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
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