Adcirca

Generic Name: tadalafil (ta DAL a fil)
Brand Names: Adcirca, Cialis

What is Adcirca?

Adcirca is a prescription medicine used to treat pulmonary arterial hypertension (PAH, high blood pressure in your lungs) to improve your ability to exercise.

It is not known if Adcirca is safe or effective in children.

Read this patient information before you start taking Adcirca and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information about Adcirca

Never take Adcirca with any nitrate medicines:

• Your blood pressure could drop quickly to an unsafe level
• You could get dizzy, faint and even have a heart attack or stroke.

Nitrates include:

• Medicines that treat chest pain (angina)
• Nitroglycerin in any form including tablets, patches, sprays, and ointments
• Other nitrate medicines (isosorbide mononitrate or dinitrate)
• Street drugs that are inhaled, called "poppers" (amyl nitrate, butyl nitrate or nitrite)

Ask your healthcare provider or pharmacist if you are not sure if you take a nitrate medicine.

Who should not take Adcirca?

Do not take Adcirca if you

• take any medicines called nitrates.
• use recreational drugs called "poppers" like amyl nitrate, butyl nitrate or nitrite.
• are allergic to tadalafil or any other ingredient in Adcirca. See "What are the ingredients in Adcirca?" at the end of this leaflet.

Before taking Adcirca

Before taking Adcirca, tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to Adcirca or Cialis or any of its ingredients. See the end of this leaflet for a complete list of ingredients in Adcirca.
• have pulmonary veno-occlusive disease (PVOD)
• have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack
• have low blood pressure or high blood pressure that is not controlled
• have liver problems
• have kidney problems or get dialysis
• have stomach ulcers
• have retinitis pigmentosa, a rare genetic eye disease
• have ever had any sudden vision loss, including any damage to your optic nerve or NAION.
• have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing
• 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
• a recent history (in the past 6 months) of a stroke, or congestive heart failure;
• are pregnant or planning to become pregnant. It is not known if Adcirca will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breast feed. It is not known if Adcirca passes into your breast milk. You and your healthcare provider should decide if you will take Adcirca or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Adcirca and other medicines may affect each other.

Especially tell your healthcare provider if you take any of these medicines:

• nitrates (See "What is the most important information I should know about Adcirca?")
• anti-hypertensives, used to treat high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint.
• alpha blockers, used to treat prostate disease and high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint.
• protease inhibitors, used to treat HIV infection, such as ritonavir (Norvir, Kaletra)
• ketoconazole (Extina, Xolegal, Ketozole, Nizoral A-D, Nizoral) itraconazole (Sporanox)
• erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine)
• rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• bosentan (Tracleer)
• phenobarbital, phenytoin (Dilantin), carbamazepine (Tegretol)
• Cialis or other medicines or treatments for erectile dysfunction (impotence). Adcirca is also marketed as Cialis for the treatment of male erectile dysfunction (impotence). Do not take both Adcirca and Cialis. Do not take Adcirca and other medicines or treatments for erectile dysfunction.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Adcirca?

• Take Adcirca exactly as your healthcare provider tells you.
• Take Adcirca tablets at the same time every day. You should take both tablets at the same time, one after the other, every day. Do not split your dose.
• Adcirca can be taken with or without food.
• Do not change your dose or stop taking Adcirca without speaking to your healthcare provider.
• If you take too much Adcirca, call your healthcare provider or go to an emergency department right away.

See also: Adcirca dosage (in more detail)

What should I avoid while taking Adcirca?

Do not have more than 4 alcohol-containing drinks in a short period of time while you take Adcirca. Drinking too much alcohol can lower your blood pressure. You could get dizzy or faint.

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

See also: Adcirca and alcohol (in more detail)

Adcirca side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Adcirca: 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 tadalafil. Stop using Adcirca 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 Adcirca 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: Adcirca side effects (in more detail)

What other drugs will affect Adcirca?

Before taking Adcirca, 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); or

• 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 Adcirca. 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.

How Should I Store Adcirca?

Store Adcirca at room temperature between 59° and 86°F (15° and 30°C).

Keep Adcirca and all medicines out of the reach of children.

General Information about the safe and effective use of Adcirca

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Adcirca for a condition for which it was not prescribed. Do not give Adcirca to other people, even if they have the same symptoms you have. It may harm them. This patient information leaflet summarizes the most important information about Adcirca. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Adcirca that is written for healthcare professionals.

What Are The Ingredients In Adcirca?

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.

Where can I get more information?

• Your pharmacist can provide more information about Adcirca.