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Drug Name


Important Safety Information for ######® (tadalafil) tablets
What Is The Most Important Information I Should Know About ######?

Do not take ###### 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 ##### called “poppers” like amyl nitrite and butyl nitrite
are allergic to ###### 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 ###### 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 ###. 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 ######?

###### is not right for everyone. Only your healthcare provider and you can decide if ###### is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. You should not take ###### if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking ######, 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 ######?

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)
###### is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take both ###### and ADCIRCA. Do not take sildenafil citrate (Revatio®) with ######.

What Should I Avoid While Taking ######?

Do not use other ED medicines or ED treatments while taking ######.
Do not drink too much alcohol when taking ###### (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 ######?

The most common side effects with ###### are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. ### who get back pain and muscle aches usually get it 12 to 24 hours after taking ######. 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, ### taking prescription ED tablets, including ######, 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 ###### and call a healthcare provider right away. 



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