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What is Cialis (tadalafil)?

Cialis (tadalafil) relaxes muscles and increases blood flow to particular areas of the body.
Cialis (tadalafil) is used to treat erectile dysfunction (impotence).
Cialis (tadalafil) may also be used for purposes other than those listed in this medication guide.

What should I discuss with my doctor before taking Cialis (tadalafil)?

Do not take Cialis (tadalafil) if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (“poppers”). Taking tadalafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

A small number of patients have had a sudden loss of eyesight after taking tadalafil. This type of vision loss is caused by decreased blood flow to the optic nerve of the eye. It is not clear whether tadalafil is the actual cause of such vision loss. Sudden vision loss with tadalafil use has occurred most often in people with heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

Before taking Cialis (tadalafil), tell your doctor if you have:
heart disease or heart rhythm problems;
a recent history of heart attack (within the past 90 days);
a recent history of stroke or congestive heart failure (within the past 6 months);
angina (chest pain);
high or low blood pressure;
liver disease;
kidney disease (or if you are on dialysis);
a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
a bleeding disorder such as hemophilia;
a stomach ulcer;
retinitis pigmentosa (an inherited condition of the eye);
a physical deformity of the penis (such as Peyronie’s disease); or
if you have been told you should not have sexual intercourse for health reasons.

If you have any of these conditions, you may not be able to use tadalafil or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B: Although tadalafil is not for use in women, this medication is not expected to be harmful to an unborn baby. Do not use tadalafil without telling your doctor if you are pregnant or plan to become pregnant during treatment.
Although Cialis (tadalafil) is not for use in women, it is not known if tadalafil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
You may need a lower dose of this medication if you are older than 65. Follow your doctor’s instructions.

How should I take Cialis (tadalafil)?

Take each dose with a full glass of water.
Avoid taking High-fat food before taking Viagra as it may cause the medicine to take more time to start working.
Tadalafil is usually taken only when needed, 30 – 60 minutes before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.
Do not take tadalafil more than once a day. Allow 24 hours to pass between doses.
Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a tadalafil overdose may include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

What should I avoid while taking tadalafil?

Avoid drinking alcohol, which can increase some of the side effects of tadalafil.
Grapefruit and grapefruit juice may interact with tadalafil. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Do not use any other drug to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), unless your doctor tells you to.

What are the possible side effects of tadalafil?

If you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw during sexual activity, stop and call your doctor right away. You could be having a serious side effect of tadalafil.
Stop using tadalafil and get emergency medical help if you have sudden vision loss.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tadalafil and call your doctor at once if you have any of these serious side effects:
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
irregular heartbeat;
swelling in your hands, ankles, or feet;
shortness of breath;
vision changes;
feeling light-headed, fainting; or
penis erection that is painful or lasts 4 hours or longer.
Continue taking tadalafil and talk with your doctor if you have any of these less serious side effects:
warmth or redness in your face, neck, or chest;
stuffy nose;
headache;
upset stomach; or
back pain.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What drug(s) may interact with Cialis (tadalafil)?

Do not take tadalafil if you are taking the following medications:
nitroglycerin-type drugs for the heart or chest pain such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, even if these are only taken occasionally

Cialis (tadalafil) may also interact with the following medications:
alpha blockers, such as alfuzosin (UroXatral), doxazosin (Cardura), prazosin (Minipress), or terazosin (Hytrin), used to treat high blood pressure or an enlarged prostate.
bosentan
certain antibiotics such as clarithromycin, erythromycin, troleandomycin
certain drugs used for seizures such as carbamazepine, phenytoin, and phenobarbital
cimetidine
cisapride
diltiazem
grapefruit juice
medicines for fungal infections (fluconazole, itraconazole, ketoconazole, voriconazole)
mibefradil
nicardipine
certain medicines for the treatment of HIV infection or AIDS
quinidine
rifabutin, rifampin or rifapentine
some drugs for treating depression, anxiety or other mood problems (examples: fluoxetine, fluvoxamine, nefazodone)
verapamil

Erectile Dysfunction

Cialis

Cialis is indicated for the treatment of erectile dysfunction. Cialis is a phosphodiesterase type 5 (PDE5) inhibitor. It works by helping to increase blood flow into the penis during sexual stimulation. This helps you to achieve and maintain an erection.

Use Cialis as directed by your doctor.

  • Take Cialis by mouth with or without food.
  • For use as needed: Take Cialis at least 30 minutes before sexual activity, as directed by your doctor. Cialis may work for up to 36 hours after you take it.
  • For daily use: Take Cialis regularly at about the same time each day.
  • Check with your doctor before you eat grapefruit or drink grapefruit juice while you are taking Cialis.
  • For use as needed: If you miss a dose of Cialis and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor. For daily use: If you miss a dose of Cialis, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
  • The recommended starting dose of Cialis for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
  • The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
  • Cialis for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of Cialis, this should be taken into consideration.

For Once Daily Use

  • The recommended starting dose of Cialis for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
  • The Cialis dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

Ask your health care provider any questions you may have about how to use Cialis.

Store Cialis at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cialis out of the reach of children and away from pets.

Active Ingredient: Tadalafil.

Inactive Ingredients: Croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

Do NOT use Cialis if:

  • you are allergic to any ingredient in Cialis
  • you have severe kidney problems and will be taking Cialis daily
  • you have severe liver problems or certain hereditary degenerative eye problems (eg, retinitis pigmentosa)
  • you have certain heart problems (eg, unstable angina, angina during sexual intercourse, uncontrolled irregular heartbeat), low blood pressure, or uncontrolled high blood pressure
  • you have had a heart attack within the past 90 days or you have had severe heart failure or a stroke within the past 6 months
  • you are taking a nitrate (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, patch, ointment), or nitroprusside
  • you have been advised by your doctor to avoid sexual activity because of heart problems
  • you use certain recreational drugs called “poppers” (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)
  • you take another PDE5 inhibitor (eg, sildenafil, vardenafil) or another medicine that contains tadalafil.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Cialis. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a deformed penis (eg, Peyronie disease, cavernosal fibrosis), blood cell problems (eg, sickle cell anemia, leukemia, multiple myeloma), or any other condition that may increase the risk of a prolonged erection (priapism)
  • if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
  • if you have a history of certain eye problems (eg, retinitis pigmentosa, sudden vision loss, optic neuropathy, macular degeneration) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
  • if you have a history of liver or kidney problems, dialysis, lung problems (eg, pulmonary veno-occlusive disease), high or low blood pressure, ulcers, bleeding problems, heart problems (eg, heart failure, irregular heartbeat, aortic stenosis, angina), or blood vessel problems
  • if you have a history of heart attack, stroke, or life-threatening irregular heartbeat.

Some medicines may interact with Cialis. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
  • Azole antifungals (eg, itraconazole), HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Cialis’s side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, phenytoin, or rifampin because they may decrease Cialis’s effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cialis may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • Cialis may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Cialis with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Cialis may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not drink large amounts of alcohol (eg, 5 drinks or more) while you take Cialis. Doing so may increase your risk of dizziness, headache, fast heartbeat, and low blood pressure.
  • Patients with heart problems who take Cialis may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion; vision or speech changes; one-sided weakness; or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
  • Cialis may rarely cause a prolonged (eg, more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
  • Cialis does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
  • Cialis will not prevent pregnancy. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
  • Cialis may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
  • Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Cialis. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
  • Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Cialis. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
  • Do not use other medicines or treatments for ED while you are taking Cialis without first checking with your doctor.
  • Use Cialis with caution in the elderly; they may be more sensitive to its effects.
  • Cialis is not recommended for use in children younger 18 years.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Dizziness; flushing; headache; heartburn; mild back or muscle pain; stomach upset; stuffy or runny nose.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; memory loss; numbness of an arm or leg; one-sided weakness; prolonged, painful erection; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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