National Geographic : 2005 May
Patient Information CIALIS®(See-AL-iss) (tadalafil) tablets Read the Patient Information about CIALISbefore 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 CIALISwhen you start taking it and at regular checkups. Ifyou do not understand the information, or have questions, talk with your doctor or pharmacist. What important information should you know about CIALIS? CIALIScan 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 CIALISif you: * take any medicines called "nitrates." * use recreational drugs called "poppers" like amyl nitrate and butyl nitrate. * take medicines called alpha blockers, other than Flomax ® (tamsulosin HCI) 0.4 mg daily. (See "Who should not take CIALIS?") Tell all 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 CIALISremains 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 medications affect CIALIS?"). 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 ifthe condition bothers him. CIALISmay help a man with EDget and keep an erection when he is sexually excited. CIALISdoes 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 CIALISis only for men with ED.CIALISis not for women or children. CIALISmust be used only under a doctor's care. Howdoes CIALISwork? 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. CIALIShelps increase blood flow to the penis and may help men with EDget 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. Whocan take CIALIS? Talk to your doctor to decide if CIALISis right for you. CIALIShas 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. Whoshould not take CIALIS? Do not take CIALISifyou: *take any medicines called "nitrates" (See "What important information should you know about CIALIS?"). Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain inyour 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 CIALISif 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® 0.4 mg daily. Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. IfCIALISis taken with alpha blockers other than Flomax® 0.4 mg daily, your blood pressure could suddenly drop to an unsafe level.You could get dizzyand faint. *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 ifyour heart is already weak from a heart attack or heart disease. *are allergic to CIALISor any of its ingredients. The active ingredient in CIALIS is called tadalafil. See the end of this leaflet for a complete list of ingredients. 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 bleeding problem * 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 Can other medications affect CIALIS? Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. CIALISand 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 important information should you know about CIALIS?") * medicines called alphablockers. Theseinclude Hytrin® (terazosin HCI),Flomax® (tamsulosin HCI),Cardura®(doxazosin mesylate),Minipress® (prazosin HCI) or Uroxatral® (alfuzosin HCI). * ritonavir (Norvir®) or indinavir (Crixivan®) * ketoconazoleor itraconazole (suchas Nizoral® or Sporanox®) * erythromycin * other medicines or treatments for ED Howshould you take CIALIS? Take CIALISexactly as your doctor prescribes. CIALIScomes in different doses (5 mg, 10 mg, and 20 mg). For most men, the recommended starting dose is 10 mg. CIALISshould be taken no more than once a day. Some men can only take a low dose of CIALISbecause of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you. * Ifyou 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 CIALISto 10 mg and may also limit you to one tablet in 48 hours (2 days) or one tablet in 72 hours (3 days). Take one CIALIStablet before sexual activity. In some patients, the ability to have sexual activity was improved at 30 minutes after taking CIALISwhen compared to a sugar pill. The ability to have sexual activity was improved up to 36 hours after taking CIALISwhen compared to a sugar pill. You and your doctor should consider this in deciding when you should take CIALISprior to sexual activity. Some form of sexual stimulation is needed for an erection to happen with CIALIS.CIALISmay be taken with or without meals. Do not change your dose of CIALISwithout 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. Ifyou take too much CIALIS,call your doctor or emergency room right away. What are the possible side effects of CIALIS? The most common side effects with CIALISare 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. Callyour doctor if you get a side effect that bothers you or one that willnot go away. CIALISmay 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. Howshould CIALISbe stored? * Store CIALISat room temperature between 59° and 86°F (15° and 30°C). * Keep CIALISand 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 CIALISfor a condition for which it was not prescribed. Do not give CIALISto other people, even if they have the same symptoms that you have. It may harm them. This leaflet summarizes the most important information about CIALIS.If you would likemore information, talk with your healthcare provider. You can ask your doctor or pharmacist for information about CIALISthat is written for health professionals. For more information you can also visit www.cialis.com, or call 1-877 -CIALIS1 (1-877 -242 -5471). What are the ingredients of CIALIS? Active Ingredient: tadalafil Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin. Rxonly Norvir® (ritonavir) and Hytrin® (terazosin HCI)are registered trademarks of Abbott Laboratories Crixivan ® (indinavir sulfate) is a registered trademark of Merck & Co., Inc. Nizoral® (ketoconazole) and Sporanox® (itraconazole) are registered trademarks of Janssen Pharmaceutica, Inc. Flomax® (tamsulosin HCI) is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc. Cardura® (doxazosin mesylate) and Minipress® (prazosin HCI)are registered trademarks of Pfizer, Inc. Uroxatral® (alfuzosin HCI)is a registered trademark of Sanofi-Synthelabo Literature revised November 24, 2003 PV4601AMP PRINTEDINUSA Manufactured for LillyICOS LLC by Eli Lillyand Company Indianapolis, IN46285, USA www.cialis.com Copyright © 2003, LillyICOSLLC.Allrights reserved.