Tadalafil Treatment Report

Precautions

Instructions

Side Effects

Interactions

Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket), or 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.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking tadalafil, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease or heart rhythm problems;
• a recent history a 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.

Tadalafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking tadalafil, most of whom also had 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.

It is not clear whether tadalafil is the actual cause of vision loss. Stop using tadalafil and get emergency medical help if you have sudden vision loss.

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 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.

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.

Avoid using other medicines to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), without first talking to your doctor.

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Since tadalafil 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. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

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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.

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 tadalafil and call your doctor at once if you have any of these serious side effects:

• 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;
• swelling in your hands, ankles, or feet;
• shortness of breath;
• seizure (convulsions);
• vision changes;
• feeling light-headed, fainting; or
• penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

• warmth or redness in your face, neck, or chest;
• stuffy nose, 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.

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Before taking tadalafil, tell your doctor about all other medications you use for erectile dysfunction, or if you are using any of the following medications:

• conivaptan (Vaprisol);
• diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
• doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin);
• imatinib (Gleevec);
• isoniazid (for treating tuberculosis);
• rifampin (Rifadin, Rimactane);
• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
• an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
• an antidepressant such as nefazodone;
• heart or blood pressure medications;
• HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir), and others; or
• seizure medication such as carbamazepine (Tegretol), phenobarbital (Luminal), or phenytoin (Dilantin).

This list is not complete and there may be other drugs that can interact with tadalafil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Cialis, tadalafil, and Adcirca

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