21

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

 

Information for Partners

Is your partner experiencing erectile dysfunction (ED)?
You may be thinking, "It's me." But what you should know is that ED is a real, treatable medical condition that's often caused by another health problem, such as diabetes or heart disease, or by certain medicines. And when the issue goes beyond occasional problems with getting or maintaining an erection, it may be time to act.

There are several ways you can be involved and help your partner get started with treatment:

  • Learn everything you can about ED and the available treatment options, and share that information with your partner. Once both of you have all the facts, your partner can work with his doctor to make a better-informed decision about what to do next.
  • Talk with your partner about what's going on and encourage him to see his doctor to learn if he has ED and how treatment can help. Offer to make the appointment for him or to go see his doctor with him. ED is a condition that is treatable, but may not go away on its own.
  • Learn about the two CIALIS dosing options—Find out how CIALIS for daily use and 36-hour CIALIS differ, so that you and your partner can better decide which option may be right for him. And be sure to also read all of the Important Safety Information about both CIALIS options.
  • Offer to make a list of all prescription and nonprescription medicines, vitamins, and herbal supplements that your partner is taking, as complications may result when used in combination with certain drugs, including both CIALIS dosing options. Specifically, your partner should let the doctor know if he takes any of the following*:
    • Medicines called nitrates. Nitrates are commonly used to treat chest pain, which is a symptom of heart disease. Your partner should not take CIALIS if he takes nitrates, because the combination can cause a sudden, unsafe drop in blood pressure.
    • 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 partner's blood pressure could suddenly drop, causing him to get dizzy or faint. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), or Uroxatral® (alfuzosin HCl).
    • Other medicines used to treat high blood pressure
    • Medicines called HIV protease inhibitors, such as ritonavir (Norvir®) or lopinavir/ritonavir (Kaletra®)
    • Ketoconazole (Nizoral®)
    • Itraconazole (Sporanox®)
    • Erythromycin
    • Other medicines or treatments for ED
    • CIALIS is also marketed as ADCIRCA® (tadalafil) for the treatment of pulmonary arterial hypertension. Your partner should not take both CIALIS and ADCIRCA, nor should he take sildenafil citrate (Revatio®) with CIALIS.
  • Talk with your partner about expectations so both of you can be on the same page.

There are also things you can do to help your partner after he begins treatment:

  • Make sure your partner takes CIALIS as directed by his doctor
    • CIALIS for daily use should be taken at around the same time every day.
    • 36-hour CIALIS should be taken at least 30 minutes before sexual activity. Everyone is different. Your partner may need to take CIALIS an hour before sexual activity.
    • If an ED tablet doesn't work, it may be because a man is not taking it correctly.
  • Encourage your partner to be patient and give CIALIS some time to work
    • Your partner may need to take CIALIS more than once before he sees results. If he takes CIALIS a few times and still isn't satisfied with the results, he should talk with his doctor, as his dose may need to be adjusted. Your partner should not take more than one tablet of CIALIS per day.
    • If your partner is taking CIALIS for daily use, it could take up to 4 to 5 days (one dose each day) or longer before it starts to work for him. Your partner should not take more than one CIALIS for daily use tablet per day.
    • CIALIS will not cause your partner to have an erection unless he is sexually stimulated.
    • After continued use of CIALIS for daily use or 36-hour CIALIS, ask your partner to talk to his doctor if he's not getting the results he was expecting.

Understand what CIALIS can and can't do.

CIALIS for daily use and 36-hour CIALIS will not protect you or your partner against sexually transmitted diseases, including HIV, or serve as a male form of birth control. However, both CIALIS dosing options, when taken as directed by a doctor, can help with erections. In clinical trials, they improved men's:

  • Satisfaction with the hardness of erections
  • Satisfaction with sexual intercourse

It's important to remember that CIALIS can only help your partner get an erection sufficient for sexual activity when he is sexually stimulated. CIALIS should not give him a spontaneous erection. Also keep in mind that CIALIS may not work right away, so you and your partner may need to attempt sexual intercourse more than once before achieving success.

*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.

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