The Authorized Generic of Cialis®

INDICATIONS: TADALAFIL TABLETS are approved to treat erectile dysfunction (ED 2.5 mg, 5 mg, 10 mg, 20 mg), the signs and symptoms of benign prostatic hyperplasia (BPH 5 mg), and both ED and the signs and symptoms of BPH (5 mg). Taking TADALAFIL TABLETS with finasteride when starting BPH treatment has been studied for 26 weeks. TADALAFIL TABLETS are not for women or children.

IMPORTANT SAFETY INFORMATION FOR TADALAFIL TABLETS

What Is The Most Important Information I Should Know About TADALAFIL TABLETS?

Do not take TADALAFIL TABLETS if you:

• take medicines called "nitrates" such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure; or use recreational drugs called "poppers" like amyl nitrite and butyl nitrite.
• take medicines called guanylate cyclase stimulators such as riociguat (Adempas®)*, a medicine used to treat pulmonary hypertension as the combination may cause an unsafe drop in blood pressure.
• are allergic to TADALAFIL TABLETS 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 TADALAFIL TABLETS 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 it is already weak from a heart attack or heart disease.

What Should I Tell My Healthcare Provider Before Taking TADALAFIL TABLETS?

TADALAFIL TABLETS are not right for everyone. Only your healthcare provider and you can decide if TADALAFIL TABLETS are right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. Do not take TADALAFIL TABLETS if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking TADALAFIL TABLETS, 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 heart attack
• pulmonary hypertension
• low blood pressure or 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 TADALAFIL TABLETS?

Tell your healthcare provider about all the medicines you take, especially:

• medicines called “nitrates” which are often prescribed for chest pain
• medicines called guanylate cyclase stimulators, such as riociguat (Adempas^®)*, used to treat pulmonary arterial hypertension and chronic-thromboembolic hypertension
• 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)
• tadalafil is also marketed as ADCIRCA* for the treatment of pulmonary arterial hypertension. Do not take both TADALAFIL TABLETS and ADCIRCA*. Do not take sildenafil citrate (Revatio^®)* with TADALAFIL TABLETS.

How Should I Take TADALAFIL TABLETS?

• TADALAFIL TABLETS should not be taken more than one time each day. If you miss a dose, you may take it when you remember but do not take more than one dose per day. Take TADALAFIL TABLETS exactly as your healthcare provider prescribes it.

What Should I Avoid While Taking TADALAFIL TABLETS?

• Do not use other ED medicines or ED treatments.
• Do not drink too much alcohol (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 TADALAFIL TABLETS?

The most common side effects with TADALAFIL TABLETS 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 TADALAFIL TABLETS. 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 TADALAFIL TABLETS, reported the following:
  • a sudden decrease or loss of vision. It is uncertain whether PDE5 inhibitors directly cause the vision loss.
  • a sudden decrease or loss of 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 TADALAFIL TABLETS 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.

TADALAFIL TABLETS do not:

Cure ED, increase a man’s sexual desire, protect a man or his partner from sexually transmitted diseases, including HIV or serve as a male form of birth control.

TADALAFIL TABLETS are available by prescription only.

* The brands listed are trademarks of their respective owners and are not trademarks of Prasco, LLC. The makers of these brands are not affiliated with and do not endorse Prasco, LLC or its products.

PR ISI 12NOV2018

For more information please see the full Prescribing Information and Patient Information.