Patient Education - English

• Generic Name: tadalafil

• Pronounced: ta DAL a fil

• Brand Names: Adcirca, Cialis

What is the most important information I should know about tadalafil?

Do not take tadalafil if you are allergic to it, or 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 can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

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.

Do not take tadalafil more than once a day. Allow 24 hours to pass between doses.

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.

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.

What is tadalafil?

Tadalafil relaxes muscles and increases blood flow to particular areas of the body.

Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) in men. Another brand of sildenafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Tadalafil may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking tadalafil?

Do not take tadalafil if you are allergic to it, or 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 can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

If you have any of these other conditions, you may need a tadalafil dose adjustment or special tests:

• heart disease or heart rhythm problems;
• a recent heart attack (within the past 90 days);
• a recent history (within the past 6 months) of stroke or congestive heart failure;
• 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. Tadalafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether 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.

How should I take tadalafil?

Take 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.

Tadalafil can be taken with or without food.

Cialis is usually taken only when needed, just before sexual activity. However, Cialis may also be taken daily (at a lower dose), regardless of when sexual activity is planned. Follow your doctor's instructions.

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.

Adcirca is usually taken once per day. Follow your doctor's instructions. Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Do not take tadalafil 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 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.

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

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

What should I avoid while taking tadalafil?

Drinking alcohol can increase certain 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 erectile dysfunction, such as sildenafil (Viagra) or vardenafil (Levitra) while you are taking tadalafil.

What are the possible side effects of tadalafil?

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:

• 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, ankles, or feet;
• seizure (convulsions);
• feeling light-headed, fainting; or
• penis erection that is painful or lasts 4 hours or longer.

Less serious 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.

What other drugs will affect tadalafil?

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:

• rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), or rifapentine (Priftin);
• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
• an antifungal medicine such as itraconazole (Sporanox), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Xolegal, Ketozole, Nizoral), 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 medications such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan);
• HIV or AIDS medications such as darunavir (Prezista), efavirenz (Sustiva), etravirine (Intelence), lopinavir and ritonavir (Kaletra), nevirapine (Viramune), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir), and others; or
• seizure medications such as carbamazepine (Tegretol), phenytoin (Dilantin), and others.

This list is not complete and other drugs may interact with tadalafil. 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.

Where can I get more information?

Your pharmacist can provide more information about tadalafil.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.