14 CLINICAL STUDIES

Especially tell your healthcare provider

if you take any of the

following:* medicines called nitrates (see

• Cialis 5 mg can be prescribed for both erectile dysfunction and BPH.
• It is important to follow the dosage instructions precisely.
• The medication does not cause an erection on its own.
• Use caution when driving, as side effects may impair alertness.
• Patients should discuss all health conditions before starting treatment.
• Cialis 5 mg is not a cure but helps manage symptoms.

“What Is The Most Important Information

• Not a cure for erectile dysfunction.
• Does not increase sexual desire or libido.
• Requires sexual stimulation to work.
• Works only in the presence of nitric oxide.
• Does not cause erections without stimulation.

I Should Know About CIALIS?”)

These include Hytrin® (terazosin HCl), Flomax®

Drug Label Information

See also “What Are The Possible Side Effects Of 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 fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. 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. protect a man or his partner from sexually transmitted diseases, including HIV.

Use in children

Speak to your healthcare provider about ways to guard against sexually transmitted diseases. serve as a male form of birth control CIALIS is only for men over the age of 18 who have ED, including men with diabetes or who have undergone prostatectomy CIALIS is not for women or children. CIALIS must be used only under a healthcare provider's care. 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?

Getting rid of any unwanted medicine

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. 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. 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 controlled have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including a condition called NAION 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 Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress®

(prazosin HCl) or Uroxatral® (alfuzosin HCl).

5.1 Cardiovascular

Always check with your healthcare provider before starting or stopping any medicines. 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.

Alternatives for erectile dysfunction (ED)

Do not take Revatio® with CIALIS.How Should I Take CIALIS?Take CIALIS exactly as your healthcare provider prescribes it. 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.

Do not use CIALIS if:

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. 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). 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.