stimulation is needed for an erection to happen with CIALIS.CIALIS may be taken with or without meals.Do not change your dose of CIALIS without talking to your doctor.Your doctor may lower your dose or raise your dose, depending on how your body reacts to CIALIS.Do not drink alcohol to excess when taking CIALIS (for example, 5 glasses of wine or 5 shots of whiskey).When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.If you take too much CIALIS, call your doctor or emergency room right away.(back to questions)

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.Patients 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 by themselves within 48 hours.Call your doctor if you get a side effect that bothers you or one that will not go away.(back to questions)

CIALIS 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 CIALIS.For more information, ask your doctor or pharmacist. (back to questions)

How should CIALIS be stored? Store CIALIS at room temperature between 59° and 86°F (15° and 30°C).Keep CIALIS and all medicines out of the reach of children. (back to questions)

General Information. Cialis is not for everyone.If you take nitrates, often used for chest pain (also known as angina), or alpha-blockers (other than Flomax® 0.4 mg once daily), prescribed for prostate problems or high blood pressure, do not take Cialis.Such combinations could cause a sudden, unsafe drop in blood pressure.Don't drink alcohol in excess (to a level of intoxication) with Cialis.This combination may increase your chances of getting dizzy or lowering your blood pressure.Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV.

The most common side effects with Cialis were headache and upset stomach.Backache and muscle ache were also reported, sometimes with delayed onset.Most men weren't bothered by the side effects enough to stop taking Cialis.Although a rare occurrence, men who experience an erection for more than 4 hours (priapism) should seek immediate medical attention.Discuss your medical conditions and medications with your doctor to ensure Cialis is right for you and that you are healthy enough for sexual activity. In clinical trials, Cialis was shown to improve the ability of men with ED to have a single successful intercourse attempt as long as 36 hours after dosing.Cialis has not been studied for multiple sexual attempts per dose.

Flomax® (tamsulosin HCl) is a registered trademark of Boehringer Ingelheim

Cialis is available by prescription only.For additional safety information, talk to your doctor.

Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo dosing.There were 2, 2, and 1 outliers (subjects with a decrease from baseline in standing systolic blood pressure of > 30 mm Hg at one or more time points) following administration of tadalafil 10 mg, 20 mg, and placebo, respectively.There were no subjects with a standing systolic blood pressure < 85 mm Hg.No severe adverse events potentially related to blood-pressure effects were reported.No syncope was reported.

In the second tamsulosin study, healthy subjects (N=39 treated; and 35 completed) received 14 days of once per day dosing of tadalafil 5 mg or placebo in a two-period crossover design.4 mg was added for the last seven days of each period.