Generic Name: tadalafil (ta-DAL-a-fil)
Brand Name: Adcirca

Adcirca is used for:

Treating high blood pressure in the lungs (pulmonary arterial hypertension [PAH]. It may also be used for other conditions as determined by your doctor.

Adcirca is a phosphodiesterase type 5 (PDE5) inhibitor. It works by relaxing and dilating the vessels in the lungs. This lowers the blood pressure in the lungs and helps to improve your ability to exercise.

Do NOT use Adcirca if:

  • you are allergic to any ingredient in Adcirca
  • you have severe kidney or liver problems, certain hereditary eye problems (eg, retinitis pigmentosa), or if you are on dialysis
  • you have pulmonary veno-occlusive disease (PVOD)
  • you take a nitrate (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, patch, spray, ointment), or nitroprusside
  • you take another medicine that contains tadalafil, another PDE5 inhibitor (eg, sildenafil, vardenafil), an azole antifungal (eg, itraconazole, ketoconazole), or rifampin
  • you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Adcirca:

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

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • 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 history of a prolonged (more than 4 hours) or painful erection (priapism)
  • if you have a deformed penis (eg, Peyronie disease, cavernosal fibrosis), certain blood cell problems (eg, sickle cell anemia, leukemia, multiple myeloma), or other conditions that may increase the risk of a prolonged or painful erection (priapism)
  • if you have low blood pressure, uncontrolled high blood pressure, blood vessel problems, angina (chest pain), heart problems (eg, heart valve disease, congestive heart failure, irregular heartbeat) or a history of these conditions
  • if you have a history of heart attack, stroke, life-threatening irregular heartbeat, liver or kidney problems, dialysis, ulcers, or bleeding problems
  • if you have a history of eye or vision problems (eg, decreased vision or vision loss, optic nerve problems, retina problems) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
  • if you take medicine for erectile dysfunction (ED)

Some MEDICINES MAY INTERACT with Adcirca. 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, or nitrates (eg, isosorbide, nitroglycerin) because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
  • Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Adcirca's side effects
  • Barbiturates (eg, phenobarbital), bosentan, carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Adcirca's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Adcirca 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.

How to use Adcirca:

Use Adcirca as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Adcirca. Talk to your pharmacist if you have questions about this information.
  • Take Adcirca by mouth with or without food.
  • Adcirca works best if it is taken at the same time each day.
  • Check with your doctor before you eat grapefruit or drink grapefruit juice while you are taking Adcirca.
  • If you miss a dose of Adcirca, 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.

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

Important safety information:

  • Adcirca may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Adcirca with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Adcirca 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, 4 or 5 drinks or more) while you take Adcirca. Doing so may increase your risk of dizziness, headache, fast heartbeat, and low blood pressure.
  • Patients with heart problems who take Adcirca 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.
  • Adcirca may rarely cause a prolonged (eg, longer 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.
  • Adcirca 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 Adcirca. 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 Adcirca. 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 medicines or treatments for ED while you are taking Adcirca without first checking with your doctor.
  • Use Adcirca with caution in the ELDERLY; they may be more sensitive to its effects.
  • Use Adcirca with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Adcirca while you are pregnant. It is not known if Adcirca is found in breast milk. If you are or will be breast-feeding while you use Adcirca, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Adcirca:

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:

Flushing; headache; heartburn; mild pain in the arms, legs, or back; muscle pain; nausea; stomach upset; stuffy 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; confusion; fainting; fast or irregular heartbeat; memory loss; numbness in 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; shortness of breath or wheezing; slurred speech; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes; sudden, severe headache or vomiting.

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. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; prolonged erection; severe dizziness; severe or persistent back or muscle pain; severe or persistent vision changes.

Proper storage of Adcirca:

Store Adcirca 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 Adcirca out of the reach of children and away from pets.

General information:

  • If you have any questions about Adcirca, please talk with your doctor, pharmacist, or other health care provider.
  • Adcirca is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Adcirca or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Adcirca. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Adcirca. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Adcirca.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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