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CIALIS

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" 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 or hives.

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, heart failure, irregular heartbeats, or have had a heart attack
  • high or low blood pressure
  • stroke
  • liver or kidney problems
  • severe vision loss, including a condition called NAION
  • retinitis pigmentosa, a rare genetic (runs in families) eye disease
  • 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, 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 not for women or children.
CIALIS must be used only under a healthcare provider's care.

CIALIS is available by prescription only. For additional information, talk to your healthcare provider and see full Patient and Prescribing Information.

How should I take Cialis?

Take Cialis exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Cialis can be taken with or without food. Do not break or split a Cialis tablet. Swallow it whole.

Cialis is usually taken only once per day. Follow your doctor's instructions. For erectile dysfunction, take the medicine just before sexual activity but not more than once per day.

Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Do not take Cialis more than once a day. Allow 24 hours to pass between doses. If you take the medication daily, take it at the same time each day. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Store Cialis at room temperature away from moisture and heat.

See also: Cialis dosage (in more detail)

What happens if I miss a dose?

Since Cialis is used as needed, you are not likely to be on a dosing schedule.

If you take tadalafil every day and you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

What should I avoid while taking Cialis?

Drinking alcohol can increase certain side effects of Cialis.

Grapefruit and grapefruit juice may interact with Cialis and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Avoid using other medicines to treat erectile dysfunction, such as sildenafil (Viagra) or vardenafil (Levitra) while you are taking Cialis.

Cialis side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Cialis: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of Cialis. Stop using this medicine and call your doctor at once if you have any of these serious side effects:

  • changes in vision or sudden vision loss;

  • ringing in your ears, or sudden hearing loss;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • irregular heartbeat;

  • shortness of breath, swelling in your hands or feet;

  • seizure (convulsions);

  • feeling light-headed, fainting; or

  • penis erection that is painful or lasts 4 hours or longer.

Less serious Cialis side effects may include:

  • redness or warmth in your face, neck, or chest;

  • cold symptoms such as stuffy nose, sneezing, or sore throat;

  • headache;

  • memory problems;

  • diarrhea, upset stomach; or

  • muscle pain, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Cialis (in more detail)

Cialis Dosing Information

Usual Adult Dose of Cialis for Erectile Dysfunction:

10 mg orally taken prior to anticipated sexual activity. The maximum recommended dosing frequency is once per day in most patients.
Alternatively, 2.5 mg orally once daily, without regard to timing of sexual activity. May increase to 5 mg orally once daily based on efficacy and tolerability.

What other drugs will affect Cialis?

Before taking Cialis, tell your doctor about all other medicines you use, especially:

  • rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, Rifater, Rifamate), or rifapentine (Priftin);

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

  • an antidepressant such as nefazodone;

  • a barbiturate such as phenobarbital (Solfoton);

  • drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

  • heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin, Verelan);

  • HIV or AIDS medications such as darunavir (Prezista), efavirenz (Sustiva), etravirine (Intelence), nevirapine (Viramune), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir, Kaletra), and others; or

  • seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.

This list is not complete and other drugs may interact with Cialis. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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