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12 CLINICAL PHARMACOLOGY

You may attempt sexual activity at any time between doses.If you miss a dose, you may take it when you remember but do not take more than one dose per day.Some form of sexual stimulation is needed for an erection to happen with CIALIS.Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition.What Should I Avoid While Taking CIALIS?Do not use other ED medicines or ED treatments while taking CIALIS.Do not drink too much alcohol when taking CIALIS (for example, 5 glasses of wine or 5 shots of whiskey).

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Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.Some form of sexual stimulation is needed for an erection to happen with CIALIS.CIALIS does not:cure EDincrease a man's sexual desireprotect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.serve as a male form of birth controlCIALIS is only for men over the age of 18 who have ED, including men with diabetes or who have undergone prostatectomyCIALIS is not for women or children.CIALIS must be used only under a healthcare provider's care.Who Should Not Take CIALIS?Do not take CIALIS if you:take any medicines called “nitrates”.use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About CIALIS?”)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. Before taking CIALIS, tell your healthcare provider about all your medical problems, including if you:are allergic to CIALIS or ADCIRCA any of its ingredients. 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?See “What Is The Most Important Information I Should Know About 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 side effects include: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.Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including CIALIS) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these.

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Your healthcare provider will prescribe the dose that is right for you.Some men can only take a low dose of CIALIS or may have to take it less often, because of medical conditions or medicines they take.Do not change your dose or the way you take CIALIS without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to CIALIS and your health condition.CIALIS may be taken with or without meals.If you take too much CIALIS, call your healthcare provider or emergency room right away.There are two ways to take CIALIS:CIALIS for use as needed:Do not take CIALIS more than one time each day.Take one CIALIS tablet before you expect to have sexual activity. You may be able to have sexual activity at 30 minutes after taking CIALIS and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take CIALIS before sexual activity. Some form of sexual stimulation is needed for an erection to happen with CIALIS.Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition.ORCIALIS for once daily use:Do not take CIALIS more than one time each day.Take one CIALIS tablet every day at about the same time of day. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including CIALIS, and call a healthcare provider right away.Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking CIALIS and contact a healthcare provider right away.These are not all the possible side effects of CIALIS.

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Especially tell your healthcare provider if you take any of the following:*medicines called nitrates (see “What Is The Most Important Information I Should Know About CIALIS?”)medicines called alpha blockers. Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If CIALIS is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.other medicines to treat high blood pressure (hypertension)medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)ketoconazole (Nizoral®)itraconazole (Sporanox®)erythromycinother medicines or treatments for ED.CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take Revatio® with CIALIS.How Should I Take CIALIS?Take CIALIS exactly as your healthcare provider prescribes it. For more information, ask your healthcare provider or pharmacist.How Should I Store CIALIS?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.General Information About CIALIS:Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use CIALIS for a condition for which it was not prescribed. Do not give CIALIS to other people, even if they have the same symptoms that you have. It may harm them.This is a summary of the most important information about CIALIS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIALIS that is written for health providers. *The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.Literature revised July 28, 2009 Read this important information before you start taking CIALIS and each time you get a refill.

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See the end of this leaflet for a complete list of ingredients in CIALIS.have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems.have low blood pressure or have high blood pressure that is not controlledhave had a strokehave liver problemshave kidney problems or require dialysishave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including a condition called NAIONhave stomach ulcershave a bleeding problemhave a deformed penis shape or Peyronie's diseasehave had an erection that lasted more than 4 hourshave blood cell problems such as sickle cell anemia, multiple myeloma, or leukemiaCan Other Medicines Affect CIALIS?Tell your healthcare provider 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 healthcare provider before starting or stopping any medicines. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist. What Is The Most Important Information I Should Know About CIALIS? CIALIS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. 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. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite. Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates. Tell all of your healthcare providers that you take CIALIS. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took CIALIS. 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 (see “Can Other Medicines Affect CIALIS?”). 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 your heart is already weak from a heart attack or heart disease.



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