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Important Safety Information Prescribing Information Patient Information

Select Important Safety Information

Do not take CIALIS if you:

  • take medicine called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain, or use recreational drugs called "poppers" like amyl or butyl nitrite, 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. It 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.

Click here for more complete safety information for CIALIS

 

What Can Cause ED?

There are many things that can contribute to erectile dysfunction (ED)—from physical issues, like another health condition, to possible side effects of medicines that you're taking. Even emotional or personal issues can play a role. But for most men, ED can be treated, whether the cause is physical or psychological.

Possible physical conditions and other factors that can lead to ED include:

  • High blood pressure (also called hypertension)
    High blood pressure can damage blood vessels throughout the body, including those in the penis.
  • Diabetes (high blood sugar)
    Diabetes can increase the chances of having ED. Over time, high blood sugar can damage blood vessels and nerves in the penis.
  • High blood cholesterol
    Over time, high blood cholesterol can cause blood vessels throughout the body, including those in the penis, to narrow. If this happens, then not enough blood flows into the penis for a firm erection.
  • Nerve diseases
    Diseases that affect the nerves, such as Parkinson's disease and multiple sclerosis, can increase the chances of having ED. The penis may not receive nerve messages from the brain or spinal cord. And without the nerve messages, blood may not flow into the penis.
  • Surgery or injury (especially prostate, bladder, or rectal surgery)
    Surgery or injuries to the pelvic area can damage nerves or blood vessels leading to the penis.
  • Low hormone levels
    Low levels of male hormone (testosterone) may affect a man's ability to get an erection. ED can also happen when a man's thyroid hormone level is too high or too low.
  • Lifestyle factors
    Smoking, being overweight, drinking too much alcohol, not being physically active, or using recreational drugs can cause ED.
  • Side effect of medication
    ED can be a side effect of some medicines, including those that treat high blood pressure and antihistamines (like medicines that treat allergies). If you take one of these medicines and think it may be causing ED, don't stop taking it without first talking with your doctor.
  • Emotional or personal issues
    Less often, ED may be caused by emotional or personal issues—from ongoing stress or relationship problems to depression or anxiety about sexual performance.

If you think you have any of these conditions, be sure to talk to your doctor. Whatever the cause of your ED, only your doctor can determine if treatment is right for you.

ED can be an early warning sign of a serious health problem—heart disease, high blood pressure, or diabetes. Be sure to tell your doctor if you think you might have ED.

CIALIS is indicated for the treatment of men with erectile dysfunction (ED), men with the signs and symptoms of benign prostatic hyperplasia (BPH), and men with both ED and the signs and symptoms of BPH.

Important Safety Information for CIALIS® (tadalafil) tablets

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

Do not take CIALIS if you:

  • take medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure
  • use recreational drugs called "poppers" like amyl nitrite and butyl nitrite
  • 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 your heart 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. You should 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 have had a heart attack
  • high or low blood pressure or have high blood pressure that is not controlled
  • stroke
  • liver or kidney problems or require dialysis
  • retinitis pigmentosa, a rare genetic (runs in families) eye disease
  • severe vision loss, including a condition called NAION
  • stomach ulcers or a bleeding problem
  • a deformed penis shape or Peyronie's disease
  • an erection that lasted more than 4 hours
  • blood 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 if you take:

  • medicines called "nitrates" which are often prescribed for chest pain
  • 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.

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?

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
  • serve as a male form of birth control

CIALIS is available by prescription only. For additional information, talk to your healthcare provider and see full Patient and Prescribing Information.

TD Con-F ISI 16DEC2011