Cialis®
Brand Name: Cialis
Active Ingredient:   Tadalafil 
Strength(s): 5 mg, 10mg, and 20 mg           
Dosage Form(s):   Tablets
Company Name:    Lilly ICOS LLC
Availability:         Prescription only
*Date Approved by the FDA:   November 21, 2003
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Cialis used for?

Cialis is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.  ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. Cialis may help a man with ED get and keep an erection when he is sexually excited.

Cialis does not:

  • cure ED
  • increase a man’s sexual desire
  • protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your doctor about ways to guard against sexually transmitted diseases.
  • serve as a male form of birth control.

 

Cialis is only for men with ED.  Cialis is not for women or children. Cialis must be used only under a doctor’s care.

 

Who should not use Cialis?

Special Warnings with Cialis:

Cialis can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines such as nitrates and alpha-blockers, and recreational drugs that contain nitrates called "poppers".  A sudden drop in your blood pressure could cause you to become dizzy, faint, or have a heart attack or stroke.

 

Tell all your healthcare providers that you take Cialis.  If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Cialis.

 

Who should not take Cialis?

Do not take Cialis if you:

  • take any medicines called “nitrates”
  • use recreational drugs called "poppers like amyl nitrate and butyl nitrate
  • take medicines called “alpha blockers”, other than Flomax® 0.4 mg daily
  • have been told by your healthcare provider to not have sexual activity because of health problems
  • are allergic to Cialis or any of its ingredients

 

What should I tell my health care provider?

Tell your health care provider if you:

  • have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack
  • have low blood pressure or have high blood pressure that is not controlled
  • have had a stroke
  • have liver problems
  • have kidney problems or require dialysis 
  • have retinitis pigmentosa, a rare genetic (runs in families) eye disease
  • have stomach ulcers
  • have a bleeding problem
  • have a deformed penis shape or Peyronie’s disease
  • have had an erection that lasted more than 4 hours
  • have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

 

Tell your doctor about all the medicines you take including prescription and non-prescription

medicines, vitamins, and herbal supplements. Cialis and other medicines may affect each other.

Especially tell your doctor if you take any of the following:

  • medicines called nitrates
  • medicines called alpha blockers. These include Hytrin® (terazosin), Flomax® (tamsulosin), Cardura® (doxazosin), Minipress® (prazosin) or Uroxatral (alfuzosin).
  • ritonavir (Norvir®) or indinavir (Crixivan®)
  • ketoconazole or itraconazole (such as Nizoral® or Sporanox®)
  • erythromycin
  • other medicines or treatments for ED

 What are some possible side effects of Cialis? (This list is NOT a complete list of side effects reported with Cialis.  Your health care provider can discuss with you a more complete list of side effects.) 

 The most common side effects with Cialis are:

  • headache
  • indigestion
  • back pain
  • muscle aches
  • flushing
  • stuffy or runny nose

These side effects usually go away after a few hours. Patients 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 by themselves within 48 hours.

 Cialis may uncommonly cause:

  • an erection that won’t go away (priapism)
  • vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green

 For more detailed information about Cialis, ask your health care provider or pharmacist.

 

Link to Cialis's Approved Labeling and Patient Information

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Posted:  2/3/2004